chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: She is not feeling good again today whenever she tries to eat, couldnt keep anything down; Couldn't eat; Next day, she was very sleepy; Starting Thursday night, she was very dizzy; Disoriented; On same day, she had little pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (She is not feeling good again today whenever she tries to eat, couldnt keep anything down), FEEDING DISORDER (Couldn't eat), SOMNOLENCE (Next day, she was very sleepy), DIZZINESS (Starting Thursday night, she was very dizzy) and DISORIENTATION (Disoriented) in a 79-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.     Concomitant products included DILTIAZEM, CLOPIDOGREL BISULFATE (PLAVIX), INSULIN LISPRO (HUMALOG), LOSARTAN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 03-Nov-2021, the patient experienced VACCINATION SITE PAIN (On same day, she had little pain at injection site). On 04-Nov-2021, the patient experienced SOMNOLENCE (Next day, she was very sleepy), DIZZINESS (Starting Thursday night, she was very dizzy) and DISORIENTATION (Disoriented). On 09-Nov-2021, the patient experienced GASTROINTESTINAL DISORDER (She is not feeling good again today whenever she tries to eat, couldnt keep anything down) and FEEDING DISORDER (Couldn't eat). On 07-Nov-2021, DIZZINESS (Starting Thursday night, she was very dizzy) and DISORIENTATION (Disoriented) had resolved. At the time of the report, GASTROINTESTINAL DISORDER (She is not feeling good again today whenever she tries to eat, couldnt keep anything down) and FEEDING DISORDER (Couldn't eat) had not resolved and SOMNOLENCE (Next day, she was very sleepy) and VACCINATION SITE PAIN (On same day, she had little pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: low (Low) sugar went down.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Restlessness
Clinical narrative: a little restless; brain fogginess/looped out in my head; sore arms; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (a little restless), FEELING ABNORMAL (brain fogginess/looped out in my head) and MYALGIA (sore arms) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 025A21A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced RESTLESSNESS (a little restless) and MYALGIA (sore arms). 08-Nov-2021, the patient experienced FEELING ABNORMAL (brain fogginess/looped out in my head). The patient was treated with TRAZODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RESTLESSNESS (a little restless) and FEELING ABNORMAL (brain fogginess/looped out in my head) had not resolved and MYALGIA (sore arms) was resolving.            Concomitant drugs were not reported. Treatment included swim spa.  The patient thought that might have received a incorrect dosage.   This case was linked to MOD-2021-381283 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Feels chest tightness; Trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Feels chest tightness) and DYSPNOEA (Trouble breathing) 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 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced CHEST DISCOMFORT (Feels chest tightness) and DYSPNOEA (Trouble breathing). At the time of the report, CHEST DISCOMFORT (Feels chest tightness) and DYSPNOEA (Trouble breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medication was not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Genital infection female
Clinical narrative: gyneco infection; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL INFECTION FEMALE (gyneco infection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, 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 experienced GENITAL INFECTION FEMALE (gyneco infection). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Gynecological infection, at an unspecified dose and frequency. At the time of the report, GENITAL INFECTION FEMALE (gyneco infection) outcome was unknown.            No concomitant medications were reported. Patient had mentioned that she was experiencing an gyneco infection and she needed to take an antibiotic.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received, contains No new information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Tinnitus
Clinical narrative: buzzing ears, even more intense since the 2nd dose.; weakness, even more intense since the 2nd dose; headaches, even more intense since the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (buzzing ears, even more intense since the 2nd dose.), ASTHENIA (weakness, even more intense since the 2nd dose) and HEADACHE (headaches, even more intense since the 2nd dose) in a 59-year-old female patient 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 TINNITUS (buzzing ears, even more intense since the 2nd dose.), ASTHENIA (weakness, even more intense since the 2nd dose) and HEADACHE (headaches, even more intense since the 2nd dose). At the time of the report, TINNITUS (buzzing ears, even more intense since the 2nd dose.), ASTHENIA (weakness, even more intense since the 2nd dose) and HEADACHE (headaches, even more intense since the 2nd dose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   The patient reported some side effects after the Moderna vaccine (both doses) 4 or 6 months ago. She doesn´t remembered exact date. Since the 1st dose she started to feel headaches, buzzing ears and weakness, but even more intense since the 2nd dose.  Treatment information was not reported. This case concerns a 70-year-old, male patient with no relevant medical history, who experienced the unexpected events of Tinnitus, Headache and Asthenia. The events occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was unknown since events from the 1st dose had an unknown outcome. The event headache is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-381151 (Patient Link).; Sender's Comments: This case concerns a 70-year-old, male patient with no relevant medical history, who experienced the unexpected events of Tinnitus, Headache and Asthenia. The events occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was unknown since events from the 1st dose had an unknown outcome. The event headache is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
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.   Concomitant product use was not provided by the reporter.   No treatment information was provided.  Company Comment: This case concerns a patient with unknown age and gender with no reported medical history , who experienced serious, unexpected event of Cerebrovascular accident with occurred on an unknown date with an unknown dose number of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the event is unknown. The benefit -risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up received contains no new information.; Sender's Comments: This case concerns a patient with unknown age and gender with no reported medical history , who experienced serious, unexpected event of Cerebrovascular accident with occurred on an unknown date with an unknown dose number of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the event is unknown. The benefit -risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: They found that the patient received expired vaccine of Moderna COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They found that the patient received expired vaccine of Moderna COVID-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They found that the patient received expired vaccine of Moderna COVID-19). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (They found that the patient received expired vaccine of Moderna COVID-19) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow-up received on 11-NOV-2021 contains non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; 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 HEADACHE (headaches) 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 HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medication provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired vaccine; 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 EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) 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 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.            No treatment information was provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a 37-year-old male patient 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 March 2021, the patient experienced DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-381238 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Non-significant Follow-up
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm with one shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm with one shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm with one shot). At the time of the report, PAIN IN EXTREMITY (Sore arm with one shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided by the reporter No treatment information was provided by the reporter This case concerns a 71-year-old female patient with no relevant medical history, who experienced the unexpected event of Pain in Extremity. The event occurred on an unknown date after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-381260, MOD-2021-381265 (Patient Link).; Sender's Comments: This case concerns a 71-year-old female patient with no relevant medical history, who experienced the unexpected event of Pain in Extremity. The event occurred on an unknown date after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Illness, Nausea, Somnolence
Clinical narrative: patient felt sick after the second vaccine; no appetite for 24 to 38 hours after his second vaccine; patient was sleepy after the second vaccine; nauseous after the second vaccine; patient was coughing; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (patient felt sick after the second vaccine), DECREASED APPETITE (no appetite for 24 to 38 hours after his second vaccine), SOMNOLENCE (patient was sleepy after the second vaccine), COUGH (patient was coughing) and NAUSEA (nauseous after the second vaccine) in a 36-year-old male patient 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. In October 2021, the patient experienced COUGH (patient was coughing). On an unknown date, the patient experienced ILLNESS (patient felt sick after the second vaccine), DECREASED APPETITE (no appetite for 24 to 38 hours after his second vaccine), SOMNOLENCE (patient was sleepy after the second vaccine) and NAUSEA (nauseous after the second vaccine). At the time of the report, ILLNESS (patient felt sick after the second vaccine), DECREASED APPETITE (no appetite for 24 to 38 hours after his second vaccine), SOMNOLENCE (patient was sleepy after the second vaccine), COUGH (patient was coughing) and NAUSEA (nauseous after the second vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient has been very sick with Covid-19 like symptoms recently. The patient never got tested for Covid-19. The patient had coughing and is just getting past the sickness now. No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-381234 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: underwent temperature excursion; 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 PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion) had resolved.            No concomitant medication was provided. No treatment medication was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Inflammation, Malaise, Migraine
Clinical narrative: Her head and scalp felt inflamed; Her neck was killing her; It felt like a massive migraine; Head and scalp felt inflamed and puffy; She couldn't get out of bed; Head was hurting unbearably; Shoulders were killing her; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Her head and scalp felt inflamed), NECK PAIN (Her neck was killing her), MIGRAINE (It felt like a massive migraine), SKIN SWELLING (Head and scalp felt inflamed and puffy) and MALAISE (She couldn't get out of bed) in a 70-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.     The patient's past medical history included Fall (Patient was walking in the dark, misstepped and hit her head on a wall) on 31-Oct-2021.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 05-Nov-2021, the patient experienced INFLAMMATION (Her head and scalp felt inflamed), NECK PAIN (Her neck was killing her), MIGRAINE (It felt like a massive migraine), SKIN SWELLING (Head and scalp felt inflamed and puffy), MALAISE (She couldn't get out of bed), HEADACHE (Head was hurting unbearably) and ARTHRALGIA (Shoulders were killing her). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 07-Nov-2021, INFLAMMATION (Her head and scalp felt inflamed), NECK PAIN (Her neck was killing her), MIGRAINE (It felt like a massive migraine), SKIN SWELLING (Head and scalp felt inflamed and puffy), MALAISE (She couldn't get out of bed), HEADACHE (Head was hurting unbearably) and ARTHRALGIA (Shoulders were killing her) had resolved.            No concomitant medications were provided.  Treatment medication also included Ice for head.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Skin swelling
Clinical narrative: Her head and scalp felt inflamed; Her neck was killing her; It felt like a massive migraine; Head and scalp felt inflamed and puffy; She couldn't get out of bed; Head was hurting unbearably; Shoulders were killing her; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Her head and scalp felt inflamed), NECK PAIN (Her neck was killing her), MIGRAINE (It felt like a massive migraine), SKIN SWELLING (Head and scalp felt inflamed and puffy) and MALAISE (She couldn't get out of bed) in a 70-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.     The patient's past medical history included Fall (Patient was walking in the dark, misstepped and hit her head on a wall) on 31-Oct-2021.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 05-Nov-2021, the patient experienced INFLAMMATION (Her head and scalp felt inflamed), NECK PAIN (Her neck was killing her), MIGRAINE (It felt like a massive migraine), SKIN SWELLING (Head and scalp felt inflamed and puffy), MALAISE (She couldn't get out of bed), HEADACHE (Head was hurting unbearably) and ARTHRALGIA (Shoulders were killing her). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 07-Nov-2021, INFLAMMATION (Her head and scalp felt inflamed), NECK PAIN (Her neck was killing her), MIGRAINE (It felt like a massive migraine), SKIN SWELLING (Head and scalp felt inflamed and puffy), MALAISE (She couldn't get out of bed), HEADACHE (Head was hurting unbearably) and ARTHRALGIA (Shoulders were killing her) had resolved.            No concomitant medications were provided.  Treatment medication also included Ice for head.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: A little bit of fatigue the 2nd time; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little bit of fatigue the 2nd time) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 029120A) for COVID-19 vaccination.     The patient's past medical history included Flu.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (A little bit of fatigue the 2nd time). At the time of the report, FATIGUE (A little bit of fatigue the 2nd time) outcome was unknown.            No concomitant medications were reported. No treatment medications was provided   This case was linked to MOD-2021-381236, MOD-2021-381265 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dyspnoea, Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, ASTHENIA, DYSPNOEA, INFLUENZA LIKE ILLNESS and PYREXIA in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 1039F21A, 030M20A, and 029120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced PYREXIA, CHILLS, and NAUSEA. On an unknown date, the patient experienced ILLNESS, ASTHENIA, DYSPNOEA, and INFLUENZA LIKE ILLNESS. At the time of the report, ILLNESS, ASTHENIA, DYSPNOEA, INFLUENZA LIKE ILLNESS, PYREXIA, CHILLS, and NAUSEA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 08-Nov-2021, Body temperature 101 (High).         Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Reporter stated With the booster however, she ran around like crazy yesterday after getting the vaccine, when she came home, she was fine, she went to bed but at 12:30 she woke up, and had fever (temperature at 101), chills, and nausea. She hardly ever got sick. Today she was still nauseated but she had been able to eat chicken noodle soup. When she worked from the couch to the kitchen, she was really weak. She felt like she felt when she had the flu few years ago. She felt so weak, and she was usually high energy, she went to the gym yesterday, but this took the wind out of her last night.  -This case concerns a 71-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of Illness, Asthenia, Influenza like illness, and Dyspnea, and the expected non-serious events of Pyrexia, Chills, and Nausea. The events occurred on the day after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier doses was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-381260 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, ASTHENIA, DYSPNOEA, INFLUENZA LIKE ILLNESS and PYREXIA in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 1039F21A, 030M20A, and 029120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced PYREXIA, CHILLS, and NAUSEA. On an unknown date, the patient experienced ILLNESS, ASTHENIA, DYSPNOEA, and INFLUENZA LIKE ILLNESS. At the time of the report, ILLNESS, ASTHENIA, DYSPNOEA, INFLUENZA LIKE ILLNESS, PYREXIA, CHILLS, and NAUSEA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 08-Nov-2021, Body temperature 101 (High).         Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Reporter stated With the booster however, she ran around like crazy yesterday after getting the vaccine, when she came home, she was fine, she went to bed but at 12:30 she woke up, and had fever (temperature at 101), chills, and nausea. She hardly ever got sick. Today she was still nauseated but she had been able to eat chicken noodle soup. When she worked from the couch to the kitchen, she was really weak. She felt like she felt when she had the flu few years ago. She felt so weak, and she was usually high energy, she went to the gym yesterday, but this took the wind out of her last night.  -This case concerns a 71-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of Illness, Asthenia, Influenza like illness, and Dyspnea, and the expected non-serious events of Pyrexia, Chills, and Nausea. The events occurred on the day after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier doses was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-381260 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient had booster vaccine on 29-Oct-2021, vaccine had expired on 27-Oct-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had booster vaccine on 29-Oct-2021, vaccine had expired on 27-Oct-2021) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had booster vaccine on 29-Oct-2021, vaccine had expired on 27-Oct-2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient had booster vaccine on 29-Oct-2021, vaccine had expired on 27-Oct-2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The vaccine was properly stored.  This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the event expired product administered. The event expired product administered occurred right after the booster dose of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the event expired product administered. The event expired product administered occurred right after the booster dose of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications were not reported. Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was properly stored but it was expired; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer stage IV (Spread to sternum and lung) since 2019 and Penicillin allergy.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        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.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Patient did not feel well for 2 days after second shot; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Patient did not feel well for 2 days after second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced MALAISE (Patient did not feel well for 2 days after second shot). On 10-Mar-2021, MALAISE (Patient did not feel well for 2 days after second shot) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-380869 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 2020 and Environmental allergy. Concomitant products included LISINOPRIL for Hypertension.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drugs were reported. Vaccine expired  27-Oct-2021, It was properly stored.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Nausea
Clinical narrative: Weakness; Chills; Achiness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), CHILLS (Chills), MYALGIA (Achiness) and NAUSEA (Nausea) in a 72-year-old male patient 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 ASTHENIA (Weakness), CHILLS (Chills), MYALGIA (Achiness) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Weakness), CHILLS (Chills), MYALGIA (Achiness) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: "little reaction" after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("little reaction" after the second dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 09-Nov-2021, the patient experienced VACCINATION COMPLICATION ("little reaction" after the second dose). At the time of the report, VACCINATION COMPLICATION ("little reaction" after the second dose) outcome was unknown.            No concomitants and treatment drugs are provided.   This case was linked to MOD-2021-381165 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: A little achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (A little achy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 immunisation: Johnson and johnson COVID-19 vaccine (The next day the patient woke up nd was still queasy.) on 07-Mar-2021. Past adverse reactions to the above products included Chills worsened with Johnson and johnson COVID-19 vaccine.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced MYALGIA (A little achy). At the time of the report, MYALGIA (A little achy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  After the introduction of Johnson and Johnson vaccination, the patient had really bad chills on the middle of the night. On the next day, the patient was queasy and had low grade flu symptoms for the whole day.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Lowgrade tiredness; Fever; Chills; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Achiness) and FATIGUE (Lowgrade tiredness) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Achiness). On an unknown date, the patient experienced FATIGUE (Lowgrade tiredness). On 09-Nov-2021, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Achiness) and FATIGUE (Lowgrade tiredness) had resolved.            No concomitant medications were reported. No treatment medications were reported. Normal symptoms after second dose. Patient had low-grade tiredness, which lasted 2 and half days.
Age: 59.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for Vaccination.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    The patient had FLUARIX vaccine on right deltoid along with Moderna booster dose.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-370135 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.  The patient received booster dose of Moderna vaccine and Fluarix (379TF, intramuscular, at right deltoid) on the same day.   This case was linked to MOD-2021-370138 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SAG 4V (FLUAD QUAD) for Vaccination.    No Medical History information was reported.   On 29-Oct-2021 at 1:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and INFLUENZA VACCINE INACT SAG 4V (FLUAD QUAD) (Intramuscular) 1 dosage form. On 30-Oct-2021 at 8:00 AM, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    No treatment and concomitant medications were provided.    This case was linked to MOD-2021-370445 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for Vaccination.    No Medical History information was reported.   On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    No concomitant medications information was reported.  No treatment medications were provided.   This case was linked to MOD-2021-370191 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) 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 product use was reported. No treatment information was provided.    This case was linked to MOD-2021-370217 (Patient Link).