chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), MONTELUKAST SODIUM (SINGULAIR), NAPROXEN and OMEPRAZOLE for an unknown indication.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported. The patient was not known to be experiencing any side effects or symptoms at this time.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered as booster dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered as booster dose) in a 67-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, 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 EXPIRED PRODUCT ADMINISTERED (expired vaccine administered as booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered as booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-361756 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Pyrexia
Clinical narrative: sick after second dose; fever after second dose; chills after second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick after second dose), PYREXIA (fever after second dose) and CHILLS (chills after second dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included TIA (a couple of years ago and the left side of face and arm got numb), Myocarditis in 1963 and Pericarditis in 1963. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 07-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 an unknown date, the patient experienced ILLNESS (sick after second dose), PYREXIA (fever after second dose) and CHILLS (chills after second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (sick after second dose), PYREXIA (fever after second dose) and CHILLS (chills after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips
Clinical narrative: issues with the lips/ chronic crusting on lips; This spontaneous case was reported by a pharmacist and describes the occurrence of CHAPPED LIPS (issues with the lips/ chronic crusting on lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHAPPED LIPS (issues with the lips/ chronic crusting on lips). At the time of the report, CHAPPED LIPS (issues with the lips/ chronic crusting on lips) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Treatment included oral steroids and topical antifungals.  Patient experienced the reaction some months after the second dose
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: took a 2 hour nap; felt tired after his second Moderna Covid-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (took a 2 hour nap) and FATIGUE (felt tired after his second Moderna Covid-19 vaccination) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (took a 2 hour nap) and FATIGUE (felt tired after his second Moderna Covid-19 vaccination). At the time of the report, SOMNOLENCE (took a 2 hour nap) and FATIGUE (felt tired after his second Moderna Covid-19 vaccination) outcome was unknown.            No concomitant medications were reported   No treatment information was provided
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site swelling (swelling of arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 014MM20A and 0256C1) for COVID-19 immunization. Concurrent medical conditions included immunocompromised and Myasthenia gravis. On Feb 26, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 intramuscular; 1 dosage form. On Oct 20, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site swelling (swelling of arm). At the time of the report, vaccination site swelling (swelling of arm) resolved. No concomitant medication or treatment information provided. Reportedly, after 1st and 2nd dose for about a week and a half the patient reported swelling of arm after receiving each dose, which then resolved. The patient on the phone reports no reaction after 3rd dose, which is why she is questioning the dose this was. Also stated that unsure if the wife received a Moderna booster 3rd dose for being immunocompromised with myasthenia gravis. This case linked to MOD-2021-361631 (patient link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Electrocardiogram, Epistaxis
Clinical narrative: involuntary twitching in different parts of the body/twitching primarily area was in the throat towards left side; had diarrhea; tinnitus (actually had it before); bloody nose; dizziness; joint pain; experience fatigue; soreness of the arm for couple day/soreness continue but was minor; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (involuntary twitching in different parts of the body/twitching primarily area was in the throat towards left side), DIARRHOEA (had diarrhea), TINNITUS (tinnitus (actually had it before)), EPISTAXIS (bloody nose) and DIZZINESS (dizziness) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tinnitus (had it before). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), IBUPROFEN (MOTRIN IB), VITAMIN C [ASCORBIC ACID] and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (involuntary twitching in different parts of the body/twitching primarily area was in the throat towards left side), DIARRHOEA (had diarrhea), TINNITUS (tinnitus (actually had it before)), EPISTAXIS (bloody nose), DIZZINESS (dizziness), ARTHRALGIA (joint pain), FATIGUE (experience fatigue) and MYALGIA (soreness of the arm for couple day/soreness continue but was minor). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE TWITCHING (involuntary twitching in different parts of the body/twitching primarily area was in the throat towards left side), DIARRHOEA (had diarrhea), TINNITUS (tinnitus (actually had it before)), EPISTAXIS (bloody nose), DIZZINESS (dizziness), ARTHRALGIA (joint pain), FATIGUE (experience fatigue) and MYALGIA (soreness of the arm for couple day/soreness continue but was minor) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Sinus rhythm: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient went to Urgent Care to get fully checked on the side effect especially on the twitching and patient stated they took Claritin after 1st week but it was more for allergies but afterward it was fine. Other concomitant medications include Vitamin gummies and Claritin.   This case was linked to MOD-2021-362000 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscle twitching, Myalgia, Sinus rhythm, Tinnitus
Clinical narrative: involuntary twitching in different parts of the body/twitching primarily area was in the throat towards left side; had diarrhea; tinnitus (actually had it before); bloody nose; dizziness; joint pain; experience fatigue; soreness of the arm for couple day/soreness continue but was minor; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (involuntary twitching in different parts of the body/twitching primarily area was in the throat towards left side), DIARRHOEA (had diarrhea), TINNITUS (tinnitus (actually had it before)), EPISTAXIS (bloody nose) and DIZZINESS (dizziness) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tinnitus (had it before). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), IBUPROFEN (MOTRIN IB), VITAMIN C [ASCORBIC ACID] and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (involuntary twitching in different parts of the body/twitching primarily area was in the throat towards left side), DIARRHOEA (had diarrhea), TINNITUS (tinnitus (actually had it before)), EPISTAXIS (bloody nose), DIZZINESS (dizziness), ARTHRALGIA (joint pain), FATIGUE (experience fatigue) and MYALGIA (soreness of the arm for couple day/soreness continue but was minor). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE TWITCHING (involuntary twitching in different parts of the body/twitching primarily area was in the throat towards left side), DIARRHOEA (had diarrhea), TINNITUS (tinnitus (actually had it before)), EPISTAXIS (bloody nose), DIZZINESS (dizziness), ARTHRALGIA (joint pain), FATIGUE (experience fatigue) and MYALGIA (soreness of the arm for couple day/soreness continue but was minor) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Sinus rhythm: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient went to Urgent Care to get fully checked on the side effect especially on the twitching and patient stated they took Claritin after 1st week but it was more for allergies but afterward it was fine. Other concomitant medications include Vitamin gummies and Claritin.   This case was linked to MOD-2021-362000 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore and painful arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Very sore and painful arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20) for COVID-19 vaccination.     Concomitant products included THIAMAZOLE (METHIMAZOLE) and PROPRANOLOL for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Very sore and painful arm). At the time of the report, PAIN IN EXTREMITY (Very sore and painful arm) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported by the reporter   This case was linked to MOD-2021-361994 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Pyrexia
Clinical narrative: Fever of 101.3 degree F/fever of 100.6 degree F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.3 degree F/fever of 100.6 degree F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Patient takes medication twice a day for hypertension). Concomitant products included VALSARTAN, HYDRALAZINE, HYDROCHLOROTHIAZIDE and ATENOLOL for an unknown indication.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced PYREXIA (Fever of 101.3 degree F/fever of 100.6 degree F). The patient was treated with PARACETAMOL (TYLENOL) on 23-Oct-2021 for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 101.3 degree F/fever of 100.6 degree F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Blood pressure measurement: 160/96 (High) BP was160/96 mmHg. On 23-Oct-2021, Body temperature: 101.3 (High) 101.3 Degree Fahrenheit and 100.6 (High) 100.6 Degree Fahrenheit after an hour of taking Tylenol. On 23-Oct-2021, Heart rate: 96 (High) 96 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had reported that on October 23 2021 blood pressure was 160/96 mmHg  and his pulse was 96 beats per minute which was not typical for him. Patient also had a fever of 101.3 degree Fahrenheit, so they took some Tylenol and then after an hour, it was 100.6 degree Fahrenheit.    This case was linked to MOD-2021-361891, MOD-2021-361949 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for an unknown indication.    No Medical History information was reported.   On 18-Oct-2021, the patient received first dose of INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) (Intramuscular) 1 dosage form. On 18-Oct-2021 at 11:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021 at 11:50 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Oct-2021 at 11:50 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment details were reported.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2021.    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 RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was provided. No concomitants was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021 at 11:21 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 18-Oct-2021 at 11:21 AM, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided. 16 patients received 0.25 ml booster dose. 3 patients received 0.5 ml full dose.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu-like symptoms; Shaking chills; Aches; Fell asleep and woke up feeling fine; Chills; Low fever; Joint pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Oct-2021 and was forwarded to Moderna on 23-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), TREMOR (Shaking chills), PAIN (Aches), SOMNOLENCE (Fell asleep and woke up feeling fine) and CHILLS (Chills) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), TREMOR (Shaking chills), PAIN (Aches), SOMNOLENCE (Fell asleep and woke up feeling fine), CHILLS (Chills), PYREXIA (Low fever) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 03-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), TREMOR (Shaking chills), PAIN (Aches), CHILLS (Chills), PYREXIA (Low fever) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, SOMNOLENCE (Fell asleep and woke up feeling fine) had resolved.            No concomitant medications are provided .   This case was linked to MOD-2021-362300 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Tremor
Clinical narrative: Flu-like symptoms; Shaking chills; Aches; Fell asleep and woke up feeling fine; Chills; Low fever; Joint pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Oct-2021 and was forwarded to Moderna on 23-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), TREMOR (Shaking chills), PAIN (Aches), SOMNOLENCE (Fell asleep and woke up feeling fine) and CHILLS (Chills) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), TREMOR (Shaking chills), PAIN (Aches), SOMNOLENCE (Fell asleep and woke up feeling fine), CHILLS (Chills), PYREXIA (Low fever) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 03-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), TREMOR (Shaking chills), PAIN (Aches), CHILLS (Chills), PYREXIA (Low fever) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, SOMNOLENCE (Fell asleep and woke up feeling fine) had resolved.            No concomitant medications are provided .   This case was linked to MOD-2021-362300 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Illness
Clinical narrative: extreme dizziness; weakness; I am sick; I am almost dying here; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness), ASTHENIA (weakness), ILLNESS (I am sick) and FEELING ABNORMAL (I am almost dying here) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (extreme dizziness), ASTHENIA (weakness), ILLNESS (I am sick) and FEELING ABNORMAL (I am almost dying here). At the time of the report, DIZZINESS (extreme dizziness), ASTHENIA (weakness), ILLNESS (I am sick) and FEELING ABNORMAL (I am almost dying here) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.   Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Spotting for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Spotting for 2 days) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Spotting for 2 days). At the time of the report, VACCINATION COMPLICATION (Spotting for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-363522 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Added reporter information. Patient information updated. Added product information. Event information updated.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: all the glands in his lower area got really large; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (all the glands in his lower area got really large) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced LYMPHADENOPATHY (all the glands in his lower area got really large). At the time of the report, LYMPHADENOPATHY (all the glands in his lower area got really large) outcome was unknown.            High blood pressure concomitant medications were reported. Steroids were given as treatment.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Felt a little headachy; Tiny fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Felt a little headachy) and PYREXIA (Tiny fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Ventricular contractions premature (Patient had Pre ventricular contractions) and Hormone replacement therapy (low dose bioidentical hormone replacement, since their late 40s.).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HEADACHE (Felt a little headachy) and PYREXIA (Tiny fever). At the time of the report, HEADACHE (Felt a little headachy) and PYREXIA (Tiny fever) 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 was reported.  No treatment medications were reported.   This case was linked to MOD-2021-362429 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling at the injection site; redness at the injection site; tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (tenderness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Blood cholesterol abnormal and AFib. Concomitant products included SIMVASTATIN for an unknown indication.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (tenderness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (tenderness at the injection site) had resolved.            The patient was also using steroid for asthma.   The patient was very active, did yoga and she used to stretching.   This case was linked to MOD-2021-361771, MOD-2021-362552 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling at the location; Redness; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the location), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Tenderness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A29A) for COVID-19 vaccination.     The patient's past medical history included AFib. Concurrent medical conditions included Asthma and Cholesterol. Concomitant products included SIMVASTATIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling at the location), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Tenderness). At the time of the report, VACCINATION SITE SWELLING (Swelling at the location), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported also included steroids for their asthma. No treatment information was provided.  The patient post receiving their first dose of vaccine experienced swelling at the location and developed redness and tenderness that lasted might be for 4 days.  The patient reported that they were taking steroids for their asthma condition. The patient also mentioned that they were very active, did yoga, and used to stretch.   This case was linked to MOD-2021-361771, MOD-2021-362546 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-355973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-355973:Original cluster case-MOD-2021-355973
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: breakthrough COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (breakthrough COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (breakthrough COVID-19). At the time of the report, COVID-19 (breakthrough COVID-19) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  This spontaneous report concerns a male patient of unknown age with no relevant medical history who experienced a non-serious unexpected event of COVID-19 (breakthrough COVID-19 infection). The event occurred unknown duration after receiving the second dose of mRNA-1273. As per the report, the patient was fully vaccinated with mRNA-1273. However, there is no information on first dose of the vaccine or on the latency between the two doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-362734 (Patient Link).; Sender's Comments: This spontaneous report concerns a male patient of unknown age with no relevant medical history who experienced a non-serious unexpected event of COVID-19 (breakthrough COVID-19 infection). The event occurred unknown duration after receiving the second dose of mRNA-1273. As per the report, the patient was fully vaccinated with mRNA-1273. However, there is no information on first dose of the vaccine or on the latency between the two doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication provided The Moderna vial (10 dose, 0.5ml) was removed from the freezer to the refrigerator on 10-11-2021 without any temperature variations in the transfer from the freezer. The solution was off white in color.  No variation in color from all the other previously used vials. 16 patients received 0.25 ml booster dose. 3 patients received 0.5 ml full dose.   This case was linked to US-MODERNATX, INC.-MOD-2021-355973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-355973:cluster master file MOD-2021-355973
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: he got a lump on his arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE MASS (he got a lump on his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (he got a lump on his arm). At the time of the report, VACCINATION SITE MASS (he got a lump on his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got the flu shot 4 years ago and I was sick for 10 days; Initial information received on 22-Oct-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional under reference number: US-SA-SAC20211027000289. This case involves an unknown age and unknown gender patient who was administered the flu shot 4 years ago and i was sick for 10 days (Illness) while receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event got the flu shot 4 years ago and i was sick for 10 days (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the patient was recovered from the event.  There was be no information on the batch number for this case.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Feeling cold, Nausea
Clinical narrative: Severe nausea,  temp of 103, severe cold flashes
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: The patient developed erythema 4 to 6 inches below the injection site of PNEUMOVAX 23; This spontaneous report was received from a pharmacist concerning a 67-year-old male patient. Pertinent medical history and concomitant therapy was unknown. There were no drug reactions/ allergies.  On 20-OCT-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # U010533, expiration date reported and confirm upon internal validation; strength was unknown) 0.5 mL, once, intramuscularly for vaccination.    On 21-OCT-2021, the patient developed erythema 4 to 6 inches below the injection site of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). The patient saw the pharmacist. The treatment was not given for the events. No lab diagnostics/studies was performed. The outcome of erythema was reported as recovering/resolving. The causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold, Pain
Clinical narrative: achy; wicked cold in the night; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2021, the patient received the 2nd dose of Shingrix. In October 2021, less than a day after receiving Shingrix, the patient experienced pain and feeling cold. On an unknown date, the outcome of the pain and feeling cold were unknown.   It was unknown if the reporter considered the pain and feeling cold to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Shingrix and was wicked cold in the night and achy. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Asthenia, Decreased appetite, Discharge, Herpes zoster
Clinical narrative: Very painful; no taste and appetite; no taste and appetite; no energy; sores were big and oozing; sores were big and oozing; Rash; sick; Got shingles June 6th (after both vaccine shots).\ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On 6th June 2021, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain, appetite absent, taste absent, loss of energy, skin ulcer, discharge, rash and sickness. On an unknown date, the outcome of the vaccination failure, shingles, pain, appetite absent, taste absent, loss of energy, skin ulcer, discharge and sickness were unknown and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, pain, appetite absent, taste absent, loss of energy, skin ulcer, discharge, rash and sickness to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got shingles after both Shingles vaccine shots. The patient stated he/she very painful, no taste and appetite, no energy and sores were big and oozing. The rash was just leaving and starting to feel normal. It was told vaccine could had aggravated the shingles as had the virus in our body. Had been so sick. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Pain, Rash, Skin ulcer, Vaccination failure
Clinical narrative: Very painful; no taste and appetite; no taste and appetite; no energy; sores were big and oozing; sores were big and oozing; Rash; sick; Got shingles June 6th (after both vaccine shots).\ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On 6th June 2021, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain, appetite absent, taste absent, loss of energy, skin ulcer, discharge, rash and sickness. On an unknown date, the outcome of the vaccination failure, shingles, pain, appetite absent, taste absent, loss of energy, skin ulcer, discharge and sickness were unknown and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, pain, appetite absent, taste absent, loss of energy, skin ulcer, discharge, rash and sickness to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got shingles after both Shingles vaccine shots. The patient stated he/she very painful, no taste and appetite, no energy and sores were big and oozing. The rash was just leaving and starting to feel normal. It was told vaccine could had aggravated the shingles as had the virus in our body. Had been so sick. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Electric shock sensation
Clinical narrative: Neurological electrical shock; dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of electric shock sensation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had twice in his/her life).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced electric shock sensation and dizziness. On an unknown date, the outcome of the electric shock sensation and dizziness were recovered/resolved.   It was unknown if the reporter considered the electric shock sensation and dizziness to be related to Shingrix.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that Shingrix vaccine had caused horrible problems. The patient experienced neurological electrical shocks all over the body and dizziness. The patient stated that the symptoms had lasted 4 months at the time of reporting. The patient did not wish to received 2nd vaccine. The follow-up would not be possible as no contact details available.
Age: 36.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: received both doses; second dose less than 2 month apart of the 1 dose; - received both doses; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 36-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number AP545, expiry date 25th January 2023) and (batch number KS4T7, expiry date unknown) for prophylaxis.   On 19th October 2021, the patient received the 1st dose of Shingrix. On 3rd September 2021, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 3rd September 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 19th October 2021, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and drug dose administration interval too short were unknown.  Additional details were provided as follows: The patient received 1st dose on 3rd September 2021, batch number AP545 expiry date 25th January 2023, batch number KS4T7. The patient received 2nd dose of Shingrix less than 2 month apart of the 1 dose, which led to shortening of vaccination schedule. The patient received 1st and 2nd dose of shingrix at the age of 36 years old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.