chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: every time she drinks something it makes her stomach turn.; can't eat and unable to keep food or solids down. She reported that she is just able to drink fluids currently; wakes up in cold sweats at night; she became "queasy",; the chills like a burning cold sensation inside of her body; nausea; fever; headache; pain in right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in right arm), FEEDING DISORDER (can't eat and unable to keep food or solids down. She reported that she is just able to drink fluids currently), COLD SWEAT (wakes up in cold sweats at night), NAUSEA (she became "queasy",) and CHILLS (the chills like a burning cold sensation inside of her body) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine on 16-Mar-2021 and Pfizer COVID-19 vaccine on 07-Apr-2021.    On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN IN EXTREMITY (pain in right arm), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache). On 21-Aug-2021, the patient experienced FEEDING DISORDER (can't eat and unable to keep food or solids down. She reported that she is just able to drink fluids currently), COLD SWEAT (wakes up in cold sweats at night), NAUSEA (she became "queasy",) and CHILLS (the chills like a burning cold sensation inside of her body). On 24-Aug-2021, the patient experienced VOMITING (every time she drinks something it makes her stomach turn.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 18-Aug-2021, PAIN IN EXTREMITY (pain in right arm), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache) had resolved. At the time of the report, FEEDING DISORDER (can't eat and unable to keep food or solids down. She reported that she is just able to drink fluids currently) and COLD SWEAT (wakes up in cold sweats at night) outcome was unknown and NAUSEA (she became "queasy",), CHILLS (the chills like a burning cold sensation inside of her body) and VOMITING (every time she drinks something it makes her stomach turn.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On 22-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.         The patient was not taking any concomitant medications.  Patient stated that the doctor ordered some tests for her, but the results were not come back yet and mentioned her doctor thought the events could be associated with a stomach bug but was unsure.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site 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.   In February 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.            No concomitant medications reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: fully vaccinated but recently tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (fully vaccinated but recently tested positive for 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 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 COVID-19 (fully vaccinated but recently tested positive for COVID-19). At the time of the report, COVID-19 (fully vaccinated but recently tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant drug details were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: The caller has not received a 2nd dose and it is beyond 35 days after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (The caller has not received a 2nd dose and it is beyond 35 days after 1st dose) 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 31-Jan-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 (The caller has not received a 2nd dose and it is beyond 35 days after 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (The caller has not received a 2nd dose and it is beyond 35 days after 1st dose) outcome 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 details were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had a headache for two days and everything resolved itself; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (had a headache for two days and everything resolved itself) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (had a headache for two days and everything resolved itself). On 27-Mar-2021, HEADACHE (had a headache for two days and everything resolved itself) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided  No treatment medications were provided.     This case was linked to MOD-2021-295311 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received her 1st dose on 04Jan2021 and 2nd dose on 30Jul2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her 1st dose on 04Jan2021 and 2nd dose on 30Jul2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her 1st dose on 04Jan2021 and 2nd dose on 30Jul2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her 1st dose on 04Jan2021 and 2nd dose on 30Jul2021) had resolved.            Concomitant medication was not provided. Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: in the refrigerator for more than 12 hours; Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (in the refrigerator for more than 12 hours) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (in the refrigerator for more than 12 hours). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved. At the time of the report, PRODUCT STORAGE ERROR (in the refrigerator for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Pain in extremity, Vaccination site mass, Vaccination site pain
Clinical narrative: slightly raised red bump at the injection site; stiffness in the arm; pain in the arm is aching; experiencing pain in the arm at the injection site; previously had a headache which was very aggravating and lasted 6 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (slightly raised red bump at the injection site), MUSCULOSKELETAL STIFFNESS (stiffness in the arm), PAIN IN EXTREMITY (pain in the arm is aching), VACCINATION SITE PAIN (experiencing pain in the arm at the injection site) and HEADACHE (previously had a headache which was very aggravating and lasted 6 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE MASS (slightly raised red bump at the injection site), MUSCULOSKELETAL STIFFNESS (stiffness in the arm), PAIN IN EXTREMITY (pain in the arm is aching), VACCINATION SITE PAIN (experiencing pain in the arm at the injection site) and HEADACHE (previously had a headache which was very aggravating and lasted 6 days). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (slightly raised red bump at the injection site), MUSCULOSKELETAL STIFFNESS (stiffness in the arm) and VACCINATION SITE PAIN (experiencing pain in the arm at the injection site) outcome was unknown, PAIN IN EXTREMITY (pain in the arm is aching) had not resolved and HEADACHE (previously had a headache which was very aggravating and lasted 6 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was stated that tylenol for the headache, but she was constantly taking it every day, and the headache kept coming back.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of inappropriate schedule of product administration (patient received the first dose and never got the second one/came in March for the first one and for the second one in August) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. August 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In August 2021, patient experienced inappropriate schedule of product administration (patient received the first dose and never got the second one/came in March for the first one and for the second one in August). In August 2021, inappropriate schedule of product administration (patient received the first dose and never got the second one/came in March for the first one and for the second one in August) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered and temperature exposure > 24 hours; Vaccine administered and temperature exposure > 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered and temperature exposure > 24 hours) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered and temperature exposure > 24 hours) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021 at 10:10 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered and temperature exposure > 24 hours) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered and temperature exposure > 24 hours). On 20-Aug-2021, PRODUCT STORAGE ERROR (Vaccine administered and temperature exposure > 24 hours) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered and temperature exposure > 24 hours) 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.   Concomitant product use was not provided by the reporter.   Reporter explained the events as the opened vial of Moderna COVID-19 Vaccine was sitting in the refrigerator for 9 days. The vial was punctured on 11AUG2021and supposed to be thrown out, but it was accidentally put back in the fridge.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up document was received on 26-AUG-2021 and contains reporters email address. On 04-Sep-2021: Additional information received on 04 Sep 2021 contains new significant information. Reporter details updated, Product details updated and onset date updated.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Off label use, Vaccination site pain
Clinical narrative: Pain at injection site for 3rd dose; 3rd dose given to patient who is not immunocompromised; 3rd dose interchanged with Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site for 3rd dose), OFF LABEL USE (3rd dose given to patient who is not immunocompromised) and INTERCHANGE OF VACCINE PRODUCTS (3rd dose interchanged with Pfizer vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.   Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History Information was reported.  Concomitant products included LISINOPRIL, CLOPIDOGREL BISULFATE (PLAVIX) and ATORVASTATIN for an unknown indication.   On 02-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site for 3rd dose), OFF LABEL USE (3rd dose given to patient who is not immunocompromised) and INTERCHANGE OF VACCINE PRODUCTS (3rd dose interchanged with Pfizer vaccine). On 21-Aug-2021, OFF LABEL USE (3rd dose given to patient who is not immunocompromised) and INTERCHANGE OF VACCINE PRODUCTS (3rd dose interchanged with Pfizer vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at injection site for 3rd dose) outcome was unknown.            No treatment medications were reported.  Symptoms: It was reported that patient received first two doses Pfizer vaccine and experienced events, patient was not immunocompromised and received 3rd dose of vaccine as Moderna Vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days passed since the first dose without getting the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days passed since the first dose without getting the second dose) 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 27-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 (More than 36 days passed since the first dose without getting the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days passed since the first dose without getting the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Loss of personal independence in daily activities, Nausea
Clinical narrative: coma type sleep; stomach abdominal cramps; rash on face; nose swelled up; sore inside of nose; can't do normal activity.; feeling weak; very tired; Nauseous; vomiting a few times; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (coma type sleep), ABDOMINAL PAIN UPPER (stomach abdominal cramps), RASH (rash on face), SWELLING (nose swelled up) and RHINALGIA (sore inside of nose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included DOXYCYCLINE for an unknown indication.    On 12-Aug-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 SOMNOLENCE (coma type sleep), ABDOMINAL PAIN UPPER (stomach abdominal cramps), RASH (rash on face), SWELLING (nose swelled up), RHINALGIA (sore inside of nose), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't do normal activity.), ASTHENIA (feeling weak), FATIGUE (very tired), NAUSEA (Nauseous) and VOMITING (vomiting a few times). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (coma type sleep), ABDOMINAL PAIN UPPER (stomach abdominal cramps), RASH (rash on face), SWELLING (nose swelled up), RHINALGIA (sore inside of nose), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't do normal activity.), ASTHENIA (feeling weak), FATIGUE (very tired), NAUSEA (Nauseous) and VOMITING (vomiting a few times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported having an autoimmune condition
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rhinalgia, Somnolence, Swelling, Vomiting
Clinical narrative: coma type sleep; stomach abdominal cramps; rash on face; nose swelled up; sore inside of nose; can't do normal activity.; feeling weak; very tired; Nauseous; vomiting a few times; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (coma type sleep), ABDOMINAL PAIN UPPER (stomach abdominal cramps), RASH (rash on face), SWELLING (nose swelled up) and RHINALGIA (sore inside of nose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included DOXYCYCLINE for an unknown indication.    On 12-Aug-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 SOMNOLENCE (coma type sleep), ABDOMINAL PAIN UPPER (stomach abdominal cramps), RASH (rash on face), SWELLING (nose swelled up), RHINALGIA (sore inside of nose), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't do normal activity.), ASTHENIA (feeling weak), FATIGUE (very tired), NAUSEA (Nauseous) and VOMITING (vomiting a few times). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (coma type sleep), ABDOMINAL PAIN UPPER (stomach abdominal cramps), RASH (rash on face), SWELLING (nose swelled up), RHINALGIA (sore inside of nose), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't do normal activity.), ASTHENIA (feeling weak), FATIGUE (very tired), NAUSEA (Nauseous) and VOMITING (vomiting a few times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported having an autoimmune condition
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Sore arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nausea) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nausea) was resolving.            No Concomitant medications were reported   No Treatment information was received   This case was linked to MOD-2021-295486 (E2B Linked Report). This case was linked to MOD-2021-011799, MOD-2021-066100 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow-up contains Event outcome updated.; Sender's Comments:  MOD-2021-295486:same reporter, same event and different patient
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Had the same thing (arm was red, hot, hard and itchy at injection site); Had the same thing (arm was red, hot, hard and itchy at injection site); Had the same thing (arm was red, hot, hard and itchy at injection site); Had the same thing (arm was red, hot, hard and itchy at injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Had the same thing (arm was red, hot, hard and itchy at injection site)), VACCINATION SITE INDURATION (Had the same thing (arm was red, hot, hard and itchy at injection site)), VACCINATION SITE PRURITUS (Had the same thing (arm was red, hot, hard and itchy at injection site)) and VACCINATION SITE ERYTHEMA (Had the same thing (arm was red, hot, hard and itchy at injection site)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 WARMTH (Had the same thing (arm was red, hot, hard and itchy at injection site)), VACCINATION SITE INDURATION (Had the same thing (arm was red, hot, hard and itchy at injection site)), VACCINATION SITE PRURITUS (Had the same thing (arm was red, hot, hard and itchy at injection site)) and VACCINATION SITE ERYTHEMA (Had the same thing (arm was red, hot, hard and itchy at injection site)). At the time of the report, VACCINATION SITE WARMTH (Had the same thing (arm was red, hot, hard and itchy at injection site)), VACCINATION SITE INDURATION (Had the same thing (arm was red, hot, hard and itchy at injection site)), VACCINATION SITE PRURITUS (Had the same thing (arm was red, hot, hard and itchy at injection site)) and VACCINATION SITE ERYTHEMA (Had the same thing (arm was red, hot, hard and itchy at injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment medications reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine administered to patient; She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours). On 24-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 24-Aug-2021, PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was unknown. The treatment information was not provided by the reporter.  Dose was administered using the expired punctured vial beyond 12 hours.  Injected the expired Moderna COVID-19 vaccine to 7 patients.  Number of doses/vials.  7 doses/ 1 vial; Total amount of time the vial was exposed to Refrigerator temperature: Greater than 12 hours in the refrigerator.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours; Expired vaccine administered to patient; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours). On 23-Aug-2021, PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours) had resolved. On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided  On 24AUG2021, They Injected the expired Moderna COVID-19 vaccine to 7 patients between 8AM - 11:30AM. Number of doses/vials : 7 doses/ 1 vial. Date the vial was initially stored in the refrigerator : 23AUG2021.  Total amount of time the vial was exposed to Refrigerator temperature: Greater than 12 hours in the refrigerator. The nurse states that the vial was placed in the sharps container by now.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Intentional dose omission, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: 36 days after first shot and has not received the second shot; Fever 101.5  F; Body ache; Slight cough; Congestion; Positive COVID Test; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.5  F), MYALGIA (Body ache), COUGH (Slight cough), NASAL CONGESTION (Congestion) and SARS-COV-2 ANTIBODY TEST POSITIVE (Positive COVID Test) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PYREXIA (Fever 101.5  F), MYALGIA (Body ache), COUGH (Slight cough), NASAL CONGESTION (Congestion) and SARS-COV-2 ANTIBODY TEST POSITIVE (Positive COVID Test). On 24-Aug-2021, the patient experienced INTENTIONAL DOSE OMISSION (36 days after first shot and has not received the second shot). On 04-Aug-2021, PYREXIA (Fever 101.5  F), MYALGIA (Body ache), COUGH (Slight cough) and NASAL CONGESTION (Congestion) had resolved. At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (Positive COVID Test) outcome was unknown and INTENTIONAL DOSE OMISSION (36 days after first shot and has not received the second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 antibody test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications were reported. no treatment drugs were reported. Symptoms went away after 4 days. She did a COVID test at a local pharmacy on 01AUG2021 COVID  test result came back positive for COVID-19 Disease on 02AUG2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive
Clinical narrative: 36 days after first shot and has not received the second shot; Fever 101.5  F; Body ache; Slight cough; Congestion; Positive COVID Test; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.5  F), MYALGIA (Body ache), COUGH (Slight cough), NASAL CONGESTION (Congestion) and SARS-COV-2 ANTIBODY TEST POSITIVE (Positive COVID Test) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PYREXIA (Fever 101.5  F), MYALGIA (Body ache), COUGH (Slight cough), NASAL CONGESTION (Congestion) and SARS-COV-2 ANTIBODY TEST POSITIVE (Positive COVID Test). On 24-Aug-2021, the patient experienced INTENTIONAL DOSE OMISSION (36 days after first shot and has not received the second shot). On 04-Aug-2021, PYREXIA (Fever 101.5  F), MYALGIA (Body ache), COUGH (Slight cough) and NASAL CONGESTION (Congestion) had resolved. At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (Positive COVID Test) outcome was unknown and INTENTIONAL DOSE OMISSION (36 days after first shot and has not received the second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 antibody test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications were reported. no treatment drugs were reported. Symptoms went away after 4 days. She did a COVID test at a local pharmacy on 01AUG2021 COVID  test result came back positive for COVID-19 Disease on 02AUG2021.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Intercepted product administration error
Clinical narrative: vaccine was given from a vial punctured more than 12 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCEPTED PRODUCT ADMINISTRATION ERROR (vaccine was given from a vial punctured more than 12 hours ago) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced INTERCEPTED PRODUCT ADMINISTRATION ERROR (vaccine was given from a vial punctured more than 12 hours ago). On 20-Aug-2021, INTERCEPTED PRODUCT ADMINISTRATION ERROR (vaccine was given from a vial punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was picked from the hospital which is 5 minutes away from the vaccination site. After this 5 minutes vial was put in the refrigerator on 17Aug2021. It was punctured on 18Aug2021 and dose was given on 20Aug2021. Vial had not suffered any temperature excursion and was had been less than 24 hours exposed to room temperature. No concomitant medications were provided by reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Vaccination complication
Clinical narrative: "not feeling great"; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("not feeling great") and HEADACHE (headaches) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION ("not feeling great") and HEADACHE (headaches). The patient was treated with LOSARTAN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION ("not feeling great") and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) increased.         Sometime in April the patient stopped taking losartan and he said he was feeling fine.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstruation delayed, Pregnancy test
Clinical narrative: 4 moths since last period; Got second dose recently on 07Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (4 moths since last period) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose recently on 07Aug2021) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 025A2114) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovarian syndrome.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose recently on 07Aug2021). On an unknown date, the patient experienced MENSTRUATION DELAYED (4 moths since last period). On 07-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose recently on 07Aug2021) had resolved. At the time of the report, MENSTRUATION DELAYED (4 moths since last period) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: negative (Negative) Not pregnant.         No concomitant medications were reported. No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Achiness; Tiredness; Slight soreness in my upper left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slight soreness in my upper left arm), PAIN (Achiness) and FATIGUE (Tiredness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to metals and Diabetes since 01-Aug-2019. Concomitant products included METFORMIN from 01-Aug-2019 to an unknown date, GLIPIZIDE from 15-Aug-2019 to an unknown date and EMPAGLIFLOZIN (JARDIANCE) from 07-Jan-2021 to an unknown date for Diabetes.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021 at 10:30 AM, 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 PAIN IN EXTREMITY (Slight soreness in my upper left arm), PAIN (Achiness) and FATIGUE (Tiredness). At the time of the report, PAIN IN EXTREMITY (Slight soreness in my upper left arm), PAIN (Achiness) and FATIGUE (Tiredness) had resolved. Not Provided          Treatment information was not provided by the reporter.  other concomitant medications included centrum silver multi-vitamin from 01-jan-2016 and still ongoing,  it was used for general health purpose and taken orally 1 per day and Ester-c vitamin was taken from 01-jan-2003 and still ongoing, it was used for Immune system health  and taken orally 500mg/1 per day.   This case was linked to MOD-2021-056082 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypersomnia, Movement disorder, Pain in extremity
Clinical narrative: sleeping non stop 15 hours per day, and cannot stay awake; Arm was also sore; Every time he woke up, his body would shut down.; He reports that after the vaccine, he feels drained, and depleted of energy completed.; He is very fatigued, and cannot drink coffee to help with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping non stop 15 hours per day, and cannot stay awake), PAIN IN EXTREMITY (Arm was also sore), MOVEMENT DISORDER (Every time he woke up, his body would shut down.), ASTHENIA (He reports that after the vaccine, he feels drained, and depleted of energy completed.) and FATIGUE (He is very fatigued, and cannot drink coffee to help with fatigue) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Degeneration of intervertebral disc, site unspecified and Supraventricular tachycardia. Concomitant products included ALPRAZOLAM and CLONAZEPAM for Anxiety, ASPIRIN [ACETYLSALICYLIC ACID] for Degeneration of intervertebral disc, site unspecified.    On 16-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 HYPERSOMNIA (sleeping non stop 15 hours per day, and cannot stay awake), PAIN IN EXTREMITY (Arm was also sore), MOVEMENT DISORDER (Every time he woke up, his body would shut down.), ASTHENIA (He reports that after the vaccine, he feels drained, and depleted of energy completed.) and FATIGUE (He is very fatigued, and cannot drink coffee to help with fatigue). At the time of the report, HYPERSOMNIA (sleeping non stop 15 hours per day, and cannot stay awake), ASTHENIA (He reports that after the vaccine, he feels drained, and depleted of energy completed.) and FATIGUE (He is very fatigued, and cannot drink coffee to help with fatigue) had not resolved and PAIN IN EXTREMITY (Arm was also sore) and MOVEMENT DISORDER (Every time he woke up, his body would shut down.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: They gave a patient his 2nd dose yesterday, 23Aug2021 after giving him his first dose on 2Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They gave a patient his 2nd dose yesterday, 23Aug2021 after giving him his first dose on 2Aug2021) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They gave a patient his 2nd dose yesterday, 23Aug2021 after giving him his first dose on 2Aug2021). On 23-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They gave a patient his 2nd dose yesterday, 23Aug2021 after giving him his first dose on 2Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Sore arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) and NAUSEA (Nausea) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm) and NAUSEA (Nausea). At the time of the report, MYALGIA (Sore arm) and NAUSEA (Nausea) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-295365 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-295365:same reporter, same event and different patient