chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Nightly waking up to sweat soaked sheets; This spontaneous case was reported by a non-health professional and describes the occurrence of NIGHT SWEATS (Nightly waking up to sweat soaked sheets) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (Nightly waking up to sweat soaked sheets). At the time of the report, NIGHT SWEATS (Nightly waking up to sweat soaked sheets) outcome was unknown.      It was reported two weeks after the booster, Patient was nightly waking up to sweat soaked sheets.  No Concomitant medication were reported. No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm is still killing them a month after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is still killing them a month after getting the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm is still killing them a month after getting the vaccine). At the time of the report, VACCINATION SITE PAIN (arm is still killing them a month after getting the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-418640, MOD-2021-419667 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Eye ulcer, Illness, Pain in extremity
Clinical narrative: arm was so sore; eye problems/It was sore/so sick; ulcer in eyelash; so sick; chills/Shaking; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was so sore), EYE PAIN (eye problems/It was sore/so sick), EYE ULCER (ulcer in eyelash), ILLNESS (so sick) and CHILLS (chills/Shaking) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm was so sore), EYE PAIN (eye problems/It was sore/so sick), EYE ULCER (ulcer in eyelash), ILLNESS (so sick) and CHILLS (chills/Shaking). At the time of the report, PAIN IN EXTREMITY (arm was so sore), EYE PAIN (eye problems/It was sore/so sick), EYE ULCER (ulcer in eyelash), ILLNESS (so sick) and CHILLS (chills/Shaking) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I gave a moderna vaccine that was expired.  It was punctured the day prior so it was over 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I gave a moderna vaccine that was expired.  It was punctured the day prior so it was over 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I gave a moderna vaccine that was expired.  It was punctured the day prior so it was over 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I gave a moderna vaccine that was expired.  It was punctured the day prior so it was over 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cold sweat, Gait disturbance
Clinical narrative: shaking; could barely walk, it hurt to walk; hot and cold sweats; cold sweats; 104°F fever; body aches,had muscle pain; chills; joint pain; Four days later she had no mobility from the hip down; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), GAIT DISTURBANCE (could barely walk, it hurt to walk), HYPERHIDROSIS (hot and cold sweats), COLD SWEAT (cold sweats) and MOBILITY DECREASED (Four days later she had no mobility from the hip down) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included ALS (family history of ALS and Guillain-Barre syndrome (great grand father, grand father and father).) and Guillain-Barre syndrome (family history of ALS and Guillain-Barre syndrome (great grand father, grand father and father).).   On 26-Feb-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) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TREMOR (shaking), HYPERHIDROSIS (hot and cold sweats), PYREXIA (104°F fever), MYALGIA (body aches,had muscle pain), CHILLS (chills) and ARTHRALGIA (joint pain). 30-Mar-2021, the patient experienced GAIT DISTURBANCE (could barely walk, it hurt to walk). 30-Mar-2021, the patient experienced COLD SWEAT (cold sweats). On an unknown date, the patient experienced MOBILITY DECREASED (Four days later she had no mobility from the hip down). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. In April 2021, TREMOR (shaking), GAIT DISTURBANCE (could barely walk, it hurt to walk), HYPERHIDROSIS (hot and cold sweats), COLD SWEAT (cold sweats), MOBILITY DECREASED (Four days later she had no mobility from the hip down), PYREXIA (104°F fever), MYALGIA (body aches,had muscle pain), CHILLS (chills) and ARTHRALGIA (joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 104 (High) 104°F fever. In April 2021, Laboratory test: normal (normal) everything came back normal. In April 2021, X-ray: normal (normal) everything came back normal.         Concomitant product use was not provided by the reporter.  Patient did not have side effects after the first dose.  Patient had a hospital visit four days later. Patient reported that ten days after the hospital visit,everything went back to normal (legs and everything).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Laboratory test, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: shaking; could barely walk, it hurt to walk; hot and cold sweats; cold sweats; 104°F fever; body aches,had muscle pain; chills; joint pain; Four days later she had no mobility from the hip down; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), GAIT DISTURBANCE (could barely walk, it hurt to walk), HYPERHIDROSIS (hot and cold sweats), COLD SWEAT (cold sweats) and MOBILITY DECREASED (Four days later she had no mobility from the hip down) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included ALS (family history of ALS and Guillain-Barre syndrome (great grand father, grand father and father).) and Guillain-Barre syndrome (family history of ALS and Guillain-Barre syndrome (great grand father, grand father and father).).   On 26-Feb-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) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TREMOR (shaking), HYPERHIDROSIS (hot and cold sweats), PYREXIA (104°F fever), MYALGIA (body aches,had muscle pain), CHILLS (chills) and ARTHRALGIA (joint pain). 30-Mar-2021, the patient experienced GAIT DISTURBANCE (could barely walk, it hurt to walk). 30-Mar-2021, the patient experienced COLD SWEAT (cold sweats). On an unknown date, the patient experienced MOBILITY DECREASED (Four days later she had no mobility from the hip down). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. In April 2021, TREMOR (shaking), GAIT DISTURBANCE (could barely walk, it hurt to walk), HYPERHIDROSIS (hot and cold sweats), COLD SWEAT (cold sweats), MOBILITY DECREASED (Four days later she had no mobility from the hip down), PYREXIA (104°F fever), MYALGIA (body aches,had muscle pain), CHILLS (chills) and ARTHRALGIA (joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 104 (High) 104°F fever. In April 2021, Laboratory test: normal (normal) everything came back normal. In April 2021, X-ray: normal (normal) everything came back normal.         Concomitant product use was not provided by the reporter.  Patient did not have side effects after the first dose.  Patient had a hospital visit four days later. Patient reported that ten days after the hospital visit,everything went back to normal (legs and everything).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, X-ray
Clinical narrative: shaking; could barely walk, it hurt to walk; hot and cold sweats; cold sweats; 104°F fever; body aches,had muscle pain; chills; joint pain; Four days later she had no mobility from the hip down; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), GAIT DISTURBANCE (could barely walk, it hurt to walk), HYPERHIDROSIS (hot and cold sweats), COLD SWEAT (cold sweats) and MOBILITY DECREASED (Four days later she had no mobility from the hip down) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included ALS (family history of ALS and Guillain-Barre syndrome (great grand father, grand father and father).) and Guillain-Barre syndrome (family history of ALS and Guillain-Barre syndrome (great grand father, grand father and father).).   On 26-Feb-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) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TREMOR (shaking), HYPERHIDROSIS (hot and cold sweats), PYREXIA (104°F fever), MYALGIA (body aches,had muscle pain), CHILLS (chills) and ARTHRALGIA (joint pain). 30-Mar-2021, the patient experienced GAIT DISTURBANCE (could barely walk, it hurt to walk). 30-Mar-2021, the patient experienced COLD SWEAT (cold sweats). On an unknown date, the patient experienced MOBILITY DECREASED (Four days later she had no mobility from the hip down). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. In April 2021, TREMOR (shaking), GAIT DISTURBANCE (could barely walk, it hurt to walk), HYPERHIDROSIS (hot and cold sweats), COLD SWEAT (cold sweats), MOBILITY DECREASED (Four days later she had no mobility from the hip down), PYREXIA (104°F fever), MYALGIA (body aches,had muscle pain), CHILLS (chills) and ARTHRALGIA (joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 104 (High) 104°F fever. In April 2021, Laboratory test: normal (normal) everything came back normal. In April 2021, X-ray: normal (normal) everything came back normal.         Concomitant product use was not provided by the reporter.  Patient did not have side effects after the first dose.  Patient had a hospital visit four days later. Patient reported that ten days after the hospital visit,everything went back to normal (legs and everything).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Burned like area at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Burned like area at the vaccination site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION SITE PAIN (Burned like area at the vaccination site). At the time of the report, VACCINATION SITE PAIN (Burned like area at the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Daughter did not feel well after getting the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Daughter did not feel well after getting the Moderna vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Daughter did not feel well after getting the Moderna vaccine). At the time of the report, MALAISE (Daughter did not feel well after getting the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided. No treatment medication was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: received booster instead of third shot; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (received booster instead of third shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J & J Vaccine (Lot number 1805025) in March 2020. Past adverse reactions to the above products included No adverse event with J & J Vaccine. Concurrent medical conditions included Immunocompromised (Autoimmune patient).    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (received booster instead of third shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 01-Nov-2021, ACCIDENTAL UNDERDOSE (received booster instead of third shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            Symptoms: It was reported that the patient was immunocompromised and should have received full dose of vaccine instead of half dose.  No concomitant medications were reported No treatment medications were reported
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Myalgia, Pain, Wrong technique in device usage process
Clinical narrative: Soreness; Achiness; the plunger broke halfway through the shot; received the full booster dose or not as some of the vaccine ran onto his arm; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (the plunger broke halfway through the shot), ACCIDENTAL UNDERDOSE (received the full booster dose or not as some of the vaccine ran onto his arm), MYALGIA (Soreness) and PAIN (Achiness) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 016M20A and 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CITALOPRAM for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (the plunger broke halfway through the shot) and ACCIDENTAL UNDERDOSE (received the full booster dose or not as some of the vaccine ran onto his arm). On an unknown date, the patient experienced MYALGIA (Soreness) and PAIN (Achiness). On 04-Nov-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (the plunger broke halfway through the shot) and ACCIDENTAL UNDERDOSE (received the full booster dose or not as some of the vaccine ran onto his arm) had resolved. At the time of the report, MYALGIA (Soreness) and PAIN (Achiness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-418844, MOD-2021-418848 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Myalgia, Pain
Clinical narrative: Bad pain in the right side of his back; difficult to walk; shooting pain when walking on left side; leg muscles were bothering him/pain goes down his leg to his calf; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Bad pain in the right side of his back), GAIT DISTURBANCE (difficult to walk), PAIN (shooting pain when walking on left side) and MYALGIA (leg muscles were bothering him/pain goes down his leg to his calf) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery. Concurrent medical conditions included Diabetes.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced BACK PAIN (Bad pain in the right side of his back), GAIT DISTURBANCE (difficult to walk), PAIN (shooting pain when walking on left side) and MYALGIA (leg muscles were bothering him/pain goes down his leg to his calf). At the time of the report, BACK PAIN (Bad pain in the right side of his back), GAIT DISTURBANCE (difficult to walk), PAIN (shooting pain when walking on left side) and MYALGIA (leg muscles were bothering him/pain goes down his leg to his calf) outcome was unknown.            No concomitant medications reported. No treatment reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Approximately 12 hours after receiving eah dose, he experienced some soreness and achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Approximately 12 hours after receiving eah dose, he experienced some soreness and achiness) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CITALOPRAM for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Approximately 12 hours after receiving eah dose, he experienced some soreness and achiness). On 25-Jan-2021, PAIN (Approximately 12 hours after receiving eah dose, he experienced some soreness and achiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported   This case was linked to MOD-2021-418822, MOD-2021-418848 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Skin atrophy, Vaccination site reaction
Clinical narrative: COVID Arm; Caused skin to droop under arm; Had sores in it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), SKIN ATROPHY (Caused skin to droop under arm) and PAIN OF SKIN (Had sores in it) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID Arm), SKIN ATROPHY (Caused skin to droop under arm) and PAIN OF SKIN (Had sores in it). At the time of the report, VACCINATION SITE REACTION (COVID Arm), SKIN ATROPHY (Caused skin to droop under arm) and PAIN OF SKIN (Had sores in it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.  Caller also reported she heard of seeing more of "COVID Arm" after people have  Moderna COVID-19 vaccine.   This case was linked to MOD-2021-419549, MOD-2021-419641 (Patient Link).   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired booster dose administered (> 12 hours post puncture); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered (> 12 hours post puncture)) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078J21A, 005C21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021 at 11:51 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021 at 11:51 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered (> 12 hours post puncture)). On 20-Dec-2021 at 11:51 AM, EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered (> 12 hours post puncture)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.  Reporter stated that date the vial was initially stored in the refrigerator was 18-Dec-2021 and vial was first punctured at 8:54 AM on 18-Dec-2021. And the vial did not undergo any temperature excursions Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) is approximately 29 hours.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Bad back) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Bad back). At the time of the report, BACK PAIN (Bad back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The patient took unspecified medications as treatment.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: a patient who is immunocompromised received only 0.25mL as a booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (a patient who is immunocompromised received only 0.25mL as a booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In October 2021, the patient experienced ACCIDENTAL UNDERDOSE (a patient who is immunocompromised received only 0.25mL as a booster). In October 2021, ACCIDENTAL UNDERDOSE (a patient who is immunocompromised received only 0.25mL as a booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Reporter did not allow further contact
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Overdosed him with a full shot instead of a half shot.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Overdosed him with a full shot instead of a half shot.) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 02820A and 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Overdosed him with a full shot instead of a half shot.). On 20-Dec-2021, ACCIDENTAL OVERDOSE (Overdosed him with a full shot instead of a half shot.) had resolved.            No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-419407, MOD-2021-419262 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Tinnitus
Clinical narrative: Patient had not received his 2nd dose since 04MAR2021 and asked should he get the 2nd dose?; Experienced severe tinnitus and ear ringing.; Experienced severe tinnitus and ear ringing.; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of TINNITUS (Experienced severe tinnitus and ear ringing.), the second episode of TINNITUS (Experienced severe tinnitus and ear ringing.) and PRODUCT DOSE OMISSION ISSUE (Patient had not received his 2nd dose since 04MAR2021 and asked should he get the 2nd dose?) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient had not received his 2nd dose since 04MAR2021 and asked should he get the 2nd dose?). In March 2021, the patient experienced the first episode of TINNITUS (Experienced severe tinnitus and ear ringing.) and the second episode of TINNITUS (Experienced severe tinnitus and ear ringing.). On 04-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Patient had not received his 2nd dose since 04MAR2021 and asked should he get the 2nd dose?) had resolved. In May 2021, last episode of TINNITUS (Experienced severe tinnitus and ear ringing.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication use was reported.  The patient had been asked to wait at least 9- to 120 days before receiving the second shot.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mobility decreased, Pain in extremity
Clinical narrative: Her arm still hurts/she can't sleep on that arm; Hurts when she takes a group picture because she can't lift her arm like that; She is swollen under the armpit area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm still hurts/she can't sleep on that arm), MOBILITY DECREASED (Hurts when she takes a group picture because she can't lift her arm like that) and LYMPHADENOPATHY (She is swollen under the armpit area) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Her arm still hurts/she can't sleep on that arm), MOBILITY DECREASED (Hurts when she takes a group picture because she can't lift her arm like that) and LYMPHADENOPATHY (She is swollen under the armpit area). At the time of the report, PAIN IN EXTREMITY (Her arm still hurts/she can't sleep on that arm), MOBILITY DECREASED (Hurts when she takes a group picture because she can't lift her arm like that) and LYMPHADENOPATHY (She is swollen under the armpit area) had not resolved.            No relevant concomitant medications were reported.  Patient has seen her gynecologist and primary care doctor and was told to wait 6 months to see how she feels and the 6 months has come and gone. Treatment includes application of heat to the area but patient is still experiencing these events.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Flushing, Malaise, Pain
Clinical narrative: next day I stayed in bed/did not feel quite with it; My face flushed when I went outsid/I felt drained; achy; I was in a haze; I felt real bad/like I had a dark cloud over my head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt real bad/like I had a dark cloud over my head), MALAISE (next day I stayed in bed/did not feel quite with it), FLUSHING (My face flushed when I went outsid/I felt drained), PAIN (achy) and VISION BLURRED (I was in a haze) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06S21A or 06521A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced FEELING ABNORMAL (I felt real bad/like I had a dark cloud over my head). On 08-Oct-2021, the patient experienced MALAISE (next day I stayed in bed/did not feel quite with it), FLUSHING (My face flushed when I went outsid/I felt drained), PAIN (achy) and VISION BLURRED (I was in a haze). At the time of the report, FEELING ABNORMAL (I felt real bad/like I had a dark cloud over my head), MALAISE (next day I stayed in bed/did not feel quite with it), FLUSHING (My face flushed when I went outsid/I felt drained), PAIN (achy) and VISION BLURRED (I was in a haze) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2021, Blood pressure measurement: increased (High) Increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-419138 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: next day I stayed in bed/did not feel quite with it; My face flushed when I went outsid/I felt drained; achy; I was in a haze; I felt real bad/like I had a dark cloud over my head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt real bad/like I had a dark cloud over my head), MALAISE (next day I stayed in bed/did not feel quite with it), FLUSHING (My face flushed when I went outsid/I felt drained), PAIN (achy) and VISION BLURRED (I was in a haze) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06S21A or 06521A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced FEELING ABNORMAL (I felt real bad/like I had a dark cloud over my head). On 08-Oct-2021, the patient experienced MALAISE (next day I stayed in bed/did not feel quite with it), FLUSHING (My face flushed when I went outsid/I felt drained), PAIN (achy) and VISION BLURRED (I was in a haze). At the time of the report, FEELING ABNORMAL (I felt real bad/like I had a dark cloud over my head), MALAISE (next day I stayed in bed/did not feel quite with it), FLUSHING (My face flushed when I went outsid/I felt drained), PAIN (achy) and VISION BLURRED (I was in a haze) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2021, Blood pressure measurement: increased (High) Increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-419138 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Had an odd side effect after the Moderna vaccines/Phantosmia an odd smell no matter where I am; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Had an odd side effect after the Moderna vaccines/Phantosmia an odd smell no matter where I am) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced PAROSMIA (Had an odd side effect after the Moderna vaccines/Phantosmia an odd smell no matter where I am). At the time of the report, PAROSMIA (Had an odd side effect after the Moderna vaccines/Phantosmia an odd smell no matter where I am) had resolved.            No concomitant medications were reported. No treatment information was provided.  The patient stated that after 2nd vaccine, the symptom took at least a month to go away.   This case was linked to MOD-2021-419291 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient stated that she received a booster dose of 2.5ml; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Patient stated that she received a booster dose of 2.5ml) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient stated that she received a booster dose of 2.5ml). At the time of the report, ACCIDENTAL OVERDOSE (Patient stated that she received a booster dose of 2.5ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment information was reported by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Depressed mood, Tremor, Vaccination site pain
Clinical narrative: Shaky bones; Low energy; Felt down; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky bones), ASTHENIA (Low energy), DEPRESSED MOOD (Felt down) and VACCINATION SITE PAIN (Injection site pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 006321A and 044B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced TREMOR (Shaky bones), ASTHENIA (Low energy), DEPRESSED MOOD (Felt down) and VACCINATION SITE PAIN (Injection site pain). In December 2021, TREMOR (Shaky bones), ASTHENIA (Low energy), DEPRESSED MOOD (Felt down) and VACCINATION SITE PAIN (Injection site pain) had resolved.            No treatment medications were reported.   This case was linked to MOD-2021-419281 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: Eye discomfort; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Eye discomfort) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (Eye discomfort). At the time of the report, OCULAR DISCOMFORT (Eye discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-418640 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash). At the time of the report, RASH ERYTHEMATOUS (Red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.    No treatment medications were reported.   This case was linked to MOD-2021-419233, MOD-2021-419298 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches) and HEADACHE (headache). At the time of the report, PAIN (body aches) and HEADACHE (headache) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Hypoaesthesia, Pyrexia
Clinical narrative: feeling crappy; no energy; freezing my butt off due to the fever; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling crappy), ASTHENIA (no energy), HYPOAESTHESIA (freezing my butt off due to the fever) and PYREXIA (low grade fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054H21A, 002C21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection (undetectable HIV).   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-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 FEELING ABNORMAL (feeling crappy), ASTHENIA (no energy), HYPOAESTHESIA (freezing my butt off due to the fever) and PYREXIA (low grade fever). At the time of the report, FEELING ABNORMAL (feeling crappy), ASTHENIA (no energy), HYPOAESTHESIA (freezing my butt off due to the fever) and PYREXIA (low grade fever) was resolving.            Concomitant medication of the patient was unknown.  The patient received unknown corrective treatment for the events. The symptoms of the patient some sort of wearing off.   This case was linked to MOD-2021-419311, MOD-2021-419320 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Phastosmia/ odd smell no matter where I am/ t's strong and constant; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Phastosmia/ odd smell no matter where I am/ t's strong and constant) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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. On an unknown date, the patient experienced PAROSMIA (Phastosmia/ odd smell no matter where I am/ t's strong and constant). At the time of the report, PAROSMIA (Phastosmia/ odd smell no matter where I am/ t's strong and constant) had not resolved.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-419222 (Patient Link).   Reporter did not allow further contact
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 42 days for administration of second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 42 days for administration of second dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 42 days for administration of second dose). On 01-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 42 days for administration of second dose) had resolved.            Concomitant medications were not reported. Treatment medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: does not need to wear glasses anymore/can see fine without glasses; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (does not need to wear glasses anymore/can see fine without glasses) in an elderly 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (does not need to wear glasses anymore/can see fine without glasses). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (does not need to wear glasses anymore/can see fine without glasses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that  Patient is in his 70s.   No concomitant drug details were reported. No treatment details were reported.    This case was linked to MOD-2021-418455, MOD-2021-418640 (Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Charley-horse; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Charley-horse) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection (Undetectable HIV).    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Charley-horse). At the time of the report, MUSCLE SPASMS (Charley-horse) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-419280, MOD-2021-419320 (Patient Link).