chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: arm sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm sore at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (arm sore at injection site). At the time of the report, INJECTION SITE PAIN (arm sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-407544 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A little sore arm after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little sore arm after 2nd shot) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (A little sore arm after 2nd shot). On 08-Feb-2021, PAIN IN EXTREMITY (A little sore arm after 2nd shot) had resolved.            No Concomitant product use was reported.  After the 2nd shot, they had a little sore arm for a few days.  No treatment information was provided.   This case was linked to MOD-2021-407363, MOD-2021-407441 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Urticaria
Clinical narrative: Broke-out in hives/Hives started on abdomen and under arms, spread to random places on the body /One area heals and hives pop-up on another body part/Inflamed Hive Lesions/Hives come and go; A little sore arm after 3rd shot; Chills arm after 3rd shot; Nausea arm after 3rd shot; Headache arm after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke-out in hives/Hives started on abdomen and under arms, spread to random places on the body /One area heals and hives pop-up on another body part/Inflamed Hive Lesions/Hives come and go), MYALGIA (A little sore arm after 3rd shot), CHILLS (Chills arm after 3rd shot), NAUSEA (Nausea arm after 3rd shot) and HEADACHE (Headache arm after 3rd shot) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced MYALGIA (A little sore arm after 3rd shot), CHILLS (Chills arm after 3rd shot), NAUSEA (Nausea arm after 3rd shot) and HEADACHE (Headache arm after 3rd shot). On 17-Nov-2021, the patient experienced URTICARIA (Broke-out in hives/Hives started on abdomen and under arms, spread to random places on the body /One area heals and hives pop-up on another body part/Inflamed Hive Lesions/Hives come and go). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 1 dosage form; PREDNISONE for Hives, at a dose of Prednisone for 7 days and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form. On 09-Nov-2021, MYALGIA (A little sore arm after 3rd shot) had resolved. On 10-Nov-2021, CHILLS (Chills arm after 3rd shot), NAUSEA (Nausea arm after 3rd shot) and HEADACHE (Headache arm after 3rd shot) had resolved. At the time of the report, URTICARIA (Broke-out in hives/Hives started on abdomen and under arms, spread to random places on the body /One area heals and hives pop-up on another body part/Inflamed Hive Lesions/Hives come and go) had not resolved.            It was reported within 12 hours after booster had chills, nausea, and headache.  After the booster shot she had a little sore arm for a few days. The patient  took Tylenol and missed work had those symptoms for 3 days. On 17-Nov-2021, broke in hives. Hives started on abdomen and under arms then spread to random places on the body. On 19-Nov-2021, the doctor gave a steroid shot. It did not help. On 22-Nov-2021 started Prednisone for 7 days and Benadryl oral. The lesions were inflamed also. 09-Dec-2021 (Today ) the inflammation had improved but still had hives coming and going.   This case was linked to MOD-2021-407363, MOD-2021-407436, MOD-2021-407436 (Patient Link).
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment details were reported.  The box of vials was received on 14-Oct-2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had the same side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had the same side effects) 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 COMPLICATION (had the same side effects). At the time of the report, VACCINATION COMPLICATION (had the same side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The caller reported that a relative of their had the same side effects.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-403246, MOD-2021-403284 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: He's had an adverse effect to the shot/They started on my leg's after my 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He's had an adverse effect to the shot/They started on my leg's after my 1st shot) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (20 years ago). Concurrent medical conditions included Penicillin allergy, Drug allergy (Statins) and Allergy to chemicals (Sulfur).    On 09-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 VACCINATION COMPLICATION (He's had an adverse effect to the shot/They started on my leg's after my 1st shot). At the time of the report, VACCINATION COMPLICATION (He's had an adverse effect to the shot/They started on my leg's after my 1st shot) 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 details were reported.   This case was linked to MOD-2021-407399, MOD-2021-407221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow up received contains no new information.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  The box of vials were received from a location on 14-Oct-2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00 A,M to 4:00 P.M. It was reported that 4 vials had been used/administered to the patient, 1 open/punctured and about half used. 5 vials remained unpunctured.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: she had a little swelling and redness on injection site; she had a little swelling and redness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (she had a little swelling and redness on injection site) and VACCINATION SITE ERYTHEMA (she had a little swelling and redness on injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE SWELLING (she had a little swelling and redness on injection site) and VACCINATION SITE ERYTHEMA (she had a little swelling and redness on injection site). On 05-Apr-2021, VACCINATION SITE SWELLING (she had a little swelling and redness on injection site) and VACCINATION SITE ERYTHEMA (she had a little swelling and redness on injection site) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-407551   (Patient Link).
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  The box of vials was received on 14-Oct-2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Pain; Axillary swelling; Fever 102F; Muscle aches in the vaccination arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Axillary swelling), PYREXIA (Fever 102F), MYALGIA (Muscle aches in the vaccination arm) and HEADACHE (Headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 mcg. On 01-Dec-2021, the patient experienced PAIN (Pain) and MYALGIA (Muscle aches in the vaccination arm). 01-Dec-2021, the patient experienced SWELLING (Axillary swelling), PYREXIA (Fever 102F) and HEADACHE (Headache). On 01-Dec-2021, PYREXIA (Fever 102F) had resolved. On 02-Dec-2021, PAIN (Pain), SWELLING (Axillary swelling) and MYALGIA (Muscle aches in the vaccination arm) had resolved. On 04-Dec-2021, HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, Body temperature: 102 (High) 102F.         No Concomitant medications were reported.  No Treatment details were reported.  All symptoms were resolved by 05 December 2021
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Pain; Axillary swelling; Fever 102F; Muscle aches in the vaccination arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Axillary swelling), PYREXIA (Fever 102F), MYALGIA (Muscle aches in the vaccination arm) and HEADACHE (Headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 mcg. On 01-Dec-2021, the patient experienced PAIN (Pain) and MYALGIA (Muscle aches in the vaccination arm). 01-Dec-2021, the patient experienced SWELLING (Axillary swelling), PYREXIA (Fever 102F) and HEADACHE (Headache). On 01-Dec-2021, PYREXIA (Fever 102F) had resolved. On 02-Dec-2021, PAIN (Pain), SWELLING (Axillary swelling) and MYALGIA (Muscle aches in the vaccination arm) had resolved. On 04-Dec-2021, HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, Body temperature: 102 (High) 102F.         No Concomitant medications were reported.  No Treatment details were reported.  All symptoms were resolved by 05 December 2021
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave an adolescent a booster dose of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave an adolescent a booster dose of the Moderna Covid-19 Vaccine) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave an adolescent a booster dose of the Moderna Covid-19 Vaccine). On 09-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave an adolescent a booster dose of the Moderna Covid-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The patient received 2 doses of Pfizer as their primary series, patient did not have the administration dates, but stated that booster dose was taken after more than 6 months since their second dose.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Concussion, Dyspnoea, Illness
Clinical narrative: Was sick, out of work for 4 days; Had difficulty breathing; Hit head at work, concussion; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick, out of work for 4 days), DYSPNOEA (Had difficulty breathing) and CONCUSSION (Hit head at work, concussion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CONCUSSION (Hit head at work, concussion). On an unknown date, the patient experienced ILLNESS (Was sick, out of work for 4 days) and DYSPNOEA (Had difficulty breathing). The patient was treated with GABAPENTIN for Concussion, at an unspecified dose and frequency; AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Concussion, at an unspecified dose and frequency; TRAZODONE for Concussion, at a dose of 50 mg at bedtime and METOPROLOL for Concussion, at a dose of 50 mg once a day. At the time of the report, ILLNESS (Was sick, out of work for 4 days), DYSPNOEA (Had difficulty breathing) and CONCUSSION (Hit head at work, concussion) outcome was unknown.            It was reported that the patient was on leave from work since the patient had concussion.  No concomitant medications were reported.   This case was linked to MOD-2021-407432, MOD-2021-407321, MOD-2021-407545 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Breath sounds, Dyspnoea, Feeling abnormal, Influenza like illness, Myalgia
Clinical narrative: she is not having trouble breathing so much, but it hurts when she breathes; he can hear her breathe with difficulty when she speaks; like a bad flu; she's miserable.She feels worse now than with second dose; she has pains and aches all over; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (she is not having trouble breathing so much, but it hurts when she breathes), BREATH SOUNDS (he can hear her breathe with difficulty when she speaks), INFLUENZA LIKE ILLNESS (like a bad flu), FEELING ABNORMAL (she's miserable.She feels worse now than with second dose) and MYALGIA (she has pains and aches all over) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, 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 DYSPNOEA (she is not having trouble breathing so much, but it hurts when she breathes), BREATH SOUNDS (he can hear her breathe with difficulty when she speaks), INFLUENZA LIKE ILLNESS (like a bad flu), FEELING ABNORMAL (she's miserable.She feels worse now than with second dose) and MYALGIA (she has pains and aches all over). At the time of the report, DYSPNOEA (she is not having trouble breathing so much, but it hurts when she breathes), BREATH SOUNDS (he can hear her breathe with difficulty when she speaks), INFLUENZA LIKE ILLNESS (like a bad flu), FEELING ABNORMAL (she's miserable.She feels worse now than with second dose) and MYALGIA (she has pains and aches all over) outcome was unknown.            The patient had no fever no difficulty breathing previous to the shots not and not diagnosed with COVID-19. The patient was pretty healthy, never diagnosed with heart problems or breathing problems. No concomitant medications were reported. No treatment information was provided.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Recipient vaccinated post expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Recipient vaccinated post expiry) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Recipient vaccinated post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Recipient vaccinated post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Malaise, Musculoskeletal stiffness, Swelling
Clinical narrative: Pain and swelling in his armpit; Neck was stiff; Can't touch his armpit because it is tender/very tender; Pain and swelling in his armpit; Tired; Not feeling his best; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Pain and swelling in his armpit), MUSCULOSKELETAL STIFFNESS (Neck was stiff), MALAISE (Not feeling his best), TENDERNESS (Can't touch his armpit because it is tender/very tender) and AXILLARY PAIN (Pain and swelling in his armpit) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 029K20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Dec-2021 at 4:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced MALAISE (Not feeling his best) and FATIGUE (Tired). On 07-Dec-2021, the patient experienced SWELLING (Pain and swelling in his armpit), MUSCULOSKELETAL STIFFNESS (Neck was stiff), TENDERNESS (Can't touch his armpit because it is tender/very tender) and AXILLARY PAIN (Pain and swelling in his armpit). The patient was treated with IBUPROFEN for Pain and Swelling, at an unspecified dose and frequency. At the time of the report, SWELLING (Pain and swelling in his armpit) had not resolved and MUSCULOSKELETAL STIFFNESS (Neck was stiff), MALAISE (Not feeling his best), TENDERNESS (Can't touch his armpit because it is tender/very tender), AXILLARY PAIN (Pain and swelling in his armpit) and FATIGUE (Tired) outcome was unknown.            No Concomitant medication was reported.     Treatment medications included cold towel.  Patient also had something towards the groin area but does not attribute that to the vaccine.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Pain and swelling in his armpit; Neck was stiff; Can't touch his armpit because it is tender/very tender; Pain and swelling in his armpit; Tired; Not feeling his best; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Pain and swelling in his armpit), MUSCULOSKELETAL STIFFNESS (Neck was stiff), MALAISE (Not feeling his best), TENDERNESS (Can't touch his armpit because it is tender/very tender) and AXILLARY PAIN (Pain and swelling in his armpit) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 029K20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Dec-2021 at 4:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced MALAISE (Not feeling his best) and FATIGUE (Tired). On 07-Dec-2021, the patient experienced SWELLING (Pain and swelling in his armpit), MUSCULOSKELETAL STIFFNESS (Neck was stiff), TENDERNESS (Can't touch his armpit because it is tender/very tender) and AXILLARY PAIN (Pain and swelling in his armpit). The patient was treated with IBUPROFEN for Pain and Swelling, at an unspecified dose and frequency. At the time of the report, SWELLING (Pain and swelling in his armpit) had not resolved and MUSCULOSKELETAL STIFFNESS (Neck was stiff), MALAISE (Not feeling his best), TENDERNESS (Can't touch his armpit because it is tender/very tender), AXILLARY PAIN (Pain and swelling in his armpit) and FATIGUE (Tired) outcome was unknown.            No Concomitant medication was reported.     Treatment medications included cold towel.  Patient also had something towards the groin area but does not attribute that to the vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Moderna vial was punctured 21 times instead of 20 and a patient got the 21st dose.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Moderna vial was punctured 21 times instead of 20 and a patient got the 21st dose.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 012M20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Moderna vial was punctured 21 times instead of 20 and a patient got the 21st dose.). On 08-Dec-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Moderna vial was punctured 21 times instead of 20 and a patient got the 21st dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had no reaction during the 15 minutes they remained ate the facility.  No concomitant medications were reported. No treatment medications were reported.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        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.  The box of vials was received on 14 Oct 2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: HCP to return call with actual number of recipients vaccinated post expiry.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP to return call with actual number of recipients vaccinated post expiry.) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP to return call with actual number of recipients vaccinated post expiry.). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (HCP to return call with actual number of recipients vaccinated post expiry.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The box of vials were received on 14-Oct-2021. The vial was frozen when received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00 hours to 4:00 hours. The 4 vials had been used/administered to the patient, 1 open/punctured and about half used. 5 vials remained unpunctured.  Treatment information was not reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 08-Jun-2015, Hypertension since 05-Nov-2015 and Hyperlipidemia since 05-Nov-2015. Concomitant products included ROSUVASTATIN CALCIUM (ROSUVASTIN) from 05-Nov-2015 to an unknown date for Hyperlipidemia, VALSARTAN from 05-Nov-2015 to an unknown date for Hypertension, LEVOTHYROXINE from 05-Nov-2015 to an unknown date for Hypothyroidism.    On 17-Nov-2021 at 8:25 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was tested positive for COVID-19 in past. No treatment were reported.   This case was linked to MOD-2021-389253, MOD-2021-407640, MOD-2021-407615, MOD-2021-407628 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination complication
Clinical narrative: Spent most of the day in bed, not worth anything for 3 days; Wiped out; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Spent most of the day in bed, not worth anything for 3 days) and FATIGUE (Wiped out) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Wiped out). On 05-Mar-2021, the patient experienced VACCINATION COMPLICATION (Spent most of the day in bed, not worth anything for 3 days). In March 2021, VACCINATION COMPLICATION (Spent most of the day in bed, not worth anything for 3 days) had resolved. At the time of the report, FATIGUE (Wiped out) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-407483, MOD-2021-407593 .
Sex: U
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: sees circles from her left eye when she gets up; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (sees circles from her left eye when she gets up) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced VITREOUS FLOATERS (sees circles from her left eye when she gets up). At the time of the report, VITREOUS FLOATERS (sees circles from her left eye when she gets up) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Patient mentioned that she is going to see an Opthalmologist on 10DEC2021. Patient mentioned that she may have a detached retinae. Patient did not mention which eye detached retina is in before she concluded the telephone call.   This case was linked to MOD-2021-407587 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 21-Aug-2017, Malignant hypertension since 18-Oct-2013 and Mixed hyperlipidemia since 18-Oct-2021. Concomitant products included SERTRALINE from 18-Sep-2013 to an unknown date for Depression, ATORVASTATIN from 15-Jan-2014 to an unknown date for Hyperlipidemia, LEVOTHYROXINE from 21-Jun-2017 to an unknown date for Hypothyroidism, TRAZODONE from 18-Sep-2013 to an unknown date for Insomnia, MELOXICAM from 18-Sep-2013 to an unknown date for Joint pain, IBANDRONATE SODIUM (IBANDRONATE) from 08-Aug-2016 to an unknown date for Osteopenia.    On 17-Nov-2021 at 9:53 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Nov-2021 at 9:53 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Nov-2021 at 9:53 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-407640 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: chills; fever; nausea; vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomiting) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomiting) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient experienced chills, fever, nausea and vomiting now. Concomitant medication use was not provided Treatment information was not provided   Reporter did not allow further contact
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test positive
Clinical narrative: Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesterolemia and GERD. Concomitant products included OMEPRAZOLE for GERD, ATORVASTATIN CALCIUM (LIPITOR) for Hypercholesterolemia, LOSARTAN for Hypertension.    On 17-Nov-2021 at 10:13 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, SARS-CoV-2 test positive: positive (Positive) PCR test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-389253, MOD-2021-407570, MOD-2021-407615, MOD-2021-407628 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Feels terrible; raised with bumps and blisters; it is really hot; hands are ice cubes/hands are freezing; throat is sore; rash that is about 4-5 inches long on the arm at the injection site; arm is swollen/is double the size and under the arm in the armpit area too; Chills/Chills are bad; Fever/had fever; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels terrible), VACCINATION SITE VESICLES (raised with bumps and blisters), VACCINATION SITE WARMTH (it is really hot), PERIPHERAL COLDNESS (hands are ice cubes/hands are freezing) and OROPHARYNGEAL PAIN (throat is sore) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Complex regional pain syndrome (7-8 years), Adrenal insufficiency, Asthma and Migraine. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, OXYCODONE, CELECOXIB (CELEBREX), OMEPRAZOLE, MONTELUKAST, SUCRALFATE (CARAFATE), ZOLPIDEM TARTRATE (AMBIEN), SIMVASTATIN, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feels terrible), VACCINATION SITE VESICLES (raised with bumps and blisters), VACCINATION SITE WARMTH (it is really hot), PERIPHERAL COLDNESS (hands are ice cubes/hands are freezing), OROPHARYNGEAL PAIN (throat is sore), VACCINATION SITE RASH (rash that is about 4-5 inches long on the arm at the injection site), VACCINATION SITE SWELLING (arm is swollen/is double the size and under the arm in the armpit area too), CHILLS (Chills/Chills are bad), PYREXIA (Fever/had fever), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (Feels terrible), VACCINATION SITE VESICLES (raised with bumps and blisters), VACCINATION SITE WARMTH (it is really hot), PERIPHERAL COLDNESS (hands are ice cubes/hands are freezing), OROPHARYNGEAL PAIN (throat is sore), VACCINATION SITE RASH (rash that is about 4-5 inches long on the arm at the injection site), VACCINATION SITE SWELLING (arm is swollen/is double the size and under the arm in the armpit area too), CHILLS (Chills/Chills are bad), PYREXIA (Fever/had fever), HEADACHE (headache) and NAUSEA (nausea) had not resolved.            It was reported that patient had lot of health problems.  No treatment medication information was given.   This case was linked to MOD-2021-407234 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Pyrexia, Vaccination site rash, Vaccination site swelling, Vaccination site vesicles
Clinical narrative: Feels terrible; raised with bumps and blisters; it is really hot; hands are ice cubes/hands are freezing; throat is sore; rash that is about 4-5 inches long on the arm at the injection site; arm is swollen/is double the size and under the arm in the armpit area too; Chills/Chills are bad; Fever/had fever; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels terrible), VACCINATION SITE VESICLES (raised with bumps and blisters), VACCINATION SITE WARMTH (it is really hot), PERIPHERAL COLDNESS (hands are ice cubes/hands are freezing) and OROPHARYNGEAL PAIN (throat is sore) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Complex regional pain syndrome (7-8 years), Adrenal insufficiency, Asthma and Migraine. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, OXYCODONE, CELECOXIB (CELEBREX), OMEPRAZOLE, MONTELUKAST, SUCRALFATE (CARAFATE), ZOLPIDEM TARTRATE (AMBIEN), SIMVASTATIN, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feels terrible), VACCINATION SITE VESICLES (raised with bumps and blisters), VACCINATION SITE WARMTH (it is really hot), PERIPHERAL COLDNESS (hands are ice cubes/hands are freezing), OROPHARYNGEAL PAIN (throat is sore), VACCINATION SITE RASH (rash that is about 4-5 inches long on the arm at the injection site), VACCINATION SITE SWELLING (arm is swollen/is double the size and under the arm in the armpit area too), CHILLS (Chills/Chills are bad), PYREXIA (Fever/had fever), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (Feels terrible), VACCINATION SITE VESICLES (raised with bumps and blisters), VACCINATION SITE WARMTH (it is really hot), PERIPHERAL COLDNESS (hands are ice cubes/hands are freezing), OROPHARYNGEAL PAIN (throat is sore), VACCINATION SITE RASH (rash that is about 4-5 inches long on the arm at the injection site), VACCINATION SITE SWELLING (arm is swollen/is double the size and under the arm in the armpit area too), CHILLS (Chills/Chills are bad), PYREXIA (Fever/had fever), HEADACHE (headache) and NAUSEA (nausea) had not resolved.            It was reported that patient had lot of health problems.  No treatment medication information was given.   This case was linked to MOD-2021-407234 (Patient Link).