chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lhermitte's sign, Magnetic resonance imaging, Magnetic resonance imaging head, Magnetic resonance imaging neck, Nervousness
Clinical narrative: Lhermitte's Reaction when bending neck; Nervousness feeling entire body like a caffeine feeling; pins and needles; This spontaneous case was reported by a consumer and describes the occurrence of LHERMITTE'S SIGN (Lhermitte's Reaction when bending neck), NERVOUSNESS (Nervousness feeling entire body like a caffeine feeling) and PARAESTHESIA (pins and needles) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Q11Q21A and Q35L21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Anxiety. Concomitant products included HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) for Anxiety, VITAMIN B COMPLEX for an unknown indication.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced PARAESTHESIA (pins and needles). On 18-Jul-2021, the patient experienced LHERMITTE'S SIGN (Lhermitte's Reaction when bending neck) and NERVOUSNESS (Nervousness feeling entire body like a caffeine feeling). At the time of the report, LHERMITTE'S SIGN (Lhermitte's Reaction when bending neck) and NERVOUSNESS (Nervousness feeling entire body like a caffeine feeling) had not resolved and PARAESTHESIA (pins and needles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2021, SARS-CoV-2 test: positive (Positive) Infinity biologix TAQPATH SARS-CoV-2 Assay RT-PCR based. On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, Magnetic resonance imaging head: normal (normal) normal. On an unknown date, Magnetic resonance imaging neck: normal (normal) normal.         Patient took MRI thorax which showed spinal fluid was normal. Patient stated that knees, limbs felt weak and during shower while bending the neck resulted in vibration that passes down to hands. Treatment medication was not reported.   This case was linked to MOD-2021-313186 (E2B Linked Report). This case was linked to MOD-2021-313186 (Patient Link).; Sender's Comments:  MOD-2021-313186:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: Lhermitte's Reaction when bending neck; Nervousness feeling entire body like a caffeine feeling; pins and needles; This spontaneous case was reported by a consumer and describes the occurrence of LHERMITTE'S SIGN (Lhermitte's Reaction when bending neck), NERVOUSNESS (Nervousness feeling entire body like a caffeine feeling) and PARAESTHESIA (pins and needles) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Q11Q21A and Q35L21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Anxiety. Concomitant products included HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) for Anxiety, VITAMIN B COMPLEX for an unknown indication.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced PARAESTHESIA (pins and needles). On 18-Jul-2021, the patient experienced LHERMITTE'S SIGN (Lhermitte's Reaction when bending neck) and NERVOUSNESS (Nervousness feeling entire body like a caffeine feeling). At the time of the report, LHERMITTE'S SIGN (Lhermitte's Reaction when bending neck) and NERVOUSNESS (Nervousness feeling entire body like a caffeine feeling) had not resolved and PARAESTHESIA (pins and needles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2021, SARS-CoV-2 test: positive (Positive) Infinity biologix TAQPATH SARS-CoV-2 Assay RT-PCR based. On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, Magnetic resonance imaging head: normal (normal) normal. On an unknown date, Magnetic resonance imaging neck: normal (normal) normal.         Patient took MRI thorax which showed spinal fluid was normal. Patient stated that knees, limbs felt weak and during shower while bending the neck resulted in vibration that passes down to hands. Treatment medication was not reported.   This case was linked to MOD-2021-313186 (E2B Linked Report). This case was linked to MOD-2021-313186 (Patient Link).; Sender's Comments:  MOD-2021-313186:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Herpes zoster
Clinical narrative: developed shingles again; all blistered up; red spots; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (developed shingles again), BLISTER (all blistered up) and ERYTHEMA (red spots) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 015MA0A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Previously administered products included for Shingles: shingles vaccination in 2020. Concurrent medical conditions included Immunocompromised.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (developed shingles again), BLISTER (all blistered up) and ERYTHEMA (red spots). The patient was treated with VALACYCLOVIR [VALACICLOVIR] ongoing since an unknown date at a dose of 1 gram three times a day. At the time of the report, HERPES ZOSTER (developed shingles again), BLISTER (all blistered up) and ERYTHEMA (red spots) outcome was unknown.            No concomitants medications was reported.  No treatments medications was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-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 FATIGUE (very tired). At the time of the report, FATIGUE (very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter.  No Treatment Information was provided by the reporter.   This case was linked to MOD-2021-373656, MOD-2021-373660 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: 5 patients administered vaccine after temperature excursion; 5 patients administered vaccine after temperature excursion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Nov-2021 and was forwarded to Moderna on 02-Nov-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients administered vaccine after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (5 patients administered vaccine after temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients administered vaccine after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (5 patients administered vaccine after temperature excursion). On 27-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients administered vaccine after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (5 patients administered vaccine after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-373513 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Feeling abnormal, Headache
Clinical narrative: Weak after booster; Pain after booster; Felt  worst again after booster; Super sick again after booster; Chills after booster; Headache after booster/Headache on 27OCT2021; Body Aches after booster; Fever 102.8F after booster/Fever 102.2F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt  worst again after booster), VACCINATION COMPLICATION (Super sick again after booster), ASTHENIA (Weak after booster), PAIN (Pain after booster) and PYREXIA (Fever 102.8F after booster/Fever 102.2F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever 102.8F after booster/Fever 102.2F). On 03-Oct-2021, the patient experienced HEADACHE (Headache after booster/Headache on 27OCT2021) and MYALGIA (Body Aches after booster). On 27-Oct-2021, the patient experienced FEELING ABNORMAL (Felt  worst again after booster), VACCINATION COMPLICATION (Super sick again after booster), PAIN (Pain after booster) and CHILLS (Chills after booster). On 28-Oct-2021, the patient experienced ASTHENIA (Weak after booster). On 03-Oct-2021, PYREXIA (Fever 102.8F after booster/Fever 102.2F) had resolved. On 17-Oct-2021, HEADACHE (Headache after booster/Headache on 27OCT2021) and MYALGIA (Body Aches after booster) had resolved. On 28-Oct-2021, FEELING ABNORMAL (Felt  worst again after booster), VACCINATION COMPLICATION (Super sick again after booster), PAIN (Pain after booster) and CHILLS (Chills after booster) had resolved. At the time of the report, ASTHENIA (Weak after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Body temperature: 102.8f (High) Fever 102.8F for a couple of days. On 27-Oct-2021, Body temperature: 102.2f (High) Fever 102.2F.         No Concomitant product use was reported. No treatment information was provided.  The patient reported that after the third dose they had Fever of 102.8F for a couple of days and on 03-Oct-2021, they began to have a headache and Body Aches for 2 weeks. On 27-Oct-2021, the patient felt worst and super sick again with Fever of 102.2F and Chills and also developed aches, pain, and headache again. On 28-Oct-2021 they felt better but was weak but no more fever since then.   This case was linked to MOD-2021-373647, MOD-2021-373656, MOD-2021-373647 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Vaccination complication
Clinical narrative: Weak after booster; Pain after booster; Felt  worst again after booster; Super sick again after booster; Chills after booster; Headache after booster/Headache on 27OCT2021; Body Aches after booster; Fever 102.8F after booster/Fever 102.2F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt  worst again after booster), VACCINATION COMPLICATION (Super sick again after booster), ASTHENIA (Weak after booster), PAIN (Pain after booster) and PYREXIA (Fever 102.8F after booster/Fever 102.2F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever 102.8F after booster/Fever 102.2F). On 03-Oct-2021, the patient experienced HEADACHE (Headache after booster/Headache on 27OCT2021) and MYALGIA (Body Aches after booster). On 27-Oct-2021, the patient experienced FEELING ABNORMAL (Felt  worst again after booster), VACCINATION COMPLICATION (Super sick again after booster), PAIN (Pain after booster) and CHILLS (Chills after booster). On 28-Oct-2021, the patient experienced ASTHENIA (Weak after booster). On 03-Oct-2021, PYREXIA (Fever 102.8F after booster/Fever 102.2F) had resolved. On 17-Oct-2021, HEADACHE (Headache after booster/Headache on 27OCT2021) and MYALGIA (Body Aches after booster) had resolved. On 28-Oct-2021, FEELING ABNORMAL (Felt  worst again after booster), VACCINATION COMPLICATION (Super sick again after booster), PAIN (Pain after booster) and CHILLS (Chills after booster) had resolved. At the time of the report, ASTHENIA (Weak after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Body temperature: 102.8f (High) Fever 102.8F for a couple of days. On 27-Oct-2021, Body temperature: 102.2f (High) Fever 102.2F.         No Concomitant product use was reported. No treatment information was provided.  The patient reported that after the third dose they had Fever of 102.8F for a couple of days and on 03-Oct-2021, they began to have a headache and Body Aches for 2 weeks. On 27-Oct-2021, the patient felt worst and super sick again with Fever of 102.2F and Chills and also developed aches, pain, and headache again. On 28-Oct-2021 they felt better but was weak but no more fever since then.   This case was linked to MOD-2021-373647, MOD-2021-373656, MOD-2021-373647 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Discomfort, Feeling abnormal, Inflammation
Clinical narrative: Tingling sensation in her arm, neck, feet, muscles and back; Uncomfortable; Back pain; Whole body was hurting me; Inflammatory situation; Nerve pain; Trouble in putting shoes on and is uncomfortable when things touch her feet; Body felt different; Kind of like flu feeling; Low fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation in her arm, neck, feet, muscles and back), DISCOMFORT (Uncomfortable), BACK PAIN (Back pain), PAIN (Whole body was hurting me) and INFLAMMATION (Inflammatory situation) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Operation NOS (Patient had operation on neck 1 year ago). Previously administered products included for Product used for unknown indication: Flu vaccine (Patient had a 1 day reaction to flu vaccine taken about 1 month ago.).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Kind of like flu feeling), PYREXIA (Low fever) and CHILLS (Chills). On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation in her arm, neck, feet, muscles and back), DISCOMFORT (Uncomfortable), BACK PAIN (Back pain), PAIN (Whole body was hurting me), INFLAMMATION (Inflammatory situation), NEURALGIA (Nerve pain), LIMB DISCOMFORT (Trouble in putting shoes on and is uncomfortable when things touch her feet) and FEELING ABNORMAL (Body felt different). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and Physical therapy for Back pain. On 18-Feb-2021, INFLUENZA LIKE ILLNESS (Kind of like flu feeling), PYREXIA (Low fever) and CHILLS (Chills) had resolved. At the time of the report, PARAESTHESIA (Tingling sensation in her arm, neck, feet, muscles and back), DISCOMFORT (Uncomfortable), BACK PAIN (Back pain), PAIN (Whole body was hurting me), INFLAMMATION (Inflammatory situation), NEURALGIA (Nerve pain), LIMB DISCOMFORT (Trouble in putting shoes on and is uncomfortable when things touch her feet) and FEELING ABNORMAL (Body felt different) outcome was unknown.            No concomitant medications were provided.   Patient tried acupuncture , steroid shot for back , therapy and physical therapy. Patient talked to multiple HCP's who have not been able to give patient a diagnosis.   This case was linked to MOD-2021-373689 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Limb discomfort, Neuralgia, Pain, Paraesthesia
Clinical narrative: Tingling sensation in her arm, neck, feet, muscles and back; Uncomfortable; Back pain; Whole body was hurting me; Inflammatory situation; Nerve pain; Trouble in putting shoes on and is uncomfortable when things touch her feet; Body felt different; Kind of like flu feeling; Low fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation in her arm, neck, feet, muscles and back), DISCOMFORT (Uncomfortable), BACK PAIN (Back pain), PAIN (Whole body was hurting me) and INFLAMMATION (Inflammatory situation) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Operation NOS (Patient had operation on neck 1 year ago). Previously administered products included for Product used for unknown indication: Flu vaccine (Patient had a 1 day reaction to flu vaccine taken about 1 month ago.).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Kind of like flu feeling), PYREXIA (Low fever) and CHILLS (Chills). On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation in her arm, neck, feet, muscles and back), DISCOMFORT (Uncomfortable), BACK PAIN (Back pain), PAIN (Whole body was hurting me), INFLAMMATION (Inflammatory situation), NEURALGIA (Nerve pain), LIMB DISCOMFORT (Trouble in putting shoes on and is uncomfortable when things touch her feet) and FEELING ABNORMAL (Body felt different). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and Physical therapy for Back pain. On 18-Feb-2021, INFLUENZA LIKE ILLNESS (Kind of like flu feeling), PYREXIA (Low fever) and CHILLS (Chills) had resolved. At the time of the report, PARAESTHESIA (Tingling sensation in her arm, neck, feet, muscles and back), DISCOMFORT (Uncomfortable), BACK PAIN (Back pain), PAIN (Whole body was hurting me), INFLAMMATION (Inflammatory situation), NEURALGIA (Nerve pain), LIMB DISCOMFORT (Trouble in putting shoes on and is uncomfortable when things touch her feet) and FEELING ABNORMAL (Body felt different) outcome was unknown.            No concomitant medications were provided.   Patient tried acupuncture , steroid shot for back , therapy and physical therapy. Patient talked to multiple HCP's who have not been able to give patient a diagnosis.   This case was linked to MOD-2021-373689 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Tingling sensation in her arm, neck, feet, muscles and back; Uncomfortable; Back pain; Whole body was hurting me; Inflammatory situation; Nerve pain; Trouble in putting shoes on and is uncomfortable when things touch her feet; Body felt different; Kind of like flu feeling; Low fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation in her arm, neck, feet, muscles and back), DISCOMFORT (Uncomfortable), BACK PAIN (Back pain), PAIN (Whole body was hurting me) and INFLAMMATION (Inflammatory situation) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Operation NOS (Patient had operation on neck 1 year ago). Previously administered products included for Product used for unknown indication: Flu vaccine (Patient had a 1 day reaction to flu vaccine taken about 1 month ago.).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Kind of like flu feeling), PYREXIA (Low fever) and CHILLS (Chills). On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation in her arm, neck, feet, muscles and back), DISCOMFORT (Uncomfortable), BACK PAIN (Back pain), PAIN (Whole body was hurting me), INFLAMMATION (Inflammatory situation), NEURALGIA (Nerve pain), LIMB DISCOMFORT (Trouble in putting shoes on and is uncomfortable when things touch her feet) and FEELING ABNORMAL (Body felt different). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and Physical therapy for Back pain. On 18-Feb-2021, INFLUENZA LIKE ILLNESS (Kind of like flu feeling), PYREXIA (Low fever) and CHILLS (Chills) had resolved. At the time of the report, PARAESTHESIA (Tingling sensation in her arm, neck, feet, muscles and back), DISCOMFORT (Uncomfortable), BACK PAIN (Back pain), PAIN (Whole body was hurting me), INFLAMMATION (Inflammatory situation), NEURALGIA (Nerve pain), LIMB DISCOMFORT (Trouble in putting shoes on and is uncomfortable when things touch her feet) and FEELING ABNORMAL (Body felt different) outcome was unknown.            No concomitant medications were provided.   Patient tried acupuncture , steroid shot for back , therapy and physical therapy. Patient talked to multiple HCP's who have not been able to give patient a diagnosis.   This case was linked to MOD-2021-373689 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: Administered dose past the manufacture expiry date; Full 3rd dose of 0.5 mL was administered on accident instead of 0.25mL; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose past the manufacture expiry date) and ACCIDENTAL OVERDOSE (Full 3rd dose of 0.5 mL was administered on accident instead of 0.25mL) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose past the manufacture expiry date) and ACCIDENTAL OVERDOSE (Full 3rd dose of 0.5 mL was administered on accident instead of 0.25mL). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose past the manufacture expiry date) and ACCIDENTAL OVERDOSE (Full 3rd dose of 0.5 mL was administered on accident instead of 0.25mL) had resolved.        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. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vulvovaginal burning sensation, Vulvovaginal discomfort
Clinical narrative: Patient feels like she is coming down with a vaginal yeast infection; Burning sensation; 2 days of fatigue/Tired; 2 days of fever; This spontaneous case was reported by a consumer and describes the occurrence of VULVOVAGINAL DISCOMFORT (Patient feels like she is coming down with a vaginal yeast infection), VULVOVAGINAL BURNING SENSATION (Burning sensation), FATIGUE (2 days of fatigue/Tired) and PYREXIA (2 days of fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 010A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced FATIGUE (2 days of fatigue/Tired) and PYREXIA (2 days of fever). On an unknown date, the patient experienced VULVOVAGINAL DISCOMFORT (Patient feels like she is coming down with a vaginal yeast infection) and VULVOVAGINAL BURNING SENSATION (Burning sensation). The patient was treated with ESTROGEN NOS on 05-Nov-2021 for Vulvovaginal burning sensation, at a dose of UNK dosage form. At the time of the report, VULVOVAGINAL DISCOMFORT (Patient feels like she is coming down with a vaginal yeast infection) outcome was unknown, VULVOVAGINAL BURNING SENSATION (Burning sensation) and PYREXIA (2 days of fever) was resolving and FATIGUE (2 days of fatigue/Tired) had not resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up was received and adverse events added, treatment updated
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema, Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (had some symptoms that went away in two weeks) and lymphoedema/the lymphatic system (the back of her head was swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; at an unspecified dose. On an unknown date, patient experienced vaccination complication (had some symptoms that went away in two weeks) and lymphoedema/the lymphatic system (the back of her head was swollen). At the time of the report, vaccination complication (had some symptoms that went away in two weeks) resolved; and lymphoedema/the lymphatic system (the back of her head was swollen) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-320633 (patient link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   No relevant concomitant medications was reported. Treatment information was not provided. After first 2 doses patient experienced fever.   This case was linked to MOD-2021-373142, MOD-2021-373950 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-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) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-373949 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (received Moderna booster shot and just found out the vial expired) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (received Moderna booster shot and just found out the vial expired). At the time of the report, administered expired product (received Moderna booster shot and just found out the vial expired) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness, Vaccination site pain
Clinical narrative: tenderness in armpit; swollen lymph node from collarbone to ear; experienced sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness in armpit), LYMPHADENOPATHY (swollen lymph node from collarbone to ear) and VACCINATION SITE PAIN (experienced sore arm) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 immunisation: COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (patient received his first dose of the Johnson and Johnson COVID-19 vaccine on 07-APR-2021 in the right non dominant arm and on an unknown date, the second dose was received as well. Date and lot and expiration date was unknown) on 07-Apr-2021.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tenderness in armpit), LYMPHADENOPATHY (swollen lymph node from collarbone to ear) and VACCINATION SITE PAIN (experienced sore arm). At the time of the report, TENDERNESS (tenderness in armpit), LYMPHADENOPATHY (swollen lymph node from collarbone to ear) and VACCINATION SITE PAIN (experienced sore arm) had not resolved.            No concomitant medications were reported.  Treatment information was not provided. The patient received a booster dose in the right non dominant arm.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Left arm is red; Arm was sore the next day, and seems to be getting worse which describes it as red and swelling; Left arm is swollen; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Left arm is red), CONDITION AGGRAVATED (Arm was sore the next day, and seems to be getting worse which describes it as red and swelling), VACCINATION SITE SWELLING (Left arm is swollen) and VACCINATION SITE PAIN (Arm was sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 013M20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Left arm is red), CONDITION AGGRAVATED (Arm was sore the next day, and seems to be getting worse which describes it as red and swelling), VACCINATION SITE SWELLING (Left arm is swollen) and VACCINATION SITE PAIN (Arm was sore). At the time of the report, VACCINATION SITE ERYTHEMA (Left arm is red), CONDITION AGGRAVATED (Arm was sore the next day, and seems to be getting worse which describes it as red and swelling), VACCINATION SITE SWELLING (Left arm is swollen) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient asked if she can take Benadryl or not.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches with the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headaches with the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches with the vaccine). At the time of the report, HEADACHE (Headaches with 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.   No concomitant medication was reported. The treatment information was unknown. The reporter stated that she knows of people getting headaches with the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Six patients admininstered expired doses of the Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients admininstered expired doses of the Moderna COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients admininstered expired doses of the Moderna COVID-19 vaccine). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Six patients admininstered expired doses of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Illness, Nasopharyngitis, Nausea, Pain in extremity
Clinical narrative: big red 3 inch diameter welt at injection site hurts, itches; big red 3 inch diameter welt at injection site hurts, itches; I felt terribly sick; Feels like having a bad cold; third dose was given on 19OCT2021 with expiration of 13OCT2021; Have a sore arm; nauseated; big red 3 inch diameter welt at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I felt terribly sick), NASOPHARYNGITIS (Feels like having a bad cold), PAIN IN EXTREMITY (Have a sore arm), VACCINATION SITE PAIN (big red 3 inch diameter welt at injection site hurts, itches) and VACCINATION SITE PRURITUS (big red 3 inch diameter welt at injection site hurts, itches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 011M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (Have a sore arm), NAUSEA (nauseated) and VACCINATION SITE URTICARIA (big red 3 inch diameter welt at injection site). On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (third dose was given on 19OCT2021 with expiration of 13OCT2021). On an unknown date, the patient experienced ILLNESS (I felt terribly sick), NASOPHARYNGITIS (Feels like having a bad cold), VACCINATION SITE PAIN (big red 3 inch diameter welt at injection site hurts, itches) and VACCINATION SITE PRURITUS (big red 3 inch diameter welt at injection site hurts, itches). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (MUCINEX COLD & FLU) at an unspecified dose and frequency and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) at an unspecified dose and frequency. On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (third dose was given on 19OCT2021 with expiration of 13OCT2021) had resolved. At the time of the report, ILLNESS (I felt terribly sick), NASOPHARYNGITIS (Feels like having a bad cold), VACCINATION SITE PAIN (big red 3 inch diameter welt at injection site hurts, itches) and VACCINATION SITE PRURITUS (big red 3 inch diameter welt at injection site hurts, itches) outcome was unknown and PAIN IN EXTREMITY (Have a sore arm), NAUSEA (nauseated) and VACCINATION SITE URTICARIA (big red 3 inch diameter welt at injection site) was resolving.            No concomitant medication was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: big red 3 inch diameter welt at injection site hurts, itches; big red 3 inch diameter welt at injection site hurts, itches; I felt terribly sick; Feels like having a bad cold; third dose was given on 19OCT2021 with expiration of 13OCT2021; Have a sore arm; nauseated; big red 3 inch diameter welt at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I felt terribly sick), NASOPHARYNGITIS (Feels like having a bad cold), PAIN IN EXTREMITY (Have a sore arm), VACCINATION SITE PAIN (big red 3 inch diameter welt at injection site hurts, itches) and VACCINATION SITE PRURITUS (big red 3 inch diameter welt at injection site hurts, itches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 011M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (Have a sore arm), NAUSEA (nauseated) and VACCINATION SITE URTICARIA (big red 3 inch diameter welt at injection site). On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (third dose was given on 19OCT2021 with expiration of 13OCT2021). On an unknown date, the patient experienced ILLNESS (I felt terribly sick), NASOPHARYNGITIS (Feels like having a bad cold), VACCINATION SITE PAIN (big red 3 inch diameter welt at injection site hurts, itches) and VACCINATION SITE PRURITUS (big red 3 inch diameter welt at injection site hurts, itches). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (MUCINEX COLD & FLU) at an unspecified dose and frequency and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) at an unspecified dose and frequency. On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (third dose was given on 19OCT2021 with expiration of 13OCT2021) had resolved. At the time of the report, ILLNESS (I felt terribly sick), NASOPHARYNGITIS (Feels like having a bad cold), VACCINATION SITE PAIN (big red 3 inch diameter welt at injection site hurts, itches) and VACCINATION SITE PRURITUS (big red 3 inch diameter welt at injection site hurts, itches) outcome was unknown and PAIN IN EXTREMITY (Have a sore arm), NAUSEA (nauseated) and VACCINATION SITE URTICARIA (big red 3 inch diameter welt at injection site) was resolving.            No concomitant medication was reported.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   4 vials with 44 doses were initially stored in the refrigerator on 24-SEP-2021 and did not undergo any temperature excursion. Dosing was done between 24Oct2021 - 27Oct2021. No concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  It was reported that number of doses/vials were 4 vials (15 dose) 44 doses.  It was reported that the date the vial initially stored in the refrigerator 24-Sep-2021. It was also reported that the date of administration of vaccine was 24-Oct-2021 to 27-Oct-2021. The vial did not undergo any temperature excursions.