chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Eye pain, Fatigue, Headache
Clinical narrative: Eye pain on the right side; Soreness in the armpit; Bad headache; Tired; Achy; Whole arm turned red/spread far on my whole arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), EYE PAIN (Eye pain on the right side), ERYTHEMA (Whole arm turned red/spread far on my whole arm), AXILLARY PAIN (Soreness in the armpit) and HEADACHE (Bad headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 044A21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS], MULTIVITAMIN [VITAMINS NOS] and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced ERYTHEMA (Whole arm turned red/spread far on my whole arm). On 20-Nov-2021, the patient experienced PAIN (Achy) and FATIGUE (Tired). On 23-Nov-2021, the patient experienced HEADACHE (Bad headache). On 24-Nov-2021, the patient experienced EYE PAIN (Eye pain on the right side) and AXILLARY PAIN (Soreness in the armpit). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) for Headache, at a dose of 1 dosage form. At the time of the report, PAIN (Achy) and FATIGUE (Tired) had resolved, EYE PAIN (Eye pain on the right side) and AXILLARY PAIN (Soreness in the armpit) outcome was unknown, ERYTHEMA (Whole arm turned red/spread far on my whole arm) was resolving and HEADACHE (Bad headache) had not resolved.            The patient said they had a severe reaction. The patient received the Moderna COVID-19 booster vaccine on 19-Nov-2021. After receiving the vaccine, their whole arm turned red where they got the shot. The patient said it spread far on their whole arm and by 20-Nov-2021, Saturday they felt achy and tired. On 21-Nov/22-Nov-2021, it went back to normal. On 23-Nov-2021, the patient got a bad headache and took Motrin. On 24-Nov-2021, the patient woke up with a headache and characterized it as a headache with eye pain on the right side. The patient does have soreness in the armpit where they got the shot as well. Reportedly, the redness was going away and the was their main concern.   This case was linked to MOD-2021-396560, MOD-2021-395909 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Eye pain on the right side; Soreness in the armpit; Bad headache; Tired; Achy; Whole arm turned red/spread far on my whole arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), EYE PAIN (Eye pain on the right side), ERYTHEMA (Whole arm turned red/spread far on my whole arm), AXILLARY PAIN (Soreness in the armpit) and HEADACHE (Bad headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 044A21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS], MULTIVITAMIN [VITAMINS NOS] and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced ERYTHEMA (Whole arm turned red/spread far on my whole arm). On 20-Nov-2021, the patient experienced PAIN (Achy) and FATIGUE (Tired). On 23-Nov-2021, the patient experienced HEADACHE (Bad headache). On 24-Nov-2021, the patient experienced EYE PAIN (Eye pain on the right side) and AXILLARY PAIN (Soreness in the armpit). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) for Headache, at a dose of 1 dosage form. At the time of the report, PAIN (Achy) and FATIGUE (Tired) had resolved, EYE PAIN (Eye pain on the right side) and AXILLARY PAIN (Soreness in the armpit) outcome was unknown, ERYTHEMA (Whole arm turned red/spread far on my whole arm) was resolving and HEADACHE (Bad headache) had not resolved.            The patient said they had a severe reaction. The patient received the Moderna COVID-19 booster vaccine on 19-Nov-2021. After receiving the vaccine, their whole arm turned red where they got the shot. The patient said it spread far on their whole arm and by 20-Nov-2021, Saturday they felt achy and tired. On 21-Nov/22-Nov-2021, it went back to normal. On 23-Nov-2021, the patient got a bad headache and took Motrin. On 24-Nov-2021, the patient woke up with a headache and characterized it as a headache with eye pain on the right side. The patient does have soreness in the armpit where they got the shot as well. Reportedly, the redness was going away and the was their main concern.   This case was linked to MOD-2021-396560, MOD-2021-395909 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Is coughing a side effect of the vaccine?; 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 COUGH (Is coughing a side effect of 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 COUGH (Is coughing a side effect of the vaccine?). At the time of the report, COUGH (Is coughing a side effect of the vaccine?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Hypoaesthesia, Strabismus, Vaccination complication
Clinical narrative: Strabismus in here left eye; Seeing double vision; Numbness in her right side, her leg, her arm; The complications are also on the left side; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Seeing double vision), HYPOAESTHESIA (Numbness in her right side, her leg, her arm), VACCINATION COMPLICATION (The complications are also on the left side) and STRABISMUS (Strabismus in here left eye) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced DIPLOPIA (Seeing double vision), HYPOAESTHESIA (Numbness in her right side, her leg, her arm) and VACCINATION COMPLICATION (The complications are also on the left side). On 25-Nov-2021, the patient experienced STRABISMUS (Strabismus in here left eye). At the time of the report, DIPLOPIA (Seeing double vision), HYPOAESTHESIA (Numbness in her right side, her leg, her arm) and VACCINATION COMPLICATION (The complications are also on the left side) had not resolved and STRABISMUS (Strabismus in here left eye) outcome was unknown.            No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-396458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: follow up received on 25-nov-2021 contains significant information Event added.
Age: 85.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood thyroid stimulating hormone decreased
Clinical narrative: Low levels of TSH; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD THYROID STIMULATING HORMONE DECREASED (Low levels of TSH) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM tablet for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and LEVOTHYROXINE SODIUM (unknown route) 100 microgram. On an unknown date, the patient experienced BLOOD THYROID STIMULATING HORMONE DECREASED (Low levels of TSH). At the time of the report, BLOOD THYROID STIMULATING HORMONE DECREASED (Low levels of TSH) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Menopause, Tinnitus (Had history of tinnitus,when blood pressure was elevated and feels a pulse sensation in ears.) and Blood pressure high. Concomitant products included CALCIUM for Menopause.    On 15-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 VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications also included fiber supplement (to help with menopause). Treatment included Hydration.   This case was linked to MOD-2021-396702, MOD-2021-396724 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Pyrexia
Clinical narrative: no energy/she has degenerated/she doesn't feel like doing anything; no appetite; woke up feverish in the middle of the night; bad case of chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy/she has degenerated/she doesn't feel like doing anything), DECREASED APPETITE (no appetite), CHILLS (bad case of chills) and PYREXIA (woke up feverish in the middle of the night) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced CHILLS (bad case of chills). On an unknown date, the patient experienced ASTHENIA (no energy/she has degenerated/she doesn't feel like doing anything), DECREASED APPETITE (no appetite) and PYREXIA (woke up feverish in the middle of the night). At the time of the report, ASTHENIA (no energy/she has degenerated/she doesn't feel like doing anything), DECREASED APPETITE (no appetite), CHILLS (bad case of chills) and PYREXIA (woke up feverish in the middle of the night) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-396682 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Nausea
Clinical narrative: Drain; Nausea; She received the first two doses two weeks apart in March 2021.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Drain), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received the first two doses two weeks apart in March 2021.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FATIGUE (Drain), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received the first two doses two weeks apart in March 2021.). In March 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received the first two doses two weeks apart in March 2021.) had resolved. At the time of the report, FATIGUE (Drain) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-396661 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: muscle aches; joint pain; fatigue; fever; chills; flu like symptoms for 36 hours , States the symptoms were" in and out; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms for 36 hours , States the symptoms were" in and out), MYALGIA (muscle aches), ARTHRALGIA (joint pain), FATIGUE (fatigue) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by patient.  Concomitant products included PLANTAGO OVATA FIBRE (FIBER SUPPLEMENT) for Menopause.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-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 INFLUENZA LIKE ILLNESS (flu like symptoms for 36 hours , States the symptoms were" in and out), MYALGIA (muscle aches), ARTHRALGIA (joint pain), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms for 36 hours , States the symptoms were" in and out), MYALGIA (muscle aches), ARTHRALGIA (joint pain), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) had resolved.            Treatment was given hydration after 1st and 2nd dose symptoms. Other concomitant product included unspecified Calcium supplement.   This case was linked to MOD-2021-396654 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: muscle aches; joint pain; fatigue; fever; chills; flu like symptoms for 36 hours , States the symptoms were" in and out; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms for 36 hours , States the symptoms were" in and out), MYALGIA (muscle aches), ARTHRALGIA (joint pain), FATIGUE (fatigue) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by patient.  Concomitant products included PLANTAGO OVATA FIBRE (FIBER SUPPLEMENT) for Menopause.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-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 INFLUENZA LIKE ILLNESS (flu like symptoms for 36 hours , States the symptoms were" in and out), MYALGIA (muscle aches), ARTHRALGIA (joint pain), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms for 36 hours , States the symptoms were" in and out), MYALGIA (muscle aches), ARTHRALGIA (joint pain), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) had resolved.            Treatment was given hydration after 1st and 2nd dose symptoms. Other concomitant product included unspecified Calcium supplement.   This case was linked to MOD-2021-396654 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Autoantibody positive, Autoantibody test
Clinical narrative: Donated in September and received a letter from the people he donated blood to, stating that he has tested positive for "Warm auto antibody; This spontaneous case was reported by a consumer and describes the occurrence of AUTOANTIBODY POSITIVE (Donated in September and received a letter from the people he donated blood to, stating that he has tested positive for "Warm auto antibody) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood donation (Patient states he used to donate blood all the time).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-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 AUTOANTIBODY POSITIVE (Donated in September and received a letter from the people he donated blood to, stating that he has tested positive for "Warm auto antibody). At the time of the report, AUTOANTIBODY POSITIVE (Donated in September and received a letter from the people he donated blood to, stating that he has tested positive for "Warm auto antibody) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Autoantibody test: positive (Positive) tested positive for "Warm auto antibody".         The patient stated that he used to donate blood all the time, and he donated in September, and then received a letter from the people he donated blood to, stating that he had tested positive for "Warm auto antibody". It caused minor harm, but it could cause anyone a problem if they had a transfusion, and they won't take patient's blood anymore. The patient stated that the only thing he could think that caused this was that he received the Moderna vaccine, and wanted to know if it is one of the side effects. Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine used; Temperature was out of range at 10 degree celcius for 1 hour and 20 minutes; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Temperature was out of range at 10 degree celcius for 1 hour and 20 minutes) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension and Cholesterol. Concomitant products included METFORMIN, LOSARTAN and PRAVASTATIN for an unknown indication.    On 07-Oct-2021 at 9:21 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Temperature was out of range at 10 degree celcius for 1 hour and 20 minutes). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Temperature was out of range at 10 degree celcius for 1 hour and 20 minutes) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine was stored in refrigerator on 06 Oct 2021 at 3:30pm. The door of refrigerator was slightly open. Patient experience no side effects.  No treatment medication reported by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Sudden hearing loss/profound hearing loss; This spontaneous case was reported by a nurse and describes the occurrence of DEAFNESS (Sudden hearing loss/profound hearing loss) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (On 27Oct2021 started taking a high dose of prednisone to treat an autoimmune condition). Concomitant products included PREDNISONE from 27-Oct-2021 to an unknown date for Autoimmune disorder.   On 31-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 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 27-Oct-2021, the patient experienced DEAFNESS (Sudden hearing loss/profound hearing loss) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Sudden hearing loss/profound hearing loss) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  On 30 Oct 2021, patient received 0.25 ml Moderna booster dose and was advised to get a full 3rd dose.  Patient informed that there was no relation between her condition and Moderna vaccine because she was diagnosed with the syndrome in her 50s. But this was advancing.  Company comment: This case concerns a 66-year-old female patient with no relevant medical history, who experienced the unexpected event of Deafness. The event occurred on approximately 9 months after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since the only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-396762 (Link).; Sender's Comments: This case concerns a 66-year-old female patient with no relevant medical history, who experienced the unexpected event of Deafness. The event occurred on approximately 9 months after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since the only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: body aches after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches after the booster dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 39F21A, RA182 and 20G20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), URSODEOXYCHOLIC ACID (URSODIOL) and MESALAZINE (MESALAMINE) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced MYALGIA (body aches after the booster dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches after the booster dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had an antibody test done before she received the booster dose and her antibody test came back low.   This case was linked to MOD-2021-396808 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: giving the shot in the bone, and not in the muscle (too high); This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (giving the shot in the bone, and not in the muscle (too high)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (giving the shot in the bone, and not in the muscle (too high)). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (giving the shot in the bone, and not in the muscle (too high)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication was provided.   Reporter did not allow further contact
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: temperature logger was out of range at 10C for 1 hour 20 mins and returned to normal and 6 vials of this moderna was administered to patient; moderna vial in refrigerator was discovered that refrigerator door was ajar and temperature logger was out of range at 10C for 1 hour 20 mins; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (temperature logger was out of range at 10C for 1 hour 20 mins and returned to normal and 6 vials of this moderna was administered to patient) and PRODUCT STORAGE ERROR (moderna vial in refrigerator was discovered that refrigerator door was ajar and temperature logger was out of range at 10C for 1 hour 20 mins) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021 at 11:32 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021 at 3:30 PM, the patient experienced PRODUCT STORAGE ERROR (moderna vial in refrigerator was discovered that refrigerator door was ajar and temperature logger was out of range at 10C for 1 hour 20 mins). On 14-Oct-2021 at 11:32 AM, the patient experienced PRODUCT ADMINISTRATION ERROR (temperature logger was out of range at 10C for 1 hour 20 mins and returned to normal and 6 vials of this moderna was administered to patient). On 06-Oct-2021 at 4:50 PM, PRODUCT STORAGE ERROR (moderna vial in refrigerator was discovered that refrigerator door was ajar and temperature logger was out of range at 10C for 1 hour 20 mins) had resolved. On 14-Oct-2021 at 11:32 AM, PRODUCT ADMINISTRATION ERROR (temperature logger was out of range at 10C for 1 hour 20 mins and returned to normal and 6 vials of this moderna was administered to patient) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported. The temperature logger was out of range at 10C for 1 hour 20 mins and Door was closed immediately and temperature returned to normal.  No side effects reported to patient.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The 6 vials of moderna were used to administer doses ot 9 patients between the dates 07 Oct 20121 to 22 Oct 2021; On date 06-Oct-2021 at 3. 30 pm Moderna vials were in refrigerator, and the refrigerator door was slightly open. Data logger showed that temperature was out of range at 10 degree Celsius for 1 hour and 20 minutes; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (On date 06-Oct-2021 at 3. 30 pm Moderna vials were in refrigerator, and the refrigerator door was slightly open. Data logger showed that temperature was out of range at 10 degree Celsius for 1 hour and 20 minutes) and EXPIRED PRODUCT ADMINISTERED (The 6 vials of moderna were used to administer doses ot 9 patients between the dates 07 Oct 20121 to 22 Oct 2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for an unknown indication.     No Medical History information was reported.    On 22-Oct-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (On date 06-Oct-2021 at 3. 30 pm Moderna vials were in refrigerator, and the refrigerator door was slightly open. Data logger showed that temperature was out of range at 10 degree Celsius for 1 hour and 20 minutes). On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The 6 vials of moderna were used to administer doses ot 9 patients between the dates 07 Oct 20121 to 22 Oct 2021). On 06-Oct-2021, PRODUCT STORAGE ERROR (On date 06-Oct-2021 at 3. 30 pm Moderna vials were in refrigerator, and the refrigerator door was slightly open. Data logger showed that temperature was out of range at 10 degree Celsius for 1 hour and 20 minutes) had resolved. On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The 6 vials of moderna were used to administer doses ot 9 patients between the dates 07 Oct 20121 to 22 Oct 2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter.  Treatment details was not reported by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Off label use
Clinical narrative: immunocompromised patient got booster dose instead of 3rd dose; immunocompromised patient got booster dose instead of 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient got booster dose instead of 3rd dose) and OFF LABEL USE (immunocompromised patient got booster dose instead of 3rd dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Autoimmune disorder NOS: high dose of prednisone (started taking a high dose of prednisone to treat an autoimmune condition and which caused sudden hearing loss.) on 27-Oct-2021. Past adverse reactions to the above products included Hearing loss with high dose of prednisone. Concurrent medical conditions included Autoimmune disorder NOS (patient was diagnosed with a syndrome when was in their 50s.).    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient got booster dose instead of 3rd dose) and OFF LABEL USE (immunocompromised patient got booster dose instead of 3rd dose). On 30-Oct-2021, ACCIDENTAL UNDERDOSE (immunocompromised patient got booster dose instead of 3rd dose) and OFF LABEL USE (immunocompromised patient got booster dose instead of 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drug reported.   No Treatment drug reported.   This case was linked to MOD-2021-396729 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine used; Incorrect product storage; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Incorrect product storage) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Incorrect product storage). On 15-Oct-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, PRODUCT STORAGE ERROR (Incorrect product storage) had resolved. On 15-Oct-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  Moderna vials were in refrigerator when was discovered the refrigerator door was slightly agar. The data  logger showed that temperature was out of range at 10 degree Celsius for 1 hour and 20 minutes. The door was immediately closed and temperature retuned to normal. Patient did not experience any side effects.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Menstruation irregular, Vaccination complication
Clinical narrative: Affecting her menstrual period , menstrual period came early; Weird side effects; Feeling more tired; This spontaneous case was reported by an other health care professional and describes the occurrence of MENSTRUATION IRREGULAR (Affecting her menstrual period , menstrual period came early), VACCINATION COMPLICATION (Weird side effects) and FATIGUE (Feeling more tired) 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 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MENSTRUATION IRREGULAR (Affecting her menstrual period , menstrual period came early), VACCINATION COMPLICATION (Weird side effects) and FATIGUE (Feeling more tired). At the time of the report, MENSTRUATION IRREGULAR (Affecting her menstrual period , menstrual period came early), VACCINATION COMPLICATION (Weird side effects) and FATIGUE (Feeling more tired) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitants were reported.  Patient felt it was affecting her menstrual period as the menstrual period came early. The period came one week later after the vaccination, but it was still early for her menstrual cycle.  Treatment medication was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired the day after receiving her second Moderna COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tired the day after receiving her second Moderna COVID-19 vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. RA182 and 20G20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), URSODEOXYCHOLIC ACID (URSODIOL) and (MESALAMINE) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (tired the day after receiving her second Moderna COVID-19 vaccine). At the time of the report, FATIGUE (tired the day after receiving her second Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included blood pressure medication. No treatment details were reported.   This case was linked to MOD-2021-396732 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy) had not resolved. Not Provided          No concomitant products were reported. No treatment drugs were reported  patient have a question regarding booster dose, patient felt it was dangerous thing to takewhich might leads to moebius syndrome.  Company comment: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected adverse event of special interest of Bells' Palsy. The event occurred approximately the same month after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected adverse event of special interest of Bells' Palsy. The event occurred approximately the same month after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Chronic hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Chronic hives) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 058E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Chronic hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC HIVES RELIEF) (oral) for Urticaria, at a dose of 10 mg and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Urticaria, at a dose of 25 mg. At the time of the report, URTICARIA (Chronic hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.      The dermatologist will do a biopsy in 2 weeks and prescribe Prednisone if she is still having the symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: giving the shot in the bone, and not in the muscle (too high); This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (giving the shot in the bone, and not in the muscle (too high)) 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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (giving the shot in the bone, and not in the muscle (too high)). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (giving the shot in the bone, and not in the muscle (too high)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: sore arm; headache; joints kind of hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and ARTHRALGIA (joints kind of hurting) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy. Concurrent medical conditions included Infection (it was something that the patient had for a while. The patient had to take 3 types of medications because of infection.) and Stomach inflammation (it was not confirmed if the patient had polyps or ulcers).    On 29-Mar-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 IN EXTREMITY (sore arm), HEADACHE (headache) and ARTHRALGIA (joints kind of hurting). The patient was treated with DOXYCYCLINE on 23-Nov-2021 for Adverse event, at a dose of 100 milligram twice a day; OMEPRAZOLE on 23-Nov-2021 for Adverse event, at a dose of 40 milligram twice a day and METRONIDAZOLE on 23-Nov-2021 for Adverse event, at a dose of 500 milligram three times a day. At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and ARTHRALGIA (joints kind of hurting) outcome was unknown.            The patient took unspecified concomitant medications for other health conditions. The patient had an appointment to get the booster shot, which was scheduled for 30-Nov-2021. The pills information (taken for infection) revealed that the patient could not take any vaccines while taking the medications.   This case was linked to MOD-2021-397027 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: Sore arm; Headache; Joints kind of hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and ARTHRALGIA (Joints kind of hurting) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and ARTHRALGIA (Joints kind of hurting). The patient was treated with DOXYCYCLINE on 23-Nov-2021 for Adverse event, at a dose of 100 milligram twice a day; OMEPRAZOLE on 23-Nov-2021 for Adverse event, at a dose of 40 milligram twice a day and METRONIDAZOLE on 23-Nov-2021 for Adverse event, at a dose of 500 milligram three times a day. At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and ARTHRALGIA (Joints kind of hurting) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient was taking unspecified concomitant medications for other health conditions.   This case was linked to MOD-2021-396953 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Headache, Lethargy, Nausea
Clinical narrative: Feeling Lethargic; Shortness of breath; No strength in leg; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Feeling Lethargic), DYSPNOEA (Shortness of breath), ASTHENIA (No strength in leg), HEADACHE (Headache) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced LETHARGY (Feeling Lethargic), DYSPNOEA (Shortness of breath), ASTHENIA (No strength in leg), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, LETHARGY (Feeling Lethargic), DYSPNOEA (Shortness of breath), ASTHENIA (No strength in leg), HEADACHE (Headache) and NAUSEA (Nausea) was resolving.            No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose) 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 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received expired dose) had resolved.            Concomitant medication information was not provided by the reporter.                             Treatment information was not provided by the reporter.