chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: The dose "beat him up"; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (The dose "beat him up") in a 66-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (The dose "beat him up"). At the time of the report, IMMUNISATION REACTION (The dose "beat him up") outcome was unknown.            Concomitant product use was not provided by the reporter. It was reported that after receiving the first Moderna primary series dose, the patient did not experience any side effects. Treatment information was not provided.   This case was linked to MOD-2022-593083 (Patient Link).   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Neck pain, Vaccination site pain
Clinical narrative: pain in the back of her neck; pain in the site of injection; headache; chills, she felt like she was freezing; too tired, too fatigued; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (pain in the back of her neck), VACCINATION SITE PAIN (pain in the site of injection), HEADACHE (headache), CHILLS (chills, she felt like she was freezing) and FATIGUE (too tired, too fatigued) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L21B, 031H21A, 003A21A and 006M20A) for COVID-19 prophylaxis. The patient's past medical history included Broken leg. Previously administered products included for Drug use for unknown indication: Shingles. Past adverse reactions to the above products included Pain in arm with Shingles. Concurrent medical conditions included Dust allergy. Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, HYDROCODONE for Pain. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2022, the patient experienced VACCINATION SITE PAIN (pain in the site of injection), HEADACHE (headache), CHILLS (chills, she felt like she was freezing) and FATIGUE (too tired, too fatigued). On 17-Jun-2022, the patient experienced NECK PAIN (pain in the back of her neck). On 16-Jun-2022 at 2:00 PM, VACCINATION SITE PAIN (pain in the site of injection), HEADACHE (headache), CHILLS (chills, she felt like she was freezing) and FATIGUE (too tired, too fatigued) had resolved. On 17-Jun-2022, NECK PAIN (pain in the back of her neck) had resolved. It was reported that the patient did not experience any COVID or was tested positive. No treatment medications was reported. This case was linked to MOD-2022-593081 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in the back of her neck; pain in the site of injection; headache; chills, she felt like she was freezing; too tired, too fatigued; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (pain in the back of her neck), VACCINATION SITE PAIN (pain in the site of injection), HEADACHE (headache), CHILLS (chills, she felt like she was freezing) and FATIGUE (too tired, too fatigued) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L21B, 031H21A, 003A21A and 006M20A) for COVID-19 prophylaxis. The patient's past medical history included Broken leg. Previously administered products included for Drug use for unknown indication: Shingles. Past adverse reactions to the above products included Pain in arm with Shingles. Concurrent medical conditions included Dust allergy. Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, HYDROCODONE for Pain. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2022, the patient experienced VACCINATION SITE PAIN (pain in the site of injection), HEADACHE (headache), CHILLS (chills, she felt like she was freezing) and FATIGUE (too tired, too fatigued). On 17-Jun-2022, the patient experienced NECK PAIN (pain in the back of her neck). On 16-Jun-2022 at 2:00 PM, VACCINATION SITE PAIN (pain in the site of injection), HEADACHE (headache), CHILLS (chills, she felt like she was freezing) and FATIGUE (too tired, too fatigued) had resolved. On 17-Jun-2022, NECK PAIN (pain in the back of her neck) had resolved. It was reported that the patient did not experience any COVID or was tested positive. No treatment medications was reported. This case was linked to MOD-2022-593081 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Neck pain, Vaccination site pain
Clinical narrative: bit of pain in the arm of injection (left arm) for about 12 hours; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (bit of pain in the arm of injection (left arm) for about 12 hours) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 003A21A and 006M20A) for COVID-19 prophylaxis.     Patient did not test positive for COVID.  The patient's past medical history included Broken leg. Previously administered products included for Product used for unknown indication: Shingles shot. Past adverse reactions to the above products included Pain in arm with Shingles shot. Concurrent medical conditions included Dust allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Allergy NOS, HYDROCODONE for Pain.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (bit of pain in the arm of injection (left arm) for about 12 hours). At the time of the report, VACCINATION SITE PAIN (bit of pain in the arm of injection (left arm) for about 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's height was 5 foot 3 inches. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The Adverse Event did not cause patient to seek medical care. No treatment was given.   This case was linked to MOD-2022-593078 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: bit of pain in the arm of injection (left arm) for about 12 hours; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (bit of pain in the arm of injection (left arm) for about 12 hours) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 003A21A and 006M20A) for COVID-19 prophylaxis.     Patient did not test positive for COVID.  The patient's past medical history included Broken leg. Previously administered products included for Product used for unknown indication: Shingles shot. Past adverse reactions to the above products included Pain in arm with Shingles shot. Concurrent medical conditions included Dust allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Allergy NOS, HYDROCODONE for Pain.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (bit of pain in the arm of injection (left arm) for about 12 hours). At the time of the report, VACCINATION SITE PAIN (bit of pain in the arm of injection (left arm) for about 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's height was 5 foot 3 inches. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The Adverse Event did not cause patient to seek medical care. No treatment was given.   This case was linked to MOD-2022-593078 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: Sores mouth; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (Sores mouth) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and METHOTREXATE (unknown route) at an unspecified dose. On an unknown date, the patient experienced STOMATITIS (Sores mouth). At the time of the report, STOMATITIS (Sores mouth) had resolved.            No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporters causality for the events sores mouth with Humira (Adalimumab) was reported as not related. The reporter's causality for the event of sores mouth with Methotrexate was reported as probable.  No treatment medication information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Feeling abnormal, Feeling of body temperature change
Clinical narrative: Felt beat up next day/ Felt like crap; Did not feel like getting out of bed/did not feel like doing anything; Felt like he had a fever even though he did not actually have a fever according to the thermometer; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Felt beat up next day/ Felt like crap), ASTHENIA (Did not feel like getting out of bed/did not feel like doing anything) and FEELING OF BODY TEMPERATURE CHANGE (Felt like he had a fever even though he did not actually have a fever according to the thermometer) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt beat up next day/ Felt like crap). an unknown date, the patient experienced ASTHENIA (Did not feel like getting out of bed/did not feel like doing anything) and FEELING OF BODY TEMPERATURE CHANGE (Felt like he had a fever even though he did not actually have a fever according to the thermometer). At the time of the report, FEELING ABNORMAL (Felt beat up next day/ Felt like crap), ASTHENIA (Did not feel like getting out of bed/did not feel like doing anything) and FEELING OF BODY TEMPERATURE CHANGE (Felt like he had a fever even though he did not actually have a fever according to the thermometer) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: no fever Not actually had fever according to the thermometer.         No concomitant medications were reported. It was reported that after receiving the first dose, patient did not experienced any side effects and side effects of booster dose eventually resolved. No treatment medications were reported.   This case was linked to MOD-2022-593077 (Patient Link).   Reporter did not allow further contact
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received their second dose too soon; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their second dose too soon) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 037A22B and 037A22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 21-Jun-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 21-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their second dose too soon). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their second dose too soon) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity, Product storage error
Clinical narrative: Post puncture vial was stored in the Fridge; vaccine administered to patient greater than 12 hours (14 hours) post puncture; patient was called and reported having a sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (patient was called and reported having a sore arm), EXPIRED PRODUCT ADMINISTERED (vaccine administered to patient greater than 12 hours (14 hours) post puncture) and PRODUCT STORAGE ERROR (Post puncture vial was stored in the Fridge) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jun-2022 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 17-Jun-2022, the patient experienced PAIN IN EXTREMITY (patient was called and reported having a sore arm). On 17-Jun-2022 at 2:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered to patient greater than 12 hours (14 hours) post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Post puncture vial was stored in the Fridge). At the time of the report, PAIN IN EXTREMITY (patient was called and reported having a sore arm), EXPIRED PRODUCT ADMINISTERED (vaccine administered to patient greater than 12 hours (14 hours) post puncture) and PRODUCT STORAGE ERROR (Post puncture vial was stored in the Fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was over 55 years of age.  Concomitant medications details were not reported by the reporter.  Reporter confirmed that the patient completed their Moderna vaccine series, however lot numbers were no known.  On 16 Jun 2022 vial was initially stored in the refrigerator and was first punctured on 16 Jun 2022 at 10:30 am and a booster dose was administered to patient on 17 Jun 2022 at 2PM from the vial.  post puncture Vial was returned to the Fridge.vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 5-10 min maximum.  No temperature excursions.  Treatment details was not reported by the reporter.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Burning sensation, Erythema
Clinical narrative: headache; shoulder aching; arm red and her back,; back hurting/aching; neck hurting/aching; underarm hurting; was sore; tired; noticed swelling on her right armpit, a lymph node or something; arm aching; burning sensation in the area where she got the vaccine,woke up in the evening because arm was hurting; right arm felt pretty numb; burning sensation went down her right arm later in the day; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (burning sensation went down her right arm later in the day), ERYTHEMA (arm red and her back,), BACK PAIN (back hurting/aching), NECK PAIN (neck hurting/aching) and HYPOAESTHESIA (right arm felt pretty numb) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jun-2022, the patient experienced BURNING SENSATION (burning sensation went down her right arm later in the day), HYPOAESTHESIA (right arm felt pretty numb) and PAIN IN EXTREMITY (arm aching). 19-Jun-2022, the patient experienced VACCINATION SITE PAIN (burning sensation in the area where she got the vaccine,woke up in the evening because arm was hurting). On 20-Jun-2022, the patient experienced ERYTHEMA (arm red and her back,), BACK PAIN (back hurting/aching), NECK PAIN (neck hurting/aching), AXILLARY PAIN (underarm hurting), MYALGIA (was sore), FATIGUE (tired) and VACCINATION SITE LYMPHADENOPATHY (noticed swelling on her right armpit, a lymph node or something). On an unknown date, the patient experienced HEADACHE (headache) and ARTHRALGIA (shoulder aching). At the time of the report, BURNING SENSATION (burning sensation went down her right arm later in the day), ERYTHEMA (arm red and her back,), BACK PAIN (back hurting/aching), NECK PAIN (neck hurting/aching), HYPOAESTHESIA (right arm felt pretty numb), AXILLARY PAIN (underarm hurting), PAIN IN EXTREMITY (arm aching), VACCINATION SITE PAIN (burning sensation in the area where she got the vaccine,woke up in the evening because arm was hurting), MYALGIA (was sore), FATIGUE (tired), VACCINATION SITE LYMPHADENOPATHY (noticed swelling on her right armpit, a lymph node or something), HEADACHE (headache) and ARTHRALGIA (shoulder aching) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient was not taking any concomitant medications  No known allergy; always been sensitive. Every time she got a vaccine she would get a flu like feeling but will be good after 3 days; Sensitive after blood extractions she will get skin bruises that will disappear after 2 weeks.  No treatment medications were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Myalgia, Neck pain
Clinical narrative: headache; shoulder aching; arm red and her back,; back hurting/aching; neck hurting/aching; underarm hurting; was sore; tired; noticed swelling on her right armpit, a lymph node or something; arm aching; burning sensation in the area where she got the vaccine,woke up in the evening because arm was hurting; right arm felt pretty numb; burning sensation went down her right arm later in the day; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (burning sensation went down her right arm later in the day), ERYTHEMA (arm red and her back,), BACK PAIN (back hurting/aching), NECK PAIN (neck hurting/aching) and HYPOAESTHESIA (right arm felt pretty numb) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jun-2022, the patient experienced BURNING SENSATION (burning sensation went down her right arm later in the day), HYPOAESTHESIA (right arm felt pretty numb) and PAIN IN EXTREMITY (arm aching). 19-Jun-2022, the patient experienced VACCINATION SITE PAIN (burning sensation in the area where she got the vaccine,woke up in the evening because arm was hurting). On 20-Jun-2022, the patient experienced ERYTHEMA (arm red and her back,), BACK PAIN (back hurting/aching), NECK PAIN (neck hurting/aching), AXILLARY PAIN (underarm hurting), MYALGIA (was sore), FATIGUE (tired) and VACCINATION SITE LYMPHADENOPATHY (noticed swelling on her right armpit, a lymph node or something). On an unknown date, the patient experienced HEADACHE (headache) and ARTHRALGIA (shoulder aching). At the time of the report, BURNING SENSATION (burning sensation went down her right arm later in the day), ERYTHEMA (arm red and her back,), BACK PAIN (back hurting/aching), NECK PAIN (neck hurting/aching), HYPOAESTHESIA (right arm felt pretty numb), AXILLARY PAIN (underarm hurting), PAIN IN EXTREMITY (arm aching), VACCINATION SITE PAIN (burning sensation in the area where she got the vaccine,woke up in the evening because arm was hurting), MYALGIA (was sore), FATIGUE (tired), VACCINATION SITE LYMPHADENOPATHY (noticed swelling on her right armpit, a lymph node or something), HEADACHE (headache) and ARTHRALGIA (shoulder aching) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient was not taking any concomitant medications  No known allergy; always been sensitive. Every time she got a vaccine she would get a flu like feeling but will be good after 3 days; Sensitive after blood extractions she will get skin bruises that will disappear after 2 weeks.  No treatment medications were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: headache; shoulder aching; arm red and her back,; back hurting/aching; neck hurting/aching; underarm hurting; was sore; tired; noticed swelling on her right armpit, a lymph node or something; arm aching; burning sensation in the area where she got the vaccine,woke up in the evening because arm was hurting; right arm felt pretty numb; burning sensation went down her right arm later in the day; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (burning sensation went down her right arm later in the day), ERYTHEMA (arm red and her back,), BACK PAIN (back hurting/aching), NECK PAIN (neck hurting/aching) and HYPOAESTHESIA (right arm felt pretty numb) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jun-2022, the patient experienced BURNING SENSATION (burning sensation went down her right arm later in the day), HYPOAESTHESIA (right arm felt pretty numb) and PAIN IN EXTREMITY (arm aching). 19-Jun-2022, the patient experienced VACCINATION SITE PAIN (burning sensation in the area where she got the vaccine,woke up in the evening because arm was hurting). On 20-Jun-2022, the patient experienced ERYTHEMA (arm red and her back,), BACK PAIN (back hurting/aching), NECK PAIN (neck hurting/aching), AXILLARY PAIN (underarm hurting), MYALGIA (was sore), FATIGUE (tired) and VACCINATION SITE LYMPHADENOPATHY (noticed swelling on her right armpit, a lymph node or something). On an unknown date, the patient experienced HEADACHE (headache) and ARTHRALGIA (shoulder aching). At the time of the report, BURNING SENSATION (burning sensation went down her right arm later in the day), ERYTHEMA (arm red and her back,), BACK PAIN (back hurting/aching), NECK PAIN (neck hurting/aching), HYPOAESTHESIA (right arm felt pretty numb), AXILLARY PAIN (underarm hurting), PAIN IN EXTREMITY (arm aching), VACCINATION SITE PAIN (burning sensation in the area where she got the vaccine,woke up in the evening because arm was hurting), MYALGIA (was sore), FATIGUE (tired), VACCINATION SITE LYMPHADENOPATHY (noticed swelling on her right armpit, a lymph node or something), HEADACHE (headache) and ARTHRALGIA (shoulder aching) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient was not taking any concomitant medications  No known allergy; always been sensitive. Every time she got a vaccine she would get a flu like feeling but will be good after 3 days; Sensitive after blood extractions she will get skin bruises that will disappear after 2 weeks.  No treatment medications were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Inadvertently administer the vaccine 11 days after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administer the vaccine 11 days after expiration date) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 071F21A, 013A21A and 012M20A) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products.  Previously administered products included for Drug use for unknown indication: TDAP (0.5ml and right deltoid.) on 22-Nov-2021. Past adverse reactions to the above products included No adverse event with TDAP.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administer the vaccine 11 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administer the vaccine 11 days after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Date the vial  initially stored in the refrigerator was 27-May-2022 and the vial had not undergone any temperature excursions.  No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: inadvertently administer  the vaccine 11 days after expiration date; The expired vial was stored in the refrigerator on 27may2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (The expired vial was stored in the refrigerator on 27may2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 102M20A and 013A21a) for COVID-19 prophylaxis.     The patient had no known allergies.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced PRODUCT STORAGE ERROR (The expired vial was stored in the refrigerator on 27may2022). On 31-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (The expired vial was stored in the refrigerator on 27may2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The patient's height was reported as 6 foot 2 inches. It was unknown whether the patient ever had been diagnosed with/ tested positive for COVID 19. Acute and Chronic illness at the time of vaccination was reported as none.  On 31-May-2022, patient was administered with first booster dose. Number of doses/vials administered were reported as one vial. The vial had not undergone any temperature excursions.  No treatment medication were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Inadvertently administered the vaccine 11 days after expiration date, to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the vaccine 11 days after expiration date, to 16 patients.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 065F21a, 013M20A and 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the vaccine 11 days after expiration date, to 16 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the vaccine 11 days after expiration date, to 16 patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Past medical history of the patient including allergies (medications, food and other products) was unknown.  Concomitant product use was not provided by the reporter.  It was unknown if patient ever had COVID positive test or diagnosis.  Medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination was none.  It was unknown if other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  On 19-Nov-2021, the patient received first booster dose.  On 27-May-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  On 31-May-2022, the patient received second booster dose.  Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: inadvertently administer  the vaccine 11 days after expiration date; The expired vial was stored in the refrigerator on 27may2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (The expired vial was stored in the refrigerator on 27may2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 065F21A, 037B21A and 026A21A) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products. It was unknown if patient had ever tested positive for COVID. Patient had no acute or chronic illness at the time of vaccination. It was unknown if the patient took any other vaccines within one month prior to Moderna covid-19 vaccine.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced PRODUCT STORAGE ERROR (The expired vial was stored in the refrigerator on 27may2022). On 31-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (The expired vial was stored in the refrigerator on 27may2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The height of the patient was reported as 5 foot and 3 inch. The vial was initially stored in the refrigerator on 27-May-2022.No temperature excursion was reported for the vials. It was unknown if the patient took any medical care because of events. Also it was unknown if the patient had similar events in the past.  No treatment medication information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: inadvertently administer  the vaccine 11 days after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 033C21A, 013A21a and 012M21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE on 01-Oct-2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Levaquin).   On 04-Feb-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 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was initially stored in the refrigerator on 27-May-2022.  The vial did not undergo any temperature excursions.  Number of doses/vials was reported as 1 vial.  It was unknown whether the patient had been diagnosed with or tested positive for COVID 19.  No treatment medication information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022; Inadvertently administered the vaccine 11 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 065F21a, 013A21A and 012M20A) for COVID-19 prophylaxis.     Allergies (medications, food and other products): None.    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 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the vaccine 11 days after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had no medical history related to both acute and chronic illnesses at the time of vaccination. It was unknown if the patient had any other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were reported. It was reported that the vial was initially stored in the refrigerator on 27-May-2022 and the vial had not undergone any temperature excursions. It was unknown if the adverse events had caused patient to seek medical care (office visit, urgent care, emergency room, hospitalized). No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Several hours later the patient returned and advised she was mistaken and that she has never received a covid vaccine before and wanted to receive the full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Several hours later the patient returned and advised she was mistaken and that she has never received a covid vaccine before and wanted to receive the full dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Jun-2022, the patient experienced ACCIDENTAL UNDERDOSE (Several hours later the patient returned and advised she was mistaken and that she has never received a covid vaccine before and wanted to receive the full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Several hours later the patient returned and advised she was mistaken and that she has never received a covid vaccine before and wanted to receive the full dose) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  A patient was advised she needed a booster and had misplaced her vaccine card. She was given her booster vaccine. Several hours later the patient returned and stated that patient was mistaken and never had a covid vaccine before and wanted to receive a full dose, again the patient called and stated that received first dose but never received a second dose.  Vaccine facility attempted to check the vaccine database but due to patient being an out of state resident they weren't able to verify any information (according to the health department).  Treatment information was not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022; inadvertently administer  the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 065F21A, 037B21A and 018B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Past medical history of the patient including allergies (medications, food and other products) was unknown.  No concomitant medication was reported.  It was unknown if patient ever had COVID positive test or diagnosis.  Medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination was none.  It was unknown if other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  1 vial was involved. On 27-May-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 071F21A and 033c21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Past medical history of the patient including allergies (medications, food and other products) was unknown.  No concomitant medication was reported.  It was unknown if patient ever had COVID positive test or diagnosis.  Medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination was none.  It was unknown if other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  1 vial was involved. On 27-May-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment information was provided.