chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: flue like symptoms; No appetite; bed ridden for a whole day; Achy body; nauseous; Fever of 100.3; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flue like symptoms), DECREASED APPETITE (No appetite), BEDRIDDEN (bed ridden for a whole day), MYALGIA (Achy body) and NAUSEA (nauseous) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol and Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), ROSUVASTATIN for Cholesterol, METOPROLOL for an unknown indication.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (flue like symptoms), DECREASED APPETITE (No appetite), BEDRIDDEN (bed ridden for a whole day), MYALGIA (Achy body), NAUSEA (nauseous) and PYREXIA (Fever of 100.3). On 05-Nov-2021, PYREXIA (Fever of 100.3) had resolved. On 06-Nov-2021, BEDRIDDEN (bed ridden for a whole day) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flue like symptoms), DECREASED APPETITE (No appetite), MYALGIA (Achy body) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Body temperature: 100.3 (High) Body temperature High-100.3.         Reporter stated that patient was taking concomitant medication metoprolol for betablocker, rosuvastatin for cholesterol control and famotidine for acid reflux. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pyrexia, Somnolence
Clinical narrative: was drowsy; chills; headache; fever; felt like was getting the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like was getting the flu), SOMNOLENCE (was drowsy), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   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 INFLUENZA LIKE ILLNESS (felt like was getting the flu). On an unknown date, the patient experienced SOMNOLENCE (was drowsy), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (felt like was getting the flu), SOMNOLENCE (was drowsy), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-376977 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: perpetual migraine/daily migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE. The patient was treated with NURTEC for Migraine, at an unspecified dose and frequency and FIORICET for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE outcome was unknown.            Concomitant medication not reported.   Most recent FOLLOW-UP information incorporated above includes on 08-Nov-2021 Significant follow up, lot number and drug start dates given.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Vaccination complication
Clinical narrative: Guillain-Barre syndrome; severe side effects/symptoms persisted/started after receiving the booster; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 027A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-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 GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant) and VACCINATION COMPLICATION (severe side effects/symptoms persisted/started after receiving the booster). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) and VACCINATION COMPLICATION (severe side effects/symptoms persisted/started after receiving the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment reported.  Company comment: This case concerns a  59-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Guillain-Barre syndrome. The event occurred on an unknown date after the third dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the second dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  59-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Guillain-Barre syndrome. The event occurred on an unknown date after the third dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the second dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 6 patients got a dose of the Modena vaccine from a vial that was stored in a super cold freezer temperature with -66°C and colder; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (6 patients got a dose of the Modena vaccine from a vial that was stored in a super cold freezer temperature with -66°C and colder) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) 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 PRODUCT STORAGE ERROR (6 patients got a dose of the Modena vaccine from a vial that was stored in a super cold freezer temperature with -66°C and colder). At the time of the report, PRODUCT STORAGE ERROR (6 patients got a dose of the Modena vaccine from a vial that was stored in a super cold freezer temperature with -66°C and colder) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.  HP stated that at least 6 patients got a dose of a Moderna vaccine from a vials previously stored in this freezer of temperature is -66°C and colder between 01Sep2021 till past Monday,11Nov2021. vials of 14 doses are still in the ultracold freezer, 1 vial is thawed and in the refrigerator,  HCP is looked for some guidance in regards to the vaccines in the freezer and a vial that has already been thawed and is under refrigerator conditions, but remains unpunctured.  Excursion duration: From the packing slip HCP found out the date in the computer stated it was received in 01Sep2021, but HCP stated they think it was there before that date, and that the quality check stated 19Aug2021.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received contains dose number information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site irritation, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Arm became very irritated), VACCINATION SITE ERYTHEMA (Arm became red), VACCINATION SITE SWELLING (Arm became swollen) and VACCINATION SITE PRURITUS (Arm became very very itchy from the shoulder to the elbow) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 010A21A and 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL, MULTIVITAMIN [VITAMINS NOS], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FISH OIL, METOPROLOL and MAGNESIUM for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced VACCINATION SITE IRRITATION (Arm became very irritated), VACCINATION SITE ERYTHEMA (Arm became red) and VACCINATION SITE SWELLING (Arm became swollen). On 22-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Arm became very very itchy from the shoulder to the elbow). On 25-Oct-2021, VACCINATION SITE PRURITUS (Arm became very very itchy from the shoulder to the elbow) had resolved. At the time of the report, VACCINATION SITE IRRITATION (Arm became very irritated), VACCINATION SITE ERYTHEMA (Arm became red) and VACCINATION SITE SWELLING (Arm became swollen) outcome was unknown.            No treatment was reported by the reporter.   This case was linked to MOD-2021-377059, MOD-2021-377032.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Additional information include no new information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Headache, Hyperhidrosis
Clinical narrative: Back pain; Sciatica; Left feeling weak and down; Starting to feel sweaty; Still running a low grade fever/Fever as high as 101.7 degrees Fahrenheit/Wake up with Fever; Headache during the night; Still has aches and pains; Lethargic; Still has aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), PAIN (Still has aches and pains), BACK PAIN (Back pain), SCIATICA (Sciatica) and ASTHENIA (Left feeling weak and down) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905 and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced LETHARGY (Lethargic), PAIN (Still has aches and pains) and MYALGIA (Still has aches and pains). On 04-Nov-2021, the patient experienced HEADACHE (Headache during the night). On 05-Nov-2021, the patient experienced BACK PAIN (Back pain), SCIATICA (Sciatica), ASTHENIA (Left feeling weak and down), HYPERHIDROSIS (Starting to feel sweaty) and PYREXIA (Still running a low grade fever/Fever as high as 101.7 degrees Fahrenheit/Wake up with Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LETHARGY (Lethargic), PAIN (Still has aches and pains), PYREXIA (Still running a low grade fever/Fever as high as 101.7 degrees Fahrenheit/Wake up with Fever) and MYALGIA (Still has aches and pains) had not resolved and BACK PAIN (Back pain), SCIATICA (Sciatica), ASTHENIA (Left feeling weak and down), HYPERHIDROSIS (Starting to feel sweaty) and HEADACHE (Headache during the night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Body temperature: 101.7 (High) 101.7 degrees Fahrenheit. In November 2021, Body temperature: 99.9 (High) 99.9 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Pain, Pyrexia, Sciatica
Clinical narrative: Back pain; Sciatica; Left feeling weak and down; Starting to feel sweaty; Still running a low grade fever/Fever as high as 101.7 degrees Fahrenheit/Wake up with Fever; Headache during the night; Still has aches and pains; Lethargic; Still has aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), PAIN (Still has aches and pains), BACK PAIN (Back pain), SCIATICA (Sciatica) and ASTHENIA (Left feeling weak and down) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905 and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced LETHARGY (Lethargic), PAIN (Still has aches and pains) and MYALGIA (Still has aches and pains). On 04-Nov-2021, the patient experienced HEADACHE (Headache during the night). On 05-Nov-2021, the patient experienced BACK PAIN (Back pain), SCIATICA (Sciatica), ASTHENIA (Left feeling weak and down), HYPERHIDROSIS (Starting to feel sweaty) and PYREXIA (Still running a low grade fever/Fever as high as 101.7 degrees Fahrenheit/Wake up with Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LETHARGY (Lethargic), PAIN (Still has aches and pains), PYREXIA (Still running a low grade fever/Fever as high as 101.7 degrees Fahrenheit/Wake up with Fever) and MYALGIA (Still has aches and pains) had not resolved and BACK PAIN (Back pain), SCIATICA (Sciatica), ASTHENIA (Left feeling weak and down), HYPERHIDROSIS (Starting to feel sweaty) and HEADACHE (Headache during the night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Body temperature: 101.7 (High) 101.7 degrees Fahrenheit. In November 2021, Body temperature: 99.9 (High) 99.9 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Interchange of vaccine products, Nasal congestion, Oropharyngeal discomfort, Pain
Clinical narrative: Drainage to throat; Nasal congestion; Nose was running like a faucet; Continuous rash over her body which is itching; Fatigue; Last night throat was burning really bad on one side; Body aches; 1st/2nd COVID19 vaccine doses were Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st/2nd COVID19 vaccine doses were Pfizer), THROAT IRRITATION (Last night throat was burning really bad on one side), OROPHARYNGEAL DISCOMFORT (Drainage to throat), NASAL CONGESTION (Nasal congestion) and RHINORRHOEA (Nose was running like a faucet) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine on 16-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Anxiety, Depression and Autoimmune disorder (undiagnosed autoimmune condition.).    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st/2nd COVID19 vaccine doses were Pfizer). On 04-Nov-2021, the patient experienced THROAT IRRITATION (Last night throat was burning really bad on one side) and PAIN (Body aches). On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (Drainage to throat), NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Nose was running like a faucet), RASH PRURITIC (Continuous rash over her body which is itching) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency. On 03-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st/2nd COVID19 vaccine doses were Pfizer) had resolved. At the time of the report, THROAT IRRITATION (Last night throat was burning really bad on one side), RHINORRHOEA (Nose was running like a faucet), PAIN (Body aches) and FATIGUE (Fatigue) outcome was unknown and OROPHARYNGEAL DISCOMFORT (Drainage to throat), NASAL CONGESTION (Nasal congestion) and RASH PRURITIC (Continuous rash over her body which is itching) had not resolved.            No concomitant products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received contains significant information, patient details, medical history and event details updated.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Rhinorrhoea, Throat irritation
Clinical narrative: Drainage to throat; Nasal congestion; Nose was running like a faucet; Continuous rash over her body which is itching; Fatigue; Last night throat was burning really bad on one side; Body aches; 1st/2nd COVID19 vaccine doses were Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st/2nd COVID19 vaccine doses were Pfizer), THROAT IRRITATION (Last night throat was burning really bad on one side), OROPHARYNGEAL DISCOMFORT (Drainage to throat), NASAL CONGESTION (Nasal congestion) and RHINORRHOEA (Nose was running like a faucet) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine on 16-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Anxiety, Depression and Autoimmune disorder (undiagnosed autoimmune condition.).    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st/2nd COVID19 vaccine doses were Pfizer). On 04-Nov-2021, the patient experienced THROAT IRRITATION (Last night throat was burning really bad on one side) and PAIN (Body aches). On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (Drainage to throat), NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Nose was running like a faucet), RASH PRURITIC (Continuous rash over her body which is itching) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency. On 03-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st/2nd COVID19 vaccine doses were Pfizer) had resolved. At the time of the report, THROAT IRRITATION (Last night throat was burning really bad on one side), RHINORRHOEA (Nose was running like a faucet), PAIN (Body aches) and FATIGUE (Fatigue) outcome was unknown and OROPHARYNGEAL DISCOMFORT (Drainage to throat), NASAL CONGESTION (Nasal congestion) and RASH PRURITIC (Continuous rash over her body which is itching) had not resolved.            No concomitant products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received contains significant information, patient details, medical history and event details updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: For the first dose, patient reports soreness in the arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (For the first dose, patient reports soreness in the arm for a few days) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Joint pain (she experienced this problem 20 years old ago, the joint pain, but the pain went away when she reduced her salt intake).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (For the first dose, patient reports soreness in the arm for a few days). At the time of the report, PAIN IN EXTREMITY (For the first dose, patient reports soreness in the arm for a few days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-377022 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Inflammation, Malaise, Mobility decreased, Nerve compression
Clinical narrative: could not get up; suffering from a pinched nerve; did not feel well; inflammation; a lot of pain in her bones that she had fractured in the past: in the 8th bone in her back; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not get up), NERVE COMPRESSION (suffering from a pinched nerve), MALAISE (did not feel well), INFLAMMATION (inflammation) and BONE PAIN (a lot of pain in her bones that she had fractured in the past: in the 8th bone in her back) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced MOBILITY DECREASED (could not get up), NERVE COMPRESSION (suffering from a pinched nerve), MALAISE (did not feel well), INFLAMMATION (inflammation) and BONE PAIN (a lot of pain in her bones that she had fractured in the past: in the 8th bone in her back). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (could not get up), NERVE COMPRESSION (suffering from a pinched nerve), MALAISE (did not feel well), INFLAMMATION (inflammation) and BONE PAIN (a lot of pain in her bones that she had fractured in the past: in the 8th bone in her back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication was provided by the reporter.   Patient had a pinched nerve before but it had not happened to her for a long time. That morning patient was suffering from a pinched nerve. Patient was also having a lot of pain in her bones that she had fractured in the past: in the 8th bone in her back and her left wrist.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: could not get up; suffering from a pinched nerve; did not feel well; inflammation; a lot of pain in her bones that she had fractured in the past: in the 8th bone in her back; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not get up), NERVE COMPRESSION (suffering from a pinched nerve), MALAISE (did not feel well), INFLAMMATION (inflammation) and BONE PAIN (a lot of pain in her bones that she had fractured in the past: in the 8th bone in her back) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced MOBILITY DECREASED (could not get up), NERVE COMPRESSION (suffering from a pinched nerve), MALAISE (did not feel well), INFLAMMATION (inflammation) and BONE PAIN (a lot of pain in her bones that she had fractured in the past: in the 8th bone in her back). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (could not get up), NERVE COMPRESSION (suffering from a pinched nerve), MALAISE (did not feel well), INFLAMMATION (inflammation) and BONE PAIN (a lot of pain in her bones that she had fractured in the past: in the 8th bone in her back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication was provided by the reporter.   Patient had a pinched nerve before but it had not happened to her for a long time. That morning patient was suffering from a pinched nerve. Patient was also having a lot of pain in her bones that she had fractured in the past: in the 8th bone in her back and her left wrist.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: have a headache after getting the Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (have a headache after getting the Booster dose) 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 05-Nov-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 an unknown date, the patient experienced HEADACHE (have a headache after getting the Booster dose). At the time of the report, HEADACHE (have a headache after getting the Booster dose) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.  Patient wanted to know if it was okay to take sumatriptan which it is a migraine medication
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperpyrexia
Clinical narrative: 105°F fever; dull headache everyday; Tiredness; Chills; This spontaneous case was reported by a patient and describes the occurrence of HYPERPYREXIA (105°F fever) in a 55-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 Seasonal allergy.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERPYREXIA (105°F fever) (seriousness criterion medically significant), HEADACHE (dull headache everyday), FATIGUE (Tiredness) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERPYREXIA (105°F fever), HEADACHE (dull headache everyday), FATIGUE (Tiredness) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105 (High) 105 °F fever.         No concomitant medications were reported.  Patient's primary vaccination was J&J.  Patient thinks that the adverse events might be related to seasonal allergies.  Company comment: This case concerns a 55-year-old, female patient with no relevant medical history, who experienced the unexpected, serious event of hyperpyrexia and other associated expected, non-serious events following administration of the booster dose of the Moderna COVID-19 Vaccine. The start dates of the events were not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Of note, the patient thinks that the events might be related to seasonal allergies. However, these events are not the common symptoms of seasonal allergy. Information has been requested to further assess the case.; Sender's Comments: This case concerns a 55-year-old, female patient with no relevant medical history, who experienced the unexpected, serious event of hyperpyrexia and other associated expected, non-serious events following administration of the booster dose of the Moderna COVID-19 Vaccine. The start dates of the events were not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Of note, the patient thinks that the events might be related to seasonal allergies. However, these events are not the common symptoms of seasonal allergy. Information has been requested to further assess the case.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Achiness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achiness) and HEADACHE (Headache) 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 05-Nov-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 MYALGIA (Achiness) and HEADACHE (Headache). At the time of the report, MYALGIA (Achiness) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient wanted to find out if she can use Tylenol or Motrin for the achiness and headache.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up document contains no new information On 09-Nov-2021: Follow up document contains no new information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave 7 vaccines that were expired today from the same vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 7 vaccines that were expired today from the same vial) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 7 vaccines that were expired today from the same vial). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Gave 7 vaccines that were expired today from the same vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Interchange of vaccine products
Clinical narrative: feeling light headed; headaches; receiving Pfizer's COVID19 vaccine as a 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling light headed), INTERCHANGE OF VACCINE PRODUCTS (receiving Pfizer's COVID19 vaccine as a 2nd dose) and HEADACHE (headaches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.    Co-suspect product included non-company product BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No medical history was provided by the reporter.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (feeling light headed), INTERCHANGE OF VACCINE PRODUCTS (receiving Pfizer's COVID19 vaccine as a 2nd dose) and HEADACHE (headaches). At the time of the report, DIZZINESS (feeling light headed) and HEADACHE (headaches) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (receiving Pfizer's COVID19 vaccine as a 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient takes everyday medicine as concomitant medication. No treatment medications were provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Pruritus, Restlessness
Clinical narrative: can't sit still but I'm not sure if it is anxiety driven; muscle tension; skin feels like it's scratchy; This spontaneous case was reported by a pharmacist and describes the occurrence of RESTLESSNESS (can't sit still but I'm not sure if it is anxiety driven), MUSCLE TIGHTNESS (muscle tension) and PRURITUS (skin feels like it's scratchy) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced RESTLESSNESS (can't sit still but I'm not sure if it is anxiety driven), MUSCLE TIGHTNESS (muscle tension) and PRURITUS (skin feels like it's scratchy). At the time of the report, RESTLESSNESS (can't sit still but I'm not sure if it is anxiety driven) had not resolved and MUSCLE TIGHTNESS (muscle tension) and PRURITUS (skin feels like it's scratchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine/ Expired vaccine doses administered to unknown # of patients/Dose administered after 30-day Use By Date or after manufacturer date of expiry; 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 (Received expired vaccine/ Expired vaccine doses administered to unknown # of patients/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) 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 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine/ Expired vaccine doses administered to unknown # of patients/Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine/ Expired vaccine doses administered to unknown # of patients/Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that the moderna vaccine was received on 03 Sep 2021 and was received as frozen. Date(s) of administration of vaccine: November 1st, 2nd and 3rd of 2021 No Concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received with No new information
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: He had headaches on the same day; Second dose also in February, two  weeks a part; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (He had headaches on the same day) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose also in February, two  weeks a part) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HEADACHE (He had headaches on the same day) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose also in February, two  weeks a part). In February 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose also in February, two  weeks a part) had resolved. At the time of the report, HEADACHE (He had headaches on the same day) outcome was unknown.            No treatment medication was provided.  Patient was on concomitant medication- blood thinners, heart medications, blood pressure, cholesterol, diabetes and pain medications.   This case was linked to MOD-2021-377203.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Malaise, Palpitations, Pyrexia, Tremor
Clinical narrative: atrial fibrillation; hear started racing; shakiness; didn't feel good; fever; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation), PALPITATIONS (hear started racing), TREMOR (shakiness), MALAISE (didn't feel good) and PYREXIA (fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 013M20A and 012L20A) 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 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-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 TREMOR (shakiness), MALAISE (didn't feel good) and PYREXIA (fever). On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) and PALPITATIONS (hear started racing). In October 2021, TREMOR (shakiness), MALAISE (didn't feel good) and PYREXIA (fever) had resolved. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation) and PALPITATIONS (hear started racing) had resolved.            Concomitant medications included were cholesterol medication, sinuses medication (allergies). No treatment information was provided.  Company comment This case concerns  a 71 year old male , with no reported medical history , who experienced , Non-serious  , unexpected. AESI  event of Atrial fibrillation , which occurred  2 days after vaccination with the 3rd dose (Booster dose) of mRNA-1273 vaccine (Moderna Covid 19 Vaccine). The re-challenge for this case is not applicable since the event occurred on the 3rd dose and no additional doses will be given. The benefit risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) is not affected by this report. This case was downgraded from serious : Medically Significant to non-serious .   This case was linked to MOD-2021-377177 (Patient Link).; Sender's Comments: This case concerns  a 71 year old male , with no reported medical history , who experienced , Non-serious  , unexpected. AESI  event of Atrial fibrillation , which occurred  2 days after vaccination with the 3rd dose (Booster dose) of mRNA-1273 vaccine (Moderna Covid 19 Vaccine). The re-challenge for this case is not applicable since the event occurred on the 3rd dose and no additional doses will be given. The benefit risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) is not affected by this report. This case was downgraded from serious : Medically Significant to non-serious .
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: injection site was very painful; whole body was aching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site was very painful) and MYALGIA (whole body was aching) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A, 027L20A and 034F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (injection site was very painful) and MYALGIA (whole body was aching). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection site was very painful) and MYALGIA (whole body was aching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported. The patient experiencing side effects same after doses 1 and 2, but not as painful.   This case was linked to MOD-2021-377195, MOD-2021-377282.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of vaccination complication in a  patient of an unknown age and gender who received mRNA-1273  for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (3 other cases of autoimmune condition reactions). At the time of the report, VACCINATION COMPLICATION (3 other cases of autoimmune condition reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication given. No treatment information given.   This case was linked to MOD21-161705.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: whole body was aching (after dose 1); injection site was very painful (after dose 1); This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (whole body was aching (after dose 1)) and VACCINATION SITE PAIN (injection site was very painful (after dose 1)) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A, 031M20A and 034F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-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 MYALGIA (whole body was aching (after dose 1)) and VACCINATION SITE PAIN (injection site was very painful (after dose 1)). At the time of the report, MYALGIA (whole body was aching (after dose 1)) and VACCINATION SITE PAIN (injection site was very painful (after dose 1)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-377214, MOD-2021-377195.