chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm; Swollen arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 013L20A and 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism in 1995 and Cholesterol high in 1999. Concomitant products included SIMVASTATIN (ZOCOR) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, TRAZODONE for Insomnia, CALCIUM for Osteopenia, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache). On 29-Oct-2021, HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen arm) had not resolved.            No treatment medication was reported.   This case was linked to MOD-2021-372770, MOD-2021-365112 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: chills; fever; joint paint; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint paint) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint paint). At the time of the report, CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint paint) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were reported.   This case was linked to MOD-2021-372579, MOD-2021-372818 (Patient Link).
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. The reporter did not know which dosage it was, if it was 0.5 or 0.25ML or 50 or 100mcg, and it was stated as  one from the booster dose.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  On 14-Oct-2021, vial was removed from freezer into refrigerator. It was never opened before today and temperature was never compromised.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Chills, Inappropriate schedule of product administration, Malaise, Myalgia
Clinical narrative: She woke up feeling fine and her period symptoms also stopped out of nowhere; Her period just stopped out of nowhere; Had common side effects of chills; Second shot within 5 hours she started to feel achy,she was hurting all over; Patient got her first shot on 20Sept2021 and second shot 1Nov2021; It was a rough night; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (It was a rough night), THERAPEUTIC RESPONSE UNEXPECTED (She woke up feeling fine and her period symptoms also stopped out of nowhere), AMENORRHOEA (Her period just stopped out of nowhere), CHILLS (Had common side effects of chills) and MYALGIA (Second shot within 5 hours she started to feel achy,she was hurting all over) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced MALAISE (It was a rough night), CHILLS (Had common side effects of chills), MYALGIA (Second shot within 5 hours she started to feel achy,she was hurting all over) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her first shot on 20Sept2021 and second shot 1Nov2021). On 02-Nov-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She woke up feeling fine and her period symptoms also stopped out of nowhere) and AMENORRHOEA (Her period just stopped out of nowhere). On 01-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her first shot on 20Sept2021 and second shot 1Nov2021) had resolved. On 02-Nov-2021, MALAISE (It was a rough night), CHILLS (Had common side effects of chills) and MYALGIA (Second shot within 5 hours she started to feel achy,she was hurting all over) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She woke up feeling fine and her period symptoms also stopped out of nowhere) had resolved and AMENORRHOEA (Her period just stopped out of nowhere) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: She woke up feeling fine and her period symptoms also stopped out of nowhere; Her period just stopped out of nowhere; Had common side effects of chills; Second shot within 5 hours she started to feel achy,she was hurting all over; Patient got her first shot on 20Sept2021 and second shot 1Nov2021; It was a rough night; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (It was a rough night), THERAPEUTIC RESPONSE UNEXPECTED (She woke up feeling fine and her period symptoms also stopped out of nowhere), AMENORRHOEA (Her period just stopped out of nowhere), CHILLS (Had common side effects of chills) and MYALGIA (Second shot within 5 hours she started to feel achy,she was hurting all over) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced MALAISE (It was a rough night), CHILLS (Had common side effects of chills), MYALGIA (Second shot within 5 hours she started to feel achy,she was hurting all over) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her first shot on 20Sept2021 and second shot 1Nov2021). On 02-Nov-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She woke up feeling fine and her period symptoms also stopped out of nowhere) and AMENORRHOEA (Her period just stopped out of nowhere). On 01-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her first shot on 20Sept2021 and second shot 1Nov2021) had resolved. On 02-Nov-2021, MALAISE (It was a rough night), CHILLS (Had common side effects of chills) and MYALGIA (Second shot within 5 hours she started to feel achy,she was hurting all over) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She woke up feeling fine and her period symptoms also stopped out of nowhere) had resolved and AMENORRHOEA (Her period just stopped out of nowhere) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: she was having severe jaw pain and it lasted until today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (she was having severe jaw pain and it lasted until today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (1st dose - 10Mar2021 with lot number EN6199 2nd dose - 31Mar2021 with lot number ER8732) from 10-Mar-2021 to 31-Mar-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included TMJ syndrome (She has a condition called TMJ and was wondering if the vaccine can trigger jaw pain.).    On 29-Oct-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN JAW (she was having severe jaw pain and it lasted until today). On 02-Nov-2021, PAIN IN JAW (she was having severe jaw pain and it lasted until today) had resolved.            Concomitant information was not reported. Treatment information was not reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that they mistakenly administered expired vaccine today which was removed from freezer on 14-Oct-2021 into refrigerator and never opened before administration and temperature was never compromised. It was also reported that it was patient's third dose, and it was a 0.25-ml dose and no information regarding first or second dose were provided.  No concomitant medications were reported.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Injection site erythema
Clinical narrative: Sleeps 18 hours day; Achy; Blochy red arm; Extreme fatigue; Chills; Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeps 18 hours day), PAIN (Achy), INJECTION SITE ERYTHEMA (Blochy red arm), FATIGUE (Extreme fatigue) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced HYPERSOMNIA (Sleeps 18 hours day), PAIN (Achy), INJECTION SITE ERYTHEMA (Blochy red arm), FATIGUE (Extreme fatigue), CHILLS (Chills) and HEADACHE (Very bad headache). At the time of the report, HYPERSOMNIA (Sleeps 18 hours day), PAIN (Achy), FATIGUE (Extreme fatigue), CHILLS (Chills) and HEADACHE (Very bad headache) outcome was unknown and INJECTION SITE ERYTHEMA (Blochy red arm) had not resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient received their Moderna COVID-19 Booster shot on 28-Oct-2021 and experienced extreme fatigue and was sleeping 18 hours day. Th patient also developed chills, achy and had very bad headache. Reportedly, the patient was still having blotchy arm below the injection site and it was red but doesn't hurt or itch.  Patient does not have any underlying conditions and was not taking any medications and was not allergic.  Company comment: This is a spontaneous  case concerning a 80-year-old male patient with no relevant medical history, who experienced the non-serious  unexpected events Hypersomnia and Pain and expected injection site erythema, fatigue, chills and headache . The events occurred after the third (booster) dose of mRNA-1273 Moderna vaccine on an unknown date.  The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This is a spontaneous  case concerning a 80-year-old male patient with no relavant medical history, who experienced the non-serious  unexpected events Hypersonmnia and Pain and expected injection site erythema, fatigue, chills and headache . The events occurred after the third (booster) dose of mRNA-1273 Moderna vaccine on an unknown date.  The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Sleeps 18 hours day; Achy; Blochy red arm; Extreme fatigue; Chills; Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeps 18 hours day), PAIN (Achy), INJECTION SITE ERYTHEMA (Blochy red arm), FATIGUE (Extreme fatigue) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced HYPERSOMNIA (Sleeps 18 hours day), PAIN (Achy), INJECTION SITE ERYTHEMA (Blochy red arm), FATIGUE (Extreme fatigue), CHILLS (Chills) and HEADACHE (Very bad headache). At the time of the report, HYPERSOMNIA (Sleeps 18 hours day), PAIN (Achy), FATIGUE (Extreme fatigue), CHILLS (Chills) and HEADACHE (Very bad headache) outcome was unknown and INJECTION SITE ERYTHEMA (Blochy red arm) had not resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient received their Moderna COVID-19 Booster shot on 28-Oct-2021 and experienced extreme fatigue and was sleeping 18 hours day. Th patient also developed chills, achy and had very bad headache. Reportedly, the patient was still having blotchy arm below the injection site and it was red but doesn't hurt or itch.  Patient does not have any underlying conditions and was not taking any medications and was not allergic.  Company comment: This is a spontaneous  case concerning a 80-year-old male patient with no relevant medical history, who experienced the non-serious  unexpected events Hypersomnia and Pain and expected injection site erythema, fatigue, chills and headache . The events occurred after the third (booster) dose of mRNA-1273 Moderna vaccine on an unknown date.  The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This is a spontaneous  case concerning a 80-year-old male patient with no relavant medical history, who experienced the non-serious  unexpected events Hypersonmnia and Pain and expected injection site erythema, fatigue, chills and headache . The events occurred after the third (booster) dose of mRNA-1273 Moderna vaccine on an unknown date.  The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Feeling cold
Clinical narrative: Body temperature dropping; Coldness; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Body temperature dropping) and FEELING COLD (Coldness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced BODY TEMPERATURE DECREASED (Body temperature dropping) and FEELING COLD (Coldness). On 03-Mar-2021, BODY TEMPERATURE DECREASED (Body temperature dropping) and FEELING COLD (Coldness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       no concomitant medications and treatment medications were provided.   This case was linked to MOD-2021-372771 (Patient Link).   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt a little tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt a little tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications reported.   This case was linked to MOD-2021-372881, MOD-2021-372950 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (a little tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (a little tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (a little tired) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-372881, MOD-2021-372938 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Ear inflammation
Clinical narrative: Horse voice; Inflammation in the ear; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Horse voice) and EAR INFLAMMATION (Inflammation in the ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   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 DYSPHONIA (Horse voice) and EAR INFLAMMATION (Inflammation in the ear). At the time of the report, DYSPHONIA (Horse voice) and EAR INFLAMMATION (Inflammation in the ear) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant drug details were reported. No treatment details were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was given by reporter. No treatment medication was given by reporter.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: had a temperature of almost 102 F which is similar to what happened after the other doses; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (had a temperature of almost 102 F. which is similar to what happened after the other doses) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-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 PYREXIA (had a temperature of almost 102 F. which is similar to what happened after the other doses). At the time of the report, PYREXIA (had a temperature of almost 102 F. which is similar to what happened after the other doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 F. (High) 102 F.     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. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-372655, MOD-2021-373022 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: really tired; a little headachy; soreness at the injection site with both injections; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really tired), HEADACHE (a little headachy) and VACCINATION SITE PAIN (soreness at the injection site with both injections) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (really tired) and HEADACHE (a little headachy). In 2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site with both injections). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 23-Jan-2021, FATIGUE (really tired) and HEADACHE (a little headachy) had resolved. At the time of the report, VACCINATION SITE PAIN (soreness at the injection site with both injections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported.   This case was linked to MOD-2021-373097 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Brother-in-law got vaccinated with Moderna Covid-19 vaccine & got Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Brother-in-law got vaccinated with Moderna Covid-19 vaccine & got Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Brother-in-law got vaccinated with Moderna Covid-19 vaccine & got Covid-19). At the time of the report, COVID-19 (Brother-in-law got vaccinated with Moderna Covid-19 vaccine & got Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided. Reporter reported-  She wants us to disregard her previous report as 1 & she is not sure if her brother-in -law got the Moderna vaccine.  she does not want to skew out records.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Significant follow up received including new Events, & Case related data.; Sender's Comments: This case concerns a male patient with no reported medical history, who experienced the non-serious, unexpected and AESI event of COVID-19. The event occurred approximately on an unknown date after receiving an unknown dose number of the mRNA-1273 Moderna COVID-19 vaccine. The rechallenge was not applicable, as vaccination, event and dose number are not available. The benefit-risk relationship of the mRNA-1273 Moderna COVID-19 vaccine is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: more symptoms with booster dose than first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (more symptoms with booster dose than first dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (more symptoms with booster dose than first dose). At the time of the report, VACCINATION COMPLICATION (more symptoms with booster dose than first dose) outcome was unknown.            Concomitant medications was not provided by the reporter Treatment information was not provided   This case was linked to MOD-2021-373949 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  (removed from freezer 10-14-21 into refrigerator and never opened before today and temperature never compromised )
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. no treatment was reported. (removed from freezer 10-14-21 into refrigerator and never opened before today and temperature never compromised)
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that the vial was kept in refrigerator on 14-Oct-2021 and reported no temperature excursion.   This case was linked to MOD-2021-372310 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Pyrexia, Vaccination site reaction
Clinical narrative: Really sick; COVID arm; chills; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick), VACCINATION SITE REACTION (COVID arm), CHILLS (chills), FATIGUE (Tired) and PYREXIA (Fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ILLNESS (Really sick), VACCINATION SITE REACTION (COVID arm), CHILLS (chills), FATIGUE (Tired) and PYREXIA (Fever). In September 2021, ILLNESS (Really sick), VACCINATION SITE REACTION (COVID arm), CHILLS (chills), FATIGUE (Tired) and PYREXIA (Fever) had resolved.            No treatment medication was provided. No concomitant medication was provided.  The adverse events lasted a little over a day.   This case was linked to MOD-2021-373350 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: left arm under the injection site is  warm; left arm under the injection site is red; left arm under the injection site is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (left arm under the injection site is  warm), VACCINATION SITE ERYTHEMA (left arm under the injection site is red) and VACCINATION SITE PRURITUS (left arm under the injection site is itchy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. (0 or U)17F21A, 026A21A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW), ATENOLOL, MULTIVITAMIN [VITAMINS NOS], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ATORVASTATIN, MAGNESIUM and FAMOTIDINE (PEPCID AC) for an unknown indication.   On 04-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 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced VACCINATION SITE WARMTH (left arm under the injection site is  warm), VACCINATION SITE ERYTHEMA (left arm under the injection site is red) and VACCINATION SITE PRURITUS (left arm under the injection site is itchy). At the time of the report, VACCINATION SITE WARMTH (left arm under the injection site is  warm), VACCINATION SITE ERYTHEMA (left arm under the injection site is red) and VACCINATION SITE PRURITUS (left arm under the injection site is itchy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: injection site after booster is warm; injection site after booster is red; injection site after booster itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site after booster is warm), VACCINATION SITE ERYTHEMA (injection site after booster is red) and VACCINATION SITE PRURITUS (injection site after booster itches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Oct-2021, the patient experienced VACCINATION SITE WARMTH (injection site after booster is warm), VACCINATION SITE ERYTHEMA (injection site after booster is red) and VACCINATION SITE PRURITUS (injection site after booster itches). At the time of the report, VACCINATION SITE WARMTH (injection site after booster is warm), VACCINATION SITE ERYTHEMA (injection site after booster is red) and VACCINATION SITE PRURITUS (injection site after booster itches) outcome was unknown.            No concomitant medications reported. No treatment medications reported.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on Moderna COVID19 Vaccine on 02Mar2021 and  second dose on 09Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on Moderna COVID19 Vaccine on 02Mar2021 and  second dose on 09Apr2021) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on Moderna COVID19 Vaccine on 02Mar2021 and  second dose on 09Apr2021). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on Moderna COVID19 Vaccine on 02Mar2021 and  second dose on 09Apr2021) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: flu like symptoms; fatigue; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and FATIGUE (fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MWA and 011LZOA) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa), Allergy to antibiotic (Levaquin) and Drug allergy (Medrol PAK). Concomitant products included VITAMIN D NOS and VITAMIN B COMPLEX for Vitamin supplementation.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-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 INFLUENZA LIKE ILLNESS (flu like symptoms) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and FATIGUE (fatigue) outcome was unknown.            No treatment medication was reported.   This case was linked to MOD-2021-008089, MOD-2021-370395 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Swelling in the back of the throat; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling in the back of the throat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 042L20A) 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) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHARYNGEAL SWELLING (Swelling in the back of the throat). On 02-Mar-2021, PHARYNGEAL SWELLING (Swelling in the back of the throat) had resolved.            Patient took couple of concomitant medications but did not provide names. No treatment medications were provided. Patient stated that symptoms were a 3 on scale of 1 to 10 and was able to drink water and stayed there and symptoms dissipated in less than half hour. Patient experienced reaction and asked whether to get booster dose considering the reaction.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headaches; Fever; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headaches) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches) and PYREXIA (Fever). At the time of the report, HEADACHE (Headaches) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) 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 medications were reported.  It was reported that on 14-Oct-2021, the vial was removed from refrigerator and was not opened before vaccination and temperature was not compromised.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Gouty arthritis, Therapeutic response unexpected
Clinical narrative: Took two weeks to go away/arthritis went away/ I've not had a pain since; Gouty arthritis; This spontaneous case was reported by a consumer and describes the occurrence of GOUTY ARTHRITIS (Gouty arthritis) and THERAPEUTIC RESPONSE UNEXPECTED (Took two weeks to go away/arthritis went away/ I've not had a pain since) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced GOUTY ARTHRITIS (Gouty arthritis). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Took two weeks to go away/arthritis went away/ I've not had a pain since). At the time of the report, GOUTY ARTHRITIS (Gouty arthritis) and THERAPEUTIC RESPONSE UNEXPECTED (Took two weeks to go away/arthritis went away/ I've not had a pain since) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  The patient went on a common medicine that treats gouty arthritis. He does not know the name of it.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown.            No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-373311 (Patient Link).