chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Pain, Rash
Clinical narrative: Arm hurts; pain; Tired; she had a red rash that is lifted up a bit; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm hurts), PAIN (pain), FATIGUE (Tired) and RASH (she had a red rash that is lifted up a bit) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history  ).    On 30-Mar-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 LIMB DISCOMFORT (Arm hurts), PAIN (pain), FATIGUE (Tired) and RASH (she had a red rash that is lifted up a bit). At the time of the report, LIMB DISCOMFORT (Arm hurts), PAIN (pain), FATIGUE (Tired) and RASH (she had a red rash that is lifted up a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Pain, Pain in jaw, Pyrexia
Clinical narrative: low grade fever - 99.4 to 100.1; dry cough; nasal congestion; a little bit achy; achy mouth - jaw aching; sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm), PYREXIA (low grade fever - 99.4 to 100.1), COUGH (dry cough), NASAL CONGESTION (nasal congestion) and PAIN (a little bit achy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergic to cats, Hay fever (hay fever to certain plants.) and Mastectomy. Concurrent medical conditions included Drug allergy (codeine).    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 13-Feb-2021, the patient experienced PYREXIA (low grade fever - 99.4 to 100.1), COUGH (dry cough), NASAL CONGESTION (nasal congestion), PAIN (a little bit achy) and PAIN IN JAW (achy mouth - jaw aching). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm), PYREXIA (low grade fever - 99.4 to 100.1), COUGH (dry cough), NASAL CONGESTION (nasal congestion), PAIN (a little bit achy) and PAIN IN JAW (achy mouth - jaw aching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99.4 to 100.1 99.4 to 100.1. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: low grade fever - 99.4 to 100.1; dry cough; nasal congestion; a little bit achy; achy mouth - jaw aching; sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm), PYREXIA (low grade fever - 99.4 to 100.1), COUGH (dry cough), NASAL CONGESTION (nasal congestion) and PAIN (a little bit achy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergic to cats, Hay fever (hay fever to certain plants.) and Mastectomy. Concurrent medical conditions included Drug allergy (codeine).    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 13-Feb-2021, the patient experienced PYREXIA (low grade fever - 99.4 to 100.1), COUGH (dry cough), NASAL CONGESTION (nasal congestion), PAIN (a little bit achy) and PAIN IN JAW (achy mouth - jaw aching). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm), PYREXIA (low grade fever - 99.4 to 100.1), COUGH (dry cough), NASAL CONGESTION (nasal congestion), PAIN (a little bit achy) and PAIN IN JAW (achy mouth - jaw aching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99.4 to 100.1 99.4 to 100.1. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Vaccination site reaction
Clinical narrative: Diarrhea; Redness in the arm of the injection; Sensibility in the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ERYTHEMA (Redness in the arm of the injection) and VACCINATION SITE REACTION (Sensibility in the arm of injection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 01-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), ERYTHEMA (Redness in the arm of the injection) and VACCINATION SITE REACTION (Sensibility in the arm of injection). At the time of the report, DIARRHOEA (Diarrhea), ERYTHEMA (Redness in the arm of the injection) and VACCINATION SITE REACTION (Sensibility in the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Pain, Peripheral swelling
Clinical narrative: the pain in the arm increased; minimum stomach side effects; some chills; headache; she had pink skin and rash; it was swollen; tenderness at the injection site; it was a little painful; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (tenderness at the injection site), VACCINATION SITE PAIN (it was a little painful), PAIN (the pain in the arm increased), ABDOMINAL DISCOMFORT (minimum stomach side effects) and CHILLS (some chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE PAIN (it was a little painful). On 30-Mar-2021, the patient experienced PAIN (the pain in the arm increased), ABDOMINAL DISCOMFORT (minimum stomach side effects), CHILLS (some chills), HEADACHE (headache), PHOTOSENSITIVITY REACTION (she had pink skin and rash) and PERIPHERAL SWELLING (it was swollen). On 31-Mar-2021, ABDOMINAL DISCOMFORT (minimum stomach side effects), CHILLS (some chills) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (tenderness at the injection site), VACCINATION SITE PAIN (it was a little painful), PAIN (the pain in the arm increased), PHOTOSENSITIVITY REACTION (she had pink skin and rash) and PERIPHERAL SWELLING (it was swollen) 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 was provided.
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Vaccination site pain
Clinical narrative: the pain in the arm increased; minimum stomach side effects; some chills; headache; she had pink skin and rash; it was swollen; tenderness at the injection site; it was a little painful; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (tenderness at the injection site), VACCINATION SITE PAIN (it was a little painful), PAIN (the pain in the arm increased), ABDOMINAL DISCOMFORT (minimum stomach side effects) and CHILLS (some chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE PAIN (it was a little painful). On 30-Mar-2021, the patient experienced PAIN (the pain in the arm increased), ABDOMINAL DISCOMFORT (minimum stomach side effects), CHILLS (some chills), HEADACHE (headache), PHOTOSENSITIVITY REACTION (she had pink skin and rash) and PERIPHERAL SWELLING (it was swollen). On 31-Mar-2021, ABDOMINAL DISCOMFORT (minimum stomach side effects), CHILLS (some chills) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (tenderness at the injection site), VACCINATION SITE PAIN (it was a little painful), PAIN (the pain in the arm increased), PHOTOSENSITIVITY REACTION (she had pink skin and rash) and PERIPHERAL SWELLING (it was swollen) 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 was provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Urticaria, Vaccination site pain
Clinical narrative: Hives; Sore Arm; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives), VACCINATION SITE PAIN (Sore Arm), CHILLS (Chills) and HEADACHE (Headache) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm), CHILLS (Chills) and HEADACHE (Headache). On 02-Apr-2021, the patient experienced URTICARIA (Hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), VACCINATION SITE PAIN (Sore Arm), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: Elevated Prostate-Specific Antigen (PSA) levels; Soreness in the arm and a little bit of tiredness, nothing to complain about; Soreness in the arm and a little bit of tiredness, nothing to complain about; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm and a little bit of tiredness, nothing to complain about), PROSTATIC SPECIFIC ANTIGEN INCREASED (Elevated Prostate-Specific Antigen (PSA) levels) and FATIGUE (Soreness in the arm and a little bit of tiredness, nothing to complain about) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis and Multiple sclerosis. Concomitant products included OFATUMUMAB (KESIMPTA) for Multiple sclerosis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm and a little bit of tiredness, nothing to complain about) and FATIGUE (Soreness in the arm and a little bit of tiredness, nothing to complain about). On 31-Mar-2021, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (Elevated Prostate-Specific Antigen (PSA) levels). On 11-Feb-2021, PAIN IN EXTREMITY (Soreness in the arm and a little bit of tiredness, nothing to complain about) and FATIGUE (Soreness in the arm and a little bit of tiredness, nothing to complain about) had resolved. At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (Elevated Prostate-Specific Antigen (PSA) levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2020, Prostatic specific antigen: 4.790 ng/mL (Inconclusive) Ultra-sensitive PSA test results: 4.790 ng/mL. On 31-Mar-2021, Prostatic specific antigen: 7.040 ng/mL (High) elevated 7.040 ng/mL.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality sleep, Vaccination site erythema
Clinical narrative: Not sleeping well; Red arm; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Not sleeping well) and VACCINATION SITE ERYTHEMA (Red arm) 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) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red arm). On 24-Mar-2021, the patient experienced POOR QUALITY SLEEP (Not sleeping well). At the time of the report, POOR QUALITY SLEEP (Not sleeping well) and VACCINATION SITE ERYTHEMA (Red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-068261 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: New AE added; Sender's Comments:  MOD21-068261:Significant FU- Event added and contact information updated
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus
Clinical narrative: feeling itchy all over; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (feeling itchy all over) and NAUSEA (nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced NAUSEA (nausea). On 28-Mar-2021, the patient experienced PRURITUS (feeling itchy all over). On 30-Mar-2021, NAUSEA (nausea) had resolved. On 31-Mar-2021, PRURITUS (feeling itchy all over) had resolved.            Concomitant product use was not provided by the reporter.  It was reported that the patient's husband called the pharmacy and was prescribed treatment with ondansetron.  Reportedly, the patient consented to be contacted by phone, home or cell.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Muscle tightness, Pain, Pain in extremity
Clinical narrative: sick; hurting everywhere; tightness in left calf muscle; cut off circulation; ringing in my ears; soreness deep in calf; joint pain, hurt badly all over especially shoulder joints; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), PAIN (hurting everywhere), MUSCLE TIGHTNESS (tightness in left calf muscle), POOR PERIPHERAL CIRCULATION (cut off circulation) and TINNITUS (ringing in my ears) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma.   On 02-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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), PAIN (hurting everywhere), MUSCLE TIGHTNESS (tightness in left calf muscle), POOR PERIPHERAL CIRCULATION (cut off circulation), TINNITUS (ringing in my ears), PAIN IN EXTREMITY (soreness deep in calf) and ARTHRALGIA (joint pain, hurt badly all over especially shoulder joints). The patient was treated with TRAZODONE at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form. At the time of the report, ILLNESS (sick), PAIN (hurting everywhere), MUSCLE TIGHTNESS (tightness in left calf muscle), POOR PERIPHERAL CIRCULATION (cut off circulation), TINNITUS (ringing in my ears), PAIN IN EXTREMITY (soreness deep in calf) and ARTHRALGIA (joint pain, hurt badly all over especially shoulder joints) outcome was unknown.        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 medications included Eye drops For open ended glaucoma. Treatment medications included Trazodone, Aspirin.   This case was linked to MOD-2021-066572 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18-May-2021 added with additional events
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Poor peripheral circulation, Tinnitus
Clinical narrative: sick; hurting everywhere; tightness in left calf muscle; cut off circulation; ringing in my ears; soreness deep in calf; joint pain, hurt badly all over especially shoulder joints; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), PAIN (hurting everywhere), MUSCLE TIGHTNESS (tightness in left calf muscle), POOR PERIPHERAL CIRCULATION (cut off circulation) and TINNITUS (ringing in my ears) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma.   On 02-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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), PAIN (hurting everywhere), MUSCLE TIGHTNESS (tightness in left calf muscle), POOR PERIPHERAL CIRCULATION (cut off circulation), TINNITUS (ringing in my ears), PAIN IN EXTREMITY (soreness deep in calf) and ARTHRALGIA (joint pain, hurt badly all over especially shoulder joints). The patient was treated with TRAZODONE at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form. At the time of the report, ILLNESS (sick), PAIN (hurting everywhere), MUSCLE TIGHTNESS (tightness in left calf muscle), POOR PERIPHERAL CIRCULATION (cut off circulation), TINNITUS (ringing in my ears), PAIN IN EXTREMITY (soreness deep in calf) and ARTHRALGIA (joint pain, hurt badly all over especially shoulder joints) outcome was unknown.        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 medications included Eye drops For open ended glaucoma. Treatment medications included Trazodone, Aspirin.   This case was linked to MOD-2021-066572 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18-May-2021 added with additional events
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: achy arm from first dose; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy arm from first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy arm from first dose). At the time of the report, PAIN (achy arm from first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The healthcare facility had an power outage on 01 April 2021. This dropped the temperature of the vials stored in freezer and refrigerator to -  Frozen vaccine 47 minutes -13.79 degree celsius Refrigerator 59 minutes 12 degree Celsius  Treatment information was not provided.  Concomitant medications were not reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature increased, Headache, Heart rate, Hypertension
Clinical narrative: generalized pain to bilateral shoulders and legs; His B/P 160/110; nausea; headache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (generalized pain to bilateral shoulders and legs), HYPERTENSION (His B/P 160/110), NAUSEA (nausea) and HEADACHE (headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 2:08 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021 at 2:12 PM, the patient experienced PAIN (generalized pain to bilateral shoulders and legs), HYPERTENSION (His B/P 160/110), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 31-Mar-2021 for Nausea, Headache, General body pain and Hypertension, at a dose of 1 dosage form. On 31-Mar-2021 at 3:00 PM, PAIN (generalized pain to bilateral shoulders and legs), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown. At the time of the report, HYPERTENSION (His B/P 160/110) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood pressure measurement: 160/110 (High) 160/110 at 14:12 and 150/100 150/100 at 15:00. On 31-Mar-2021, Body temperature increased: 98.1 (normal) 98.1. On 31-Mar-2021, Heart rate: 75 (normal) 75. On 31-Mar-2021, Oxygen saturation: 96% (normal) 96%.     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.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up  received on 16-JUN-2021 contains significant information includes, Patient demographics, event outcome, vaccination Facility information.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oxygen saturation, Pain
Clinical narrative: generalized pain to bilateral shoulders and legs; His B/P 160/110; nausea; headache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (generalized pain to bilateral shoulders and legs), HYPERTENSION (His B/P 160/110), NAUSEA (nausea) and HEADACHE (headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 2:08 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021 at 2:12 PM, the patient experienced PAIN (generalized pain to bilateral shoulders and legs), HYPERTENSION (His B/P 160/110), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 31-Mar-2021 for Nausea, Headache, General body pain and Hypertension, at a dose of 1 dosage form. On 31-Mar-2021 at 3:00 PM, PAIN (generalized pain to bilateral shoulders and legs), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown. At the time of the report, HYPERTENSION (His B/P 160/110) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood pressure measurement: 160/110 (High) 160/110 at 14:12 and 150/100 150/100 at 15:00. On 31-Mar-2021, Body temperature increased: 98.1 (normal) 98.1. On 31-Mar-2021, Heart rate: 75 (normal) 75. On 31-Mar-2021, Oxygen saturation: 96% (normal) 96%.     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.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up  received on 16-JUN-2021 contains significant information includes, Patient demographics, event outcome, vaccination Facility information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Minor side effect for first dose of moderna; Warm at injection site; Itching at injection site; 2 inch diameter red (at injection site); Little bit rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Minor side effect for first dose of moderna), VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (2 inch diameter red (at injection site)) and VACCINATION SITE RASH (Little bit rash at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 19-Mar-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ADVERSE REACTION (Minor side effect for first dose of moderna), VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (2 inch diameter red (at injection site)). 27-Mar-2021, the patient experienced VACCINATION SITE RASH (Little bit rash at injection site). On 01-Apr-2021, ADVERSE REACTION (Minor side effect for first dose of moderna), VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (2 inch diameter red (at injection site)) and VACCINATION SITE RASH (Little bit rash at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Patient did not take any medication.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional information received and Reporter information updated,Patient demographics were updated,Medical History updated
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue
Clinical narrative: weakness; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (chills) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 19-Dec-2020, Fatigue on 19-Dec-2020 and Chills on 19-Dec-2020.   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) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (weakness), CHILLS (chills) and FATIGUE (fatigue). On 18-Mar-2021, ASTHENIA (weakness), CHILLS (chills) and FATIGUE (fatigue) had resolved.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: 0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL; 0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL) and DEVICE CONNECTION ISSUE (0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL) and DEVICE CONNECTION ISSUE (0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL). At the time of the report, UNDERDOSE (0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL) and DEVICE CONNECTION ISSUE (0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL) 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.; Sender's Comments: This report refers to a case of Underdose and device connection issue for mRNA-1273, lot # unknown  with no associated AEs.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff muscle/3 x 4 inches south of vaccine injection) and VACCINATION SITE PRURITUS (On day 3 it started itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff muscle/3 x 4 inches south of vaccine injection) and VACCINATION SITE PRURITUS (On day 3 it started itching). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff muscle/3 x 4 inches south of vaccine injection) and VACCINATION SITE PRURITUS (On day 3 it started itching) outcome was unknown. Not Provided          No relevant concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to MOD-2021-067352 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24 Jun 2021 contains no new information On 15-Jul-2021: Follow up received on 15 Jul 2021 contains no new information
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain in extremity, Personality disorder, Pyrexia
Clinical narrative: Fever of 101.5 degrees Fahrenheit; Felt really sick; Arm was painful; Icky; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was painful), PERSONALITY DISORDER (Icky), ILLNESS (Felt really sick) and PYREXIA (Fever of 101.5 degrees Fahrenheit) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Non-Hodgkin's lymphoma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OLMESARTAN MEDOXOMIL (BENICAR), HYDROCHLOROTHIAZIDE, HYDROXYUREA, METOPROLOL, TADALAFIL, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was painful) and PERSONALITY DISORDER (Icky). On 26-Mar-2021, the patient experienced ILLNESS (Felt really sick). On 31-Mar-2021, the patient experienced PYREXIA (Fever of 101.5 degrees Fahrenheit). At the time of the report, PAIN IN EXTREMITY (Arm was painful), PERSONALITY DISORDER (Icky), ILLNESS (Felt really sick) and PYREXIA (Fever of 101.5 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: Bruising at the injection site; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising at the injection site) and VACCINATION SITE PAIN (Pain at the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Bruising at the injection site) and VACCINATION SITE PAIN (Pain at the injection site). On 16-Mar-2021, VACCINATION SITE BRUISING (Bruising at the injection site) and VACCINATION SITE PAIN (Pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee pain.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Knee pain). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 52 days post first shot and has not received the second shot yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (52 days post first shot and has not received the second shot yet) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (52 days post first shot and has not received the second shot yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (52 days post first shot and has not received the second shot yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant meds reported.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: pain at the site of injection on her left arm; swelling at the site of injection on her left arm; redness at the site of injection on her left arm; warmth at the site of injection on her left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (pain at the site of injection on her left arm), VACCINATION SITE SWELLING (swelling at the site of injection on her left arm), VACCINATION SITE ERYTHEMA (redness at the site of injection on her left arm) and VACCINATION SITE WARMTH (warmth at the site of injection on her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PHENOBARBITAL and METHIMAZOLE for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at the site of injection on her left arm), VACCINATION SITE SWELLING (swelling at the site of injection on her left arm), VACCINATION SITE ERYTHEMA (redness at the site of injection on her left arm) and VACCINATION SITE WARMTH (warmth at the site of injection on her left arm). At the time of the report, VACCINATION SITE PAIN (pain at the site of injection on her left arm), VACCINATION SITE SWELLING (swelling at the site of injection on her left arm), VACCINATION SITE ERYTHEMA (redness at the site of injection on her left arm) and VACCINATION SITE WARMTH (warmth at the site of injection on her left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Redness on left arm; Itchiness on left arm; Swelling on left arm; Little uncomfortable; Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Little uncomfortable), PAIN IN EXTREMITY (Little sore arm), ERYTHEMA (Redness on left arm), PRURITUS (Itchiness on left arm) and PERIPHERAL SWELLING (Swelling on left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced FEELING ABNORMAL (Little uncomfortable) and PAIN IN EXTREMITY (Little sore arm). On 04-Apr-2021, the patient experienced ERYTHEMA (Redness on left arm), PRURITUS (Itchiness on left arm) and PERIPHERAL SWELLING (Swelling on left arm). On 29-Mar-2021, FEELING ABNORMAL (Little uncomfortable) and PAIN IN EXTREMITY (Little sore arm) had resolved. At the time of the report, ERYTHEMA (Redness on left arm), PRURITUS (Itchiness on left arm) and PERIPHERAL SWELLING (Swelling on left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hangover, Somnolence
Clinical narrative: hungover; sleepy; Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HANGOVER (hungover), SOMNOLENCE (sleepy) and FATIGUE (Tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HANGOVER (hungover), SOMNOLENCE (sleepy) and FATIGUE (Tired). At the time of the report, HANGOVER (hungover), SOMNOLENCE (sleepy) and FATIGUE (Tired) had resolved.            Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided No treatment product information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Wheezing
Clinical narrative: wheezing; dizzy; bad shortness of breath; feeling weak; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (wheezing), DIZZINESS (dizzy), DYSPNOEA (bad shortness of breath) and ASTHENIA (feeling weak) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced WHEEZING (wheezing), DIZZINESS (dizzy), DYSPNOEA (bad shortness of breath) and ASTHENIA (feeling weak). At the time of the report, WHEEZING (wheezing), DIZZINESS (dizzy), DYSPNOEA (bad shortness of breath) and ASTHENIA (feeling weak) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: Rolling vials between their hands and/or tucking vial into their underarms to thaw the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Rolling vials between their hands and/or tucking vial into their underarms to thaw the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Rolling vials between their hands and/or tucking vial into their underarms to thaw the vaccine). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Rolling vials between their hands and/or tucking vial into their underarms to thaw 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm hurt; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and FATIGUE (tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Perinatal stroke (Patient had a massive stroke on birth and lost a part of the brain.). Concurrent medical conditions included Penicillin allergy, Palsy and Disability (Handicapped).    On 01-Apr-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 (arm hurt) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (arm hurt) had resolved and FATIGUE (tired) outcome was unknown.            Concomitant medications was not provided. Treatment details were not provided.