chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Hypokinesia, Neck pain
Clinical narrative: I felt like my neck had pain; Same night 11:30PM I could not move my hand; My left eye was swollen above the eye; Arm easily gets tired; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (I felt like my neck had pain), HYPOKINESIA (Same night 11:30PM I could not move my hand), EYE SWELLING (My left eye was swollen above the eye) and FATIGUE (Arm easily gets tired) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concomitant products included METFORMIN and GLIPIZIDE for Diabetes mellitus.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced NECK PAIN (I felt like my neck had pain), HYPOKINESIA (Same night 11:30PM I could not move my hand), EYE SWELLING (My left eye was swollen above the eye) and FATIGUE (Arm easily gets tired). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Pain, at an unspecified dose and frequency and BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN TOPICAL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (I felt like my neck had pain) had not resolved and HYPOKINESIA (Same night 11:30PM I could not move my hand), EYE SWELLING (My left eye was swollen above the eye) and FATIGUE (Arm easily gets tired) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Event outcome updated from unknown to not recovered for neck pain and unknown to recovered/resolved for the other events.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fatigue; Joint pain; Fever; Body aches; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever) and MYALGIA (Body aches) 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 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm soreness). On 28-May-2021, the patient experienced FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Body aches; Chills; Headache; Fever of 103.6; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 103.6) 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 MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 103.6). At the time of the report, MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 103.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.6 (High) Fever of 103.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Gastroenteritis viral
Clinical narrative: came down with the stomach bug/stomach virus; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL (came down with the stomach bug/stomach virus) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROENTERITIS VIRAL (came down with the stomach bug/stomach virus). At the time of the report, GASTROENTERITIS VIRAL (came down with the stomach bug/stomach virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment medication provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Having the listed general side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having the listed general side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Having the listed general side effects). At the time of the report, VACCINATION COMPLICATION (Having the listed general side effects) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness in the arm; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (soreness in the arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (soreness in the arm). On 22-Feb-2021, MYALGIA (soreness in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Sinusitis
Clinical narrative: Sinus infection symptoms; Swollen lymph nodes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection symptoms) and LYMPHADENOPATHY (Swollen lymph nodes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection symptoms) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, SINUSITIS (Sinus infection symptoms) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: horrible reaction to the second shot but not the first; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (horrible reaction to the second shot but not the first) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (horrible reaction to the second shot but not the first). At the time of the report, VACCINATION COMPLICATION (horrible reaction to the second shot but not the first) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: A Vaccine dose was administered to a patient while an excursion occurred; 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 STORAGE ERROR (A Vaccine dose was administered to a patient while an excursion occurred) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT STORAGE ERROR (A Vaccine dose was administered to a patient while an excursion occurred). On 28-May-2021, PRODUCT STORAGE ERROR (A Vaccine dose was administered to a patient while an excursion occurred) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Long haul side effect from the vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Long haul side effect from the vaccination) 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 19-May-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. On an unknown date, the patient experienced VACCINATION COMPLICATION (Long haul side effect from the vaccination). At the time of the report, VACCINATION COMPLICATION (Long haul side effect from the vaccination) outcome was unknown.            Concomitant medications were not reported  Treatment medication information was not reported  Action taken with mRNA-1273 in response to the event was not applicable
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: she was administered with the dose from a vial which was punctured and kept in the refrigerator for approximately 30 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (she was administered with the dose from a vial which was punctured and kept in the refrigerator for approximately 30 hours) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced PRODUCT STORAGE ERROR (she was administered with the dose from a vial which was punctured and kept in the refrigerator for approximately 30 hours). On 27-May-2021, PRODUCT STORAGE ERROR (she was administered with the dose from a vial which was punctured and kept in the refrigerator for approximately 30 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039821A) for COVID-19 immunization. The patient's past medical history included COVID-19 in April 2020. On Apr 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 28, 2021, patient experienced pyrexia (fever). The patient treated with ibuprofen, at an unspecified dose and frequency. At the time of the report, pyrexia (fever) outcome: unknown. mRNA-1273 (Moderna COVID-19 vaccine) dosing remained unchanged. Concomitant product use not provided. Patient took second dose May 26, 2021. This case linked to MOD-2021-187084 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: people saying there a side where there neck hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (people saying there a side where there neck hurts) 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 NECK PAIN (people saying there a side where there neck hurts). At the time of the report, NECK PAIN (people saying there a side where there neck hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.  After vaccination patient had neck hurts.
Sex: U
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: missing a period after the vaccine; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION IRREGULAR (missing a period after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 MENSTRUATION IRREGULAR (missing a period after the vaccine). At the time of the report, MENSTRUATION IRREGULAR (missing a period after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Husband is having the side effect of severe aches after his 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Husband is having the side effect of severe aches after his 2nd dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Husband is having the side effect of severe aches after his 2nd dose). At the time of the report, PAIN (Husband is having the side effect of severe aches after his 2nd dose) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Neuralgia
Clinical narrative: numbness in feet and legs; nerve problem; burning in legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in feet and legs), NEURALGIA (nerve problem) and BURNING SENSATION (burning in legs and feet) 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 24-May-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. On 24-May-2021, the patient experienced HYPOAESTHESIA (numbness in feet and legs), NEURALGIA (nerve problem) and BURNING SENSATION (burning in legs and feet). At the time of the report, HYPOAESTHESIA (numbness in feet and legs), NEURALGIA (nerve problem) and BURNING SENSATION (burning in legs and feet) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Weight
Clinical narrative: I continue to have nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (I continue to have nausea) 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 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced NAUSEA (I continue to have nausea). At the time of the report, NAUSEA (I continue to have nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: decreased (Low) lost 14 pounds.         No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Insomnia
Clinical narrative: not been sleeping pretty much. When ever she sleeps, she wakes up with in one hour; Second dose administered beyond 35 days interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INSOMNIA (not been sleeping pretty much. When ever she sleeps, she wakes up with in one hour) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered beyond 35 days interval) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered beyond 35 days interval). On 01-Apr-2021, the patient experienced INSOMNIA (not been sleeping pretty much. When ever she sleeps, she wakes up with in one hour). The patient was treated with MELATONIN at an unspecified dose and frequency. On 30-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered beyond 35 days interval) had resolved. At the time of the report, INSOMNIA (not been sleeping pretty much. When ever she sleeps, she wakes up with in one hour) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-187064 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine administered to patient under 18; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to patient under 18) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to patient under 18). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to patient under 18) 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.   No concomitant medication were reported. No treatment information was reported
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Left arm is in so much pain; I can barely move it; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm is in so much pain) and MOBILITY DECREASED (I can barely move it) 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 PAIN IN EXTREMITY (Left arm is in so much pain) and MOBILITY DECREASED (I can barely move it). At the time of the report, PAIN IN EXTREMITY (Left arm is in so much pain) and MOBILITY DECREASED (I can barely move it) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Husband received his second dose of Moderna  Covid 19 two and half moths later on 26May2021yo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Husband received his second dose of Moderna  Covid 19 two and half moths later on 26May2021yo) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (ASPRIN), PREDNISONE and METOPROLOL for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Husband received his second dose of Moderna  Covid 19 two and half moths later on 26May2021yo). On 26-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Husband received his second dose of Moderna  Covid 19 two and half moths later on 26May2021yo) had resolved.            This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no AEs reported.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: Painful soreness in neck; Painful soreness in shoulder opposite side of injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Painful soreness in neck) and ARTHRALGIA (Painful soreness in shoulder opposite side of injection site) 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 NECK PAIN (Painful soreness in neck) and ARTHRALGIA (Painful soreness in shoulder opposite side of injection site). At the time of the report, NECK PAIN (Painful soreness in neck) and ARTHRALGIA (Painful soreness in shoulder opposite side of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Body temperature, Hypoaesthesia, Nasal congestion, Pain in extremity
Clinical narrative: congestion feeling in the nasal passages but not actually congested; face numbness around nose and upper lip; around nose and upper lip which is kind of allergy but no sneezing or no coughing(; arm hurt little bit; Fever temperature 102 degrees; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion feeling in the nasal passages but not actually congested), HYPOAESTHESIA (face numbness around nose and upper lip), ALLERGY TO VACCINE (around nose and upper lip which is kind of allergy but no sneezing or no coughing(), PAIN IN EXTREMITY (arm hurt little bit) and PYREXIA (Fever temperature 102 degrees) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 039821A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced PAIN IN EXTREMITY (arm hurt little bit) and PYREXIA (Fever temperature 102 degrees). On 27-May-2021, the patient experienced NASAL CONGESTION (congestion feeling in the nasal passages but not actually congested), HYPOAESTHESIA (face numbness around nose and upper lip) and ALLERGY TO VACCINE (around nose and upper lip which is kind of allergy but no sneezing or no coughing(). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 27-May-2021, PAIN IN EXTREMITY (arm hurt little bit) outcome was unknown, PYREXIA (Fever temperature 102 degrees) had resolved. At the time of the report, NASAL CONGESTION (congestion feeling in the nasal passages but not actually congested), HYPOAESTHESIA (face numbness around nose and upper lip) and ALLERGY TO VACCINE (around nose and upper lip which is kind of allergy but no sneezing or no coughing() outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Body temperature: high degree Celsius (High) Fever temperature 102 degrees.         No concomitant medications were reported.   This case was linked to MOD-2021-187071 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: congestion feeling in the nasal passages but not actually congested; face numbness around nose and upper lip; around nose and upper lip which is kind of allergy but no sneezing or no coughing(; arm hurt little bit; Fever temperature 102 degrees; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion feeling in the nasal passages but not actually congested), HYPOAESTHESIA (face numbness around nose and upper lip), ALLERGY TO VACCINE (around nose and upper lip which is kind of allergy but no sneezing or no coughing(), PAIN IN EXTREMITY (arm hurt little bit) and PYREXIA (Fever temperature 102 degrees) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 039821A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced PAIN IN EXTREMITY (arm hurt little bit) and PYREXIA (Fever temperature 102 degrees). On 27-May-2021, the patient experienced NASAL CONGESTION (congestion feeling in the nasal passages but not actually congested), HYPOAESTHESIA (face numbness around nose and upper lip) and ALLERGY TO VACCINE (around nose and upper lip which is kind of allergy but no sneezing or no coughing(). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 27-May-2021, PAIN IN EXTREMITY (arm hurt little bit) outcome was unknown, PYREXIA (Fever temperature 102 degrees) had resolved. At the time of the report, NASAL CONGESTION (congestion feeling in the nasal passages but not actually congested), HYPOAESTHESIA (face numbness around nose and upper lip) and ALLERGY TO VACCINE (around nose and upper lip which is kind of allergy but no sneezing or no coughing() outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Body temperature: high degree Celsius (High) Fever temperature 102 degrees.         No concomitant medications were reported.   This case was linked to MOD-2021-187071 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, SARS-CoV-2 antibody test, Underdose
Clinical narrative: Does not know how much of the vaccine patient received/patient got partial dose in right arm; The dose leaked during administration/needle fell off; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Does not know how much of the vaccine patient received/patient got partial dose in right arm) and DEVICE CONNECTION ISSUE (The dose leaked during administration/needle fell off) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050621A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced UNDERDOSE (Does not know how much of the vaccine patient received/patient got partial dose in right arm) and DEVICE CONNECTION ISSUE (The dose leaked during administration/needle fell off). On 28-May-2021, UNDERDOSE (Does not know how much of the vaccine patient received/patient got partial dose in right arm) had resolved. At the time of the report, DEVICE CONNECTION ISSUE (The dose leaked during administration/needle fell off) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The patient got partial dose in right arm as the needle fell off and squinted on arm. As per advise from Moderna the patient was given vaccine in left arm.    Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up information was received : added email address of the reporter and updated the patient initials. On 07-Jul-2021: Patient's race and ethinic group information, allergic condition, lab data and  event  needle fell off were updated
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Immediately Felt Dizzy like she was being spun around; like she was being spun around; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Immediately Felt Dizzy like she was being spun around) and VERTIGO (like she was being spun around) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (Immediately Felt Dizzy like she was being spun around) and VERTIGO (like she was being spun around). The patient was treated with MORPHINE (intravenous) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Immediately Felt Dizzy like she was being spun around) and VERTIGO (like she was being spun around) 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 for by the reporter for the 1st vaccine dose.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-187063 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Red spot after Moderna shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spot after Moderna shot) 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 RASH MACULAR (Red spot after Moderna shot). At the time of the report, RASH MACULAR (Red spot after Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose one week after receiving 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose one week after receiving 1st 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose one week after receiving 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose one week after receiving 1st dose) had resolved.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Tinnitus
Clinical narrative: Ear ringing; Missed dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ear ringing) and PRODUCT DOSE OMISSION ISSUE (Missed dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ear ringing) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, TINNITUS (Ear ringing) had not resolved and PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses were given beyond 30 days shelf life; 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 EXPIRED PRODUCT ADMINISTERED (Doses were given beyond 30 days shelf life) 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) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given beyond 30 days shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given beyond 30 days shelf life) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received and contain Non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Muscle injury
Clinical narrative: Permanent muscle damage; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE INJURY (Permanent muscle damage) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 MUSCLE INJURY (Permanent muscle damage). At the time of the report, MUSCLE INJURY (Permanent muscle damage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: not feeling very well; Bad headaches; tired; fever with temperature up to 101 degrees; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling very well), HEADACHE (Bad headaches), FATIGUE (tired) and PYREXIA (fever with temperature up to 101 degrees) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 04-Dec-2020. Concomitant products included SIMVASTATIN, LISINOPRIL and METFORMIN for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MALAISE (not feeling very well), HEADACHE (Bad headaches), FATIGUE (tired) and PYREXIA (fever with temperature up to 101 degrees). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ASPRIN) at a dose of 1 dosage form. On 27-Mar-2021, MALAISE (not feeling very well), HEADACHE (Bad headaches), FATIGUE (tired) and PYREXIA (fever with temperature up to 101 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2020, SARS-CoV-2 test: unknown (Positive) Positive. On an unknown date, Body temperature: 101 (High) high.         As reported patient had tested positive for COVID in 4-Dec-2020, was fine after taking Z-pack and Anti histamines. The patient used Ice pack on  injection site.   This case was linked to MOD-2021-020212 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: not feeling very well; Bad headaches; tired; fever with temperature up to 101 degrees; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling very well), HEADACHE (Bad headaches), FATIGUE (tired) and PYREXIA (fever with temperature up to 101 degrees) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 04-Dec-2020. Concomitant products included SIMVASTATIN, LISINOPRIL and METFORMIN for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MALAISE (not feeling very well), HEADACHE (Bad headaches), FATIGUE (tired) and PYREXIA (fever with temperature up to 101 degrees). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ASPRIN) at a dose of 1 dosage form. On 27-Mar-2021, MALAISE (not feeling very well), HEADACHE (Bad headaches), FATIGUE (tired) and PYREXIA (fever with temperature up to 101 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2020, SARS-CoV-2 test: unknown (Positive) Positive. On an unknown date, Body temperature: 101 (High) high.         As reported patient had tested positive for COVID in 4-Dec-2020, was fine after taking Z-pack and Anti histamines. The patient used Ice pack on  injection site.   This case was linked to MOD-2021-020212 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Ear pain, Malaise, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Not feeling well; Bad cold; No sense of smell; Ear is hurting; lingering symptoms about month ago; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (Not feeling well), NASOPHARYNGITIS (Bad cold), ANOSMIA (No sense of smell), EAR PAIN (Ear is hurting) and VACCINATION COMPLICATION (lingering symptoms about month ago) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 MALAISE (Not feeling well), NASOPHARYNGITIS (Bad cold), ANOSMIA (No sense of smell), EAR PAIN (Ear is hurting) and VACCINATION COMPLICATION (lingering symptoms about month ago). At the time of the report, MALAISE (Not feeling well), NASOPHARYNGITIS (Bad cold), ANOSMIA (No sense of smell), EAR PAIN (Ear is hurting) and VACCINATION COMPLICATION (lingering symptoms about month ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Non-significant follow-up appended. On 29-Jul-2021: Significant Follow  up