chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain, Vaccination site warmth
Clinical narrative: Patient did not go back to get the second dose; In the arm of the injection, soreness; a hot feeling that moved down the arm like someone poured hot water down their arm; This case was received via Regulatory Agency (Reference number: US-irms-MOD21-125987) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a hot feeling that moved down the arm like someone poured hot water down their arm), PRODUCT DOSE OMISSION ISSUE (patient did not go back to get the second dose) and VACCINATION SITE PAIN (in the arm of the injection, soreness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (a hot feeling that moved down the arm like someone poured hot water down their arm) and VACCINATION SITE PAIN (in the arm of the injection, soreness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient did not go back to get the second dose). At the time of the report, VACCINATION SITE WARMTH (a hot feeling that moved down the arm like someone poured hot water down their arm) and VACCINATION SITE PAIN (in the arm of the injection, soreness) had resolved and PRODUCT DOSE OMISSION ISSUE (patient did not go back to get the second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over his body) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In June 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. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash all over his body). At the time of the report, RASH (Rash all over his body) outcome was unknown.            After the symptoms started patient went to see an allergist to do a scratch test for food and environmental allergy. The test indicated that he was not allergic to anything. The only thing he can relate the reaction to was the vaccine.  No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Intentional product use issue
Clinical narrative: I had difficulty in breathing after I took the first one; If I decide to take the second vaccine is it still going to be effective like if I took it when I supposed to take it on April 10, 2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I had difficulty in breathing after I took the first one) and INTENTIONAL PRODUCT USE ISSUE (If I decide to take the second vaccine is it still going to be effective like if I took it when I supposed to take it on April 10, 2021) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (I had difficulty in breathing after I took the first one) and INTENTIONAL PRODUCT USE ISSUE (If I decide to take the second vaccine is it still going to be effective like if I took it when I supposed to take it on April 10, 2021). At the time of the report, DYSPNOEA (I had difficulty in breathing after I took the first one) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (If I decide to take the second vaccine is it still going to be effective like if I took it when I supposed to take it on April 10, 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received Pfizer vaccine as 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer vaccine as 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer vaccine as 2nd dose). On 03-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer vaccine as 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a dose from an expired vial was given to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose from an expired vial was given to a patient) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, METFORMIN, PRAVASTATIN and TAMSULOSIN for an unknown indication.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose from an expired vial was given to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose from an expired vial was given to a patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatments were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Vaccination complication
Clinical narrative: even at 70° F and a small walk, she starts sweating "like a little piglet"; serious side effect to something; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (even at 70° F and a small walk, she starts sweating "like a little piglet") and VACCINATION COMPLICATION (serious side effect to something) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 HYPERHIDROSIS (even at 70° F and a small walk, she starts sweating "like a little piglet") and VACCINATION COMPLICATION (serious side effect to something). At the time of the report, HYPERHIDROSIS (even at 70° F and a small walk, she starts sweating "like a little piglet") and VACCINATION COMPLICATION (serious side effect to something) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Small dose of thyroid medication as concomitant drug.  No treatment drug information was provided by reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Neck pain, Tinnitus
Clinical narrative: tinnitus; soreness of the neck; lymph nodes in the back of her neck achy,lymph nodes in the shoulders achy; soreness of the shoulders; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), NECK PAIN (soreness of the neck), LYMPH NODE PAIN (lymph nodes in the back of her neck achy,lymph nodes in the shoulders achy) and ARTHRALGIA (soreness of the shoulders) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus), NECK PAIN (soreness of the neck), LYMPH NODE PAIN (lymph nodes in the back of her neck achy,lymph nodes in the shoulders achy) and ARTHRALGIA (soreness of the shoulders). At the time of the report, TINNITUS (tinnitus), NECK PAIN (soreness of the neck), LYMPH NODE PAIN (lymph nodes in the back of her neck achy,lymph nodes in the shoulders achy) and ARTHRALGIA (soreness of the shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included inhaler for Asthma.  No treatment medication provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Three patients were administered a single dose of the Moderna COVID-19 vaccine from a vial that had been punctured and stored for greater than 12 hours.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Three patients were administered a single dose of the Moderna COVID-19 vaccine from a vial that had been punctured and stored for greater than 12 hours.) 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 31-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Three patients were administered a single dose of the Moderna COVID-19 vaccine from a vial that had been punctured and stored for greater than 12 hours.). On 31-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Three patients were administered a single dose of the Moderna COVID-19 vaccine from a vial that had been punctured and stored for greater than 12 hours.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles long after second shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles long after second shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced HERPES ZOSTER (Shingles long after second shot). The patient was treated with ACYCLOVIR [ACICLOVIR] for Antiviral treatment, at an unspecified dose and frequency and ACRIVASTINE (BENADRYL OTC) for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles long after second shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.   This case was linked to MOD-2021-276555 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: vertigo; headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced VERTIGO (vertigo). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, VERTIGO (vertigo) and HEADACHE (headache) outcome was unknown.            Concomitantly the patient was on unspecified medications for blood pressure.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Seasonal allergy, Vaccination site pain
Clinical narrative: had the worst hay fever symptoms she has ever had in her life; clothes on her body/could not feel feet in shoes/could not feel pressure; sore at the injection site for a couple days; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (had the worst hay fever symptoms she has ever had in her life), HYPOAESTHESIA (clothes on her body/could not feel feet in shoes/could not feel pressure) and VACCINATION SITE PAIN (sore at the injection site for a couple days) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No specified medical history has been reported.  Concomitant products included ESTRADIOL and PROGESTERONE for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced SEASONAL ALLERGY (had the worst hay fever symptoms she has ever had in her life), HYPOAESTHESIA (clothes on her body/could not feel feet in shoes/could not feel pressure) and VACCINATION SITE PAIN (sore at the injection site for a couple days). At the time of the report, SEASONAL ALLERGY (had the worst hay fever symptoms she has ever had in her life) and VACCINATION SITE PAIN (sore at the injection site for a couple days) had resolved and HYPOAESTHESIA (clothes on her body/could not feel feet in shoes/could not feel pressure) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided. she was taking supplements
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included GABAPENTIN for Inflammation, NAPROXEN for Pain inflammation activated.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE PAIN (Sore at injection site). At the time of the report, VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pyrexia, Vaccination site pain
Clinical narrative: started to get a little bit of fever; Inappropriate schedule of vaccine administered; Tiredness; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), FATIGUE (Tiredness), VACCINATION SITE PAIN (vaccination site pain) and PYREXIA (started to get a little bit of fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL and PROGESTERONE for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), FATIGUE (Tiredness) and VACCINATION SITE PAIN (vaccination site pain). On an unknown date, the patient experienced PYREXIA (started to get a little bit of fever). The patient was treated with IBUPROFEN for Fever, at a dose of UNK dosage form. On 19-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, FATIGUE (Tiredness), VACCINATION SITE PAIN (vaccination site pain) and PYREXIA (started to get a little bit of fever) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Confusional state, Headache, Lethargy
Clinical narrative: very sleepy; lethargic; kind of confusion; itchiness; soreness; headache; chills; joint pain; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-126334) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy), LETHARGY (lethargic), CONFUSIONAL STATE (kind of confusion), PRURITUS (itchiness) and PAIN (soreness) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (very sleepy), LETHARGY (lethargic), CONFUSIONAL STATE (kind of confusion), PRURITUS (itchiness), PAIN (soreness), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (very sleepy), LETHARGY (lethargic), CONFUSIONAL STATE (kind of confusion), PRURITUS (itchiness), PAIN (soreness), CHILLS (chills) and ARTHRALGIA (joint pain) had resolved and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Somnolence
Clinical narrative: very sleepy; lethargic; kind of confusion; itchiness; soreness; headache; chills; joint pain; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-126334) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy), LETHARGY (lethargic), CONFUSIONAL STATE (kind of confusion), PRURITUS (itchiness) and PAIN (soreness) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (very sleepy), LETHARGY (lethargic), CONFUSIONAL STATE (kind of confusion), PRURITUS (itchiness), PAIN (soreness), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (very sleepy), LETHARGY (lethargic), CONFUSIONAL STATE (kind of confusion), PRURITUS (itchiness), PAIN (soreness), CHILLS (chills) and ARTHRALGIA (joint pain) had resolved and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cold sweat, Constipation, Headache, Illness
Clinical narrative: started feeling sick that night; Cold sweats; Upset stomach; Constipated; pounding dull headache; Fever; Body aches and pains/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (started feeling sick that night), COLD SWEAT (Cold sweats), ABDOMINAL DISCOMFORT (Upset stomach), CONSTIPATION (Constipated) and HEADACHE (pounding dull headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (put his heart in afib, ended up with triple bypass) in June 2020, Atrial fibrillation and Bypass surgery since an unknown date. Concomitant products included LISINOPRIL, EZETIMIBE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and BISOPROLOL for an unknown indication.    On 01-Aug-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 ILLNESS (started feeling sick that night), COLD SWEAT (Cold sweats), ABDOMINAL DISCOMFORT (Upset stomach), CONSTIPATION (Constipated), HEADACHE (pounding dull headache), PYREXIA (Fever) and MYALGIA (Body aches and pains/sore arm). At the time of the report, ILLNESS (started feeling sick that night), COLD SWEAT (Cold sweats), ABDOMINAL DISCOMFORT (Upset stomach), CONSTIPATION (Constipated), HEADACHE (pounding dull headache), PYREXIA (Fever) and MYALGIA (Body aches and pains/sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: started feeling sick that night; Cold sweats; Upset stomach; Constipated; pounding dull headache; Fever; Body aches and pains/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (started feeling sick that night), COLD SWEAT (Cold sweats), ABDOMINAL DISCOMFORT (Upset stomach), CONSTIPATION (Constipated) and HEADACHE (pounding dull headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (put his heart in afib, ended up with triple bypass) in June 2020, Atrial fibrillation and Bypass surgery since an unknown date. Concomitant products included LISINOPRIL, EZETIMIBE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and BISOPROLOL for an unknown indication.    On 01-Aug-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 ILLNESS (started feeling sick that night), COLD SWEAT (Cold sweats), ABDOMINAL DISCOMFORT (Upset stomach), CONSTIPATION (Constipated), HEADACHE (pounding dull headache), PYREXIA (Fever) and MYALGIA (Body aches and pains/sore arm). At the time of the report, ILLNESS (started feeling sick that night), COLD SWEAT (Cold sweats), ABDOMINAL DISCOMFORT (Upset stomach), CONSTIPATION (Constipated), HEADACHE (pounding dull headache), PYREXIA (Fever) and MYALGIA (Body aches and pains/sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Broke out in a rash (Injected arm) for 5 days after first shot; Swelled (Injected arm)  for 5 days after first shot; Red Injected arm (For 5 days after first shot); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Broke out in a rash (Injected arm) for 5 days after first shot), VACCINATION SITE SWELLING (Swelled (Injected arm)  for 5 days after first shot) and VACCINATION SITE ERYTHEMA (Red Injected arm (For 5 days after first shot)) 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 VACCINATION SITE RASH (Broke out in a rash (Injected arm) for 5 days after first shot), VACCINATION SITE SWELLING (Swelled (Injected arm)  for 5 days after first shot) and VACCINATION SITE ERYTHEMA (Red Injected arm (For 5 days after first shot)). At the time of the report, VACCINATION SITE RASH (Broke out in a rash (Injected arm) for 5 days after first shot), VACCINATION SITE SWELLING (Swelled (Injected arm)  for 5 days after first shot) and VACCINATION SITE ERYTHEMA (Red Injected arm (For 5 days after first shot)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain in my knees/pain in my wrists; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in my knees/pain in my wrists) 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 ARTHRALGIA (Joint pain in my knees/pain in my wrists). At the time of the report, ARTHRALGIA (Joint pain in my knees/pain in my wrists) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (low grade fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033c2/a) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 HEADACHE (Headache), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, HEADACHE (Headache), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 Patients given a dose from a punctured vial stored at room temperature for 34 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 Patients given a dose from a punctured vial stored at room temperature for 34 hours) 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 EXPIRED PRODUCT ADMINISTERED (4 Patients given a dose from a punctured vial stored at room temperature for 34 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 Patients given a dose from a punctured vial stored at room temperature for 34 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.   No concomitant product use was provided by the reporter. No treatment medication was provided.  Between July 21 & 23 punctured a Moderna vial in the morning and 34 hours later dosed 4 patients.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pyrexia, Vaccination site swelling
Clinical narrative: Fever of 101.7 or 8.; swelling around the injection site; injection to the medial left thigh about 3 inches from the groin either subcutaneously or into "soft tissue"; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injection to the medial left thigh about 3 inches from the groin either subcutaneously or into "soft tissue"), PYREXIA (Fever of 101.7 or 8.) and VACCINATION SITE SWELLING (swelling around the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     The patient's past medical history included Dysmorphism (dysmorphia with calcium deposits in muscle) and Arm fracture (At first injection, her right arm was broken and dislocated.). Concurrent medical conditions included Immune system disorder NOS.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 23-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injection to the medial left thigh about 3 inches from the groin either subcutaneously or into "soft tissue"). On an unknown date, the patient experienced PYREXIA (Fever of 101.7 or 8.) and VACCINATION SITE SWELLING (swelling around the injection site). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injection to the medial left thigh about 3 inches from the groin either subcutaneously or into "soft tissue") had resolved and PYREXIA (Fever of 101.7 or 8.) and VACCINATION SITE SWELLING (swelling around the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosing remained unchanged.       Concomitant medication was not provided.  Patient reported that the vaccine was documented incorrectly as being injected into her anterolateral thigh instead of her medial thigh.   Treatment medication was not provided.   This case was linked to MOD-2021-276022 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Never got the second one as has been receiving side effects reports on the news and got kind of worried; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never got the second one as has been receiving side effects reports on the news and got kind of worried) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma.    On 06-Mar-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 (Never got the second one as has been receiving side effects reports on the news and got kind of worried). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never got the second one as has been receiving side effects reports on the news and got kind of worried) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up information received on 10-Aug-2021 included that there were no side effects reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: rash; swelling of lymph node; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (rash) and LYMPHADENOPATHY (swelling of lymph node) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 RASH (rash) and LYMPHADENOPATHY (swelling of lymph node). At the time of the report, RASH (rash) outcome was unknown and LYMPHADENOPATHY (swelling of lymph node) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided by reporter.  No treatment drug information was provided by reporter.   This case was linked to MOD-2021-063924 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient younger than 18 years of age received Moderna shot; 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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age received Moderna shot) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age received Moderna shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age received Moderna shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Past 35 days for second dose/patient received the 1st dose of the vaccine in March and they are wondering about the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past 35 days for second dose/patient received the 1st dose of the vaccine in March and they are wondering about the 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.    In March 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 (Past 35 days for second dose/patient received the 1st dose of the vaccine in March and they are wondering about the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past 35 days for second dose/patient received the 1st dose of the vaccine in March and they are wondering about the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm is still sore) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (Her arm is still sore). At the time of the report, PAIN IN EXTREMITY (Her arm is still sore) had not resolved.            No concomitant medications were reported. No treatment information was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Product dose omission issue
Clinical narrative: more than 36 days have passed since the first dose and the patient has not received the second dose; felt as if she was pumped on coffee; Uncomfortable neck/neck felt like it was very tense, there was some tension there; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt as if she was pumped on coffee), FEELING ABNORMAL (Uncomfortable neck/neck felt like it was very tense, there was some tension there) and PRODUCT DOSE OMISSION ISSUE (more than 36 days have passed since the first dose and the patient has not received the second dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced FEELING ABNORMAL (felt as if she was pumped on coffee) and FEELING ABNORMAL (Uncomfortable neck/neck felt like it was very tense, there was some tension there). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 36 days have passed since the first dose and the patient has not received the second dose). On 28-Jun-2021, FEELING ABNORMAL (felt as if she was pumped on coffee) and FEELING ABNORMAL (Uncomfortable neck/neck felt like it was very tense, there was some tension there) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days have passed since the first dose and the patient has not received the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) Heart rate elevated from 24-Jun-2021 to 28-Jun-2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After 15 minutes patient's neck felt like it was very tense, there was some tension there that caught her attention, it was uncomfortable. This symptom stayed off and on for 4 days. Also her heart rate was elevated for the same amount of time, it felt as if she was pumped on coffee. Patient has not got the second dose yet and wants to know if she should get it. patient's doctor did not give much guidance on it. Patient would like to know what is the maximum dosing interval recommended?
Sex: U
Vaccine: COVID19
Symptoms: Blepharitis, Eyelid irritation
Clinical narrative: eyelids inflammation/eyelids are inflammed; eyelids burning; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHARITIS (eyelids inflammation/eyelids are inflammed) and EYELID IRRITATION (eyelids burning) 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 BLEPHARITIS (eyelids inflammation/eyelids are inflammed) and EYELID IRRITATION (eyelids burning). At the time of the report, BLEPHARITIS (eyelids inflammation/eyelids are inflammed) and EYELID IRRITATION (eyelids burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant follow up received and New event added.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.; The vaccine was administered to about 9 to 10 patients before the excursion error was discovered; vaccine expired by 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008c21A and 008c21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-207778 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) 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.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown.            No concomitant medications were provided by the reporter.   Patient experienced cold on an unspecified day of August. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.; The vaccine was administered to about 9 to 10 patients before the excursion error was discovered; vaccine expired by 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008c21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 29-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 STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided to the patient