chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Weakness; headache similar to her migraine headaches; arm also swelled up and got red at the injection site; arm also swelled up; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEADACHE (headache similar to her migraine headaches), VACCINATION SITE ERYTHEMA (arm also swelled up and got red at the injection site) and VACCINATION SITE SWELLING (arm also swelled up) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine headache, Cholesterol (Cholesterol medicine 400 mg) and Thyroid disorder NOS (Thyroid medicine). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), TRAZODONE and AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (Weakness), HEADACHE (headache similar to her migraine headaches), VACCINATION SITE ERYTHEMA (arm also swelled up and got red at the injection site) and VACCINATION SITE SWELLING (arm also swelled up). On 10-Mar-2021, HEADACHE (headache similar to her migraine headaches) had resolved. On 15-Mar-2021, ASTHENIA (Weakness) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (arm also swelled up and got red at the injection site) and VACCINATION SITE SWELLING (arm also swelled up) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included unspecified medications for cholesterol and thyroid.   Treatment information was not provided by reporter.   This case was linked to MOD-2021-074885 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Dysstasia, Headache
Clinical narrative: dizziness/for more than 24 hours he was dizzy; Could not stand up; diarrhea; Felt really very sick; nausea; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness/for more than 24 hours he was dizzy), DYSSTASIA (Could not stand up), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (Felt really very sick) and NAUSEA (nausea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery in 2001. Previously administered products included for an unreported indication: Flu vaccine. Concurrent medical conditions included Diabetes and Heart disorder.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness/for more than 24 hours he was dizzy), DYSSTASIA (Could not stand up), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (Felt really very sick), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness/for more than 24 hours he was dizzy), DYSSTASIA (Could not stand up), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (Felt really very sick), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that the doctor then suggested him to take flu vaccine in half dose which worked for him since he got sick after the flu vaccine  No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination complication
Clinical narrative: dizziness/for more than 24 hours he was dizzy; Could not stand up; diarrhea; Felt really very sick; nausea; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness/for more than 24 hours he was dizzy), DYSSTASIA (Could not stand up), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (Felt really very sick) and NAUSEA (nausea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery in 2001. Previously administered products included for an unreported indication: Flu vaccine. Concurrent medical conditions included Diabetes and Heart disorder.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness/for more than 24 hours he was dizzy), DYSSTASIA (Could not stand up), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (Felt really very sick), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness/for more than 24 hours he was dizzy), DYSSTASIA (Could not stand up), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (Felt really very sick), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that the doctor then suggested him to take flu vaccine in half dose which worked for him since he got sick after the flu vaccine  No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness; Light Headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Light Headed) 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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Light Headed). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Light Headed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-074818 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074818:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Dyspnoea, Influenza
Clinical narrative: like the flu; breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days; breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days; chills / could not get warmed up and then would go away; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (like the flu), DYSPNOEA (breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days), CONDITION AGGRAVATED (breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days) and CHILLS (chills / could not get warmed up and then would go away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 821A21A and 120A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia in 2006. Concurrent medical conditions included Blind. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Difficulty breathing.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (like the flu), DYSPNOEA (breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days), CONDITION AGGRAVATED (breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days) and CHILLS (chills / could not get warmed up and then would go away). At the time of the report, INFLUENZA (like the flu) and CHILLS (chills / could not get warmed up and then would go away) outcome was unknown and DYSPNOEA (breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days) and CONDITION AGGRAVATED (breathing felt raspy for 2 to 3 days/ then breathing was horrible for 2 days) was resolving.            Patient does breathing exercises to try to breathe better.  The patient stated that she was regularly on inhaler (SYMBICORT) which helped her the first time , but did not help the second time.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Heart rate, Heart rate irregular, Insomnia
Clinical narrative: couldn't sleep at all; rapid heartbeat at a maximum of 100bpm; felt lightheaded; mild allergic reaction described as really bad chills for about 2 hours; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep at all), HEART RATE IRREGULAR (rapid heartbeat at a maximum of 100bpm), DIZZINESS (felt lightheaded) and CHILLS (mild allergic reaction described as really bad chills for about 2 hours) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 001B21A) for COVID-19 vaccination.     no medical history information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced INSOMNIA (couldn't sleep at all), HEART RATE IRREGULAR (rapid heartbeat at a maximum of 100bpm), DIZZINESS (felt lightheaded) and CHILLS (mild allergic reaction described as really bad chills for about 2 hours). The patient was treated with PARACETAMOL (TYLENOL) on 13-Apr-2021 at a dose of 2 dosage form. On 13-Apr-2021, HEART RATE IRREGULAR (rapid heartbeat at a maximum of 100bpm) had resolved. At the time of the report, INSOMNIA (couldn't sleep at all) outcome was unknown and DIZZINESS (felt lightheaded) and CHILLS (mild allergic reaction described as really bad chills for about 2 hours) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Heart rate: 100bpm (High) maximum of 100bpm.         No relevant concomitant medications were reported. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-074863 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Rash
Clinical narrative: Rash; pain at the injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at the injection site), CHILLS (Chills) and RASH (Rash) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE PAIN (pain at the injection site) and CHILLS (Chills). On 02-Mar-2021, the patient experienced RASH (Rash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (pain at the injection site), CHILLS (Chills) and RASH (Rash) had resolved.            Action taken with m-RNA1273 was considered to be not applicable.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Her arm was swollen and it hurt.; Couldn'get out of bed; Body aches all over; As if she had the flu; her arm was swollen and it hurt.; Excruciating headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Her arm was swollen and it hurt.), BEDRIDDEN (Couldn'get out of bed), PAIN (Body aches all over), INFLUENZA LIKE ILLNESS (As if she had the flu) and PAIN IN EXTREMITY (her arm was swollen and it hurt.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PERIPHERAL SWELLING (Her arm was swollen and it hurt.), BEDRIDDEN (Couldn'get out of bed), PAIN (Body aches all over), INFLUENZA LIKE ILLNESS (As if she had the flu), PAIN IN EXTREMITY (her arm was swollen and it hurt.) and HEADACHE (Excruciating headache). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Prophylaxis, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Her arm was swollen and it hurt.), BEDRIDDEN (Couldn'get out of bed), PAIN (Body aches all over), INFLUENZA LIKE ILLNESS (As if she had the flu), PAIN IN EXTREMITY (her arm was swollen and it hurt.) and HEADACHE (Excruciating headache) outcome was unknown. Not Provided          Concomitant product use was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Her arm was swollen and it hurt.; Couldn'get out of bed; Body aches all over; As if she had the flu; her arm was swollen and it hurt.; Excruciating headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Her arm was swollen and it hurt.), BEDRIDDEN (Couldn'get out of bed), PAIN (Body aches all over), INFLUENZA LIKE ILLNESS (As if she had the flu) and PAIN IN EXTREMITY (her arm was swollen and it hurt.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PERIPHERAL SWELLING (Her arm was swollen and it hurt.), BEDRIDDEN (Couldn'get out of bed), PAIN (Body aches all over), INFLUENZA LIKE ILLNESS (As if she had the flu), PAIN IN EXTREMITY (her arm was swollen and it hurt.) and HEADACHE (Excruciating headache). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Prophylaxis, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Her arm was swollen and it hurt.), BEDRIDDEN (Couldn'get out of bed), PAIN (Body aches all over), INFLUENZA LIKE ILLNESS (As if she had the flu), PAIN IN EXTREMITY (her arm was swollen and it hurt.) and HEADACHE (Excruciating headache) outcome was unknown. Not Provided          Concomitant product use was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Hypokinesia
Clinical narrative: Could not close her hand and not able to use her arm; Blood sugar went to 500; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (Could not close her hand and not able to use her arm) and BLOOD GLUCOSE INCREASED (Blood sugar went to 500) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE, ATORVASTATIN, FUROSEMIDE, AMLODIPINE, PAROXETIN [PAROXETINE], HYDROXYZINE, CLONIDINE, CLOPIDOGREL, CALCITRIOL, ASPIRIN [ACETYLSALICYLIC ACID] and ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, IRON, PYRIDOXINE HYDROCHLORIDE, ZINC CITRATE (CORVITE [ASCORBIC ACID;CYANOCOBALAMIN;FOLIC ACID;IRON;PYRIDOXINE HYDROCHLORIDE;ZINC CITRATE]) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HYPOKINESIA (Could not close her hand and not able to use her arm) and BLOOD GLUCOSE INCREASED (Blood sugar went to 500). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPOKINESIA (Could not close her hand and not able to use her arm) and BLOOD GLUCOSE INCREASED (Blood sugar went to 500) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood glucose: high (High) Blood sugar went to 500.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received on 08-JUL-2021. Updated regarding event outcome and patient declined for follow-up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Headache, Nausea
Clinical narrative: weakness; a little bit of tightness in her chest; night sweats; feels out of breath; headache; arm redness and swelling; arm redness and swelling; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHEST DISCOMFORT (a little bit of tightness in her chest), NIGHT SWEATS (night sweats), DYSPNOEA (feels out of breath) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The Patient's Medical History was not provided.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), TRAZODONE and ALLOPURINOL (ELAVIL [ALLOPURINOL]) for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ASTHENIA (weakness), CHEST DISCOMFORT (a little bit of tightness in her chest), NIGHT SWEATS (night sweats), DYSPNOEA (feels out of breath), HEADACHE (headache), VACCINATION SITE ERYTHEMA (arm redness and swelling), VACCINATION SITE SWELLING (arm redness and swelling) and NAUSEA (nausea). At the time of the report, ASTHENIA (weakness) had not resolved, CHEST DISCOMFORT (a little bit of tightness in her chest), NIGHT SWEATS (night sweats), DYSPNOEA (feels out of breath), VACCINATION SITE ERYTHEMA (arm redness and swelling), VACCINATION SITE SWELLING (arm redness and swelling) and NAUSEA (nausea) outcome was unknown and HEADACHE (headache) had resolved.            Patient is also concomitantly taking a cholesterol and thyroid medication.  No treatment information was reported.   This case was linked to MOD-2021-074876 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Vaccination site erythema, Vaccination site swelling
Clinical narrative: weakness; a little bit of tightness in her chest; night sweats; feels out of breath; headache; arm redness and swelling; arm redness and swelling; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHEST DISCOMFORT (a little bit of tightness in her chest), NIGHT SWEATS (night sweats), DYSPNOEA (feels out of breath) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The Patient's Medical History was not provided.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), TRAZODONE and ALLOPURINOL (ELAVIL [ALLOPURINOL]) for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ASTHENIA (weakness), CHEST DISCOMFORT (a little bit of tightness in her chest), NIGHT SWEATS (night sweats), DYSPNOEA (feels out of breath), HEADACHE (headache), VACCINATION SITE ERYTHEMA (arm redness and swelling), VACCINATION SITE SWELLING (arm redness and swelling) and NAUSEA (nausea). At the time of the report, ASTHENIA (weakness) had not resolved, CHEST DISCOMFORT (a little bit of tightness in her chest), NIGHT SWEATS (night sweats), DYSPNOEA (feels out of breath), VACCINATION SITE ERYTHEMA (arm redness and swelling), VACCINATION SITE SWELLING (arm redness and swelling) and NAUSEA (nausea) outcome was unknown and HEADACHE (headache) had resolved.            Patient is also concomitantly taking a cholesterol and thyroid medication.  No treatment information was reported.   This case was linked to MOD-2021-074876 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Quarter sized rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Quarter sized rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Quarter sized rash). At the time of the report, VACCINATION SITE RASH (Quarter sized rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-074909, US-MODERNATX, INC.-MOD-2021-074979 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074909: US-MODERNATX, INC.-MOD-2021-074979:
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment included unknown antivirals.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Urticaria
Clinical narrative: night sweats; irregular heartbeat; itchy; large welts/hives/hives on trunk of my body,and back of legs; Rash across my chest and rash all over my trunk and up and down my leg; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), HEART RATE IRREGULAR (irregular heartbeat), PRURITUS (itchy), URTICARIA (large welts/hives/hives on trunk of my body,and back of legs) and RASH (Rash across my chest and rash all over my trunk and up and down my leg) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (BP) since 1996 and Drug allergy (Allergy to Sulphur). Concomitant products included IRBESARTAN from an unknown date to 23-Jun-2021 for Blood pressure high, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), VITAMIN B12 NOS and HYDROXYZINE HCL for an unknown indication.   On 29-Jan-2021, the patient received first 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 04-Feb-2021, the patient experienced NIGHT SWEATS (night sweats), HEART RATE IRREGULAR (irregular heartbeat), PRURITUS (itchy), URTICARIA (large welts/hives/hives on trunk of my body,and back of legs) and RASH (Rash across my chest and rash all over my trunk and up and down my leg). The patient was treated with METHYLPREDNISOLONE ongoing from 17-Feb-2021 for Allergy, at a dose of 4 milligram; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing from 17-Feb-2021 at a dose of 10 milligram twice a day; OMALIZUMAB (XOLAIR) for Chronic idiopathic urticaria, at a dose of 300 milligram, 3 doses; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 15-Jun-2021 for Hives, at a dose of 1 dosage form once and DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) on 15-Jun-2021 for Hives, at a dose of 1 dosage form once. At the time of the report, NIGHT SWEATS (night sweats), HEART RATE IRREGULAR (irregular heartbeat), PRURITUS (itchy), URTICARIA (large welts/hives/hives on trunk of my body,and back of legs) and RASH (Rash across my chest and rash all over my trunk and up and down my leg) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Full blood count: normal normal. On 31-Jan-2021, Urine analysis: high wbc count abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up information received on 20-Jul-2021. Events, patient information, treatment, and batch number updated.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: numbness of my face, both cheeks; weak; Numbness in feet; weirdness in the leg; Rashes underneath her boobs and is itchy; swelling under armpit; Supper supper tired; chills; Pain in the arm; Rash around the injection site; Minor headache here an there; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), HYPOAESTHESIA (Numbness in feet), FEELING ABNORMAL (weirdness in the leg), RASH PRURITIC (Rashes underneath her boobs and is itchy) and SWELLING (swelling under armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2021.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm), VACCINATION SITE RASH (Rash around the injection site) and HEADACHE (Minor headache here an there). On 12-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in feet), FEELING ABNORMAL (weirdness in the leg), RASH PRURITIC (Rashes underneath her boobs and is itchy), SWELLING (swelling under armpit), FATIGUE (Supper supper tired) and CHILLS (chills). On an unknown date, the patient experienced HYPOAESTHESIA (numbness of my face, both cheeks) and ASTHENIA (weak). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), HYPOAESTHESIA (Numbness in feet), FEELING ABNORMAL (weirdness in the leg), RASH PRURITIC (Rashes underneath her boobs and is itchy), SWELLING (swelling under armpit), HYPOAESTHESIA (numbness of my face, both cheeks), ASTHENIA (weak), VACCINATION SITE RASH (Rash around the injection site), HEADACHE (Minor headache here an there), FATIGUE (Supper supper tired) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Rash pruritic, Swelling, Vaccination site rash
Clinical narrative: numbness of my face, both cheeks; weak; Numbness in feet; weirdness in the leg; Rashes underneath her boobs and is itchy; swelling under armpit; Supper supper tired; chills; Pain in the arm; Rash around the injection site; Minor headache here an there; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), HYPOAESTHESIA (Numbness in feet), FEELING ABNORMAL (weirdness in the leg), RASH PRURITIC (Rashes underneath her boobs and is itchy) and SWELLING (swelling under armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2021.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm), VACCINATION SITE RASH (Rash around the injection site) and HEADACHE (Minor headache here an there). On 12-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in feet), FEELING ABNORMAL (weirdness in the leg), RASH PRURITIC (Rashes underneath her boobs and is itchy), SWELLING (swelling under armpit), FATIGUE (Supper supper tired) and CHILLS (chills). On an unknown date, the patient experienced HYPOAESTHESIA (numbness of my face, both cheeks) and ASTHENIA (weak). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), HYPOAESTHESIA (Numbness in feet), FEELING ABNORMAL (weirdness in the leg), RASH PRURITIC (Rashes underneath her boobs and is itchy), SWELLING (swelling under armpit), HYPOAESTHESIA (numbness of my face, both cheeks), ASTHENIA (weak), VACCINATION SITE RASH (Rash around the injection site), HEADACHE (Minor headache here an there), FATIGUE (Supper supper tired) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: sore arm; arm bruised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and CONTUSION (arm bruised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0U2B21A) for COVID-19 vaccination.     The patient's past medical history included Emphysema.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and CONTUSION (arm bruised). At the time of the report, PAIN IN EXTREMITY (sore arm) and CONTUSION (arm bruised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she had her back surgery scheduled in 20-Apr-2021  Concomitant product use was not provided.  Treatment information was not provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inappropriate age at vaccine administration; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration) in a 16-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication provided.  No treatment drugs were provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Felt really achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Felt really achy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE, MULTIVITAMINS [VITAMINS NOS], SERTRALINE, LORAZEPAM and TRAZODONE for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced MYALGIA (Felt really achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN IB) at an unspecified dose and frequency and SUCRALFATE at a dose of 1 gram. At the time of the report, MYALGIA (Felt really achy) had resolved. Not applicable      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Muscular weakness, Peripheral swelling
Clinical narrative: Taste of metal; left arm got swollen; Lost of strengh on the left arm; headache here and there sporadically, not a continuoing headache; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Taste of metal), PERIPHERAL SWELLING (left arm got swollen), MUSCULAR WEAKNESS (Lost of strengh on the left arm) and HEADACHE (headache here and there sporadically, not a continuoing headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Symptoms included body aches, headaches, lost of taste and smell and had neurological side effects until September. She lost strength on the right foot and the left hand completely. She was not able to walk and could not even open a bottle of water, could not hold things; it was called COVID hand and COVID feet, both got swollen and veins popped up). She also had reactions on heart and lungs and was treated by pulmonary doctor, neurologist and cardiologist.) in March 2020 and Back surgery in 2008. Concomitant products included MELOXICAM for Back pain, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DYSGEUSIA (Taste of metal), PERIPHERAL SWELLING (left arm got swollen), MUSCULAR WEAKNESS (Lost of strengh on the left arm) and HEADACHE (headache here and there sporadically, not a continuoing headache). On 11-Mar-2021, HEADACHE (headache here and there sporadically, not a continuoing headache) had resolved. On 12-Mar-2021, PERIPHERAL SWELLING (left arm got swollen) and MUSCULAR WEAKNESS (Lost of strengh on the left arm) had resolved. At the time of the report, DYSGEUSIA (Taste of metal) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-074905 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Insomnia
Clinical narrative: She could not sleep well; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) and INSOMNIA (She could not sleep well) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical history information was provided by the reporter.  Concomitant products included AMLODIPINE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced BACK PAIN (Back pain). On an unknown date, the patient experienced INSOMNIA (She could not sleep well). At the time of the report, BACK PAIN (Back pain) had not resolved and INSOMNIA (She could not sleep well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant product included Vitamin.  No treatment information was reported.   This case was linked to MOD-2021-117034 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Non-significant follow-up
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: mild Headache; mild temperature; mild joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild Headache), PYREXIA (mild temperature) and ARTHRALGIA (mild joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from February 2020 to March 2020 and Tendon repair (Right hand). Concurrent medical conditions included Asthma (Currently under care of pulmonologist) and Pulmonary disorder (Lung issue, currently on breathing treatment for low oxygen saturation in the blood, currently under care of pulmonologist).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (mild Headache), PYREXIA (mild temperature) and ARTHRALGIA (mild joint pain). At the time of the report, HEADACHE (mild Headache), PYREXIA (mild temperature) and ARTHRALGIA (mild joint pain) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication use was not reported.   Treatment information included steroid medication after the first dose with symptom improvement.   This case was linked to MOD-2021-074918 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: first dose Pfizer vaccine, second dose Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first dose Pfizer vaccine, second dose Moderna COVID-19 vaccine) in a 26-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first dose Pfizer vaccine, second dose Moderna COVID-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (first dose Pfizer vaccine, second dose Moderna COVID-19 vaccine) 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.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; soreness; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (soreness), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (soreness), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (soreness), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to INC.-MOD-2021-074917 (E2B Linked Report). This case was linked to MOD-2021-074917 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Additional information received on 16-Jul-2021 with no new information; Sender's Comments: INC.-MOD-2021-074917:dose 2.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: lymphadema; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHEDEMA (lymphedema) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), VITAMIN B COMPLEX and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced LYMPHEDEMA (lymphedema). The patient was treated with IBUPROFEN (oral) at an unspecified dose and frequency. At the time of the report, LYMPHEDEMA (lymphedema) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included Multivitamins, Treatment details included Ibuprofen and compression bag physical therapy.  Action taken with response to the events are not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-074688 (E2B Linked Report). This case was linked to MOD-2021-074688 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074688:1st dose
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Underdose, Wrong technique in device usage process
Clinical narrative: Patient only experienced a sore arm; Band-aid full of clear liquid; put the injection in and pulled it out really fast; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (put the injection in and pulled it out really fast), PAIN IN EXTREMITY (Patient only experienced a sore arm) and UNDERDOSE (Band-aid full of clear liquid) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 01-Mar-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (put the injection in and pulled it out really fast) and UNDERDOSE (Band-aid full of clear liquid). On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Patient only experienced a sore arm). On 01-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (put the injection in and pulled it out really fast) had resolved. On 02-Mar-2021, PAIN IN EXTREMITY (Patient only experienced a sore arm) had resolved. At the time of the report, UNDERDOSE (Band-aid full of clear liquid) outcome was unknown. Not Provided          Treatment was not provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (drew up doses of vaccine from a vial and placed syringes loaded with doses vaccine into the refrigerator) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (drew up doses of vaccine from a vial and placed syringes loaded with doses vaccine into the refrigerator). On 13-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Apr-2021, PRODUCT STORAGE ERROR (drew up doses of vaccine from a vial and placed syringes loaded with doses vaccine into the refrigerator) had resolved. On 13-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 12-Apr-2021, at 8:30 AM, an individual drew up doses of vaccine from a vial and placed syringes loaded with doses vaccine into the refrigerator. The patient received their second dose of the vaccine by IM injection at 2:15 PM on 13-Apr-2021.  No relevant concomitant medications were reported.  No treatment information was provided.