chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: If he could receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (If he could receive the second dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021c4a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (If he could receive the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (If he could receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The reporter was calling on behalf of their husband who received their first dose of the Moderna vaccine on the 02-May-2021 and wanted to know if the patient could receive the 2nd dose of the Moderna vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia
Clinical narrative: heart burn; Chest pain got worse; indigestion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (heart burn), CHEST PAIN (Chest pain got worse) and DYSPEPSIA (indigestion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included Pain management (Pain medication) since an unknown date.    On 21-Jun-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 DYSPEPSIA (heart burn), CHEST PAIN (Chest pain got worse) and DYSPEPSIA (indigestion). At the time of the report, DYSPEPSIA (heart burn) and DYSPEPSIA (indigestion) outcome was unknown and CHEST PAIN (Chest pain got worse) had not resolved.            Concomitant medications- Pain medication & Tegutall NO Treatment drug reported Patient reported - stent in his heart. Patient had undergone  ultrasound of his heart and results unknown.   This case was linked to MOD-2021-262324 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: he was sick; unable to get the second dose because he was sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he was sick) and PRODUCT DOSE OMISSION ISSUE (unable to get the second dose because he was sick) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (he was sick) and PRODUCT DOSE OMISSION ISSUE (unable to get the second dose because he was sick). At the time of the report, ILLNESS (he was sick) and PRODUCT DOSE OMISSION ISSUE (unable to get the second dose because he was sick) outcome was unknown.            Patient was taking unspecified concomitant medications. Treatment information was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: past 2nd dose time; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past 2nd dose time) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-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 PRODUCT DOSE OMISSION ISSUE (past 2nd dose time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past 2nd dose time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It has been 63 days since the first dose (patient has not received second dose); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jul-2021 and was forwarded to Moderna on 21-Jul-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been 63 days since the first dose (patient has not received second 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 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 DOSE OMISSION ISSUE (It has been 63 days since the first dose (patient has not received second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been 63 days since the first dose (patient has not received second dose)) outcome was unknown.        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   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up document received on 21-JUL-2021 contains non significant follow up.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, SARS-CoV-2 test
Clinical narrative: Anosmia; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Anosmia) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Anosmia). At the time of the report, ANOSMIA (Anosmia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) SARS-CoV-2 test and negative (Negative) SARS-CoV-2 test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Have a lot of joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Have a lot of joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Have a lot of joint pain). At the time of the report, ARTHRALGIA (Have a lot of joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment information was not provided
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received dose from an expire vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from an expire vial) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-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 EXPIRED PRODUCT ADMINISTERED (patient received dose from an expire vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose from an expire vial) 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 mentioned. No treatment medication was mentioned.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: didn't follow the storage guidelines of 12 hours and used an open vial from a day or days before for her first dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (didn't follow the storage guidelines of 12 hours and used an open vial from a day or days before for her first dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (didn't follow the storage guidelines of 12 hours and used an open vial from a day or days before for her first dose). On 17-Mar-2021, EXPIRED PRODUCT ADMINISTERED (didn't follow the storage guidelines of 12 hours and used an open vial from a day or days before for her first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   This case was linked to MOD-2021-262495 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site is hot and red; Neck pain; arm started to itch bad (All this is occurring on the injection site); pain from her shoulder to her neck/Join pain/pain all the way down from elbow to fingers; knots in her arm (All this is occurring on the injection site)/upper arm looks like it could be her calf/that is how swollen it is; injection site is hot and red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is hot and red), NECK PAIN (Neck pain), VACCINATION SITE PRURITUS (arm started to itch bad (All this is occurring on the injection site)), ARTHRALGIA (pain from her shoulder to her neck/Join pain/pain all the way down from elbow to fingers) and VACCINATION SITE SWELLING (knots in her arm (All this is occurring on the injection site)/upper arm looks like it could be her calf/that is how swollen it is) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022MQ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to NSAIDs), Drug allergy (Allergic to aspirin), Drug allergy (Allergic to benadryl) and Drug allergy (Allergic to antihistamines).    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, the patient experienced VACCINATION SITE WARMTH (injection site is hot and red), NECK PAIN (Neck pain), VACCINATION SITE PRURITUS (arm started to itch bad (All this is occurring on the injection site)), ARTHRALGIA (pain from her shoulder to her neck/Join pain/pain all the way down from elbow to fingers), VACCINATION SITE SWELLING (knots in her arm (All this is occurring on the injection site)/upper arm looks like it could be her calf/that is how swollen it is) and VACCINATION SITE ERYTHEMA (injection site is hot and red). At the time of the report, VACCINATION SITE WARMTH (injection site is hot and red), NECK PAIN (Neck pain), VACCINATION SITE PRURITUS (arm started to itch bad (All this is occurring on the injection site)), ARTHRALGIA (pain from her shoulder to her neck/Join pain/pain all the way down from elbow to fingers), VACCINATION SITE SWELLING (knots in her arm (All this is occurring on the injection site)/upper arm looks like it could be her calf/that is how swollen it is) and VACCINATION SITE ERYTHEMA (injection site is hot and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication reported included xolost 100 mg once daily. Patient was prescribed steroids for treatment.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection site is hot and red; Neck pain; arm started to itch bad (All this is occurring on the injection site); pain from her shoulder to her neck/Join pain/pain all the way down from elbow to fingers; knots in her arm (All this is occurring on the injection site)/upper arm looks like it could be her calf/that is how swollen it is; injection site is hot and red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is hot and red), NECK PAIN (Neck pain), VACCINATION SITE PRURITUS (arm started to itch bad (All this is occurring on the injection site)), ARTHRALGIA (pain from her shoulder to her neck/Join pain/pain all the way down from elbow to fingers) and VACCINATION SITE SWELLING (knots in her arm (All this is occurring on the injection site)/upper arm looks like it could be her calf/that is how swollen it is) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022MQ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to NSAIDs), Drug allergy (Allergic to aspirin), Drug allergy (Allergic to benadryl) and Drug allergy (Allergic to antihistamines).    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, the patient experienced VACCINATION SITE WARMTH (injection site is hot and red), NECK PAIN (Neck pain), VACCINATION SITE PRURITUS (arm started to itch bad (All this is occurring on the injection site)), ARTHRALGIA (pain from her shoulder to her neck/Join pain/pain all the way down from elbow to fingers), VACCINATION SITE SWELLING (knots in her arm (All this is occurring on the injection site)/upper arm looks like it could be her calf/that is how swollen it is) and VACCINATION SITE ERYTHEMA (injection site is hot and red). At the time of the report, VACCINATION SITE WARMTH (injection site is hot and red), NECK PAIN (Neck pain), VACCINATION SITE PRURITUS (arm started to itch bad (All this is occurring on the injection site)), ARTHRALGIA (pain from her shoulder to her neck/Join pain/pain all the way down from elbow to fingers), VACCINATION SITE SWELLING (knots in her arm (All this is occurring on the injection site)/upper arm looks like it could be her calf/that is how swollen it is) and VACCINATION SITE ERYTHEMA (injection site is hot and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication reported included xolost 100 mg once daily. Patient was prescribed steroids for treatment.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for Covid) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (With rheumatoid factor of multiple site). Concomitant products included TOCILIZUMAB (ACTEMRA) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient reported that the Covid was getting into the lower part of her lungs.  No concomitant medications were provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: became ill; diagnosed with COVID; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became ill) and COVID-19 (diagnosed with COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (became ill) and COVID-19 (diagnosed with COVID). At the time of the report, ILLNESS (became ill) and COVID-19 (diagnosed with COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment includes Monoclonal antibody infusion
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: left knee is swollen and tight; left knee is swollen and tight; pain in knee; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (left knee is swollen and tight), JOINT STIFFNESS (left knee is swollen and tight) and ARTHRALGIA (pain in knee) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced JOINT SWELLING (left knee is swollen and tight), JOINT STIFFNESS (left knee is swollen and tight) and ARTHRALGIA (pain in knee). At the time of the report, JOINT SWELLING (left knee is swollen and tight), JOINT STIFFNESS (left knee is swollen and tight) and ARTHRALGIA (pain in knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported  Treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Myalgia, Pyrexia, Rash erythematous
Clinical narrative: a rash on her left arm which warm; a rash on her left arm which was red and warm; ran a fever for 24 hours; achy wasn't as bad as she thought it would be; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (a rash on her left arm which warm), RASH ERYTHEMATOUS (a rash on her left arm which was red and warm), PYREXIA (ran a fever for 24 hours) and MYALGIA (achy wasn't as bad as she thought it would be) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-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 FEELING HOT (a rash on her left arm which warm), RASH ERYTHEMATOUS (a rash on her left arm which was red and warm), PYREXIA (ran a fever for 24 hours) and MYALGIA (achy wasn't as bad as she thought it would be). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, FEELING HOT (a rash on her left arm which warm) and RASH ERYTHEMATOUS (a rash on her left arm which was red and warm) had resolved and PYREXIA (ran a fever for 24 hours) and MYALGIA (achy wasn't as bad as she thought it would be) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported.   This case was linked to MOD-2021-262465 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; stopped smelling; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) and ANOSMIA (stopped smelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-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 COVID-19 (tested positive for COVID-19) and ANOSMIA (stopped smelling). At the time of the report, COVID-19 (tested positive for COVID-19) and ANOSMIA (stopped smelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         In concomitant medications high blood pressure medicine was reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: arm hurts/ legs hurt a little bit; light chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts/ legs hurt a little bit) and CHILLS (light chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurts/ legs hurt a little bit) and CHILLS (light chills). At the time of the report, PAIN IN EXTREMITY (arm hurts/ legs hurt a little bit) and CHILLS (light chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Chapped lips, Lip pain, Lip pruritus, Lip swelling, Oral discomfort
Clinical narrative: swollen lips/swelling of my lips; severely chapped; burning lips; itching lips; painful lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips/swelling of my lips), CHAPPED LIPS (severely chapped), ORAL DISCOMFORT (burning lips), LIP PRURITUS (itching lips) and LIP PAIN (painful lips) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swollen lips/swelling of my lips), CHAPPED LIPS (severely chapped), ORAL DISCOMFORT (burning lips), LIP PRURITUS (itching lips) and LIP PAIN (painful lips). At the time of the report, LIP SWELLING (swollen lips/swelling of my lips), CHAPPED LIPS (severely chapped), ORAL DISCOMFORT (burning lips), LIP PRURITUS (itching lips) and LIP PAIN (painful lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of myalgia (sore arm first day improvement second day) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced myalgia (sore arm first day improvement second day). At the time of the report, myalgia (sore arm first day improvement second day) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-262532 (patient link). Most recent follow-up information incorporated: On Jul 29, 2021: Significant follow-up appended. Patient's initials and age updated.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Asthenia, COVID-19, Chills, Pyrexia
Clinical narrative: mild side effects; 3 times since then for 2-3 days each time, he experiences chills, fever and weakness/ mild symptoms; Weakness; Fever; Chills; COVID infection in April; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID infection in April), ADVERSE EVENT (mild side effects), SYMPTOM RECURRENCE (3 times since then for 2-3 days each time, he experiences chills, fever and weakness/ mild symptoms), ASTHENIA (Weakness) and PYREXIA (Fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgical intervention (Heart surgery) in 2007. Concomitant products included ATORVASTATIN, METOPROLOL, AMLODIPINE, LEVOTHYROXINE, TAMSULOSIN, HYDROCHLOROTHIAZIDE and GABAPENTIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced COVID-19 (COVID infection in April). In July 2021, the patient experienced ASTHENIA (Weakness), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced ADVERSE EVENT (mild side effects) and SYMPTOM RECURRENCE (3 times since then for 2-3 days each time, he experiences chills, fever and weakness/ mild symptoms). On 25-Apr-2021, COVID-19 (COVID infection in April) had resolved. At the time of the report, ADVERSE EVENT (mild side effects), SYMPTOM RECURRENCE (3 times since then for 2-3 days each time, he experiences chills, fever and weakness/ mild symptoms), ASTHENIA (Weakness), PYREXIA (Fever) and CHILLS (Chills) 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 treatment medication was provided. Reporter took his father to the doctor and they did some blood work which showed no signs of infection.   This case was linked to MOD-2021-262541 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received  contains significant information: email has been updated and New events are added-Mild side effects and Symptom recurrence.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Symptom recurrence
Clinical narrative: mild side effects; 3 times since then for 2-3 days each time, he experiences chills, fever and weakness/ mild symptoms; Weakness; Fever; Chills; COVID infection in April; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID infection in April), ADVERSE EVENT (mild side effects), SYMPTOM RECURRENCE (3 times since then for 2-3 days each time, he experiences chills, fever and weakness/ mild symptoms), ASTHENIA (Weakness) and PYREXIA (Fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgical intervention (Heart surgery) in 2007. Concomitant products included ATORVASTATIN, METOPROLOL, AMLODIPINE, LEVOTHYROXINE, TAMSULOSIN, HYDROCHLOROTHIAZIDE and GABAPENTIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced COVID-19 (COVID infection in April). In July 2021, the patient experienced ASTHENIA (Weakness), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced ADVERSE EVENT (mild side effects) and SYMPTOM RECURRENCE (3 times since then for 2-3 days each time, he experiences chills, fever and weakness/ mild symptoms). On 25-Apr-2021, COVID-19 (COVID infection in April) had resolved. At the time of the report, ADVERSE EVENT (mild side effects), SYMPTOM RECURRENCE (3 times since then for 2-3 days each time, he experiences chills, fever and weakness/ mild symptoms), ASTHENIA (Weakness), PYREXIA (Fever) and CHILLS (Chills) 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 treatment medication was provided. Reporter took his father to the doctor and they did some blood work which showed no signs of infection.   This case was linked to MOD-2021-262541 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received  contains significant information: email has been updated and New events are added-Mild side effects and Symptom recurrence.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients  received doses 4 week after expiration; 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 (Patients  received doses 4 week after expiration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients  received doses 4 week after expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients  received doses 4 week after expiration) 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 concomitant medications were reported No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Labyrinthitis
Clinical narrative: is having a very bad day; feeling fatigued; labyrinthitis, an inner ear thing, and it seems to come more after the shot; This spontaneous case was reported by a patient and describes the occurrence of LABYRINTHITIS (labyrinthitis, an inner ear thing, and it seems to come more after the shot), FEELING ABNORMAL (is having a very bad day) and FATIGUE (feeling fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 LABYRINTHITIS (labyrinthitis, an inner ear thing, and it seems to come more after the shot), FEELING ABNORMAL (is having a very bad day) and FATIGUE (feeling fatigued). At the time of the report, LABYRINTHITIS (labyrinthitis, an inner ear thing, and it seems to come more after the shot), FEELING ABNORMAL (is having a very bad day) and FATIGUE (feeling fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided No concomitant medication was provided
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Consumer missed 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer missed 2nd dose) in a 47-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 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Consumer missed 2nd dose) had resolved.            No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received doses 2 week after expiration; 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 doses 2 week after expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses 2 week after expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received doses 2 week after expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  It was reported that the health care professional (HCP) noted in the records that there are patients who received doses 2 week after expiration. No further information was provided.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site erythema, Injection site pruritus, Sensitive skin, Skin warm
Clinical narrative: She experienced severe itching/ continued itchy; Redness started looking bruised; arm felt warm to touch/ arm hot to touch; Arm sensitive; Redness from point of vaccination to elbow; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (She experienced severe itching/ continued itchy), CONTUSION (Redness started looking bruised), SKIN WARM (arm felt warm to touch/ arm hot to touch), SENSITIVE SKIN (Arm sensitive) and INJECTION SITE ERYTHEMA (Redness from point of vaccination to elbow) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced INJECTION SITE PRURITUS (She experienced severe itching/ continued itchy), CONTUSION (Redness started looking bruised), SKIN WARM (arm felt warm to touch/ arm hot to touch), SENSITIVE SKIN (Arm sensitive) and INJECTION SITE ERYTHEMA (Redness from point of vaccination to elbow). In July 2021, INJECTION SITE PRURITUS (She experienced severe itching/ continued itchy), CONTUSION (Redness started looking bruised), SKIN WARM (arm felt warm to touch/ arm hot to touch), SENSITIVE SKIN (Arm sensitive) and INJECTION SITE ERYTHEMA (Redness from point of vaccination to elbow) had resolved.            No relevant concomitant medications were reported.   Treatment information was not provided.   This case was linked to MOD-2021-262510 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up information included outcome of event (itching at injection site and redness at injection site) updated to recovered/resolved from unknown and new event (redness started looking bruised, arm hot to touch, arm sensitive) added. On 29-Jul-2021: Non significant Follow-up received.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm is very sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (my arm is very sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm is very sore). At the time of the report, PAIN IN EXTREMITY (my arm is very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Lightheadedness; Body aches; Chills; Fever; Headache; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jul-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Lightheadedness), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomited). At the time of the report, DIZZINESS (Lightheadedness), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomited) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Lightheadedness; Body aches; Chills; Fever; Headache; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jul-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Lightheadedness), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomited). At the time of the report, DIZZINESS (Lightheadedness), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomited) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Numbness in head; Minor headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in head) and HEADACHE (Minor headaches) in an 80-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 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 HYPOAESTHESIA (Numbness in head) and HEADACHE (Minor headaches). At the time of the report, HYPOAESTHESIA (Numbness in head) and HEADACHE (Minor headaches) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered to  patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to  patient) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to  patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to  patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant and  treatment medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.  This report refers to a case of expired product administered for mRNA-1273, lot #054C21A with no associated AEs.; Sender's Comments: This report refers to a case of expired product administered for mRNA-1273, lot #054C21A with no associated AEs.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hotness at the injection site; Pain at injection site; Redness at the injection site; Swelling at the injection site, to the size of a quarter; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hotness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site, to the size of a quarter) and CHILLS (Chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included IBUPROFEN for Migraine.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hotness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site, to the size of a quarter) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (Hotness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site, to the size of a quarter) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The patient was prescribed steroids to alleviate her condition.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: i have a gevee of 101.8 eigjt now earliee it was 100; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (i have a gevee of 101.8 eigjt now earliee it was 100) 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 20-Jul-2021 at 10:10 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced PYREXIA (i have a gevee of 101.8 eigjt now earliee it was 100). At the time of the report, PYREXIA (i have a gevee of 101.8 eigjt now earliee it was 100) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Body temperature: 100 (High) 100 and 101.8 (High) 101.8.         No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: after the second covid vaccine shots can one have side effect symptoms after 7 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (after the second covid vaccine shots can one have side effect symptoms after 7 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (after the second covid vaccine shots can one have side effect symptoms after 7 days). At the time of the report, VACCINATION COMPLICATION (after the second covid vaccine shots can one have side effect symptoms after 7 days) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Possible pregnant patient, is mordena safe for pregnant ladies; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Possible pregnant patient, is mordena safe for pregnant ladies) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Possible pregnant patient, is mordena safe for pregnant ladies). At the time of the report, EXPOSURE DURING PREGNANCY (Possible pregnant patient, is mordena safe for pregnant ladies) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.       No concomitant medications were reported No treatment medications were reported.