chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Breakthrough case of COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough case) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced COVID-19 (Breakthrough case). At the time of the report, COVID-19 (Breakthrough case) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 27-Oct-2021, SARS-CoV-2 test positive.         No Concomitant medications were provided by the reporter.  No Treatment Information was provided by the reporter.  This case concerns a 77 year-old male patient with no reported medical history who experienced the unexpected adverse event of special interest COVID-19. The event occurred approximately 8 months after the second dose of Moderna COVID-19 vaccine. The first and second doses were administered in January and February 2021, further information was not provided. The rechallenge was unknown as the specific dates of vaccination were not provided. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Incorrect route of product administration, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to the touch; Very swollen; Hard; Patient got the booster dose (0.5ml); Moderna administered was subcutaneous and not intramuscular; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH, VACCINATION SITE SWELLING, VACCINATION SITE INDURATION, ACCIDENTAL OVERDOSE, and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous and not intramuscular) 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 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to .5 milliliter. 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 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE and INCORRECT ROUTE OF PRODUCT ADMINISTRATION. On an unknown date, the patient experienced VACCINATION SITE WARMTH, VACCINATION SITE SWELLING, and VACCINATION SITE INDURATION. On 29-Oct-2021, ACCIDENTAL OVERDOSE and INCORRECT ROUTE OF PRODUCT ADMINISTRATION had resolved. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE SWELLING, and VACCINATION SITE INDURATION outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   The nurse believed that the administration was subcutaneous and not intramuscular because her arm was very swollen, hard, and hot to the touch. Also, the patient received the booster dose on her right arm (not sure if it is the dominant one), same arm of the symptoms, on the back side of the arm and the lower arm.  The 1st and 2nd dose of the Moderna COVID-19 vaccine but, the caller does not know the exact dates nor the lot numbers (The caller thinks the 1st dose was on January or February).   No concomitant medications were reported. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: 10 patients administered vaccine after temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (10 patients administered vaccine after temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (10 patients administered vaccine after temperature excursion). On 05-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (10 patients administered vaccine after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  It was stated that, the number of vials/doses was 50 doses and the vaccine distributed from freezer to vaccine clinic for immediate use. On 05-AUG-2021, the single vial was punctured at 8:45 and it was given to 10 patients.   This case was linked to MOD-2021-373651.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY outcome was unknown.            No concomitant medication were provided. No treatment information were given.   This case was linked to MOD-2021-369011, MOD-2021-370524 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Lacrimation increased, Limb discomfort, Paraesthesia, Peripheral swelling
Clinical narrative: eyelids at the bottom are both watery; slight fever; pains and needles all over my body; right arm felt so heavy; it was swollen; lost taste buds; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (right arm felt so heavy), PERIPHERAL SWELLING (it was swollen), LACRIMATION INCREASED (eyelids at the bottom are both watery), PARAESTHESIA (pains and needles all over my body) and AGEUSIA (lost taste buds) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced AGEUSIA (lost taste buds). On 18-Oct-2021, the patient experienced LIMB DISCOMFORT (right arm felt so heavy), PERIPHERAL SWELLING (it was swollen) and PARAESTHESIA (pains and needles all over my body). On 19-Oct-2021, the patient experienced LACRIMATION INCREASED (eyelids at the bottom are both watery) and PYREXIA (slight fever). In October 2021, PERIPHERAL SWELLING (it was swollen) had resolved. On 18-Oct-2021, LIMB DISCOMFORT (right arm felt so heavy) had resolved. On 19-Oct-2021, PARAESTHESIA (pains and needles all over my body) and PYREXIA (slight fever) had resolved. At the time of the report, LACRIMATION INCREASED (eyelids at the bottom are both watery) and AGEUSIA (lost taste buds) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient had right arm swelling lasted for 3 to 4 days. Event pains and needles all over patients body after the first shot and it was only the first and second night, first night was only at the feet and then second night was up to the eyes.  Company Comment: This case concerns a 54-year-old female patient, with unknown medical history, who experienced the non-serious unexpected AESI of AGEUSIA. The event occurred in an unknown date, approximately two weeks after receiving the first dose Moderna COVID 19 vaccine. The rechallenge is not applicable since the event occurred after the first dose and it has not recovered. The benefit-risk relation of the Moderna COVID 19 vaccine is unaffected by this report. no concomitants drugs were reported. no treatment drugs were reported. Second shot due on 15Nov2021.; Sender's Comments: This case concerns a 54-year-old female patient, with unknown medical history, who experienced the non-serious unexpected AESI of AGEUSIA. The event occurred in an unknown date, approximately two weeks after receiving the first dose Moderna COVID 19 vaccine. The rechallenge is not applicable since the event occurred after the first dose and it has not recovered. The benefit-risk relation of the Moderna COVID 19 vaccine is unaffected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: eyelids at the bottom are both watery; slight fever; pains and needles all over my body; right arm felt so heavy; it was swollen; lost taste buds; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (right arm felt so heavy), PERIPHERAL SWELLING (it was swollen), LACRIMATION INCREASED (eyelids at the bottom are both watery), PARAESTHESIA (pains and needles all over my body) and AGEUSIA (lost taste buds) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced AGEUSIA (lost taste buds). On 18-Oct-2021, the patient experienced LIMB DISCOMFORT (right arm felt so heavy), PERIPHERAL SWELLING (it was swollen) and PARAESTHESIA (pains and needles all over my body). On 19-Oct-2021, the patient experienced LACRIMATION INCREASED (eyelids at the bottom are both watery) and PYREXIA (slight fever). In October 2021, PERIPHERAL SWELLING (it was swollen) had resolved. On 18-Oct-2021, LIMB DISCOMFORT (right arm felt so heavy) had resolved. On 19-Oct-2021, PARAESTHESIA (pains and needles all over my body) and PYREXIA (slight fever) had resolved. At the time of the report, LACRIMATION INCREASED (eyelids at the bottom are both watery) and AGEUSIA (lost taste buds) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient had right arm swelling lasted for 3 to 4 days. Event pains and needles all over patients body after the first shot and it was only the first and second night, first night was only at the feet and then second night was up to the eyes.  Company Comment: This case concerns a 54-year-old female patient, with unknown medical history, who experienced the non-serious unexpected AESI of AGEUSIA. The event occurred in an unknown date, approximately two weeks after receiving the first dose Moderna COVID 19 vaccine. The rechallenge is not applicable since the event occurred after the first dose and it has not recovered. The benefit-risk relation of the Moderna COVID 19 vaccine is unaffected by this report. no concomitants drugs were reported. no treatment drugs were reported. Second shot due on 15Nov2021.; Sender's Comments: This case concerns a 54-year-old female patient, with unknown medical history, who experienced the non-serious unexpected AESI of AGEUSIA. The event occurred in an unknown date, approximately two weeks after receiving the first dose Moderna COVID 19 vaccine. The rechallenge is not applicable since the event occurred after the first dose and it has not recovered. The benefit-risk relation of the Moderna COVID 19 vaccine is unaffected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: exposed to COVID; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (exposed to COVID) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20Q) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 EXPOSURE TO SARS-COV-2 (exposed to COVID). At the time of the report, EXPOSURE TO SARS-COV-2 (exposed to COVID) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-370402, MOD-2021-370489 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Gait disturbance, Headache
Clinical narrative: shaking; couldn't walk properly, couldn't walk straight; totally fatigued; unbelievable headache; muscle pain; joint pain; fever of a 100° F; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), GAIT DISTURBANCE (couldn't walk properly, couldn't walk straight), FATIGUE (totally fatigued), HEADACHE (unbelievable headache) and MYALGIA (muscle pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 048A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-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 GAIT DISTURBANCE (couldn't walk properly, couldn't walk straight), FATIGUE (totally fatigued), HEADACHE (unbelievable headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever of a 100° F). On 04-Nov-2021 at 1:00 AM, the patient experienced TREMOR (shaking). At the time of the report, TREMOR (shaking), GAIT DISTURBANCE (couldn't walk properly, couldn't walk straight), FATIGUE (totally fatigued), HEADACHE (unbelievable headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever of a 100° F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Body temperature: 100 (High) 100 degree Farenheit.         No concomitant medication reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: shaking; couldn't walk properly, couldn't walk straight; totally fatigued; unbelievable headache; muscle pain; joint pain; fever of a 100° F; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), GAIT DISTURBANCE (couldn't walk properly, couldn't walk straight), FATIGUE (totally fatigued), HEADACHE (unbelievable headache) and MYALGIA (muscle pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 048A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-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 GAIT DISTURBANCE (couldn't walk properly, couldn't walk straight), FATIGUE (totally fatigued), HEADACHE (unbelievable headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever of a 100° F). On 04-Nov-2021 at 1:00 AM, the patient experienced TREMOR (shaking). At the time of the report, TREMOR (shaking), GAIT DISTURBANCE (couldn't walk properly, couldn't walk straight), FATIGUE (totally fatigued), HEADACHE (unbelievable headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever of a 100° F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Body temperature: 100 (High) 100 degree Farenheit.         No concomitant medication reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided   This case was linked to MOD-2021-375313, MOD-2021-375329 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: normal side effects to the first two Moderna Covid-19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (normal side effects to the first two Moderna Covid-19 vaccinations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (normal side effects to the first two Moderna Covid-19 vaccinations). At the time of the report, VACCINATION COMPLICATION (normal side effects to the first two Moderna Covid-19 vaccinations) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-375294, MOD-2021-375323, MOD-2021-375294.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Photophobia, Pyrexia, Somnolence
Clinical narrative: muscle tightness in shoulders/feels like her upper back and shoulders; slept for 20 hours; light sensitive; hard to go to sleep; has been doing less than normal because she does not feel good; all over achy; wrap around headache/has to limit herself reading because it makes her head hurt; severe fatigue; 101 Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (muscle tightness in shoulders/feels like her upper back and shoulders), SOMNOLENCE (slept for 20 hours), PHOTOPHOBIA (light sensitive), INSOMNIA (hard to go to sleep) and MALAISE (has been doing less than normal because she does not feel good) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 007MZ0A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (101 Fever). On an unknown date, the patient experienced MUSCLE TIGHTNESS (muscle tightness in shoulders/feels like her upper back and shoulders), SOMNOLENCE (slept for 20 hours), PHOTOPHOBIA (light sensitive), INSOMNIA (hard to go to sleep), MALAISE (has been doing less than normal because she does not feel good), MYALGIA (all over achy), HEADACHE (wrap around headache/has to limit herself reading because it makes her head hurt) and FATIGUE (severe fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE TIGHTNESS (muscle tightness in shoulders/feels like her upper back and shoulders), SOMNOLENCE (slept for 20 hours), PHOTOPHOBIA (light sensitive), INSOMNIA (hard to go to sleep), MALAISE (has been doing less than normal because she does not feel good), MYALGIA (all over achy), HEADACHE (wrap around headache/has to limit herself reading because it makes her head hurt), PYREXIA (101 Fever) and FATIGUE (severe fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has applied ice pack and heat pack for her neck.   This case was linked to MOD-2021-375409, MOD-2021-375417.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received on 09 nov 2021 contains no new information. Medical history, treatment medications added from initial document.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Felt chills; Felt a little bit nauseous; Tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, NAUSEA, and FATIGUE in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9399021) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Obesity.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, the patient experienced CHILLS, NAUSEA, and FATIGUE. At the time of the report, CHILLS, NAUSEA, and FATIGUE outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Patient stated that she is not immunocompromised. Patient didn't seem sure if she got the full dose or half a dose.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm after 1st shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-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 (sore arm after 1st shot). At the time of the report, MYALGIA (sore arm after 1st shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.   This case was linked to MOD-2021-375399, MOD-2021-375404.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Retching
Clinical narrative: Dry heaves; Get the urge to vomit but no actual vomit; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (Dry heaves) and NAUSEA (Get the urge to vomit but no actual vomit) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT RESPIMAT), ALBUTEROL [SALBUTAMOL], FUROSEMIDE, PAROXETINE, THEOPHYLLINE, VITAMIN D [VITAMIN D NOS], NIFEDIPINE, PANTOPRAZOLE, DOXAZOSIN, VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]), APIXABAN and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RETCHING (Dry heaves) and NAUSEA (Get the urge to vomit but no actual vomit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RETCHING (Dry heaves) and NAUSEA (Get the urge to vomit but no actual vomit) outcome was unknown.            Patient received third booster dose on 01NOV2021 in the left non dominant arm, lot 032P21A.   This case was linked to MOD-2021-375483 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Migraine
Clinical narrative: Flu like symptoms; Profuse sweating; Extreme, migraine like headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS, HYPERHIDROSIS, and MIGRAINE in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced INFLUENZA LIKE ILLNESS, HYPERHIDROSIS, and MIGRAINE. On 08-Oct-2021, INFLUENZA LIKE ILLNESS, HYPERHIDROSIS, and MIGRAINE had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medications were reported.    This case was linked to MOD-2021-375482 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 68-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided.; Sender's Comments: This case concerns a 68-year-old, male patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on unknown date after unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 56-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.  This case concerns a 56-year-old, female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred on unknown date after unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-375393 (Patient Link). This case concerns a 56-year-old, female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on unknown date after unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise
Clinical narrative: sore arm after second dose; did not feel good for a day after second dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel good for a day after second dose) and INJECTION SITE PAIN (sore arm after second dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Thyroid disorder NOS.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (did not feel good for a day after second dose) and INJECTION SITE PAIN (sore arm after second dose). At the time of the report, MALAISE (did not feel good for a day after second dose) had resolved and INJECTION SITE PAIN (sore arm after second dose) outcome was unknown.            Concomitant medication included unspecified high blood pressure pill and thyroid pill.  No treatment information was provided.   This case was linked to MOD-2021-375439, MOD-2021-375550 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; unknown vaccination schedule, might have been outside of window; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unknown vaccination schedule, might have been outside of window) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unknown vaccination schedule, might have been outside of window). On 06-Nov-2021, the patient experienced COVID-19 (Tested positive for COVID-19). In September 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unknown vaccination schedule, might have been outside of window) had resolved. At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 06-Nov-2021, SARS-CoV-2 test positive.      No Concomitant and Treatment medication were reported. This case of inappropriate schedule of product administration concerns a 49-year-old, female patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19. The event occurred at least 1 month after the second dose of Moderna COVID-19 vaccine (exact day of second dose unknown). The rechallenge was not applicable since the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-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 PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No treatment and concomitant medications were provided.  patient received second dose on 04Mar2021 and third dose on 06Nov2021.  The patient states she already reported her side effects to V-Safe in March after she had the second vaccine. The patient declined to provide further information. Consent declined for safety to contact the patient.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Significant Follow up received on 08112021 contains updated reporter information and patient demographics along with dose details.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: There was an error placed the vaccine back into the freezer; Vaccines were administered to 60 patients after; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (There was an error placed the vaccine back into the freezer) and EXPIRED PRODUCT ADMINISTERED (Vaccines were administered to 60 patients after) 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 PRODUCT STORAGE ERROR (There was an error placed the vaccine back into the freezer) and EXPIRED PRODUCT ADMINISTERED (Vaccines were administered to 60 patients after). At the time of the report, PRODUCT STORAGE ERROR (There was an error placed the vaccine back into the freezer) and EXPIRED PRODUCT ADMINISTERED (Vaccines were administered to 60 patients after) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  Reporter stated that vials were put back in the freezer after they were already thawed and they were kept frozen between 32 and 34 degrees Fahrenheit and the Vials were taken out of the freezer on the same day doses were administered which was between 27-Sep-2021 and 01-Oct-2021.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Product storage conditions were updated.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Got first shot Moderna and second shot Pfizer; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Got first shot Moderna and second shot Pfizer) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got first shot Moderna and second shot Pfizer). On 11-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (Got first shot Moderna and second shot Pfizer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant and treatment drugs were provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site scab
Clinical narrative: scab at the injection site/ scab just fell off after 6 months; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAB (scab at the injection site/ scab just fell off after 6 months) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-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 VACCINATION SITE SCAB (scab at the injection site/ scab just fell off after 6 months). At the time of the report, VACCINATION SITE SCAB (scab at the injection site/ scab just fell off after 6 months) had resolved.            No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received contains: updated reporter information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Deafness
Clinical narrative: got covid after her second dose of the Moderna vaccine; deafness; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (deafness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DEAFNESS (deafness) (seriousness criterion medically significant). In June 2021, the patient experienced COVID-19 (got covid after her second dose of the Moderna vaccine). At the time of the report, DEAFNESS (deafness) had not resolved and COVID-19 (got covid after her second dose of the Moderna vaccine) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Patient started experiencing Deafness after having Covid-19. The patient is in her eighties.  Company Comment: This case concerns an elderly female patient with no relevant medical history, who experienced the unexpected serious event of deafness, and the non-serious AESI event of COVID-19. The date of onset of deafness was not reported. COVID-19 occurred approximately 4 months after the second dose of mRNA-1273 Moderna vaccine. The rechallenge for COVID-19 is not applicable. The rechallenge for deafness is not applicable as the outcome of the event is unknown. Patient´s age (reported as "in her eighties") could be a confounding factor for deafness. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns an elderly female patient with no relevant medical history, who experienced the unexpected serious event of deafness, and the non-serious AESI event of COVID-19. The date of onset of deafness was not reported. COVID-19 occurred approximately 4 months after the second dose of mRNA-1273 Moderna vaccine. The rechallenge for COVID-19 is not applicable. The rechallenge for deafness is not applicable as the outcome of the event is unknown. Patient´s age (reported as "in her eighties") could be a confounding factor for deafness. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 20 expired booster doses(exp date 4 nov 2021) on 5NOV2021; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED on 5NOV2021 in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.   No Medical History information was reported.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED on 5NOV2021. On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED on 5NOV2021 had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medications were not reported.  Most recent FOLLOW-UP information incorporated above includes on 08-Nov-2021 the follow up received contains non significant information, added patient demographics.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria, Vaccination complication
Clinical narrative: Itching with hives with  never had before; Itching with hives never had before,itch; Hole stomach with hives too red; Feel okay until night, went to bed and I wasn't feeling to well; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Itching with hives with  never had before), PRURITUS (Itching with hives never had before,itch), ERYTHEMA (Hole stomach with hives too red) and VACCINATION COMPLICATION (Feel okay until night, went to bed and I wasn't feeling to well) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 10C014-825, 007M20A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included Hip fracture in 2020. Concurrent medical conditions included Weight loss (a lot of weight because of fracture and is very skinny, 90 pounds.). Concomitant products included HYDROCORTISONE for Itch, HYDROCHLOROTHIAZIDE, PARACETAMOL (TYLENOL [PARACETAMOL]), SIMVASTATIN, LISINOPRIL, CALCIUM and LATANOPROST for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced ERYTHEMA (Hole stomach with hives too red) and VACCINATION COMPLICATION (Feel okay until night, went to bed and I wasn't feeling to well). On 04-Nov-2021, the patient experienced PRURITUS (Itching with hives never had before,itch). On 04-Nov-2021 at 11:00 PM, the patient experienced URTICARIA (Itching with hives with  never had before). On 03-Nov-2021, VACCINATION COMPLICATION (Feel okay until night, went to bed and I wasn't feeling to well) had resolved. At the time of the report, URTICARIA (Itching with hives with  never had before), PRURITUS (Itching with hives never had before,itch) and ERYTHEMA (Hole stomach with hives too red) outcome was unknown.            No treatment was received by the patient.  Patient reported 2days after the vaccine, that night she experienced itching with hives never had before. Patient got up, sat on a chair to read or do something else to not think of the itching. After, the patient talked to a friend that usually got hives and told her to sleep with gloves so does not scratch during the night. The patient said: "Last night went to bed with gloves so not to scratch and sleep better.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Decreased appetite, Influenza like illness, Myalgia
Clinical narrative: flue like symptoms; No appetite; bed ridden for a whole day; Achy body; nauseous; Fever of 100.3; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flue like symptoms), DECREASED APPETITE (No appetite), BEDRIDDEN (bed ridden for a whole day), MYALGIA (Achy body) and NAUSEA (nauseous) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol and Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), ROSUVASTATIN for Cholesterol, METOPROLOL for an unknown indication.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (flue like symptoms), DECREASED APPETITE (No appetite), BEDRIDDEN (bed ridden for a whole day), MYALGIA (Achy body), NAUSEA (nauseous) and PYREXIA (Fever of 100.3). On 05-Nov-2021, PYREXIA (Fever of 100.3) had resolved. On 06-Nov-2021, BEDRIDDEN (bed ridden for a whole day) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flue like symptoms), DECREASED APPETITE (No appetite), MYALGIA (Achy body) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Body temperature: 100.3 (High) Body temperature High-100.3.         Reporter stated that patient was taking concomitant medication metoprolol for betablocker, rosuvastatin for cholesterol control and famotidine for acid reflux. Treatment details was not reported by the reporter.