chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Patient felt dizzy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Kidney cancer.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-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 DIZZINESS (Patient felt dizzy). At the time of the report, DIZZINESS (Patient felt dizzy) outcome was unknown.            No concomitant medications were reported.  Patient's weight was reported as 142.  No treatment  medications were reported.   This case was linked to MOD-2022-538915, MOD-2022-538920 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vertigo positional
Clinical narrative: Patient felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Patient felt dizzy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Kidney cancer.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-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 DIZZINESS (Patient felt dizzy). At the time of the report, DIZZINESS (Patient felt dizzy) outcome was unknown.            No concomitant medications were reported.  Patient's weight was reported as 142.  No treatment  medications were reported.   This case was linked to MOD-2022-538915, MOD-2022-538920 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Received expired 2nd booster dose beyond 12 hours post puncture; First Booster of Moderna COVID-19 vaccine was administered on 01-NOV-2021 and second booster was administered on 12-Apr-2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose beyond 12 hours post puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Booster of Moderna COVID-19 vaccine was administered on 01-NOV-2021 and second booster was administered on 12-Apr-2022.) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022 at 2:55 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022 at 2:55 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose beyond 12 hours post puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Booster of Moderna COVID-19 vaccine was administered on 01-NOV-2021 and second booster was administered on 12-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose beyond 12 hours post puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Booster of Moderna COVID-19 vaccine was administered on 01-NOV-2021 and second booster was administered on 12-Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. On 06-Apr-2022, the vial was initially stored in the refrigerator. Number of doses/vials included 1 vial (10 dose each). On 11-Apr-2022 around noon, the vial was first punctured. The vial was stored at room temperature post puncture. The vial had not undergone temperature excursions. Amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was around 26 hours. Treatment information was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administrated beyond 30 day use by date; Vaccine administrated beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine administrated beyond 30 day use by date) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was reported that patient is not immunocompromised.     On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administrated beyond 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine administrated beyond 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP reported that there was an error in documentation that occurred in their facility. The 30 day use by date was written inadvertently as 16-Apr-2022 and they found out that it was supposed to be 06-Apr-2022. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-538899, MOD-2022-538939 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine kept in the refrigerator for more than 30 days; Vaccine administrated beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine kept in the refrigerator for more than 30 days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient was not immunocompromised.     On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine kept in the refrigerator for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that there was an error in documentation that occurred in their facility.  The 30 day use by expiry date of the vaccine was written inadvertently as 16-Apr-2022 and they found out that it was supposed to be 06-Apr-2022 instead of 16-Apr-2022. The patient received the third dose as booster dose of the vaccine.  No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2022-538933, MOD-2022-538899 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fall, Fatigue, Feeling abnormal, Pain
Clinical narrative: not her at all /felt terrible; went for a walk and fell; pain in left arm/ pain radiated to the right arm; Pain radiated to the heart / pain all around heart; very tired / in bed for 2 days; Extreme achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme achiness), FEELING ABNORMAL (not her at all /felt terrible), FALL (went for a walk and fell), PAIN IN EXTREMITY (pain in left arm/ pain radiated to the right arm) and CHEST PAIN (Pain radiated to the heart / pain all around heart) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 036C21A, 032M20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID before receiving any vaccinations.). Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced PAIN (Extreme achiness). 07-Apr-2022, the patient experienced FATIGUE (very tired / in bed for 2 days). On an unknown date, the patient experienced FEELING ABNORMAL (not her at all /felt terrible), FALL (went for a walk and fell), PAIN IN EXTREMITY (pain in left arm/ pain radiated to the right arm) and CHEST PAIN (Pain radiated to the heart / pain all around heart). At the time of the report, PAIN (Extreme achiness), FEELING ABNORMAL (not her at all /felt terrible), FALL (went for a walk and fell), PAIN IN EXTREMITY (pain in left arm/ pain radiated to the right arm), CHEST PAIN (Pain radiated to the heart / pain all around heart) and FATIGUE (very tired / in bed for 2 days) outcome was unknown.            Patient received 1st booster dose on 19Aug2021 and 2nd booster dose on 07Apr2022. Treatment medications were not reported.   This case was linked to MOD-2021-034786, MOD-2022-539364 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: not her at all /felt terrible; went for a walk and fell; pain in left arm/ pain radiated to the right arm; Pain radiated to the heart / pain all around heart; very tired / in bed for 2 days; Extreme achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme achiness), FEELING ABNORMAL (not her at all /felt terrible), FALL (went for a walk and fell), PAIN IN EXTREMITY (pain in left arm/ pain radiated to the right arm) and CHEST PAIN (Pain radiated to the heart / pain all around heart) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 036C21A, 032M20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID before receiving any vaccinations.). Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced PAIN (Extreme achiness). 07-Apr-2022, the patient experienced FATIGUE (very tired / in bed for 2 days). On an unknown date, the patient experienced FEELING ABNORMAL (not her at all /felt terrible), FALL (went for a walk and fell), PAIN IN EXTREMITY (pain in left arm/ pain radiated to the right arm) and CHEST PAIN (Pain radiated to the heart / pain all around heart). At the time of the report, PAIN (Extreme achiness), FEELING ABNORMAL (not her at all /felt terrible), FALL (went for a walk and fell), PAIN IN EXTREMITY (pain in left arm/ pain radiated to the right arm), CHEST PAIN (Pain radiated to the heart / pain all around heart) and FATIGUE (very tired / in bed for 2 days) outcome was unknown.            Patient received 1st booster dose on 19Aug2021 and 2nd booster dose on 07Apr2022. Treatment medications were not reported.   This case was linked to MOD-2021-034786, MOD-2022-539364 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Oral herpes, Pyrexia
Clinical narrative: Broke out with Fever blisters in mouth, throat and nose; Muscles hurt; Fever up to 104 Fahrenheit degrees.; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Broke out with Fever blisters in mouth, throat and nose), MYALGIA (Muscles hurt) and PYREXIA (Fever up to 104 Fahrenheit degrees.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0022M21A, 039D21A, 037A21B and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Skin disorder (Skin condition, patient was taking Dupixent as a immune suppresent for the treatment) and Seasonal allergy (Seasonal changes). Concomitant products included DUPILUMAB (DUPIXENT) for Skin disorder, MONTELUKAST and SERTRALINE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022, the patient experienced MYALGIA (Muscles hurt) and PYREXIA (Fever up to 104 Fahrenheit degrees.). On 11-Apr-2022, the patient experienced ORAL HERPES (Broke out with Fever blisters in mouth, throat and nose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 11-Apr-2022, PYREXIA (Fever up to 104 Fahrenheit degrees.) had resolved. At the time of the report, ORAL HERPES (Broke out with Fever blisters in mouth, throat and nose) had not resolved and MYALGIA (Muscles hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2022, Body temperature: 104 fahrenheit degree (High) 104 Fahrenheit degree.         Patient took the second booster dose on 08-Apr-2022. Patient usually experience Fever blisters during Hormonal changes and wanted to know if she can take Acyclovir as a treatment. Patient did not wanted this medication to interfere with vaccine. Concomitant medication included Allergy pill for Seasonal changes.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea
Clinical narrative: Diarrhea; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history was not reported by the reporter.  Concurrent medical conditions included HER2 positive breast cancer (Stage 1, right breast cancer). Concomitant products included TRASTUZUMAB (HERCEPTIN) and LETROZOLE (FEMARA) for an unknown indication.    On 22-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on treatment medications was reported
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Inappropriate schedule of product administration
Clinical narrative: 1st dose - 23Jan2021; 2nd dose-10Feb2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 23Jan2021; 2nd dose-10Feb2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 051F21A, 031M20A and 028L20A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Flu shot (Patient had her flu shot sometime last year close to the date of the 1st booster but not at the same time) in 2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Hypertension, Palpitation and Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for Thyroid disorder.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 23Jan2021; 2nd dose-10Feb2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 23Jan2021; 2nd dose-10Feb2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2022, Body temperature: 102 102F, 101 101F, 99.8 99.8F and 103 103F.         It was reported that patient did not have any Covid-19 diagnosis prior to or after getting the vaccine. It was stated that patient did not take any medications for fever and no treatment medications were provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Pyrexia
Clinical narrative: Felt cold but eventually it warmed up; Had a little bit of a temperature (103F)/102 F/ 101F/99.8F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold but eventually it warmed up) and PYREXIA (Had a little bit of a temperature (103F)/102 F/ 101F/99.8F) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 051F21A, 031M20A and 028L20A) for COVID-19 vaccination.     Patient did not had any COVID-19 diagnosis prior to or after getting the vaccine.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Flu shot sometime last year close to the date of the 1st booster but not at the same time). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Hypertension, Palpitation and Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for Thyroid disorder.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced FEELING COLD (Felt cold but eventually it warmed up) and PYREXIA (Had a little bit of a temperature (103F)/102 F/ 101F/99.8F). On 12-Apr-2022, FEELING COLD (Felt cold but eventually it warmed up) had resolved. At the time of the report, PYREXIA (Had a little bit of a temperature (103F)/102 F/ 101F/99.8F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2022, Body temperature: 103f 103F, 102f 102F, 101f 101F and 99.8f 99.8F.         It was reported that on 12 April 2022, when patient woke up, she had a little bit of a temperature and felt cold but eventually it warmed up. Patient ate some and eventually she felt better. She checked her temperature before she called and it was 102F, and during the call she checked it again and it went down to 101F and 99.8F.  Patient did not take any medications for fever.   This case was linked to MOD-2022-538987 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-Apr-2022 and initially stored in the refrigerator 05-Apr-2022) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) 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) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-Apr-2022 and initially stored in the refrigerator 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-Apr-2022 and initially stored in the refrigerator 05-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that vials with a manufacturing date of 01-Dec-2021 and the expiration date of 01-Apr-2022 with the lot number 026L21B were stored in the refrigerator on 05-Apr-2022 and were administered to patients from 06-Apr-2022 to 09-Apr-2022. It was further reported that patients did not experience any adverse reactions at that time. No treatment medications were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Diarrhea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No Concomitant product use was reported.  The patient reported that following after receiving their Moderna Covid-19 vaccine, the patient experienced diarrhea and headache.  No treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain
Clinical narrative: Soreness; Received an expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 017F21A, 011M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). On an unknown date, the patient experienced PAIN (Soreness). At the time of the report, PAIN (Soreness) and EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient did not tested positive for Covid-19 and did not received any other vaccine within 1 month prior to Moderna Covid-19 vaccine. He has no chronic illnesses. He has no symptoms besides soreness.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered to patient; Product was initially stored in the refrigerator on 05-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Product was initially stored in the refrigerator on 05-Apr-2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) 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) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Product was initially stored in the refrigerator on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Product was initially stored in the refrigerator on 05-Apr-2022) outcome was unknown.        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.  It was reported that vaccine was administered to patients from 06-APR-2022 to 09-Apr-2022. The vial was initially stored in refrigerator on 05-Apr-2022. It was reported that no temperature excursion occurred and patient reported no adverse events.   This case was linked to MOD-2022-539012, MOD-2022-539071, MOD-2022-537580 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired Moderna vaccine administered to patient; expired vaccine is stored and then administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) 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) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that they received the Moderna vaccine vials with a manufacturing date of 1-Dec-2021 and an expiration date of 1-Apr-2022 Lot-026L21B. They also received Moderna vaccine vials with a manufacturing date of10-Dec-2021 with an expiration date of Jul-2022 Lot-001M21A. It was reported that vaccine was administered to patients from  06-APR-2022 to 09-Apr-2022. The vial was initially stored in refrigerator on 05-Apr-2022. It was reported that vial did not undergo temperature excursion and patient reported no adverse events at that time. No treatment medications were reported.   This case was linked to MOD-2022-539070 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm pain after first dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for immunization. Concurrent medical conditions included high blood pressure and gout. June 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm pain after first dose). At the time of the report, pain in extremity (arm pain after first dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications included high blood pressure medication and gout medication. Reporter stated her husband had arm pain after first dose. No treatment information provided. This case linked to MOD-2022-539148, MOD-2022-539162 (patient link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Arm pain after second dose; 1st dose in June2021 and 2nd dose in October2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain after second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in June2021 and 2nd dose in October2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Gout.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (Arm pain after second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in June2021 and 2nd dose in October2021). At the time of the report, PAIN IN EXTREMITY (Arm pain after second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in June2021 and 2nd dose in October2021) outcome was unknown.            Patient Date of Birth was reported.  Concomitant medications include high blood pressure medication and gout medication.  No Treatment information was reported.   This case was linked to MOD-2022-539147, MOD-2022-539162 (Patient Link).   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pulmonary thrombosis, Thrombosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Blood clot was migrating to lungs) and THROMBOSIS (Blood clot in leg) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high and Gout. In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY THROMBOSIS (Blood clot was migrating to lungs) (seriousness criterion medically significant), THROMBOSIS (Blood clot in leg) (seriousness criterion medically significant), PAIN IN EXTREMITY (leg started to hurt/ Very painful) and PERIPHERAL SWELLING (leg started to swelled up). At the time of the report, PULMONARY THROMBOSIS (Blood clot was migrating to lungs), THROMBOSIS (Blood clot in leg), PAIN IN EXTREMITY (leg started to hurt/ Very painful) and PERIPHERAL SWELLING (leg started to swelled up) outcome was unknown. Patient was on concomitant medication for high blood pressure and gout. It was reported as patient had received his booster dose in Mar (unspecified date). After the booster dose his leg started to hurt, swelled up and were very painful. He waited about a week after putting heating packs and wrapping it before ultimately going to the doctor. It was reported as he had a blood clot that was in his leg that was migrating to lungs and at the time of report he was on blood thinners. Company comment: This spontaneous case concerns a 70-year-old male patient with Concurrent medical conditions of Blood pressure high, who experienced the unexpected serious AESI of Pulmonary thrombosis and Thrombosis (seriousness criteria medically significant) which occurred on unspecified day after the third dose of mRNA-1273 Vaccine. Patients with Concurrent medical conditions of Blood pressure high remain a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a 70-year-old male patient with Concurrent medical conditions of Blood pressure high, who experienced the unexpected serious AESI of Pulmonary thrombosis and Thrombosis (seriousness criteria medically significant) which occurred on unspecified day after the third dose of mRNA-1273 Vaccine. Patients with Concurrent medical conditions of Blood pressure high remain a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 01 Apr 2022 but moved from freezer to refrigerator on 08 Apr 2022 and administered on 09 Apr 2022; Expired vaccine was given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given) and PRODUCT STORAGE ERROR (Vaccine expired on 01 Apr 2022 but moved from freezer to refrigerator on 08 Apr 2022 and administered on 09 Apr 2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01 Apr 2022 but moved from freezer to refrigerator on 08 Apr 2022 and administered on 09 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given) and PRODUCT STORAGE ERROR (Vaccine expired on 01 Apr 2022 but moved from freezer to refrigerator on 08 Apr 2022 and administered on 09 Apr 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. It was reported that patient was given dose from expired vaccine which was moved from freezer to refrigerator on 08 April 2022. The vials did not experience temperature excursions. No treatment details were reported.   This case was linked to MOD-2022-539466, MOD-2022-539467 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 01-Apr-2022 but moved from freezer to refrigerator on 08-Apr-2022; expired vaccine was given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was given) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022 but moved from freezer to refrigerator on 08-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022 but moved from freezer to refrigerator on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine was given) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022 but moved from freezer to refrigerator on 08-Apr-2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  It was reported that, affected vials did not experience temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-539457, MOD-2022-539467.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022; Received expired booster dose beyond MFG expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022 at 9:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator - 06APR2022 10:30AM The vial Didn't undergo any temperature excursions  No Concomitant Medications were provided by the Reporter No Treatment Medications were provided by the Reporter
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022; Received expired booster dose beyond MFG expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022 at 9:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 9:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  There is no temperature excursion. The vaccine was stored in the refrigerator on 06-Apr-2022 at 10:30 AM.  No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered an expired vaccines; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccines) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   On 07-Apr-2022, HCP thaws out the vial and the patient received 2nd booster.  The vial did not undergo any temperature excursions.  The treatment information was not reported.   This case was linked to MOD-2022-539487, MOD-2022-539488 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow-up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product moved to refrigerator; Receiving expired dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired dose of the Moderna COVID19 vaccine) and PRODUCT STORAGE ERROR (Product moved to refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 067h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired dose of the Moderna COVID19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product moved to refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving expired dose of the Moderna COVID19 vaccine) and PRODUCT STORAGE ERROR (Product moved to refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Vial was initially stored in the refrigerator on 18 March 2022.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Sneezing; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A, 071F21A, 026A21A and 031M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Had the flu vaccine last year on an unrecalled date not at the same time as her 1st booster). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Dust allergy.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022 at 9:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SNEEZING (Sneezing). At the time of the report, SNEEZING (Sneezing) outcome was unknown.            No concomitant medications were provided. In the evening of the same day, the patient started sneezing. The patient does not have any concomitant medical conditions and was not on any medication.  No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: Injection site pain; Injection site discomfort; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE DISCOMFORT (Injection site discomfort) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 021B21A and 040A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: TDAP (vaccination site-left arm) on 04-Jun-2021 and Flu shot (vaccination site-left arm) on 04-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu shot and TDAP. Concurrent medical conditions included Blood pressure high (5 years), Migraine (5 years), Latex allergy (latex), Drug allergy (Sertraline) and Allergy to NSAIDs (Meloxicam). Concomitant products included PROPRANOLOL for Blood pressure high, TOPIRAMATE (TOPAMAX) for Migraine.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022, the patient experienced VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE DISCOMFORT (Injection site discomfort). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of twice daily for 4 days now. At the time of the report, VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE DISCOMFORT (Injection site discomfort) outcome was unknown.      Patient was taking concomitant medication(Propranolol,Topamax) for 5 years now.  Patient have not contacted her doctor but she applied warm compress and healing pad to ease the pain and discomfort.  Patient mentioned that aside from the Moderna vaccine there were other vaccines that she received last year that included Pneumonia vaccine and Zoster vaccine received on 28Dec2021.