chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Malaise, Nasal congestion, Pain
Clinical narrative: felt under the weather like they really needed to stay in bed; not hungry; At about 1:00 AM that evening until later the next day had stuffed noses; very fatigued; little soreness following the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little soreness following the injection), MALAISE (felt under the weather like they really needed to stay in bed), DECREASED APPETITE (not hungry), NASAL CONGESTION (At about 1:00 AM that evening until later the next day had stuffed noses) and FATIGUE (very fatigued) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (little soreness following the injection). On 04-Mar-2021, the patient experienced MALAISE (felt under the weather like they really needed to stay in bed), DECREASED APPETITE (not hungry), NASAL CONGESTION (At about 1:00 AM that evening until later the next day had stuffed noses) and FATIGUE (very fatigued). On 06-Mar-2021, MALAISE (felt under the weather like they really needed to stay in bed), DECREASED APPETITE (not hungry), NASAL CONGESTION (At about 1:00 AM that evening until later the next day had stuffed noses) and FATIGUE (very fatigued) had resolved. At the time of the report, PAIN (little soreness following the injection) outcome was unknown.            Concomitant medication of the patient was not reported.   The patient attributed his symptoms to the immune response of the vaccine. The patient did not take any medications or treatments for the symptoms.   This case was linked to MOD-2021-363235 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Patient was administered an expired dose of the Moderna COVID-19 vaccine; The patient received his first two doses of the Pfizer and received a booster dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first two doses of the Pfizer and received a booster dose of the Moderna COVID-19 vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first two doses of the Pfizer and received a booster dose of the Moderna COVID-19 vaccine). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first two doses of the Pfizer and received a booster dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 5 patients received full Moderna COVID-19 dose in error/5 patients should have received half dose booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (5 patients received full Moderna COVID-19 dose in error/5 patients should have received half dose booster) 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 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (5 patients received full Moderna COVID-19 dose in error/5 patients should have received half dose booster). At the time of the report, ACCIDENTAL OVERDOSE (5 patients received full Moderna COVID-19 dose in error/5 patients should have received half dose booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chills, Cold sweat, Dysstasia
Clinical narrative: not feeling well; arm was crumping very bad; very very sick; whole body hurts; the arm, it seems like it's burning underneath the skin; sweating a lot; skin is on fire, have fire in hand; have really sharp pain in arms; knees started to shake uncontrollingly; cold sweat; can't barely stand up straight; It's almost like when you have the flu but worst; weak; feel like my whole body is controllingly shriving; body's been aching very very bad; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), MUSCLE SPASMS (arm was crumping very bad), ILLNESS (very very sick), PAIN (whole body hurts) and SKIN BURNING SENSATION (the arm, it seems like it's burning underneath the skin) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F11A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, the patient experienced MALAISE (not feeling well), MUSCLE SPASMS (arm was crumping very bad), ILLNESS (very very sick), PAIN (whole body hurts), SKIN BURNING SENSATION (the arm, it seems like it's burning underneath the skin), HYPERHIDROSIS (sweating a lot), BURNING SENSATION (skin is on fire, have fire in hand), PAIN IN EXTREMITY (have really sharp pain in arms), TREMOR (knees started to shake uncontrollingly), COLD SWEAT (cold sweat), DYSSTASIA (can't barely stand up straight), INFLUENZA LIKE ILLNESS (It's almost like when you have the flu but worst), ASTHENIA (weak), CHILLS (feel like my whole body is controllingly shriving) and MYALGIA (body's been aching very very bad). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well), MUSCLE SPASMS (arm was crumping very bad), ILLNESS (very very sick), PAIN (whole body hurts), SKIN BURNING SENSATION (the arm, it seems like it's burning underneath the skin), HYPERHIDROSIS (sweating a lot), BURNING SENSATION (skin is on fire, have fire in hand), PAIN IN EXTREMITY (have really sharp pain in arms), TREMOR (knees started to shake uncontrollingly), COLD SWEAT (cold sweat), DYSSTASIA (can't barely stand up straight), INFLUENZA LIKE ILLNESS (It's almost like when you have the flu but worst), ASTHENIA (weak), CHILLS (feel like my whole body is controllingly shriving) and MYALGIA (body's been aching very very bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Influenza like illness, Malaise, Muscle spasms
Clinical narrative: not feeling well; arm was crumping very bad; very very sick; whole body hurts; the arm, it seems like it's burning underneath the skin; sweating a lot; skin is on fire, have fire in hand; have really sharp pain in arms; knees started to shake uncontrollingly; cold sweat; can't barely stand up straight; It's almost like when you have the flu but worst; weak; feel like my whole body is controllingly shriving; body's been aching very very bad; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), MUSCLE SPASMS (arm was crumping very bad), ILLNESS (very very sick), PAIN (whole body hurts) and SKIN BURNING SENSATION (the arm, it seems like it's burning underneath the skin) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F11A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, the patient experienced MALAISE (not feeling well), MUSCLE SPASMS (arm was crumping very bad), ILLNESS (very very sick), PAIN (whole body hurts), SKIN BURNING SENSATION (the arm, it seems like it's burning underneath the skin), HYPERHIDROSIS (sweating a lot), BURNING SENSATION (skin is on fire, have fire in hand), PAIN IN EXTREMITY (have really sharp pain in arms), TREMOR (knees started to shake uncontrollingly), COLD SWEAT (cold sweat), DYSSTASIA (can't barely stand up straight), INFLUENZA LIKE ILLNESS (It's almost like when you have the flu but worst), ASTHENIA (weak), CHILLS (feel like my whole body is controllingly shriving) and MYALGIA (body's been aching very very bad). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well), MUSCLE SPASMS (arm was crumping very bad), ILLNESS (very very sick), PAIN (whole body hurts), SKIN BURNING SENSATION (the arm, it seems like it's burning underneath the skin), HYPERHIDROSIS (sweating a lot), BURNING SENSATION (skin is on fire, have fire in hand), PAIN IN EXTREMITY (have really sharp pain in arms), TREMOR (knees started to shake uncontrollingly), COLD SWEAT (cold sweat), DYSSTASIA (can't barely stand up straight), INFLUENZA LIKE ILLNESS (It's almost like when you have the flu but worst), ASTHENIA (weak), CHILLS (feel like my whole body is controllingly shriving) and MYALGIA (body's been aching very very bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Skin burning sensation, Tremor
Clinical narrative: not feeling well; arm was crumping very bad; very very sick; whole body hurts; the arm, it seems like it's burning underneath the skin; sweating a lot; skin is on fire, have fire in hand; have really sharp pain in arms; knees started to shake uncontrollingly; cold sweat; can't barely stand up straight; It's almost like when you have the flu but worst; weak; feel like my whole body is controllingly shriving; body's been aching very very bad; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), MUSCLE SPASMS (arm was crumping very bad), ILLNESS (very very sick), PAIN (whole body hurts) and SKIN BURNING SENSATION (the arm, it seems like it's burning underneath the skin) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F11A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, the patient experienced MALAISE (not feeling well), MUSCLE SPASMS (arm was crumping very bad), ILLNESS (very very sick), PAIN (whole body hurts), SKIN BURNING SENSATION (the arm, it seems like it's burning underneath the skin), HYPERHIDROSIS (sweating a lot), BURNING SENSATION (skin is on fire, have fire in hand), PAIN IN EXTREMITY (have really sharp pain in arms), TREMOR (knees started to shake uncontrollingly), COLD SWEAT (cold sweat), DYSSTASIA (can't barely stand up straight), INFLUENZA LIKE ILLNESS (It's almost like when you have the flu but worst), ASTHENIA (weak), CHILLS (feel like my whole body is controllingly shriving) and MYALGIA (body's been aching very very bad). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well), MUSCLE SPASMS (arm was crumping very bad), ILLNESS (very very sick), PAIN (whole body hurts), SKIN BURNING SENSATION (the arm, it seems like it's burning underneath the skin), HYPERHIDROSIS (sweating a lot), BURNING SENSATION (skin is on fire, have fire in hand), PAIN IN EXTREMITY (have really sharp pain in arms), TREMOR (knees started to shake uncontrollingly), COLD SWEAT (cold sweat), DYSSTASIA (can't barely stand up straight), INFLUENZA LIKE ILLNESS (It's almost like when you have the flu but worst), ASTHENIA (weak), CHILLS (feel like my whole body is controllingly shriving) and MYALGIA (body's been aching very very bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vomiting
Clinical narrative: More side effects than they had with the second dose. She states the side effects seem to be lasting longer than after the second dose.; think I need to go vomit right now; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (More side effects than they had with the second dose. She states the side effects seem to be lasting longer than after the second dose.) and VOMITING (think I need to go vomit right now) 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 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (More side effects than they had with the second dose. She states the side effects seem to be lasting longer than after the second dose.) and VOMITING (think I need to go vomit right now). At the time of the report, VACCINATION COMPLICATION (More side effects than they had with the second dose. She states the side effects seem to be lasting longer than after the second dose.) and VOMITING (think I need to go vomit right now) outcome was unknown.            Patient has think that he has been given a full dose instead because he seem to be having a lot more side effects than  he did after the second dose   Reporters states that side effects seem to be lasting longer than after the second dose  No concomitant medications information was reported.  No treatment medications were provided.   This case was linked to MOD-2021-363309 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gastrointestinal infection, Haematochezia, Stevens-Johnson syndrome
Clinical narrative: passing black blood through her stool; Stevens-Johnson Syndrome; GI distress; arthritis; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (passing black blood through her stool) and STEVENS-JOHNSON SYNDROME (Stevens-Johnson Syndrome) in a 72-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.     Concurrent medical conditions included Autoimmune disorder.    In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMATOCHEZIA (passing black blood through her stool) (seriousness criterion medically significant), STEVENS-JOHNSON SYNDROME (Stevens-Johnson Syndrome) (seriousness criterion medically significant), GASTROINTESTINAL INFECTION (GI distress) and ARTHRITIS (arthritis). At the time of the report, HAEMATOCHEZIA (passing black blood through her stool), STEVENS-JOHNSON SYNDROME (Stevens-Johnson Syndrome), GASTROINTESTINAL INFECTION (GI distress) and ARTHRITIS (arthritis) outcome was unknown.            No concomitant medication was reported. Treatment medication was not provided by the reporter.  Company Comment : This case concerns a 72-year-old female patient with past medical history of Autoimmune disorder who experienced the unexpected events of passing black blood through her stool and Stevens-Johnson syndrome. The events occurred on an unspecified date second the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as there was no details about the first dose.  The reporter did not provide the causality assessment with product use. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events are assessed as serious (medically significant) per regulatory reporting.  Stevens-Johnson syndrome is an adverse event of special interest; Sender's Comments: This case concerns a 72-year-old female patient with past medical history of Autoimmune disorder who experienced the unexpected events of passing black blood through her stool and Stevens-Johnson syndrome. The events occurred on an unspecified date second the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as there was no details about the first dose.  The reporter did not provide the causality assessment with product use. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events are assessed as serious (medically significant) per regulatory reporting.  Stevens-Johnson syndrome is an adverse event of special interest
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, 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 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  On 22 Oct 2021 vial was initially stored in the refrigerator.   This case was linked to MOD21-156586,MOD21-156570,MOD21-156562, MOD21-156556, MOD21-156443 ,MOD21-156523, MOD21-156524, MOD2 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; 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 CEREBROVASCULAR ACCIDENT (Stroke) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication use was reported.  Company comment: This case concerns a patient with of unknown age and gender with no relevant medical history reported, who experienced the unexpected event of cerebrovascular accident. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. There is no information indicating that the event is related to Moderna COVID-19 Vaccine. The case seems to be invalid.; Sender's Comments: This case concerns a patient with of unknown age and gender with no relevant medical history reported, who experienced the unexpected event of cerebrovascular accident. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. There is no information indicating that the event is related to Moderna COVID-19 Vaccine. The case seems to be invalid.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Overdose, Vaccination complication
Clinical narrative: Given a full dose instead; Having more side effects than they had with the second dose; "I think I need to go vomit right now."; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having more side effects than they had with the second dose), NAUSEA ("I think I need to go vomit right now.") and OVERDOSE (Given a full dose instead) 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 23-Oct-2021, 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. In October 2021, the patient experienced VACCINATION COMPLICATION (Having more side effects than they had with the second dose) and NAUSEA ("I think I need to go vomit right now."). On 23-Oct-2021, the patient experienced OVERDOSE (Given a full dose instead). On 23-Oct-2021, OVERDOSE (Given a full dose instead) had resolved. At the time of the report, VACCINATION COMPLICATION (Having more side effects than they had with the second dose) had not resolved and NAUSEA ("I think I need to go vomit right now.") outcome was unknown.            No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-363294, MOD-2021-362105 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). In October 2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received booster dose of vaccine on 23 Oct 2021 and 24 Oct 2021.  No concomitant medication was reported. No treatment medication was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Laziness, Pain in extremity, Pyrexia
Clinical narrative: feeling lazier; the arm was sore, not quite as bad after the second dose; fever; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (feeling lazier), PAIN IN EXTREMITY (the arm was sore, not quite as bad after the second dose) and PYREXIA (fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced LAZINESS (feeling lazier), PAIN IN EXTREMITY (the arm was sore, not quite as bad after the second dose) and PYREXIA (fever). At the time of the report, LAZINESS (feeling lazier), PAIN IN EXTREMITY (the arm was sore, not quite as bad after the second dose) and PYREXIA (fever) outcome was unknown.            Concomitant medications include: Thyroid medication and Cholesterol medication Concurrent medical condition includes: Cholesterol disorder  No treatment medications were reported.   This case was linked to MOD-2021-363314, MOD-2021-363179 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication  was reported. No treatment medication  was reported.   This case was linked to MOD-2021-363183, MOD-2021-363304, MOD-2021-363329, MOD-2021-363331, MOD-2021-363389, MOD-2021-363404, MOD-2021-363411, MOD-2021-363418, MOD-2021-363421, MOD-2021-363460, MOD-2021-363485, MOD-2021-363557, MOD-2021-363576 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: developed a rash on her arm; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (developed a rash on her arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced RASH (developed a rash on her arm). On 04-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, RASH (developed a rash on her arm) outcome 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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 042L20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received 0.5 ml dose for their booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5 ml dose for their booster) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5 ml dose for their booster). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Received 0.5 ml dose for their booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that 5 patients got a 0.5 ml dose instead of a 0.25 ml dose for their booster.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-363552, MOD-2021-363577, MOD-2021-363591, MOD-2021-363626 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Headache, Myalgia
Clinical narrative: Arm hurt; Upset stomach; Dizziness; Slept for hours; Had no energy.; Ached all over; Had a bad headache for days; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), SOMNOLENCE (Slept for hours) and ASTHENIA (Had no energy.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), SOMNOLENCE (Slept for hours), ASTHENIA (Had no energy.), MYALGIA (Ached all over), HEADACHE (Had a bad headache for days) and NAUSEA (Nausea). On 11-Mar-2021, PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), SOMNOLENCE (Slept for hours), ASTHENIA (Had no energy.), MYALGIA (Ached all over), HEADACHE (Had a bad headache for days) and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported. Treatment details was not provided. Patient stated for a week after receiving the vaccine she ached all over and had a bad headache for days. She had an upset stomach and slept for hours. She had nausea and dizziness. Her arm was hurt and she had no energy.   This case was linked to MOD-2021-363322 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Somnolence
Clinical narrative: Arm hurt; Upset stomach; Dizziness; Slept for hours; Had no energy.; Ached all over; Had a bad headache for days; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), SOMNOLENCE (Slept for hours) and ASTHENIA (Had no energy.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), SOMNOLENCE (Slept for hours), ASTHENIA (Had no energy.), MYALGIA (Ached all over), HEADACHE (Had a bad headache for days) and NAUSEA (Nausea). On 11-Mar-2021, PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), SOMNOLENCE (Slept for hours), ASTHENIA (Had no energy.), MYALGIA (Ached all over), HEADACHE (Had a bad headache for days) and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported. Treatment details was not provided. Patient stated for a week after receiving the vaccine she ached all over and had a bad headache for days. She had an upset stomach and slept for hours. She had nausea and dizziness. Her arm was hurt and she had no energy.   This case was linked to MOD-2021-363322 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Overdose, Rhinorrhoea, Vaccination site pain
Clinical narrative: stuffed up; runny nose; cough; sore arm; not immunocompromised, but received a full dose; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (not immunocompromised, but received a full dose), NASAL CONGESTION (stuffed up), RHINORRHOEA (runny nose), COUGH (cough) and VACCINATION SITE PAIN (sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A, 012M20A and 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced OVERDOSE (not immunocompromised, but received a full dose). On an unknown date, the patient experienced NASAL CONGESTION (stuffed up), RHINORRHOEA (runny nose), COUGH (cough) and VACCINATION SITE PAIN (sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. On 22-Oct-2021, OVERDOSE (not immunocompromised, but received a full dose) had resolved. At the time of the report, NASAL CONGESTION (stuffed up), RHINORRHOEA (runny nose) and COUGH (cough) had not resolved and VACCINATION SITE PAIN (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The contact is not immunocompromised. Concomitant medication use was unknown   This case was linked to MOD-2021-363393, MOD-2021-363403 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: Reaction that patient having; soreness in the arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Reaction that patient having) and VACCINATION SITE PAIN (soreness in the arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), RAMIPRIL, OXCARBAZEPINE, METOPROLOL SUCCINATE, UBIDECARENONE (COQ10 [UBIDECARENONE]), CALCIUM AMINOACETATE;CALCIUM CITRATE;CALCIUM MALATE;COLECALCIFEROL;COPPER GLYCINATE;MAGNESIUM CITRATE;MAGNESIUM GLYCINATE;MAGNESIUM MALATE;MAGNESIUM OXIDE;MANGANESE GLYCINATE;MENAQUINONE-7;SODIUM BORATE;ZINC GLYCINATE, VITAMIN C [ASCORBIC ACID], CENTRUM SILVER ADULTS 50+, BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE), LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIPLE FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE;METHYLSULFONYLMETHANE]) for an unknown indication.    On 24-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 VACCINATION COMPLICATION (Reaction that patient having) and VACCINATION SITE PAIN (soreness in the arm). At the time of the report, VACCINATION COMPLICATION (Reaction that patient having) and VACCINATION SITE PAIN (soreness in the 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.   Concomitant medications also include Astioviflex. No treatment medication details was reported.   This case was linked to MOD-2021-363477, MOD-2021-363478 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received on 25 OCT 2021 contains Reporter occupation and reporter type and additional event was added.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Joint stiffness, Musculoskeletal stiffness, Myalgia
Clinical narrative: stiffness hip joint after dose 2; stiffness deltoids after dose 2/stiffness upper back area after dose 2; muscle aches hip joint after dose 2/muscle aches deltoids after dose 2/muscle aches upper back area after dose 2; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (stiffness hip joint after dose 2), MUSCULOSKELETAL STIFFNESS (stiffness deltoids after dose 2/stiffness upper back area after dose 2) and MYALGIA (muscle aches hip joint after dose 2/muscle aches deltoids after dose 2/muscle aches upper back area after dose 2) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Coronary artery disease.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 JOINT STIFFNESS (stiffness hip joint after dose 2), MUSCULOSKELETAL STIFFNESS (stiffness deltoids after dose 2/stiffness upper back area after dose 2) and MYALGIA (muscle aches hip joint after dose 2/muscle aches deltoids after dose 2/muscle aches upper back area after dose 2). At the time of the report, JOINT STIFFNESS (stiffness hip joint after dose 2), MUSCULOSKELETAL STIFFNESS (stiffness deltoids after dose 2/stiffness upper back area after dose 2) and MYALGIA (muscle aches hip joint after dose 2/muscle aches deltoids after dose 2/muscle aches upper back area after dose 2) outcome was unknown.            No treatment details was reported. Patient takes blood pressure medication and heart medication. He is 71.   This case was linked to MOD-2021-363189, MOD-2021-363354 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose > 35 days after first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose > 35 days after first dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose > 35 days after first dose). On 28-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose > 35 days after first dose) had resolved.            Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received and AE contact information updated
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Eye pain, Fatigue, Feeling abnormal
Clinical narrative: do not feel quite right; temperature reached 100.4°F/body temperature is higher than normal; runny nose; eyes were hurting/pain in their eyeballs; could hardly sleep/tossing and turning; headaches; very very very tired; bad chills/feels like they are going to get the chills/air conditioning bothers them; left arm was very very painful; do not feel quite right; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (do not feel quite right), RHINORRHOEA (runny nose), EYE PAIN (eyes were hurting/pain in their eyeballs), INSOMNIA (could hardly sleep/tossing and turning) and FEELING ABNORMAL (do not feel quite right) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 039K20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), LENALIDOMIDE (REVLIMID), ACYCLOVIR [ACICLOVIR], VITAMINS NOS and MINERALS NOS (MINERALS) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced MALAISE (do not feel quite right). On 21-Oct-2021, the patient experienced EYE PAIN (eyes were hurting/pain in their eyeballs), INSOMNIA (could hardly sleep/tossing and turning), HEADACHE (headaches), FATIGUE (very very very tired), CHILLS (bad chills/feels like they are going to get the chills/air conditioning bothers them) and VACCINATION SITE PAIN (left arm was very very painful). On 22-Oct-2021, the patient experienced RHINORRHOEA (runny nose) and PYREXIA (temperature reached 100.4°F/body temperature is higher than normal). On 23-Oct-2021, the patient experienced FEELING ABNORMAL (do not feel quite right). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (do not feel quite right), EYE PAIN (eyes were hurting/pain in their eyeballs), INSOMNIA (could hardly sleep/tossing and turning), FEELING ABNORMAL (do not feel quite right), PYREXIA (temperature reached 100.4°F/body temperature is higher than normal), HEADACHE (headaches), FATIGUE (very very very tired), CHILLS (bad chills/feels like they are going to get the chills/air conditioning bothers them) and VACCINATION SITE PAIN (left arm was very very painful) outcome was unknown and RHINORRHOEA (runny nose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 99 degree (High) 99 Degree. On 22-Oct-2021, Body temperature: 100.4 degree (High) 100.4 Degree.