chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Scar, Ultrasound scan abnormal
Clinical narrative: patient could not raise her left arm for 3 days/next day she could hardly use it; could not raise her left arm for 3 days because it was swollen; she had a sore arm for a week; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it), PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) and PAIN IN EXTREMITY (she had a sore arm for a week) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy, Blood pressure and Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE for Blood pressure, VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it), PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) and PAIN IN EXTREMITY (she had a sore arm for a week). On 31-Jan-2021, MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it) and PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) had resolved. On 02-Feb-2021, PAIN IN EXTREMITY (she had a sore arm for a week) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. On 29-Jan-2021, patient could hardly use her left arm and it resolved on the same day. Patient put ice on the arm. No treatment drug was reported.   This case was linked to MOD-2022-618345, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: patient could not raise her left arm for 3 days/next day she could hardly use it; could not raise her left arm for 3 days because it was swollen; she had a sore arm for a week; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it), PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) and PAIN IN EXTREMITY (she had a sore arm for a week) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy, Blood pressure and Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE for Blood pressure, VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it), PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) and PAIN IN EXTREMITY (she had a sore arm for a week). On 31-Jan-2021, MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it) and PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) had resolved. On 02-Feb-2021, PAIN IN EXTREMITY (she had a sore arm for a week) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. On 29-Jan-2021, patient could hardly use her left arm and it resolved on the same day. Patient put ice on the arm. No treatment drug was reported.   This case was linked to MOD-2022-618345, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Impaired driving ability, Mammogram, Nodule, Oedema peripheral
Clinical narrative: patient could not raise her left arm for 3 days/next day she could hardly use it; could not raise her left arm for 3 days because it was swollen; she had a sore arm for a week; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it), PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) and PAIN IN EXTREMITY (she had a sore arm for a week) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy, Blood pressure and Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE for Blood pressure, VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it), PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) and PAIN IN EXTREMITY (she had a sore arm for a week). On 31-Jan-2021, MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it) and PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) had resolved. On 02-Feb-2021, PAIN IN EXTREMITY (she had a sore arm for a week) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. On 29-Jan-2021, patient could hardly use her left arm and it resolved on the same day. Patient put ice on the arm. No treatment drug was reported.   This case was linked to MOD-2022-618345, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Ultrasound scan, Weight
Clinical narrative: patient could not raise her left arm for 3 days/next day she could hardly use it; could not raise her left arm for 3 days because it was swollen; she had a sore arm for a week; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it), PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) and PAIN IN EXTREMITY (she had a sore arm for a week) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy, Blood pressure and Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE for Blood pressure, VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it), PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) and PAIN IN EXTREMITY (she had a sore arm for a week). On 31-Jan-2021, MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it) and PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) had resolved. On 02-Feb-2021, PAIN IN EXTREMITY (she had a sore arm for a week) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. On 29-Jan-2021, patient could hardly use her left arm and it resolved on the same day. Patient put ice on the arm. No treatment drug was reported.   This case was linked to MOD-2022-618345, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Limb discomfort, Oedema peripheral, Sluggishness
Clinical narrative: patient could not raise her left arm for 3 days/next day she could hardly use it; could not raise her left arm for 3 days because it was swollen; she had a sore arm for a week; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it), PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) and PAIN IN EXTREMITY (she had a sore arm for a week) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy, Blood pressure and Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE for Blood pressure, VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it), PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) and PAIN IN EXTREMITY (she had a sore arm for a week). On 31-Jan-2021, MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it) and PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) had resolved. On 02-Feb-2021, PAIN IN EXTREMITY (she had a sore arm for a week) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. On 29-Jan-2021, patient could hardly use her left arm and it resolved on the same day. Patient put ice on the arm. No treatment drug was reported.   This case was linked to MOD-2022-618345, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Headache, Lymphadenopathy, Mammogram, Pain in extremity
Clinical narrative: patient could not raise her left arm for 3 days/next day she could hardly use it; could not raise her left arm for 3 days because it was swollen; she had a sore arm for a week; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it), PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) and PAIN IN EXTREMITY (she had a sore arm for a week) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy, Blood pressure and Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE for Blood pressure, VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it), PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) and PAIN IN EXTREMITY (she had a sore arm for a week). On 31-Jan-2021, MOBILITY DECREASED (patient could not raise her left arm for 3 days/next day she could hardly use it) and PERIPHERAL SWELLING (could not raise her left arm for 3 days because it was swollen) had resolved. On 02-Feb-2021, PAIN IN EXTREMITY (she had a sore arm for a week) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. On 29-Jan-2021, patient could hardly use her left arm and it resolved on the same day. Patient put ice on the arm. No treatment drug was reported.   This case was linked to MOD-2022-618345, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Axillary pain, Biopsy breast abnormal, Biopsy lymph gland, Blood test, Headache
Clinical narrative: There was fluid into her left arm; she felt sluggish but it was not too bad; Still she felt a node in the arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Still she felt a node in the arm), OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21B, 023M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy (Iodine allergy), Blood pressure abnormal and Acid reflux (oesophageal). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE for Blood pressure abnormal, VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced LIMB DISCOMFORT (Still she felt a node in the arm) and SLUGGISHNESS (she felt sluggish but it was not too bad). In March 2022, the patient experienced OEDEMA PERIPHERAL (There was fluid into her left arm). At the time of the report, LIMB DISCOMFORT (Still she felt a node in the arm) had not resolved and OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) outcome was unknown.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient was not diagnosed/tested positive for COVID 19.  After 1st booster shot, patient's arm did not hurt, but patient felt sluggish, it was not too bad. Patient still felt a node in the arm.  In Mar-2022, patient went to ER twice because there was fluid into her left arm  and doctors drained the fluid.  The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-618210, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site swelling, Lymphadenectomy, Lymphadenopathy, Mammogram
Clinical narrative: There was fluid into her left arm; she felt sluggish but it was not too bad; Still she felt a node in the arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Still she felt a node in the arm), OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21B, 023M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy (Iodine allergy), Blood pressure abnormal and Acid reflux (oesophageal). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE for Blood pressure abnormal, VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced LIMB DISCOMFORT (Still she felt a node in the arm) and SLUGGISHNESS (she felt sluggish but it was not too bad). In March 2022, the patient experienced OEDEMA PERIPHERAL (There was fluid into her left arm). At the time of the report, LIMB DISCOMFORT (Still she felt a node in the arm) had not resolved and OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) outcome was unknown.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient was not diagnosed/tested positive for COVID 19.  After 1st booster shot, patient's arm did not hurt, but patient felt sluggish, it was not too bad. Patient still felt a node in the arm.  In Mar-2022, patient went to ER twice because there was fluid into her left arm  and doctors drained the fluid.  The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-618210, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Scar, Ultrasound scan abnormal
Clinical narrative: There was fluid into her left arm; she felt sluggish but it was not too bad; Still she felt a node in the arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Still she felt a node in the arm), OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21B, 023M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy (Iodine allergy), Blood pressure abnormal and Acid reflux (oesophageal). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE for Blood pressure abnormal, VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced LIMB DISCOMFORT (Still she felt a node in the arm) and SLUGGISHNESS (she felt sluggish but it was not too bad). In March 2022, the patient experienced OEDEMA PERIPHERAL (There was fluid into her left arm). At the time of the report, LIMB DISCOMFORT (Still she felt a node in the arm) had not resolved and OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) outcome was unknown.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient was not diagnosed/tested positive for COVID 19.  After 1st booster shot, patient's arm did not hurt, but patient felt sluggish, it was not too bad. Patient still felt a node in the arm.  In Mar-2022, patient went to ER twice because there was fluid into her left arm  and doctors drained the fluid.  The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-618210, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: There was fluid into her left arm; she felt sluggish but it was not too bad; Still she felt a node in the arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Still she felt a node in the arm), OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21B, 023M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy (Iodine allergy), Blood pressure abnormal and Acid reflux (oesophageal). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE for Blood pressure abnormal, VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced LIMB DISCOMFORT (Still she felt a node in the arm) and SLUGGISHNESS (she felt sluggish but it was not too bad). In March 2022, the patient experienced OEDEMA PERIPHERAL (There was fluid into her left arm). At the time of the report, LIMB DISCOMFORT (Still she felt a node in the arm) had not resolved and OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) outcome was unknown.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient was not diagnosed/tested positive for COVID 19.  After 1st booster shot, patient's arm did not hurt, but patient felt sluggish, it was not too bad. Patient still felt a node in the arm.  In Mar-2022, patient went to ER twice because there was fluid into her left arm  and doctors drained the fluid.  The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-618210, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Impaired driving ability, Mammogram, Nodule, Oedema peripheral
Clinical narrative: There was fluid into her left arm; she felt sluggish but it was not too bad; Still she felt a node in the arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Still she felt a node in the arm), OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21B, 023M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy (Iodine allergy), Blood pressure abnormal and Acid reflux (oesophageal). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE for Blood pressure abnormal, VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced LIMB DISCOMFORT (Still she felt a node in the arm) and SLUGGISHNESS (she felt sluggish but it was not too bad). In March 2022, the patient experienced OEDEMA PERIPHERAL (There was fluid into her left arm). At the time of the report, LIMB DISCOMFORT (Still she felt a node in the arm) had not resolved and OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) outcome was unknown.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient was not diagnosed/tested positive for COVID 19.  After 1st booster shot, patient's arm did not hurt, but patient felt sluggish, it was not too bad. Patient still felt a node in the arm.  In Mar-2022, patient went to ER twice because there was fluid into her left arm  and doctors drained the fluid.  The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-618210, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Ultrasound scan, Weight
Clinical narrative: There was fluid into her left arm; she felt sluggish but it was not too bad; Still she felt a node in the arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Still she felt a node in the arm), OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21B, 023M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy (Iodine allergy), Blood pressure abnormal and Acid reflux (oesophageal). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE for Blood pressure abnormal, VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced LIMB DISCOMFORT (Still she felt a node in the arm) and SLUGGISHNESS (she felt sluggish but it was not too bad). In March 2022, the patient experienced OEDEMA PERIPHERAL (There was fluid into her left arm). At the time of the report, LIMB DISCOMFORT (Still she felt a node in the arm) had not resolved and OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) outcome was unknown.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient was not diagnosed/tested positive for COVID 19.  After 1st booster shot, patient's arm did not hurt, but patient felt sluggish, it was not too bad. Patient still felt a node in the arm.  In Mar-2022, patient went to ER twice because there was fluid into her left arm  and doctors drained the fluid.  The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-618210, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Limb discomfort, Oedema peripheral, Sluggishness
Clinical narrative: There was fluid into her left arm; she felt sluggish but it was not too bad; Still she felt a node in the arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Still she felt a node in the arm), OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21B, 023M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy (Iodine allergy), Blood pressure abnormal and Acid reflux (oesophageal). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE for Blood pressure abnormal, VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced LIMB DISCOMFORT (Still she felt a node in the arm) and SLUGGISHNESS (she felt sluggish but it was not too bad). In March 2022, the patient experienced OEDEMA PERIPHERAL (There was fluid into her left arm). At the time of the report, LIMB DISCOMFORT (Still she felt a node in the arm) had not resolved and OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) outcome was unknown.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient was not diagnosed/tested positive for COVID 19.  After 1st booster shot, patient's arm did not hurt, but patient felt sluggish, it was not too bad. Patient still felt a node in the arm.  In Mar-2022, patient went to ER twice because there was fluid into her left arm  and doctors drained the fluid.  The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-618210, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Headache, Lymphadenopathy, Mammogram, Pain in extremity
Clinical narrative: There was fluid into her left arm; she felt sluggish but it was not too bad; Still she felt a node in the arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Still she felt a node in the arm), OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21B, 023M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (27 years cancer free) in 1991. Concurrent medical conditions included Iodine allergy (Iodine allergy), Blood pressure abnormal and Acid reflux (oesophageal). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE for Blood pressure abnormal, VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced LIMB DISCOMFORT (Still she felt a node in the arm) and SLUGGISHNESS (she felt sluggish but it was not too bad). In March 2022, the patient experienced OEDEMA PERIPHERAL (There was fluid into her left arm). At the time of the report, LIMB DISCOMFORT (Still she felt a node in the arm) had not resolved and OEDEMA PERIPHERAL (There was fluid into her left arm) and SLUGGISHNESS (she felt sluggish but it was not too bad) outcome was unknown.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient was not diagnosed/tested positive for COVID 19.  After 1st booster shot, patient's arm did not hurt, but patient felt sluggish, it was not too bad. Patient still felt a node in the arm.  In Mar-2022, patient went to ER twice because there was fluid into her left arm  and doctors drained the fluid.  The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-618210, MOD-2022-618346, MOD-2022-618347 (Patient Link).
Age: 53.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: No adverse event; Nurse called stating an expired Merck Sterile Diluent was reconstituted with MMR-II and administered to a patient on 6/8/2022. No side effects reported. Confirmed with caller that expired diluent has had no temperature excursions. AE filed. No PQC; Inappropriate preparation of medication; This spontaneous report was received from a registered nurse concerning a 53-year-old patient of unknown gender. The patient's concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On 08-JUN-2022, an expired sterile diluent (Merck Sterile Diluent) (lot # S024549, expiration date 29-MAY-2022; strength, dose, route of administration were not reported) was reconstituted with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (MMR-II) (strength, dose, route of administration, lot #, and expiration date were not reported), and was administered to the patient for prophylaxis (expired product administered, product preparation issue). The expired diluent had no temperature excursions. No side effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000565: US-009507513-2207USA002263: US-009507513-2207USA002371: US-009507513-2207USA002618:
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Product preparation error
Clinical narrative: Error: Incorrect Reconstitution-
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Incorrect Reconstitution-
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test normal, Chemotherapy, Full blood count normal, Infection
Clinical narrative: left arm from shoulder to elbow is severely swollen & painful/Arm & fingers are painful; left arm from shoulder to elbow is severely swollen & painful; Unable to move fingers on left hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Jul2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple myeloma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INJECTED LIMB MOBILITY DECREASED (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "Unable to move fingers on left hand"; ARTHRALGIA (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "left arm from shoulder to elbow is severely swollen & painful"; PAIN IN EXTREMITY (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "left arm from shoulder to elbow is severely swollen & painful/Arm & fingers are painful". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, injected limb mobility decreased.  Additional information: It was unknown if the patient had any other medication within the two weeks of vaccination. The patient had no known allergies. It was reported that 4 weeks post vaccine injection, left arm from shoulder to elbow was severely swollen and painful. The patient has lost movement in all fingers. Arm and fingers are painful. Unable to move fingers on left hand. Have had doctors look at it but nobody knows what it was. The patient wanted help.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nerve injury
Clinical narrative: left arm from shoulder to elbow is severely swollen & painful/Arm & fingers are painful; left arm from shoulder to elbow is severely swollen & painful; Unable to move fingers on left hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Jul2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple myeloma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INJECTED LIMB MOBILITY DECREASED (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "Unable to move fingers on left hand"; ARTHRALGIA (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "left arm from shoulder to elbow is severely swollen & painful"; PAIN IN EXTREMITY (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "left arm from shoulder to elbow is severely swollen & painful/Arm & fingers are painful". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, injected limb mobility decreased.  Additional information: It was unknown if the patient had any other medication within the two weeks of vaccination. The patient had no known allergies. It was reported that 4 weeks post vaccine injection, left arm from shoulder to elbow was severely swollen and painful. The patient has lost movement in all fingers. Arm and fingers are painful. Unable to move fingers on left hand. Have had doctors look at it but nobody knows what it was. The patient wanted help.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: left arm from shoulder to elbow is severely swollen & painful/Arm & fingers are painful; left arm from shoulder to elbow is severely swollen & painful; Unable to move fingers on left hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Jul2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple myeloma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INJECTED LIMB MOBILITY DECREASED (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "Unable to move fingers on left hand"; ARTHRALGIA (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "left arm from shoulder to elbow is severely swollen & painful"; PAIN IN EXTREMITY (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "left arm from shoulder to elbow is severely swollen & painful/Arm & fingers are painful". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, injected limb mobility decreased.  Additional information: It was unknown if the patient had any other medication within the two weeks of vaccination. The patient had no known allergies. It was reported that 4 weeks post vaccine injection, left arm from shoulder to elbow was severely swollen and painful. The patient has lost movement in all fingers. Arm and fingers are painful. Unable to move fingers on left hand. Have had doctors look at it but nobody knows what it was. The patient wanted help.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: left arm from shoulder to elbow is severely swollen & painful/Arm & fingers are painful; left arm from shoulder to elbow is severely swollen & painful; Unable to move fingers on left hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Jul2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple myeloma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INJECTED LIMB MOBILITY DECREASED (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "Unable to move fingers on left hand"; ARTHRALGIA (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "left arm from shoulder to elbow is severely swollen & painful"; PAIN IN EXTREMITY (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "left arm from shoulder to elbow is severely swollen & painful/Arm & fingers are painful". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, injected limb mobility decreased.  Additional information: It was unknown if the patient had any other medication within the two weeks of vaccination. The patient had no known allergies. It was reported that 4 weeks post vaccine injection, left arm from shoulder to elbow was severely swollen and painful. The patient has lost movement in all fingers. Arm and fingers are painful. Unable to move fingers on left hand. Have had doctors look at it but nobody knows what it was. The patient wanted help.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: left arm from shoulder to elbow is severely swollen & painful/Arm & fingers are painful; left arm from shoulder to elbow is severely swollen & painful; Unable to move fingers on left hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Jul2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple myeloma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INJECTED LIMB MOBILITY DECREASED (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "Unable to move fingers on left hand"; ARTHRALGIA (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "left arm from shoulder to elbow is severely swollen & painful"; PAIN IN EXTREMITY (non-serious) with onset 07Jul2022 at 10:00, outcome "not recovered", described as "left arm from shoulder to elbow is severely swollen & painful/Arm & fingers are painful". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, injected limb mobility decreased.  Additional information: It was unknown if the patient had any other medication within the two weeks of vaccination. The patient had no known allergies. It was reported that 4 weeks post vaccine injection, left arm from shoulder to elbow was severely swollen and painful. The patient has lost movement in all fingers. Arm and fingers are painful. Unable to move fingers on left hand. Have had doctors look at it but nobody knows what it was. The patient wanted help.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.