chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Illness
Clinical narrative: sickness; my shoulder has been hurting a lot; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (sickness) and ARTHRALGIA (my shoulder has been hurting a lot) 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 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ILLNESS (sickness) and ARTHRALGIA (my shoulder has been hurting a lot). At the time of the report, ILLNESS (sickness) outcome was unknown and ARTHRALGIA (my shoulder has been hurting a lot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were given. No treatment information were provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A total of three  patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A total of three  patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A total of three  patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (A total of three  patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that a total of three patients received the Moderna COVID-19 vaccine after the vaccines beyond use date 8-JAN-2022.  No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-451537 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Cough
Clinical narrative: an asthma cough; an asthma cough; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (an asthma cough) and ASTHMA (an asthma cough) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (an asthma cough) and ASTHMA (an asthma cough). At the time of the report, COUGH (an asthma cough) and ASTHMA (an asthma cough) had not 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 medication was reported. No treatment medication was reported. Patient had asthma cough and wanted to know whether they can take booster.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hypoaesthesia, Malaise, Skin discolouration
Clinical narrative: not feeling well (booster)/feels like when had Covid-19; shaky (booster); 4 fingers were blue, white in the tips and numb (booster); 4 fingers were blue, white in the tips and numb (booster); chills (booster); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well (booster)/feels like when had Covid-19), TREMOR (shaky (booster)), SKIN DISCOLOURATION (4 fingers were blue, white in the tips and numb (booster)), HYPOAESTHESIA (4 fingers were blue, white in the tips and numb (booster)) and CHILLS (chills (booster)) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 031B21A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced MALAISE (not feeling well (booster)/feels like when had Covid-19), TREMOR (shaky (booster)), SKIN DISCOLOURATION (4 fingers were blue, white in the tips and numb (booster)), HYPOAESTHESIA (4 fingers were blue, white in the tips and numb (booster)) and CHILLS (chills (booster)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, MALAISE (not feeling well (booster)/feels like when had Covid-19), TREMOR (shaky (booster)), SKIN DISCOLOURATION (4 fingers were blue, white in the tips and numb (booster)), HYPOAESTHESIA (4 fingers were blue, white in the tips and numb (booster)) and CHILLS (chills (booster)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 97.5 (normal) 97.5°F.         After booster dose patient body temperature was 97.5F also felt like when had COVID-19 No concomitant information were reported by the reporter   This case was linked to MOD-2022-451541, MOD-2022-451540 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: not feeling well (booster)/feels like when had Covid-19; shaky (booster); 4 fingers were blue, white in the tips and numb (booster); 4 fingers were blue, white in the tips and numb (booster); chills (booster); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well (booster)/feels like when had Covid-19), TREMOR (shaky (booster)), SKIN DISCOLOURATION (4 fingers were blue, white in the tips and numb (booster)), HYPOAESTHESIA (4 fingers were blue, white in the tips and numb (booster)) and CHILLS (chills (booster)) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 031B21A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced MALAISE (not feeling well (booster)/feels like when had Covid-19), TREMOR (shaky (booster)), SKIN DISCOLOURATION (4 fingers were blue, white in the tips and numb (booster)), HYPOAESTHESIA (4 fingers were blue, white in the tips and numb (booster)) and CHILLS (chills (booster)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, MALAISE (not feeling well (booster)/feels like when had Covid-19), TREMOR (shaky (booster)), SKIN DISCOLOURATION (4 fingers were blue, white in the tips and numb (booster)), HYPOAESTHESIA (4 fingers were blue, white in the tips and numb (booster)) and CHILLS (chills (booster)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 97.5 (normal) 97.5°F.         After booster dose patient body temperature was 97.5F also felt like when had COVID-19 No concomitant information were reported by the reporter   This case was linked to MOD-2022-451541, MOD-2022-451540 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A total of three  patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A total of three  patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A total of three  patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (A total of three  patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications reported. The Moderna Covid-19 vaccine was removed from the freezer on 09-Dec-2021 and was assigned a beyond use date of 08-JAN-2022. A total of three patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.    This case was linked to MOD-2022-451537, MOD-2022-451522 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: my son received a half dose for his first dose , the pharmacy gave his the 2nd half dose within 5-7 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (my son received a half dose for his first dose , the pharmacy gave his the 2nd half dose within 5-7 minutes) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2022, the patient experienced PRODUCT ADMINISTRATION ERROR (my son received a half dose for his first dose , the pharmacy gave his the 2nd half dose within 5-7 minutes). On 13-Jan-2022, PRODUCT ADMINISTRATION ERROR (my son received a half dose for his first dose , the pharmacy gave his the 2nd half dose within 5-7 minutes) had resolved.            Reporter states that her son has not reported any side effects from the two doses he received yesterday. Reporter did not have the lot number information available at this time but said will call back later to provide it.  Concomitant medications include none. Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A total of three patients received the Moderna Covid-19 vaccine after the vaccines beyond use date. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A total of three patients received the Moderna Covid-19 vaccine after the vaccines beyond use date) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A total of three patients received the Moderna Covid-19 vaccine after the vaccines beyond use date). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (A total of three patients received the Moderna Covid-19 vaccine after the vaccines beyond use date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 09-Dec-2021,Lot 064H21A Moderna Covid-19 vaccine was removed from the freezer and was assigned a beyond use date of 08-Jan-2022. Concomitant medication was not provided. Treatment information was not provided. This case was linked to MOD- 2022-451522, MOD-2022-451532 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Fatigue, Pain, Pain in jaw
Clinical narrative: slight pressure on the ear and jaw; slight pressure on the ear and jaw; very achy; exhausted; This spontaneous case was reported by a nurse and describes the occurrence of EAR DISCOMFORT (slight pressure on the ear and jaw), PAIN IN JAW (slight pressure on the ear and jaw), PAIN (very achy) and FATIGUE (exhausted) 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 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced EAR DISCOMFORT (slight pressure on the ear and jaw), PAIN IN JAW (slight pressure on the ear and jaw), PAIN (very achy) and FATIGUE (exhausted). At the time of the report, EAR DISCOMFORT (slight pressure on the ear and jaw), PAIN IN JAW (slight pressure on the ear and jaw), PAIN (very achy) and FATIGUE (exhausted) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received booster on 11 Jan 2022 at 5.00.  Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test, Swelling face, Vaccination site swelling
Clinical narrative: Swelling under the left jaw; Swelling under the left arm (size of a baseball) after first dose; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling under the left jaw), VACCINATION SITE SWELLING (Swelling under the left arm (size of a baseball) after first dose), PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2021.    On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 09-Jan-2022, the patient experienced VACCINATION SITE SWELLING (Swelling under the left arm (size of a baseball) after first dose). On 10-Jan-2022, the patient experienced SWELLING FACE (Swelling under the left jaw). On 09-Jan-2022, PYREXIA (Fever) and CHILLS (Chills) had resolved. On 14-Jan-2022, SWELLING FACE (Swelling under the left jaw) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling under the left arm (size of a baseball) after first dose) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products and treatment information were reported.  Patient received Monoclonal antibody on 18-Sep-2021 to treat COVID-19. Swelling under the  armpit was a little better but still swollen. Patient stated that his father had Lymph-node Cancer and was worried because under the arm there was the lymph node.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: taste and smell is altered/tastes an awful taste; taste and smell is altered; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (taste and smell is altered/tastes an awful taste) and PAROSMIA (taste and smell is altered) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN 15 for an unknown indication.    On 17-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (taste and smell is altered/tastes an awful taste) and PAROSMIA (taste and smell is altered). At the time of the report, TASTE DISORDER (taste and smell is altered/tastes an awful taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Neuritis, Product dose omission issue, Tinnitus
Clinical narrative: tinnitus; severe back pain; diagnosed with "neuronitis"; muscle aches; did not receive 2nd dose; This spontaneous case was reported by a physician assistant and describes the occurrence of TINNITUS (tinnitus), BACK PAIN (severe back pain), NEURITIS (diagnosed with "neuronitis"), MYALGIA (muscle aches) and PRODUCT DOSE OMISSION ISSUE (did not receive 2nd dose) 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 22-Jul-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), BACK PAIN (severe back pain), NEURITIS (diagnosed with "neuronitis"), MYALGIA (muscle aches) and PRODUCT DOSE OMISSION ISSUE (did not receive 2nd dose). At the time of the report, TINNITUS (tinnitus), BACK PAIN (severe back pain), NEURITIS (diagnosed with "neuronitis") and MYALGIA (muscle aches) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive 2nd 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 medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: arm is very tender; arm is painful when trying to move; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (arm is very tender) and PAIN IN EXTREMITY (arm is painful when trying to move) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (arm is very tender) and PAIN IN EXTREMITY (arm is painful when trying to move). At the time of the report, TENDERNESS (arm is very tender) and PAIN IN EXTREMITY (arm is painful when trying to move) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided No Treatment medication was provided.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: severe ear pain; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (severe ear pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 033C21A and 007B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, the patient experienced EAR PAIN (severe ear pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, EAR PAIN (severe ear pain) outcome was unknown.            Concomitant medications included antidepressants. PCP prescribed gabapentin and diphenhydramine. .   This case was linked to MOD-2022-451567 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Rash, Urticaria
Clinical narrative: Hives in the arm/hives all over the body; Bad rash in the arm/bad rash all over the body; Did not got a 2nd dose, due to previous symptoms with 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives in the arm/hives all over the body), RASH (Bad rash in the arm/bad rash all over the body) and PRODUCT DOSE OMISSION ISSUE (Did not got a 2nd dose, due to previous symptoms with 1st dose) 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 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives in the arm/hives all over the body), RASH (Bad rash in the arm/bad rash all over the body) and PRODUCT DOSE OMISSION ISSUE (Did not got a 2nd dose, due to previous symptoms with 1st dose). At the time of the report, URTICARIA (Hives in the arm/hives all over the body) and RASH (Bad rash in the arm/bad rash all over the body) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not got a 2nd dose, due to previous symptoms with 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient experienced a bad rash and hives on his arm and all over his body. No concomitant medications were given. No treatment information was given.   Reporter did not allow further contact
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: patient did not receive 0.25 ml of the booster dose; The syringe malfunctioned and more than 3/4 of the dose leaked out from the side of the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient did not receive 0.25 ml of the booster dose) and DEVICE CONNECTION ISSUE (The syringe malfunctioned and more than 3/4 of the dose leaked out from the side of the syringe) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced UNDERDOSE (patient did not receive 0.25 ml of the booster dose) and DEVICE CONNECTION ISSUE (The syringe malfunctioned and more than 3/4 of the dose leaked out from the side of the syringe). On 14-Jan-2022, UNDERDOSE (patient did not receive 0.25 ml of the booster dose) and DEVICE CONNECTION ISSUE (The syringe malfunctioned and more than 3/4 of the dose leaked out from the side of the syringe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Side effects to the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Side effects to the injection site). At the time of the report, VACCINATION SITE REACTION (Side effects to the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Plans on getting 2nd dose more than 3 months after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Plans on getting 2nd dose more than 3 months after first dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Plans on getting 2nd dose more than 3 months after first dose). On 26-Sep-2021, PRODUCT DOSE OMISSION ISSUE (Plans on getting 2nd dose more than 3 months after first dose) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications were not reported. Treatment medications were not reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: little bit of fever lasted around 24 hours.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little bit of fever lasted around 24 hours.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (little bit of fever lasted around 24 hours.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 08-May-2021, PYREXIA (little bit of fever lasted around 24 hours.) had resolved.            Concomitant drug included antidepressants.   This case was linked to MOD-2022-451556 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: getting hives on body ever since got the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (getting hives on body ever since got the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (getting hives on body ever since got the vaccine). At the time of the report, URTICARIA (getting hives on body ever since got the vaccine) had not 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 drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Barely even sore injection site after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Barely even sore injection site after first shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included Stomach function disorder (little stomach issue) and Irritable bowel syndrome (about 20 years ago. Has not had IBS since 20 years ago.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Barely even sore injection site after first shot). On 09-Apr-2021, VACCINATION SITE PAIN (Barely even sore injection site after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2022-452386, MOD-2022-452389 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: Barely even sore injection site after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Barely even sore injection site after first shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included Stomach function disorder (little stomach issue) and Irritable bowel syndrome (about 20 years ago. Has not had IBS since 20 years ago.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Barely even sore injection site after first shot). On 09-Apr-2021, VACCINATION SITE PAIN (Barely even sore injection site after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2022-452386, MOD-2022-452389 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Flatulence, Frequent bowel movements, Sleep disorder
Clinical narrative: Barely even sore injection site after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Barely even sore injection site after first shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included Stomach function disorder (little stomach issue) and Irritable bowel syndrome (about 20 years ago. Has not had IBS since 20 years ago.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Barely even sore injection site after first shot). On 09-Apr-2021, VACCINATION SITE PAIN (Barely even sore injection site after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2022-452386, MOD-2022-452389 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot; This spontaneous case was reported by a non-health professional and describes the occurrence of GASTROINTESTINAL DISORDER (Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome (IBS).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced GASTROINTESTINAL DISORDER (Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot). At the time of the report, GASTROINTESTINAL DISORDER (Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot) had not resolved.            No concomitant medication was provided by the reporter No treatment information was provided by the reporter Patient had a little stomach issue and IBS about 20 years ago.   This case was linked to MOD-2022-452389, MOD-2022-451586 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot; This spontaneous case was reported by a non-health professional and describes the occurrence of GASTROINTESTINAL DISORDER (Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome (IBS).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced GASTROINTESTINAL DISORDER (Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot). At the time of the report, GASTROINTESTINAL DISORDER (Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot) had not resolved.            No concomitant medication was provided by the reporter No treatment information was provided by the reporter Patient had a little stomach issue and IBS about 20 years ago.   This case was linked to MOD-2022-452389, MOD-2022-451586 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Flatulence, Frequent bowel movements, Sleep disorder
Clinical narrative: Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot; This spontaneous case was reported by a non-health professional and describes the occurrence of GASTROINTESTINAL DISORDER (Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome (IBS).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced GASTROINTESTINAL DISORDER (Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot). At the time of the report, GASTROINTESTINAL DISORDER (Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot) had not resolved.            No concomitant medication was provided by the reporter No treatment information was provided by the reporter Patient had a little stomach issue and IBS about 20 years ago.   This case was linked to MOD-2022-452389, MOD-2022-451586 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sometimes incredibly hard bowel movement after booster; Sometimes just gas after booster; Gets up in the middle of the night going to the bathroom after booster; reaggravated the stomach/Gut function is unpredictable after booster; Goes to the bathroom 8-20 times a day after booster; Sometimes severe diarrhea after booster; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sometimes incredibly hard bowel movement after booster), FLATULENCE (Sometimes just gas after booster), SLEEP DISORDER (Gets up in the middle of the night going to the bathroom after booster), ABDOMINAL DISCOMFORT (reaggravated the stomach/Gut function is unpredictable after booster) and FREQUENT BOWEL MOVEMENTS (Goes to the bathroom 8-20 times a day after booster) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 028A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome (20 years ago.) and Stomach discomfort (little stomach issue).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced ABDOMINAL DISCOMFORT (Sometimes incredibly hard bowel movement after booster), FLATULENCE (Sometimes just gas after booster), SLEEP DISORDER (Gets up in the middle of the night going to the bathroom after booster), ABDOMINAL DISCOMFORT (reaggravated the stomach/Gut function is unpredictable after booster), FREQUENT BOWEL MOVEMENTS (Goes to the bathroom 8-20 times a day after booster) and DIARRHOEA (Sometimes severe diarrhea after booster). At the time of the report, ABDOMINAL DISCOMFORT (Sometimes incredibly hard bowel movement after booster), FLATULENCE (Sometimes just gas after booster), SLEEP DISORDER (Gets up in the middle of the night going to the bathroom after booster), ABDOMINAL DISCOMFORT (reaggravated the stomach/Gut function is unpredictable after booster), FREQUENT BOWEL MOVEMENTS (Goes to the bathroom 8-20 times a day after booster) and DIARRHOEA (Sometimes severe diarrhea after booster) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient stated that after receiving the booster his stomach was reaggravated and he had to go to the bathroom 8-20 times a day, there was no blood but he sometimes had incredibly hard bowel movement, sometimes severe diarrhea and sometimes just gas. He had to get up in the middle of the night to go to the bathroom and his gut function was unpredictable.   This case was linked to MOD-2022-452386 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: Sometimes incredibly hard bowel movement after booster; Sometimes just gas after booster; Gets up in the middle of the night going to the bathroom after booster; reaggravated the stomach/Gut function is unpredictable after booster; Goes to the bathroom 8-20 times a day after booster; Sometimes severe diarrhea after booster; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sometimes incredibly hard bowel movement after booster), FLATULENCE (Sometimes just gas after booster), SLEEP DISORDER (Gets up in the middle of the night going to the bathroom after booster), ABDOMINAL DISCOMFORT (reaggravated the stomach/Gut function is unpredictable after booster) and FREQUENT BOWEL MOVEMENTS (Goes to the bathroom 8-20 times a day after booster) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 028A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome (20 years ago.) and Stomach discomfort (little stomach issue).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced ABDOMINAL DISCOMFORT (Sometimes incredibly hard bowel movement after booster), FLATULENCE (Sometimes just gas after booster), SLEEP DISORDER (Gets up in the middle of the night going to the bathroom after booster), ABDOMINAL DISCOMFORT (reaggravated the stomach/Gut function is unpredictable after booster), FREQUENT BOWEL MOVEMENTS (Goes to the bathroom 8-20 times a day after booster) and DIARRHOEA (Sometimes severe diarrhea after booster). At the time of the report, ABDOMINAL DISCOMFORT (Sometimes incredibly hard bowel movement after booster), FLATULENCE (Sometimes just gas after booster), SLEEP DISORDER (Gets up in the middle of the night going to the bathroom after booster), ABDOMINAL DISCOMFORT (reaggravated the stomach/Gut function is unpredictable after booster), FREQUENT BOWEL MOVEMENTS (Goes to the bathroom 8-20 times a day after booster) and DIARRHOEA (Sometimes severe diarrhea after booster) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient stated that after receiving the booster his stomach was reaggravated and he had to go to the bathroom 8-20 times a day, there was no blood but he sometimes had incredibly hard bowel movement, sometimes severe diarrhea and sometimes just gas. He had to get up in the middle of the night to go to the bathroom and his gut function was unpredictable.   This case was linked to MOD-2022-452386 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Flatulence, Frequent bowel movements, Sleep disorder
Clinical narrative: Sometimes incredibly hard bowel movement after booster; Sometimes just gas after booster; Gets up in the middle of the night going to the bathroom after booster; reaggravated the stomach/Gut function is unpredictable after booster; Goes to the bathroom 8-20 times a day after booster; Sometimes severe diarrhea after booster; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sometimes incredibly hard bowel movement after booster), FLATULENCE (Sometimes just gas after booster), SLEEP DISORDER (Gets up in the middle of the night going to the bathroom after booster), ABDOMINAL DISCOMFORT (reaggravated the stomach/Gut function is unpredictable after booster) and FREQUENT BOWEL MOVEMENTS (Goes to the bathroom 8-20 times a day after booster) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 028A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome (20 years ago.) and Stomach discomfort (little stomach issue).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced ABDOMINAL DISCOMFORT (Sometimes incredibly hard bowel movement after booster), FLATULENCE (Sometimes just gas after booster), SLEEP DISORDER (Gets up in the middle of the night going to the bathroom after booster), ABDOMINAL DISCOMFORT (reaggravated the stomach/Gut function is unpredictable after booster), FREQUENT BOWEL MOVEMENTS (Goes to the bathroom 8-20 times a day after booster) and DIARRHOEA (Sometimes severe diarrhea after booster). At the time of the report, ABDOMINAL DISCOMFORT (Sometimes incredibly hard bowel movement after booster), FLATULENCE (Sometimes just gas after booster), SLEEP DISORDER (Gets up in the middle of the night going to the bathroom after booster), ABDOMINAL DISCOMFORT (reaggravated the stomach/Gut function is unpredictable after booster), FREQUENT BOWEL MOVEMENTS (Goes to the bathroom 8-20 times a day after booster) and DIARRHOEA (Sometimes severe diarrhea after booster) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient stated that after receiving the booster his stomach was reaggravated and he had to go to the bathroom 8-20 times a day, there was no blood but he sometimes had incredibly hard bowel movement, sometimes severe diarrhea and sometimes just gas. He had to get up in the middle of the night to go to the bathroom and his gut function was unpredictable.   This case was linked to MOD-2022-452386 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Is a headache a side effect of the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (Is a headache a side effect of the booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Is a headache a side effect of the booster). At the time of the report, HEADACHE (Is a headache a side effect of the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant use were reported. No Treatment were reported.