chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: rash flare ups; hypersensitivity reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (hypersensitivity reaction) and RASH (rash flare ups) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder in 2012, Brain tumor in 1996, Osteoarthritis since 2019 and Thyroid disorder in 1997. Concurrent medical conditions included Sulfonamide allergy, Drug allergy (Quinolones allergy), Drug allergy and Drug allergy (Zonisamide allergy) in May 2021. Concomitant products included BENAZEPRIL for Blood pressure, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for GERD, THYROID (ARMOUR THYROID) for Thyroid disorder, RANOLAZINE for an unknown indication, TOPIRAMATE (TOPAMAX) for seisures.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HYPERSENSITIVITY (hypersensitivity reaction). On 15-Apr-2021, the patient experienced RASH (rash flare ups). At the time of the report, HYPERSENSITIVITY (hypersensitivity reaction) and RASH (rash flare ups) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was taking Seizure medication concomitantly. The patient was prescribed with steroid pack, to relieve the symptoms. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-046335, MOD-2021-046304 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: patient medical history updatedConcomitant codded
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00SC21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Jan-2021 and the estimated date of delivery was 17-Oct-2021. On 06-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 06-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: 2nd medical assistant shook vial; 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 WRONG TECHNIQUE IN DEVICE USAGE PROCESS (2nd medical assistant shook vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (2nd medical assistant shook vial). On 06-May-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (2nd medical assistant shook vial) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Exposure via breast milk, Pyrexia
Clinical narrative: Dizziness; Breastfeeding; Fever 103.5 F on Forehead and 105.7F in the Ear. (After Second Vaccine); Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), EXPOSURE VIA BREAST MILK (Breastfeeding), PYREXIA (Fever 103.5 F on Forehead and 105.7F in the Ear. (After Second Vaccine)) and CHILLS (Chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced DIZZINESS (Dizziness), EXPOSURE VIA BREAST MILK (Breastfeeding), PYREXIA (Fever 103.5 F on Forehead and 105.7F in the Ear. (After Second Vaccine)) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), EXPOSURE VIA BREAST MILK (Breastfeeding), PYREXIA (Fever 103.5 F on Forehead and 105.7F in the Ear. (After Second Vaccine)) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: 103.5f on forehead (abnormal) 103.5F on forehead. and 105.5f tympanic (abnormal) 105.5F tympanic.         No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-110294 (Parent-Child Link).   See case MOD-2021-110294 for details regarding the child case.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: arm sore; faint headache; mild nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), HEADACHE (faint headache) and NAUSEA (mild nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) for COVID-19 vaccination.     The patient's past medical history included Chickenpox (youngest of 5, aged 4), Rash (treated with benadryl) and Arm fracture (23 years ago broke arm). Concurrent medical conditions included Drug allergy.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore), HEADACHE (faint headache) and NAUSEA (mild nausea). At the time of the report, PAIN IN EXTREMITY (arm sore), HEADACHE (faint headache) and NAUSEA (mild nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment related information has been reported.   This case was linked to MOD-2021-053856 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PAIN (Pain on the vaccinated arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. Concomitant products included SPIRONOLACTONE for Acne, CYCLOBENZAPRINE for Muscle relaxant. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain on the vaccinated arm). On 07-Apr-2021, the patient experienced VACCINATION SITE RASH (Rash on the injection site). On 14-Apr-2021, VACCINATION SITE RASH (Rash on the injection site) outcome was unknown. At the time of the report, VACCINATION SITE PAIN (Pain on the vaccinated arm) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not reported. This case was linked to MOD-2021-110398.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cardiac disorder, Pain in extremity
Clinical narrative: It might be a heart problem; having pain near my underarm; having pain left upper back; having pain underneath my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (It might be a heart problem), PAIN IN EXTREMITY (having pain near my underarm), BACK PAIN (having pain left upper back) and ARTHRALGIA (having pain underneath my shoulder) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy. Concurrent medical conditions included Hemochromatosis (Patient is a carrier).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (having pain near my underarm), BACK PAIN (having pain left upper back) and ARTHRALGIA (having pain underneath my shoulder). On 06-May-2021, the patient experienced CARDIAC DISORDER (It might be a heart problem). At the time of the report, CARDIAC DISORDER (It might be a heart problem), PAIN IN EXTREMITY (having pain near my underarm), BACK PAIN (having pain left upper back) and ARTHRALGIA (having pain underneath my shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-109939 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Headache, Herpes zoster
Clinical narrative: pain in head/cannot brush or dye hair because of pain; shingles in her hair; Blister in her head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (pain in head/cannot brush or dye hair because of pain), HERPES ZOSTER (shingles in her hair) and BLISTER (Blister in her head) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HEADACHE (pain in head/cannot brush or dye hair because of pain), HERPES ZOSTER (shingles in her hair) and BLISTER (Blister in her head). At the time of the report, HEADACHE (pain in head/cannot brush or dye hair because of pain), HERPES ZOSTER (shingles in her hair) and BLISTER (Blister in her head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DCBOH) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced MALAISE (not feeling well). At the time of the report, MALAISE (not feeling well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-102905 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Discomfort, Fibrin D dimer, Head discomfort, Headache
Clinical narrative: Strong headache; Mild facial swelling; Bent down and felt pressure on head/Lot of pressure in the head; Bent down and felt the pressure on face; Rash; Mild nauseated; Pain on the vaccinated arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Mild facial swelling), HEAD DISCOMFORT (Bent down and felt pressure on head/Lot of pressure in the head), DISCOMFORT (Bent down and felt the pressure on face), RASH (Rash) and HEADACHE (Strong headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SPIRONOLACTONE for Acne, CYCLOBENZAPRINE for Muscle relaxant.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain on the vaccinated arm). On 28-Apr-2021, the patient experienced NAUSEA (Mild nauseated). On 29-Apr-2021, the patient experienced RASH (Rash). On 01-May-2021, the patient experienced SWELLING FACE (Mild facial swelling), HEAD DISCOMFORT (Bent down and felt pressure on head/Lot of pressure in the head) and DISCOMFORT (Bent down and felt the pressure on face). On 04-May-2021, the patient experienced HEADACHE (Strong headache). The patient was treated with IBUPROFEN on 01-May-2021 at a dose of 200 mg,1 tablet in the afternoon, and 2 tablets in the evening and PARACETAMOL (TYLENOL) on 06-May-2021 at a dose of 500 mg,1/2 tablet. On 30-Apr-2021, VACCINATION SITE PAIN (Pain on the vaccinated arm) had resolved. On 02-May-2021, SWELLING FACE (Mild facial swelling) had resolved. On 05-May-2021, NAUSEA (Mild nauseated) had resolved. At the time of the report, HEAD DISCOMFORT (Bent down and felt pressure on head/Lot of pressure in the head), DISCOMFORT (Bent down and felt the pressure on face), RASH (Rash) and HEADACHE (Strong headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Computerised tomogram: normal (normal) the result did not show any bleeding or blood clot.. On 05-May-2021, Magnetic resonance imaging: normal (normal) MRI of the head-the result did not show any bleeding or blood clot.. On an unknown date, Fibrin D dimer: 1.43 (High) elevated D-dimer=1.43 (above normal standard level <0.49).         Treatment drugs include Ibuprofen 200mg 1 tablet in the afternoon, and 2 tablets in the evening on 01-May-2021. Acetaminophen 500mg 1/2 tablet on 06-May-2021  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-110367 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Nausea, Rash, Swelling face, Vaccination site pain
Clinical narrative: Strong headache; Mild facial swelling; Bent down and felt pressure on head/Lot of pressure in the head; Bent down and felt the pressure on face; Rash; Mild nauseated; Pain on the vaccinated arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Mild facial swelling), HEAD DISCOMFORT (Bent down and felt pressure on head/Lot of pressure in the head), DISCOMFORT (Bent down and felt the pressure on face), RASH (Rash) and HEADACHE (Strong headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SPIRONOLACTONE for Acne, CYCLOBENZAPRINE for Muscle relaxant.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain on the vaccinated arm). On 28-Apr-2021, the patient experienced NAUSEA (Mild nauseated). On 29-Apr-2021, the patient experienced RASH (Rash). On 01-May-2021, the patient experienced SWELLING FACE (Mild facial swelling), HEAD DISCOMFORT (Bent down and felt pressure on head/Lot of pressure in the head) and DISCOMFORT (Bent down and felt the pressure on face). On 04-May-2021, the patient experienced HEADACHE (Strong headache). The patient was treated with IBUPROFEN on 01-May-2021 at a dose of 200 mg,1 tablet in the afternoon, and 2 tablets in the evening and PARACETAMOL (TYLENOL) on 06-May-2021 at a dose of 500 mg,1/2 tablet. On 30-Apr-2021, VACCINATION SITE PAIN (Pain on the vaccinated arm) had resolved. On 02-May-2021, SWELLING FACE (Mild facial swelling) had resolved. On 05-May-2021, NAUSEA (Mild nauseated) had resolved. At the time of the report, HEAD DISCOMFORT (Bent down and felt pressure on head/Lot of pressure in the head), DISCOMFORT (Bent down and felt the pressure on face), RASH (Rash) and HEADACHE (Strong headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Computerised tomogram: normal (normal) the result did not show any bleeding or blood clot.. On 05-May-2021, Magnetic resonance imaging: normal (normal) MRI of the head-the result did not show any bleeding or blood clot.. On an unknown date, Fibrin D dimer: 1.43 (High) elevated D-dimer=1.43 (above normal standard level <0.49).         Treatment drugs include Ibuprofen 200mg 1 tablet in the afternoon, and 2 tablets in the evening on 01-May-2021. Acetaminophen 500mg 1/2 tablet on 06-May-2021  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-110367 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disturbance in attention, Fatigue, Feeling abnormal, Muscular weakness
Clinical narrative: In morning patient started to feel better and next day did not feel good; Muscles are feeling weak; hard to concentrate; 3 weeks now and symptoms are not going away; very tired; patient's body started shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (patient's body started shaking), FEELING ABNORMAL (In morning patient started to feel better and next day did not feel good), MUSCULAR WEAKNESS (Muscles are feeling weak), DISTURBANCE IN ATTENTION (hard to concentrate) and SYMPTOM RECURRENCE (3 weeks now and symptoms are not going away) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced TREMOR (patient's body started shaking), MUSCULAR WEAKNESS (Muscles are feeling weak), DISTURBANCE IN ATTENTION (hard to concentrate), SYMPTOM RECURRENCE (3 weeks now and symptoms are not going away) and FATIGUE (very tired). On 17-Apr-2021, the patient experienced FEELING ABNORMAL (In morning patient started to feel better and next day did not feel good). At the time of the report, TREMOR (patient's body started shaking), FEELING ABNORMAL (In morning patient started to feel better and next day did not feel good), MUSCULAR WEAKNESS (Muscles are feeling weak), DISTURBANCE IN ATTENTION (hard to concentrate), SYMPTOM RECURRENCE (3 weeks now and symptoms are not going away) and FATIGUE (very tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, COVID-19: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Symptom recurrence, Tremor
Clinical narrative: In morning patient started to feel better and next day did not feel good; Muscles are feeling weak; hard to concentrate; 3 weeks now and symptoms are not going away; very tired; patient's body started shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (patient's body started shaking), FEELING ABNORMAL (In morning patient started to feel better and next day did not feel good), MUSCULAR WEAKNESS (Muscles are feeling weak), DISTURBANCE IN ATTENTION (hard to concentrate) and SYMPTOM RECURRENCE (3 weeks now and symptoms are not going away) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced TREMOR (patient's body started shaking), MUSCULAR WEAKNESS (Muscles are feeling weak), DISTURBANCE IN ATTENTION (hard to concentrate), SYMPTOM RECURRENCE (3 weeks now and symptoms are not going away) and FATIGUE (very tired). On 17-Apr-2021, the patient experienced FEELING ABNORMAL (In morning patient started to feel better and next day did not feel good). At the time of the report, TREMOR (patient's body started shaking), FEELING ABNORMAL (In morning patient started to feel better and next day did not feel good), MUSCULAR WEAKNESS (Muscles are feeling weak), DISTURBANCE IN ATTENTION (hard to concentrate), SYMPTOM RECURRENCE (3 weeks now and symptoms are not going away) and FATIGUE (very tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, COVID-19: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Body temperature, Dyspnoea, Heart rate
Clinical narrative: tingling in the hands; breathing problems; Anxiety; Numbness; Sensation of throat closing/difficulty in swallowing in the throat; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (tingling in the hands), DYSPNOEA (breathing problems), ANXIETY (Anxiety), HYPOAESTHESIA (Numbness) and THROAT TIGHTNESS (Sensation of throat closing/difficulty in swallowing in the throat) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On 06-May-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced THROAT TIGHTNESS (Sensation of throat closing/difficulty in swallowing in the throat). On 06-May-2021 at 5:00 PM, the patient experienced PARAESTHESIA (tingling in the hands), DYSPNOEA (breathing problems), ANXIETY (Anxiety) and HYPOAESTHESIA (Numbness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing from 06-May-2021 at a dose of 10 ml. On 06-May-2021, THROAT TIGHTNESS (Sensation of throat closing/difficulty in swallowing in the throat) had resolved. On 06-May-2021 at 6:00 PM, PARAESTHESIA (tingling in the hands), DYSPNOEA (breathing problems), ANXIETY (Anxiety) and HYPOAESTHESIA (Numbness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Blood pressure measurement: 140/90 mmHg (Inconclusive) interpretation not provided. On 06-May-2021, Body temperature: 97 degrees fahrenheit (Inconclusive) interpretation not provided. On 06-May-2021, Heart rate: 85 beats per minute (Inconclusive) interpretation not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PARAESTHESIA (tingling in the hands), DYSPNOEA (breathing problems), ANXIETY (Anxiety), HYPOAESTHESIA (Numbness) and THROAT TIGHTNESS (Sensation of throat closing/difficulty in swallowing in the throat) to be possibly related.    Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: initial additional. On 23-Jul-2021: initial additional.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Throat tightness
Clinical narrative: tingling in the hands; breathing problems; Anxiety; Numbness; Sensation of throat closing/difficulty in swallowing in the throat; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (tingling in the hands), DYSPNOEA (breathing problems), ANXIETY (Anxiety), HYPOAESTHESIA (Numbness) and THROAT TIGHTNESS (Sensation of throat closing/difficulty in swallowing in the throat) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On 06-May-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced THROAT TIGHTNESS (Sensation of throat closing/difficulty in swallowing in the throat). On 06-May-2021 at 5:00 PM, the patient experienced PARAESTHESIA (tingling in the hands), DYSPNOEA (breathing problems), ANXIETY (Anxiety) and HYPOAESTHESIA (Numbness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing from 06-May-2021 at a dose of 10 ml. On 06-May-2021, THROAT TIGHTNESS (Sensation of throat closing/difficulty in swallowing in the throat) had resolved. On 06-May-2021 at 6:00 PM, PARAESTHESIA (tingling in the hands), DYSPNOEA (breathing problems), ANXIETY (Anxiety) and HYPOAESTHESIA (Numbness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Blood pressure measurement: 140/90 mmHg (Inconclusive) interpretation not provided. On 06-May-2021, Body temperature: 97 degrees fahrenheit (Inconclusive) interpretation not provided. On 06-May-2021, Heart rate: 85 beats per minute (Inconclusive) interpretation not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PARAESTHESIA (tingling in the hands), DYSPNOEA (breathing problems), ANXIETY (Anxiety), HYPOAESTHESIA (Numbness) and THROAT TIGHTNESS (Sensation of throat closing/difficulty in swallowing in the throat) to be possibly related.    Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: initial additional. On 23-Jul-2021: initial additional.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Limb injury, Migraine, Mobility decreased, Myalgia
Clinical narrative: left arm could not lift it above shoulder; left arm could not lift it above shoulder without severe pain; flu like symptoms the first day; migraine that night (history of migraines; rash on her back, itched really bad; felt like my heart was growing; index finger "split open" by the cuticle; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (left arm could not lift it above shoulder), MYALGIA (left arm could not lift it above shoulder without severe pain), INFLUENZA LIKE ILLNESS (flu like symptoms the first day), MIGRAINE (migraine that night (history of migraines) and RASH PRURITIC (rash on her back, itched really bad) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUDESONIDE (PULMICORT), GLYCERYL TRINITRATE (NITROLINGUAL), TRAMADOL and FLUTICASONE PROPIONATE (FLUTINASE POLYNEX) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (left arm could not lift it above shoulder), MYALGIA (left arm could not lift it above shoulder without severe pain), INFLUENZA LIKE ILLNESS (flu like symptoms the first day), MIGRAINE (migraine that night (history of migraines), RASH PRURITIC (rash on her back, itched really bad), PALPITATIONS (felt like my heart was growing) and LIMB INJURY (index finger "split open" by the cuticle). At the time of the report, MOBILITY DECREASED (left arm could not lift it above shoulder), MYALGIA (left arm could not lift it above shoulder without severe pain), INFLUENZA LIKE ILLNESS (flu like symptoms the first day), MIGRAINE (migraine that night (history of migraines), RASH PRURITIC (rash on her back, itched really bad), PALPITATIONS (felt like my heart was growing) and LIMB INJURY (index finger "split open" by the cuticle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash pruritic
Clinical narrative: left arm could not lift it above shoulder; left arm could not lift it above shoulder without severe pain; flu like symptoms the first day; migraine that night (history of migraines; rash on her back, itched really bad; felt like my heart was growing; index finger "split open" by the cuticle; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (left arm could not lift it above shoulder), MYALGIA (left arm could not lift it above shoulder without severe pain), INFLUENZA LIKE ILLNESS (flu like symptoms the first day), MIGRAINE (migraine that night (history of migraines) and RASH PRURITIC (rash on her back, itched really bad) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUDESONIDE (PULMICORT), GLYCERYL TRINITRATE (NITROLINGUAL), TRAMADOL and FLUTICASONE PROPIONATE (FLUTINASE POLYNEX) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (left arm could not lift it above shoulder), MYALGIA (left arm could not lift it above shoulder without severe pain), INFLUENZA LIKE ILLNESS (flu like symptoms the first day), MIGRAINE (migraine that night (history of migraines), RASH PRURITIC (rash on her back, itched really bad), PALPITATIONS (felt like my heart was growing) and LIMB INJURY (index finger "split open" by the cuticle). At the time of the report, MOBILITY DECREASED (left arm could not lift it above shoulder), MYALGIA (left arm could not lift it above shoulder without severe pain), INFLUENZA LIKE ILLNESS (flu like symptoms the first day), MIGRAINE (migraine that night (history of migraines), RASH PRURITIC (rash on her back, itched really bad), PALPITATIONS (felt like my heart was growing) and LIMB INJURY (index finger "split open" by the cuticle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having a reaction) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced VACCINATION COMPLICATION (Having a reaction). At the time of the report, VACCINATION COMPLICATION (Having a reaction) outcome was unknown. No concomitant medications were reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-110031 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2021-110031:Case for mother.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Migraine
Clinical narrative: migraines for 3 days; still not up to speed; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines for 3 days) and FEELING ABNORMAL (still not up to speed) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced MIGRAINE (migraines for 3 days) and FEELING ABNORMAL (still not up to speed). On 04-Apr-2021, MIGRAINE (migraines for 3 days) outcome was unknown. At the time of the report, FEELING ABNORMAL (still not up to speed) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling
Clinical narrative: Hard at site of injection; Swollen underneath site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard at site of injection) and VACCINATION SITE SWELLING (Swollen underneath site of injection) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE INDURATION (Hard at site of injection) and VACCINATION SITE SWELLING (Swollen underneath site of injection). At the time of the report, VACCINATION SITE INDURATION (Hard at site of injection) and VACCINATION SITE SWELLING (Swollen underneath site of injection) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Limb discomfort, Lymphadenopathy, Vision blurred
Clinical narrative: flu like symptoms; problems with vision seemed blurry at time for a couple days; lymph's were swollen in neck and even more swollen after shots; arm is a mess; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VISION BLURRED (problems with vision seemed blurry at time for a couple days), LYMPHADENOPATHY (lymph's were swollen in neck and even more swollen after shots) and LIMB DISCOMFORT (arm is a mess) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included BUDESONIDE (PULMICORT), NITROGLYCERIN, TRAMADOL and FLUTICASONE PROPIONATE (FLUTINASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VISION BLURRED (problems with vision seemed blurry at time for a couple days), LYMPHADENOPATHY (lymph's were swollen in neck and even more swollen after shots) and LIMB DISCOMFORT (arm is a mess). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and LIMB DISCOMFORT (arm is a mess) outcome was unknown and VISION BLURRED (problems with vision seemed blurry at time for a couple days) and LYMPHADENOPATHY (lymph's were swollen in neck and even more swollen after shots) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-110469 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vaccine leaked down patient arm; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Vaccine leaked down patient arm) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Vaccine leaked down patient arm). At the time of the report, INCORRECT DOSE ADMINISTERED (Vaccine leaked down patient arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided. Concomitants were not reported.  Action taken with mRNA-1273 in response to the events was  not applicable.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Expired product administered
Clinical narrative: Second dose of the Moderna COVID-19 vaccine was expired 5 days; Chills; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Second dose of the Moderna COVID-19 vaccine was expired 5 days) and CHILLS (Chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Second dose of the Moderna COVID-19 vaccine was expired 5 days) and CHILLS (Chills). On 30-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Second dose of the Moderna COVID-19 vaccine was expired 5 days) had resolved. At the time of the report, CHILLS (Chills) outcome was unknown.            Relevant concomitant product usage were not reported by the reporter. No treatment details were added. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not experience any symptoms except a sore arm.  Concomitant medications were not reported.  No treatment details were provided    Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received and contains significant information: Vaccination date updated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt sick for a few hours after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick for a few hours after 1st dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concomitant products included Zoloft                                                         anti-anxiety/antidepressant for Antidepressant discontinuation syndrome, Metoprolol                                                     blood pressure medication for Blood pressure.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MALAISE (felt sick for a few hours after 1st dose). At the time of the report, MALAISE (felt sick for a few hours after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-110610 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-110610:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: skin was red/ Skin was angry; swelling is way more pronounced and expanded; Elbow pain, Shoulder pain, 6 out of 10 pain scale; Skin was hot; arm hurts (where she received the vaccine); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Skin was hot), VACCINATION SITE PAIN (arm hurts (where she received the vaccine)), VACCINATION SITE ERYTHEMA (skin was red/ Skin was angry), VACCINATION SITE SWELLING (swelling is way more pronounced and expanded) and ARTHRALGIA (Elbow pain, Shoulder pain, 6 out of 10 pain scale) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Anxiety, Depression NOS and Allergic reaction to analgesics (causes itchiness and nauseous). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety and Depression NOS, METOPROLOL for Blood pressure management.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE PAIN (arm hurts (where she received the vaccine)). On 04-May-2021, the patient experienced VACCINATION SITE WARMTH (Skin was hot). On 05-May-2021, the patient experienced VACCINATION SITE SWELLING (swelling is way more pronounced and expanded) and ARTHRALGIA (Elbow pain, Shoulder pain, 6 out of 10 pain scale). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (skin was red/ Skin was angry). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 4 tablets in the past 18 hours. At the time of the report, VACCINATION SITE WARMTH (Skin was hot), VACCINATION SITE PAIN (arm hurts (where she received the vaccine)), VACCINATION SITE ERYTHEMA (skin was red/ Skin was angry), VACCINATION SITE SWELLING (swelling is way more pronounced and expanded) and ARTHRALGIA (Elbow pain, Shoulder pain, 6 out of 10 pain scale) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MODERNATX, INC.-MOD-2021-110576 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-110576:for 1st dose
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Contusion, Eye colour change, Hyperventilation, Rosacea
Clinical narrative: unstable blood pressure; bruised left finger/ bruised right arm; pink eye; hyperventilated; rosacea; hives; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives), CONTUSION (bruised left finger/ bruised right arm), ROSACEA (rosacea), EYE COLOUR CHANGE (pink eye) and HYPERVENTILATION (hyperventilated) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Drug allergy (Severe allergic reactions to Cefaclor 10 years ago causing near death). Concurrent medical conditions included Blood pressure high, COPD, Arthritis (RA, psoriatic), Osteoporosis (Osteoporosis of hip) and Spinal pain (chronic spinal pain).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VOMITING (vomiting). On 10-Apr-2021, the patient experienced URTICARIA (hives). On 13-Apr-2021, the patient experienced ROSACEA (rosacea). On 16-Apr-2021, the patient experienced EYE COLOUR CHANGE (pink eye) and HYPERVENTILATION (hyperventilated). On 06-May-2021, the patient experienced CONTUSION (bruised left finger/ bruised right arm). On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (unstable blood pressure). At the time of the report, URTICARIA (hives), CONTUSION (bruised left finger/ bruised right arm), ROSACEA (rosacea), EYE COLOUR CHANGE (pink eye), HYPERVENTILATION (hyperventilated), BLOOD PRESSURE ABNORMAL (unstable blood pressure) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported. Treatment information included administration of Decadron injection on 13-Apr-2021 and 16-Apr-2021 for severe allergic reactions.