chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Sinus disorder
Clinical narrative: hard time sleep, slept really badly; has sinus; has fever 99.6F; chills; nausea; achy around neck; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard time sleep, slept really badly), SINUS DISORDER (has sinus), PYREXIA (has fever 99.6F), CHILLS (chills) and NAUSEA (nausea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. H062E21A and 04R20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included LEVOTHYROXINE and DOXAZOSIN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced INSOMNIA (hard time sleep, slept really badly), SINUS DISORDER (has sinus), PYREXIA (has fever 99.6F), CHILLS (chills), NAUSEA (nausea), MYALGIA (achy around neck) and HEADACHE (headache). At the time of the report, INSOMNIA (hard time sleep, slept really badly), SINUS DISORDER (has sinus), PYREXIA (has fever 99.6F), CHILLS (chills), NAUSEA (nausea), MYALGIA (achy around neck) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 (Inconclusive) 99.6F.         No treatment medications were reported.  Case is non-serious (lack of evidence of seriousness for all the events from a regulatory or clinical standpoint) and does not include any AESI event after correcting the coding of the event initially captured as "hypersomnia" to a more specific one according to source document. In consequence, no CC is required for this case".   This case was linked to MOD-2021-367613, MOD-2021-367566 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Immobile, Limb injury
Clinical narrative: Foot wound; passed away about a week after becoming immobile; This spontaneous case was reported by a consumer and describes the occurrence of IMMOBILE (passed away about a week after becoming immobile) and LIMB INJURY (Foot wound) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059B21A and D06B7 or 21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included WARFARIN, METOPROLOL, LEVOTHYROXINE SODIUM, MEMANTINE HYDROCHLORIDE (MEMANTINE HCL) and DONEPEZIL HYDROCHLORIDE (DONEPEZIL HCL) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMOBILE (passed away about a week after becoming immobile) (seriousness criteria death and medically significant). On an unknown date, the patient experienced LIMB INJURY (Foot wound) (seriousness criterion medically significant). The patient died in May 2021. The reported cause of death was Immobile. It is unknown if an autopsy was performed. At the time of death, LIMB INJURY (Foot wound) outcome was unknown.            Treatment information was not provided.  Concomitant medication include blood thinner medication.  This case concerns a 91-year-old female patient with no relevant medical history, who experienced the unexpected events of Immobile and Limb Injury. The events occurred approximately 9 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome, with death occurring in the following week. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 91-year-old female patient with no relevant medical history, who experienced the unexpected events of Immobile and Limb Injury. The events occurred approximately 9 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome, with death occurring in the following week. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Reported Cause(s) of Death: Immobile
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: flushness with face; soreness at the injection site; redness at the injection site; fever; horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushness with face), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), PYREXIA (fever) and HEADACHE (horrible headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu (patient get the headache & soreness with the flu shot, too. she have to get the regular dose and because of side effect). Past adverse reactions to the above products included Headache with flu.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced FLUSHING (flushness with face), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), PYREXIA (fever) and HEADACHE (horrible headache). At the time of the report, FLUSHING (flushness with face), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), PYREXIA (fever) and HEADACHE (horrible headache) 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 medication was reported by the reporter.    This case was linked to MOD-2021-367636 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Nausea, Pyrexia
Clinical narrative: hot to touch; very high fever/cools off and then have high temperature/hot to touch; headaches; chills; nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING HOT (hot to touch), PYREXIA (very high fever/cools off and then have high temperature/hot to touch), HEADACHE (headaches), CHILLS (chills) and NAUSEA (nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced FEELING HOT (hot to touch), PYREXIA (very high fever/cools off and then have high temperature/hot to touch), HEADACHE (headaches), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 27-Oct-2021 at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL COLD [DEXTROMETHORPHAN HYDROBROMIDE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) on 28-Oct-2021 at an unspecified dose and frequency. At the time of the report, FEELING HOT (hot to touch), PYREXIA (very high fever/cools off and then have high temperature/hot to touch), HEADACHE (headaches), CHILLS (chills) and NAUSEA (nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.  Patient received 1st and 2nd dose of the Pfizer vaccine.  Patient got the moderna vaccine as booster dose.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose/ received a dose on 14Oct2021 of a vial that had expired on 13Oct2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose/ received a dose on 14Oct2021 of a vial that had expired on 13Oct2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose/ received a dose on 14Oct2021 of a vial that had expired on 13Oct2021). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose/ received a dose on 14Oct2021 of a vial that had expired on 13Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Screaming, Vaccination site discolouration
Clinical narrative: lady screaming while being vaccinated; black and Blue arm injection site; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of SCREAMING (lady screaming while being vaccinated), VACCINATION SITE DISCOLOURATION (black and Blue arm injection site) and PERIPHERAL SWELLING (Swollen arm) 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 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced SCREAMING (lady screaming while being vaccinated), VACCINATION SITE DISCOLOURATION (black and Blue arm injection site) and PERIPHERAL SWELLING (Swollen arm). At the time of the report, SCREAMING (lady screaming while being vaccinated), VACCINATION SITE DISCOLOURATION (black and Blue arm injection site) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Booster dose given at 0.5ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Booster dose given at 0.5ml) 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 27-Oct-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Booster dose given at 0.5ml). On 27-Oct-2021, ACCIDENTAL OVERDOSE (Booster dose given at 0.5ml) had resolved.            Concomitant medication information not provided. Treatment information not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU (flu shot).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was stated that But I get the headache & soreness with the flu shot, too. I have to get the regular dose, because of the side effects.  No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-367618.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from vial punctured more than 12 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured more than 12 hours ago) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 014M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Seizures.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured more than 12 hours ago). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. The vial was initially stored and punctured on 26-Oct-2021.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate
Clinical narrative: Out of breath post yard work after 2nd shot/Shortness of breath on and off after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Out of breath post yard work after 2nd shot/Shortness of breath on and off after 2nd shot) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DYSPNOEA (Out of breath post yard work after 2nd shot/Shortness of breath on and off after 2nd shot). At the time of the report, DYSPNOEA (Out of breath post yard work after 2nd shot/Shortness of breath on and off after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Increased heart rate.         It was reported that the patient shortness of breath and also increased heart rate in the months of Mar-2021 and APR-2021 - which goes away and comes back. Also stated that he was exposed to COVID through his 17year old son.  Concomitant medication information was not reported  Treatment information was not reported
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: According to her after the second dose the pain  is even more painful; pain radiates more out, further than the injection site; Lump in her right  arm; She woke up with pain,the soreness woke her up; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (According to her after the second dose the pain  is even more painful), PAIN (pain radiates more out, further than the injection site), VACCINATION SITE MASS (Lump in her right  arm), VACCINATION SITE PAIN (She woke up with pain,the soreness woke her up) and VACCINATION SITE ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness). On 28-Oct-2021, the patient experienced VACCINATION SITE MASS (Lump in her right  arm) and VACCINATION SITE PAIN (She woke up with pain,the soreness woke her up). On an unknown date, the patient experienced PAIN (According to her after the second dose the pain  is even more painful) and PAIN (pain radiates more out, further than the injection site). At the time of the report, PAIN (According to her after the second dose the pain  is even more painful), PAIN (pain radiates more out, further than the injection site), VACCINATION SITE MASS (Lump in her right  arm), VACCINATION SITE PAIN (She woke up with pain,the soreness woke her up) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.            Patient is taking muscle relaxer for her broken ribs.  No concomitant medications were provided.   This case was linked to MOD-2021-368091 (Patient Link).   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Illness, Inappropriate schedule of product administration, Nausea, Retching
Clinical narrative: she has all the symptoms of covid19; felt nausea,very nauseas; Throw up; very sick; couldn't eat; was dry heaving; the first dose on the 3Aug2021 and the second dose on the 9Sept2021; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), DECREASED APPETITE (couldn't eat), RETCHING (was dry heaving), SUSPECTED COVID-19 (she has all the symptoms of covid19) and NAUSEA (felt nausea,very nauseas) in a 79-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 was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the first dose on the 3Aug2021 and the second dose on the 9Sept2021). On 11-Sep-2021, the patient experienced ILLNESS (very sick), DECREASED APPETITE (couldn't eat), RETCHING (was dry heaving), NAUSEA (felt nausea,very nauseas) and VOMITING (Throw up). On 27-Oct-2021, the patient experienced SUSPECTED COVID-19 (she has all the symptoms of covid19). On 09-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the first dose on the 3Aug2021 and the second dose on the 9Sept2021) had resolved. At the time of the report, ILLNESS (very sick), DECREASED APPETITE (couldn't eat), RETCHING (was dry heaving), SUSPECTED COVID-19 (she has all the symptoms of covid19), NAUSEA (felt nausea,very nauseas) and VOMITING (Throw up) outcome was unknown.            No treatment information was provided.  Company comment- This is a case of inappropriate schedule of product administration in a 79 year old female patient, with no medical history reported who experienced non serious unexpected  event of suspected COVID-19 after second dose of mRNA-1273. The event occurred 1 month and 19 days after second dose. The re-challenge is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-367605 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a case of inappropriate schedule of product administration in a 79 year old female patient, with no medical history reported who experienced non serious unexpected  event of suspected COVID-19 after second dose of mRNA-1273. The event occurred 1 month and 19 days after second dose. The re-challenge is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vomiting
Clinical narrative: she has all the symptoms of covid19; felt nausea,very nauseas; Throw up; very sick; couldn't eat; was dry heaving; the first dose on the 3Aug2021 and the second dose on the 9Sept2021; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), DECREASED APPETITE (couldn't eat), RETCHING (was dry heaving), SUSPECTED COVID-19 (she has all the symptoms of covid19) and NAUSEA (felt nausea,very nauseas) in a 79-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 was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the first dose on the 3Aug2021 and the second dose on the 9Sept2021). On 11-Sep-2021, the patient experienced ILLNESS (very sick), DECREASED APPETITE (couldn't eat), RETCHING (was dry heaving), NAUSEA (felt nausea,very nauseas) and VOMITING (Throw up). On 27-Oct-2021, the patient experienced SUSPECTED COVID-19 (she has all the symptoms of covid19). On 09-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the first dose on the 3Aug2021 and the second dose on the 9Sept2021) had resolved. At the time of the report, ILLNESS (very sick), DECREASED APPETITE (couldn't eat), RETCHING (was dry heaving), SUSPECTED COVID-19 (she has all the symptoms of covid19), NAUSEA (felt nausea,very nauseas) and VOMITING (Throw up) outcome was unknown.            No treatment information was provided.  Company comment- This is a case of inappropriate schedule of product administration in a 79 year old female patient, with no medical history reported who experienced non serious unexpected  event of suspected COVID-19 after second dose of mRNA-1273. The event occurred 1 month and 19 days after second dose. The re-challenge is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-367605 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a case of inappropriate schedule of product administration in a 79 year old female patient, with no medical history reported who experienced non serious unexpected  event of suspected COVID-19 after second dose of mRNA-1273. The event occurred 1 month and 19 days after second dose. The re-challenge is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced PYREXIA (Low grade fever). At the time of the report, PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   No treatment drug was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, Vaccination site pain
Clinical narrative: Pain underneath left arm; Swollen gland underneath the left arm; Ran a fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen gland underneath the left arm), PYREXIA (Ran a fever) and VACCINATION SITE PAIN (Pain underneath left arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 016B27L) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PYREXIA (Ran a fever). On 02-May-2021, the patient experienced LYMPHADENOPATHY (Swollen gland underneath the left arm). On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain underneath left arm). On 04-May-2021, PYREXIA (Ran a fever) outcome was unknown. At the time of the report, LYMPHADENOPATHY (Swollen gland underneath the left arm) and VACCINATION SITE PAIN (Pain underneath left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported. Patient took pain and inflammatory medication to help with symptoms.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The HCP administered an expired Moderna Vaccine to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 041L20A and 012A21A) 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) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that the date the vial was initially stored in the refrigerator  was Sep 8th 2021 the vial did not undergo any temperature excursions.   This case was linked to MOD-2021-366988 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Asthenia, Eye pain, Feeling hot
Clinical narrative: Anxious; Weak; Pain on his eyes, feeling them hot; Pain on his eyes, feeling them hot; Fast heartbeat; Fever; Pain at the injection site; Muscle pain; Little headache; "The wrist hurt where you put the fingers to take the blood pressure"; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxious), ASTHENIA (Weak), FEELING HOT (Pain on his eyes, feeling them hot), EYE PAIN (Pain on his eyes, feeling them hot) and PALPITATIONS (Fast heartbeat) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 022M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Oct-2021, the patient experienced ASTHENIA (Weak), FEELING HOT (Pain on his eyes, feeling them hot), EYE PAIN (Pain on his eyes, feeling them hot), PALPITATIONS (Fast heartbeat), PYREXIA (Fever), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain), HEADACHE (Little headache) and ARTHRALGIA ("The wrist hurt where you put the fingers to take the blood pressure"). On 27-Oct-2021, the patient experienced ANXIETY (Anxious). On 26-Oct-2021, ASTHENIA (Weak), FEELING HOT (Pain on his eyes, feeling them hot), EYE PAIN (Pain on his eyes, feeling them hot), PALPITATIONS (Fast heartbeat), PYREXIA (Fever), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain), HEADACHE (Little headache) and ARTHRALGIA ("The wrist hurt where you put the fingers to take the blood pressure") had resolved. At the time of the report, ANXIETY (Anxious) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Heart rate: high (High) Fast heartbeat.         No treatment information was provided.  Patient received only half a dose as he was doing fine and his laboratory results were good. Patient was concerned though because, he stated yesterday feeling anxious and today he is worried if that could affect somehow the efficacy of the vaccine.   This case was linked to MOD-2021-367850 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Myalgia, Palpitations, Pyrexia
Clinical narrative: Anxious; Weak; Pain on his eyes, feeling them hot; Pain on his eyes, feeling them hot; Fast heartbeat; Fever; Pain at the injection site; Muscle pain; Little headache; "The wrist hurt where you put the fingers to take the blood pressure"; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxious), ASTHENIA (Weak), FEELING HOT (Pain on his eyes, feeling them hot), EYE PAIN (Pain on his eyes, feeling them hot) and PALPITATIONS (Fast heartbeat) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 022M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Oct-2021, the patient experienced ASTHENIA (Weak), FEELING HOT (Pain on his eyes, feeling them hot), EYE PAIN (Pain on his eyes, feeling them hot), PALPITATIONS (Fast heartbeat), PYREXIA (Fever), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain), HEADACHE (Little headache) and ARTHRALGIA ("The wrist hurt where you put the fingers to take the blood pressure"). On 27-Oct-2021, the patient experienced ANXIETY (Anxious). On 26-Oct-2021, ASTHENIA (Weak), FEELING HOT (Pain on his eyes, feeling them hot), EYE PAIN (Pain on his eyes, feeling them hot), PALPITATIONS (Fast heartbeat), PYREXIA (Fever), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain), HEADACHE (Little headache) and ARTHRALGIA ("The wrist hurt where you put the fingers to take the blood pressure") had resolved. At the time of the report, ANXIETY (Anxious) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Heart rate: high (High) Fast heartbeat.         No treatment information was provided.  Patient received only half a dose as he was doing fine and his laboratory results were good. Patient was concerned though because, he stated yesterday feeling anxious and today he is worried if that could affect somehow the efficacy of the vaccine.   This case was linked to MOD-2021-367850 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Anxious; Weak; Pain on his eyes, feeling them hot; Pain on his eyes, feeling them hot; Fast heartbeat; Fever; Pain at the injection site; Muscle pain; Little headache; "The wrist hurt where you put the fingers to take the blood pressure"; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxious), ASTHENIA (Weak), FEELING HOT (Pain on his eyes, feeling them hot), EYE PAIN (Pain on his eyes, feeling them hot) and PALPITATIONS (Fast heartbeat) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 022M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Oct-2021, the patient experienced ASTHENIA (Weak), FEELING HOT (Pain on his eyes, feeling them hot), EYE PAIN (Pain on his eyes, feeling them hot), PALPITATIONS (Fast heartbeat), PYREXIA (Fever), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain), HEADACHE (Little headache) and ARTHRALGIA ("The wrist hurt where you put the fingers to take the blood pressure"). On 27-Oct-2021, the patient experienced ANXIETY (Anxious). On 26-Oct-2021, ASTHENIA (Weak), FEELING HOT (Pain on his eyes, feeling them hot), EYE PAIN (Pain on his eyes, feeling them hot), PALPITATIONS (Fast heartbeat), PYREXIA (Fever), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain), HEADACHE (Little headache) and ARTHRALGIA ("The wrist hurt where you put the fingers to take the blood pressure") had resolved. At the time of the report, ANXIETY (Anxious) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Heart rate: high (High) Fast heartbeat.         No treatment information was provided.  Patient received only half a dose as he was doing fine and his laboratory results were good. Patient was concerned though because, he stated yesterday feeling anxious and today he is worried if that could affect somehow the efficacy of the vaccine.   This case was linked to MOD-2021-367850 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A., 030M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported. No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: probably should have recieved a full 'additional' dose Moderna; patient who recived one J&J and one Moderna booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (probably should have recieved a full 'additional' dose Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who recived one J&J and one Moderna booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (probably should have recieved a full 'additional' dose Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who recived one J&J and one Moderna booster). At the time of the report, ACCIDENTAL UNDERDOSE (probably should have recieved a full 'additional' dose Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who recived one J&J and one Moderna booster) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose). On 14-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 provided. No treatment information provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain
Clinical narrative: aching more than with the second dose; specifically in her joints including hips, arm, back, and thumb/Joint tenderness; headache; was tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching more than with the second dose), ARTHRALGIA (specifically in her joints including hips, arm, back, and thumb/Joint tenderness), HEADACHE (headache) and FATIGUE (was tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (low IgM an autoimmune thing. .).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced PAIN (aching more than with the second dose), ARTHRALGIA (specifically in her joints including hips, arm, back, and thumb/Joint tenderness), HEADACHE (headache) and FATIGUE (was tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 28-Oct-2021 for Arthritis, at an unspecified dose and frequency. At the time of the report, PAIN (aching more than with the second dose), ARTHRALGIA (specifically in her joints including hips, arm, back, and thumb/Joint tenderness), HEADACHE (headache) and FATIGUE (was tired) outcome was unknown.            No Concomitant medication information was reported.  Around 3:30 or 4:00 last night she took an long acting arthritis. Tylenol which made her symptoms go away.The Tylenol is started to wear off and her joint soreness was coming back. She doesn't build a lot of antibodies.   This case was linked to MOD-2021-367770 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 14-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported.  It was reported that the patient did not remember the Lot number of vaccine and the expiration date.   This case was linked to MOD-2021-367730 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore injection site arm; felt fatigued for a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt fatigued for a day) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt fatigued for a day). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt fatigued for a day) outcome was unknown.            No concomitant medications was reported.  No treatment drug details was reported.   This case was linked to MOD-2021-367699 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Fatigue, Illness
Clinical narrative: arm blew up; it was red; chills; 103.3 degrees F fever; tired; it kept getting redder and bigger; got really sick; 3 full 0.5 mL doses; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (it kept getting redder and bigger), ILLNESS (got really sick), INCORRECT DOSE ADMINISTERED (3 full 0.5 mL doses), LIMB DISCOMFORT (arm blew up) and ERYTHEMA (it was red) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 006M20A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 12-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (3 full 0.5 mL doses). On an unknown date, the patient experienced PERIPHERAL SWELLING (it kept getting redder and bigger), ILLNESS (got really sick), LIMB DISCOMFORT (arm blew up), ERYTHEMA (it was red), CHILLS (chills), PYREXIA (103.3 degrees F fever) and FATIGUE (tired). The patient was treated with CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL [CHLORPHENAMINE MALEATE;DEXTROMETHORPHAN HYDROBROMIDE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 12-Oct-2021, INCORRECT DOSE ADMINISTERED (3 full 0.5 mL doses) had resolved. At the time of the report, PERIPHERAL SWELLING (it kept getting redder and bigger), ILLNESS (got really sick), LIMB DISCOMFORT (arm blew up), ERYTHEMA (it was red), CHILLS (chills), PYREXIA (103.3 degrees F fever) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.3 (abnormal) degree Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient taking inhaler as a concomitant medication for COPD. Doctor told her to take Tylenol, antihistamine and to put ice on it.