chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain, Pelvic pain
Clinical narrative: Started cramping the next day in stomach with it centered around left pelvic area. I left camping and by Saturday and Sunday it worsened in my pelvic area and could only sleep in certain positions. By the time I got home on Sunday it was to the point it would sharp shooting pains in left pelvic area, hurt to sleep and couldn?t stand upright fully, had to love slowly so called to make an appt and they got me in on Tuesday. By then it was slowly starting to get better
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore Arm Chills Fatigue Fever 102.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax normal, Gait disturbance, Hypoaesthesia, Impaired work ability, Laboratory test
Clinical narrative: Transverse Myelitis requiring IV solumedrol 1000 mg daily x 5 days then 32 mg oral BID  weaning by 4 mg daily until off (last dose 4/20/21) Hospitalized x 12 days including rehab being discharged with a walker and previously fully ambulatory 8 weeks physical therapy Off work x 7 weeks Continue to require muscle relaxer at HS Effect to right leg with tightness, numbness to right axilla and side, pain at T1 area to right anterior and posterior, gait effected , but  improving with no support Confirmed was not MS Treated for Guillain Barre post flu vaccine in 2013
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture normal, Magnetic resonance imaging, Muscle tightness, Myelitis transverse, Spinal pain
Clinical narrative: Transverse Myelitis requiring IV solumedrol 1000 mg daily x 5 days then 32 mg oral BID  weaning by 4 mg daily until off (last dose 4/20/21) Hospitalized x 12 days including rehab being discharged with a walker and previously fully ambulatory 8 weeks physical therapy Off work x 7 weeks Continue to require muscle relaxer at HS Effect to right leg with tightness, numbness to right axilla and side, pain at T1 area to right anterior and posterior, gait effected , but  improving with no support Confirmed was not MS Treated for Guillain Barre post flu vaccine in 2013
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Walking aid user, X-ray
Clinical narrative: Transverse Myelitis requiring IV solumedrol 1000 mg daily x 5 days then 32 mg oral BID  weaning by 4 mg daily until off (last dose 4/20/21) Hospitalized x 12 days including rehab being discharged with a walker and previously fully ambulatory 8 weeks physical therapy Off work x 7 weeks Continue to require muscle relaxer at HS Effect to right leg with tightness, numbness to right axilla and side, pain at T1 area to right anterior and posterior, gait effected , but  improving with no support Confirmed was not MS Treated for Guillain Barre post flu vaccine in 2013
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthma, Oxygen saturation
Clinical narrative: Woke up in the morning on March 10, 2021 with asthma symptoms. It continued through the day. Barely able to control with antihistamines and continuous usage of the antihistamines. Saw an allergist approximately March 20, 2021 because the asthma was constant. Doctor did pulse oximeter reading, listened to lungs, sent me home with inhalers. Inhalers helped take the edge off, but certainly did not cure the asthma symptoms, was slightly improving.  Had the 2nd shot 3/27/21, and symptoms got worse again. Asthma continued for another several weeks; continued round the clock antihistamines and inhalers.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Skin warm, Tenderness
Clinical narrative: Redness and swelling of injection site about 2 inches in diameter. Warm to the touch and painful. (2 out of 10 pain scale)
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Hypersomnia, Syncope
Clinical narrative: EXTREME weakness.  Completely collapsed getting out of bed.  Mother called 911, and he was transported to hospital emergency room.  EXTREME mental confusion and after being discharged from hospital colapsed again,  Had two people get him to bed, and them he slept without moving an inch from about 6AM until 11PM without going to bathroom, eating, or even rolling over.  When he woke up, he yelled out to us in another room.  He told us he was hungry.  We took him food, but he was too weak to even hold the spoon or hold up his head.  We had to hold up his head and spoon feed him.  He went back to sleep, and he slept for almost 24 hours more.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea, headache, for the 3 days following the vaccination.  No professional medical care was received, stayed home and took over the counter medications.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling hot, General physical condition abnormal, Headache
Clinical narrative: Bobby aches, headache, warm sensation all over body, accompanied by intermittent chills, Nausea, dizziness. No Fever
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Bobby aches, headache, warm sensation all over body, accompanied by intermittent chills, Nausea, dizziness. No Fever
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysphagia, Dyspnoea, Eye pain, Eye swelling
Clinical narrative: Started in the right face facial numbness and paralysis, mouth uneven, swelling, difficult to speech, swelling and numbness around my mouth, problems to swallow, breathing problems, difficult to walk. Hours after been hospitalized the paralysis affected the left side and stays there. The vision problems due swelling , pain and unable to close the left eye.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid function disorder, Facial asymmetry, Facial paralysis, Gait disturbance, Hemiplegia
Clinical narrative: Started in the right face facial numbness and paralysis, mouth uneven, swelling, difficult to speech, swelling and numbness around my mouth, problems to swallow, breathing problems, difficult to walk. Hours after been hospitalized the paralysis affected the left side and stays there. The vision problems due swelling , pain and unable to close the left eye.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Laboratory test, Magnetic resonance imaging, Mouth swelling
Clinical narrative: Started in the right face facial numbness and paralysis, mouth uneven, swelling, difficult to speech, swelling and numbness around my mouth, problems to swallow, breathing problems, difficult to walk. Hours after been hospitalized the paralysis affected the left side and stays there. The vision problems due swelling , pain and unable to close the left eye.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Swelling, Visual impairment
Clinical narrative: Started in the right face facial numbness and paralysis, mouth uneven, swelling, difficult to speech, swelling and numbness around my mouth, problems to swallow, breathing problems, difficult to walk. Hours after been hospitalized the paralysis affected the left side and stays there. The vision problems due swelling , pain and unable to close the left eye.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: given to patients after those doses had been stored in the freezer; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number L4RD3, expiry date 8th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The Shingrix dose was stored in the freezer and patient received Shingrix vaccine, which led to incorrect storage of drug. No more information available at the time of reporting.  The reporter consented to follow up by email. This case was 1 of 7 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169172:Same reporter US-GLAXOSMITHKLINE-US2021AMR170441:Same reporter US-GLAXOSMITHKLINE-US2021AMR170442:Same reporter US-GLAXOSMITHKLINE-US2021AMR170443:Same reporter US-GLAXOSMITHKLINE-US2021AMR170444:Same reporter US-GLAXOSMITHKLINE-US2021AMR170446:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: given to patients after those doses had been stored in the freezer; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number L4RD3, expiry date 8th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The Shingrix dose was stored in the freezer and patient received Shingrix vaccine, which led to incorrect storage of drug. No more information available at the time of reporting.  The reporter consented to follow up by email. This case was 1 of 7 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169172:Same reporter US-GLAXOSMITHKLINE-US2021AMR170441:Same reporter US-GLAXOSMITHKLINE-US2021AMR170442:Same reporter US-GLAXOSMITHKLINE-US2021AMR170443:Same reporter US-GLAXOSMITHKLINE-US2021AMR170444:Same reporter US-GLAXOSMITHKLINE-US2021AMR170445:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: given to patients after those doses had been stored in the freezer; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number L4RD3, expiry date 8th October 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The Shingrix dose was stored in the freezer and the patient received that Shingrix vaccine, which led to incorrect storage of drug. No more information available at the time of reporting.  The reporter consented to follow up. This case was 1 of 7 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169172:Same reporter US-GLAXOSMITHKLINE-US2021AMR170444:Same reporter US-GLAXOSMITHKLINE-US2021AMR170442:Same reporter US-GLAXOSMITHKLINE-US2021AMR170446:Same reporter US-GLAXOSMITHKLINE-US2021AMR170443:Same reporter US-GLAXOSMITHKLINE-US2021AMR170445:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: given to patients after those doses had been stored in the freezer; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number L4RD3, expiry date 8th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional case details were provided as follows: The age at vaccination was not reported.  Health care professional reported that a dose of Shingrix were given to patient after the doses had been stored in the freezer which led to incorrect storage of drug.  No more information available at the moment of call. The reporter consented to follow up by email. This case was 1 of 7 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170443:Same reporter US-GLAXOSMITHKLINE-US2021AMR170446:Same reporter US-GLAXOSMITHKLINE-US2021AMR170444:Same reporter US-GLAXOSMITHKLINE-US2021AMR170442:Same reporter US-GLAXOSMITHKLINE-US2021AMR170441:Same reporter US-GLAXOSMITHKLINE-US2021AMR170445:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: administered Shingrix Diluent only; administered Shingrix Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 41 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Single component of a two-component product administered
Clinical narrative: administered Shingrix Diluent only; administered Shingrix Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 41 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Candida infection, Dysgeusia, Immediate post-injection reaction, Injection site rash
Clinical narrative: COVID-arm (egg shaped rash that showed up after two weeks post first dose and lasted for a; metallic taste right away; burning tongue; All of her Vitamin B got wiped out; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSGEUSIA (metallic taste right away), TONGUE DISCOMFORT (burning tongue), VITAMIN B12 DECREASED (All of her Vitamin B got wiped out) and VACCINATION SITE RASH (COVID-arm (egg shaped rash that showed up after two weeks post first dose and lasted for a) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), LEVOTHYROXINE, ESTRADIOL (ESTROGEN), URSODEOXYCHOLIC ACID (LEVALON [URSODEOXYCHOLIC ACID]), DICYCLOVERINE HYDROCHLORIDE (BENTYL) and VITAMIN B COMPLEX for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 06-Jan-2021, the patient experienced DYSGEUSIA (metallic taste right away), TONGUE DISCOMFORT (burning tongue) and VITAMIN B12 DECREASED (All of her Vitamin B got wiped out). On 20-Jan-2021, the patient experienced VACCINATION SITE RASH (COVID-arm (egg shaped rash that showed up after two weeks post first dose and lasted for a). On 27-Jan-2021, VACCINATION SITE RASH (COVID-arm (egg shaped rash that showed up after two weeks post first dose and lasted for a) outcome was unknown. At the time of the report, DYSGEUSIA (metallic taste right away), TONGUE DISCOMFORT (burning tongue) and VITAMIN B12 DECREASED (All of her Vitamin B got wiped out) outcome was unknown. Not Provided          Patient took Alpha Lipoic Sustain for her burning tongue.since pandemic, patient has not had to use any of her  nebulizers.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Tongue discomfort, Vaccination site rash, Vitamin B12 decreased
Clinical narrative: COVID-arm (egg shaped rash that showed up after two weeks post first dose and lasted for a; metallic taste right away; burning tongue; All of her Vitamin B got wiped out; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSGEUSIA (metallic taste right away), TONGUE DISCOMFORT (burning tongue), VITAMIN B12 DECREASED (All of her Vitamin B got wiped out) and VACCINATION SITE RASH (COVID-arm (egg shaped rash that showed up after two weeks post first dose and lasted for a) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), LEVOTHYROXINE, ESTRADIOL (ESTROGEN), URSODEOXYCHOLIC ACID (LEVALON [URSODEOXYCHOLIC ACID]), DICYCLOVERINE HYDROCHLORIDE (BENTYL) and VITAMIN B COMPLEX for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 06-Jan-2021, the patient experienced DYSGEUSIA (metallic taste right away), TONGUE DISCOMFORT (burning tongue) and VITAMIN B12 DECREASED (All of her Vitamin B got wiped out). On 20-Jan-2021, the patient experienced VACCINATION SITE RASH (COVID-arm (egg shaped rash that showed up after two weeks post first dose and lasted for a). On 27-Jan-2021, VACCINATION SITE RASH (COVID-arm (egg shaped rash that showed up after two weeks post first dose and lasted for a) outcome was unknown. At the time of the report, DYSGEUSIA (metallic taste right away), TONGUE DISCOMFORT (burning tongue) and VITAMIN B12 DECREASED (All of her Vitamin B got wiped out) outcome was unknown. Not Provided          Patient took Alpha Lipoic Sustain for her burning tongue.since pandemic, patient has not had to use any of her  nebulizers.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Injection site erythema, Injection site pain, Injection site swelling, Muscular weakness
Clinical narrative: arm pain; arm muscle weakness; arm swelling; diarrhea; Itchy at the spot of injection; headache; urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (urticaria), PAIN IN EXTREMITY (arm pain), MUSCULAR WEAKNESS (arm muscle weakness), SWELLING (arm swelling) and DIARRHEA (diarrhea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for Hypothyroidism.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (urticaria). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), MUSCULAR WEAKNESS (arm muscle weakness), SWELLING (arm swelling), DIARRHEA (diarrhea), INJECTION SITE PRURITUS (Itchy at the spot of injection) and HEADACHE (headache). The patient was treated with DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) ongoing since an unknown date at a dose of 1 dosage form, gel. On 03-May-2021, SWELLING (arm swelling) had resolved. At the time of the report, URTICARIA (urticaria), DIARRHEA (diarrhea), INJECTION SITE PRURITUS (Itchy at the spot of injection) and HEADACHE (headache) had resolved and PAIN IN EXTREMITY (arm pain) and MUSCULAR WEAKNESS (arm muscle weakness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter said that patient took antihistamine as treatment medication.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Skin warm, Urticaria
Clinical narrative: arm pain; arm muscle weakness; arm swelling; diarrhea; Itchy at the spot of injection; headache; urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (urticaria), PAIN IN EXTREMITY (arm pain), MUSCULAR WEAKNESS (arm muscle weakness), SWELLING (arm swelling) and DIARRHEA (diarrhea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for Hypothyroidism.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (urticaria). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), MUSCULAR WEAKNESS (arm muscle weakness), SWELLING (arm swelling), DIARRHEA (diarrhea), INJECTION SITE PRURITUS (Itchy at the spot of injection) and HEADACHE (headache). The patient was treated with DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) ongoing since an unknown date at a dose of 1 dosage form, gel. On 03-May-2021, SWELLING (arm swelling) had resolved. At the time of the report, URTICARIA (urticaria), DIARRHEA (diarrhea), INJECTION SITE PRURITUS (Itchy at the spot of injection) and HEADACHE (headache) had resolved and PAIN IN EXTREMITY (arm pain) and MUSCULAR WEAKNESS (arm muscle weakness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter said that patient took antihistamine as treatment medication.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Injection site pruritus, Muscular weakness, Pain in extremity
Clinical narrative: arm pain; arm muscle weakness; arm swelling; diarrhea; Itchy at the spot of injection; headache; urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (urticaria), PAIN IN EXTREMITY (arm pain), MUSCULAR WEAKNESS (arm muscle weakness), SWELLING (arm swelling) and DIARRHEA (diarrhea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for Hypothyroidism.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (urticaria). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), MUSCULAR WEAKNESS (arm muscle weakness), SWELLING (arm swelling), DIARRHEA (diarrhea), INJECTION SITE PRURITUS (Itchy at the spot of injection) and HEADACHE (headache). The patient was treated with DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) ongoing since an unknown date at a dose of 1 dosage form, gel. On 03-May-2021, SWELLING (arm swelling) had resolved. At the time of the report, URTICARIA (urticaria), DIARRHEA (diarrhea), INJECTION SITE PRURITUS (Itchy at the spot of injection) and HEADACHE (headache) had resolved and PAIN IN EXTREMITY (arm pain) and MUSCULAR WEAKNESS (arm muscle weakness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter said that patient took antihistamine as treatment medication.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: arm pain; arm muscle weakness; arm swelling; diarrhea; Itchy at the spot of injection; headache; urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (urticaria), PAIN IN EXTREMITY (arm pain), MUSCULAR WEAKNESS (arm muscle weakness), SWELLING (arm swelling) and DIARRHEA (diarrhea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for Hypothyroidism.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (urticaria). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), MUSCULAR WEAKNESS (arm muscle weakness), SWELLING (arm swelling), DIARRHEA (diarrhea), INJECTION SITE PRURITUS (Itchy at the spot of injection) and HEADACHE (headache). The patient was treated with DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) ongoing since an unknown date at a dose of 1 dosage form, gel. On 03-May-2021, SWELLING (arm swelling) had resolved. At the time of the report, URTICARIA (urticaria), DIARRHEA (diarrhea), INJECTION SITE PRURITUS (Itchy at the spot of injection) and HEADACHE (headache) had resolved and PAIN IN EXTREMITY (arm pain) and MUSCULAR WEAKNESS (arm muscle weakness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter said that patient took antihistamine as treatment medication.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test normal, Chills, Dizziness, Fatigue
Clinical narrative: Could hardly make it to chair to sit down; dry heaves; profuse sweating; dizziness; weakness; fever; arm pain at injection site; nausea; fatigue; headache; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSKINESIA (Could hardly make it to chair to sit down), RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), DIZZINESS (dizziness) and ASTHENIA (weakness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Palpitations, Heart valve replacement since 05-Jun-2014 and Sulfonamide allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Anticoagulant therapy, PARACETAMOL (TYLENOL) for Arthritis, CALCIUM for Bone disorder, METOPROLOL and FISH OIL for Heart disorder, GLUCOSAMINE & CHONDORITIN for Joint disorder, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication, FENOFIBRATE (LIPOTHIN).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 10-Mar-2021, the patient experienced DYSKINESIA (Could hardly make it to chair to sit down), RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), DIZZINESS (dizziness), ASTHENIA (weakness), PYREXIA (fever), VACCINATION SITE PAIN (arm pain at injection site), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (headache). On 10-Mar-2021, RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), CHILLS (chills) and NAUSEA (nausea) had resolved. On 19-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue) and HEADACHE (headache) had resolved with sequelae, ASTHENIA (weakness), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain at injection site) had resolved. At the time of the report, DYSKINESIA (Could hardly make it to chair to sit down) had not resolved.            Treatment medications were not provided by reporter.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: Could hardly make it to chair to sit down; dry heaves; profuse sweating; dizziness; weakness; fever; arm pain at injection site; nausea; fatigue; headache; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSKINESIA (Could hardly make it to chair to sit down), RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), DIZZINESS (dizziness) and ASTHENIA (weakness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Palpitations, Heart valve replacement since 05-Jun-2014 and Sulfonamide allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Anticoagulant therapy, PARACETAMOL (TYLENOL) for Arthritis, CALCIUM for Bone disorder, METOPROLOL and FISH OIL for Heart disorder, GLUCOSAMINE & CHONDORITIN for Joint disorder, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication, FENOFIBRATE (LIPOTHIN).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 10-Mar-2021, the patient experienced DYSKINESIA (Could hardly make it to chair to sit down), RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), DIZZINESS (dizziness), ASTHENIA (weakness), PYREXIA (fever), VACCINATION SITE PAIN (arm pain at injection site), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (headache). On 10-Mar-2021, RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), CHILLS (chills) and NAUSEA (nausea) had resolved. On 19-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue) and HEADACHE (headache) had resolved with sequelae, ASTHENIA (weakness), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain at injection site) had resolved. At the time of the report, DYSKINESIA (Could hardly make it to chair to sit down) had not resolved.            Treatment medications were not provided by reporter.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Retching, Vomiting, X-ray
Clinical narrative: Could hardly make it to chair to sit down; dry heaves; profuse sweating; dizziness; weakness; fever; arm pain at injection site; nausea; fatigue; headache; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSKINESIA (Could hardly make it to chair to sit down), RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), DIZZINESS (dizziness) and ASTHENIA (weakness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Palpitations, Heart valve replacement since 05-Jun-2014 and Sulfonamide allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Anticoagulant therapy, PARACETAMOL (TYLENOL) for Arthritis, CALCIUM for Bone disorder, METOPROLOL and FISH OIL for Heart disorder, GLUCOSAMINE & CHONDORITIN for Joint disorder, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication, FENOFIBRATE (LIPOTHIN).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 10-Mar-2021, the patient experienced DYSKINESIA (Could hardly make it to chair to sit down), RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), DIZZINESS (dizziness), ASTHENIA (weakness), PYREXIA (fever), VACCINATION SITE PAIN (arm pain at injection site), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (headache). On 10-Mar-2021, RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), CHILLS (chills) and NAUSEA (nausea) had resolved. On 19-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue) and HEADACHE (headache) had resolved with sequelae, ASTHENIA (weakness), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain at injection site) had resolved. At the time of the report, DYSKINESIA (Could hardly make it to chair to sit down) had not resolved.            Treatment medications were not provided by reporter.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyskinesia, Fatigue
Clinical narrative: Could hardly make it to chair to sit down; dry heaves; profuse sweating; dizziness; weakness; fever; arm pain at injection site; nausea; fatigue; headache; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSKINESIA (Could hardly make it to chair to sit down), RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), DIZZINESS (dizziness) and ASTHENIA (weakness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Palpitations, Heart valve replacement since 05-Jun-2014 and Sulfonamide allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Anticoagulant therapy, PARACETAMOL (TYLENOL) for Arthritis, CALCIUM for Bone disorder, METOPROLOL and FISH OIL for Heart disorder, GLUCOSAMINE & CHONDORITIN for Joint disorder, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication, FENOFIBRATE (LIPOTHIN).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 10-Mar-2021, the patient experienced DYSKINESIA (Could hardly make it to chair to sit down), RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), DIZZINESS (dizziness), ASTHENIA (weakness), PYREXIA (fever), VACCINATION SITE PAIN (arm pain at injection site), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (headache). On 10-Mar-2021, RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), CHILLS (chills) and NAUSEA (nausea) had resolved. On 19-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue) and HEADACHE (headache) had resolved with sequelae, ASTHENIA (weakness), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain at injection site) had resolved. At the time of the report, DYSKINESIA (Could hardly make it to chair to sit down) had not resolved.            Treatment medications were not provided by reporter.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pyrexia, Retching
Clinical narrative: Could hardly make it to chair to sit down; dry heaves; profuse sweating; dizziness; weakness; fever; arm pain at injection site; nausea; fatigue; headache; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSKINESIA (Could hardly make it to chair to sit down), RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), DIZZINESS (dizziness) and ASTHENIA (weakness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Palpitations, Heart valve replacement since 05-Jun-2014 and Sulfonamide allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Anticoagulant therapy, PARACETAMOL (TYLENOL) for Arthritis, CALCIUM for Bone disorder, METOPROLOL and FISH OIL for Heart disorder, GLUCOSAMINE & CHONDORITIN for Joint disorder, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication, FENOFIBRATE (LIPOTHIN).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 10-Mar-2021, the patient experienced DYSKINESIA (Could hardly make it to chair to sit down), RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), DIZZINESS (dizziness), ASTHENIA (weakness), PYREXIA (fever), VACCINATION SITE PAIN (arm pain at injection site), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (headache). On 10-Mar-2021, RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), CHILLS (chills) and NAUSEA (nausea) had resolved. On 19-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue) and HEADACHE (headache) had resolved with sequelae, ASTHENIA (weakness), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain at injection site) had resolved. At the time of the report, DYSKINESIA (Could hardly make it to chair to sit down) had not resolved.            Treatment medications were not provided by reporter.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Could hardly make it to chair to sit down; dry heaves; profuse sweating; dizziness; weakness; fever; arm pain at injection site; nausea; fatigue; headache; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSKINESIA (Could hardly make it to chair to sit down), RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), DIZZINESS (dizziness) and ASTHENIA (weakness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Palpitations, Heart valve replacement since 05-Jun-2014 and Sulfonamide allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Anticoagulant therapy, PARACETAMOL (TYLENOL) for Arthritis, CALCIUM for Bone disorder, METOPROLOL and FISH OIL for Heart disorder, GLUCOSAMINE & CHONDORITIN for Joint disorder, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication, FENOFIBRATE (LIPOTHIN).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 10-Mar-2021, the patient experienced DYSKINESIA (Could hardly make it to chair to sit down), RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), DIZZINESS (dizziness), ASTHENIA (weakness), PYREXIA (fever), VACCINATION SITE PAIN (arm pain at injection site), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (headache). On 10-Mar-2021, RETCHING (dry heaves), HYPERHIDROSIS (profuse sweating), CHILLS (chills) and NAUSEA (nausea) had resolved. On 19-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue) and HEADACHE (headache) had resolved with sequelae, ASTHENIA (weakness), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain at injection site) had resolved. At the time of the report, DYSKINESIA (Could hardly make it to chair to sit down) had not resolved.            Treatment medications were not provided by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dizziness, Fatigue, Feeling abnormal, Hypotension
Clinical narrative: Tongue started swelling; Lips started swelling; Felt Dizzy; Felt Drunk; Blood pressure dropped; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue started swelling), LIP SWELLING (Lips started swelling), DIZZINESS (Felt Dizzy), FEELING DRUNK (Felt Drunk) and BLOOD PRESSURE DECREASED (Blood pressure dropped) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Food allergy (allergic to garlic, strawberry) since an unknown date, Allergy to nuts (peanut) since an unknown date, Allergy to molds since an unknown date, Allergy to animals (dogs, cats) since an unknown date, Pollen allergy since an unknown date, Grass allergy since an unknown date and Dust allergy since an unknown date.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 23-Mar-2021, the patient experienced SWOLLEN TONGUE (Tongue started swelling). 23-Mar-2021, the patient experienced LIP SWELLING (Lips started swelling), DIZZINESS (Felt Dizzy), FEELING DRUNK (Felt Drunk) and BLOOD PRESSURE DECREASED (Blood pressure dropped). On 24-Mar-2021, SWOLLEN TONGUE (Tongue started swelling) and LIP SWELLING (Lips started swelling) had resolved. On 26-Mar-2021, DIZZINESS (Felt Dizzy) and BLOOD PRESSURE DECREASED (Blood pressure dropped) had resolved. Benadryl helped with the reaction.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Blood pressure measurement: unk decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer reached out to her physician and cardiologist, who recommended she does not get the second dose of the vaccine. Consumer inquiring if she should get the 2nd dose of the vaccine. Consumer gave safety consent to follow up via phone  There is no product complaint associated with this case   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Loss of personal independence in daily activities, Swollen tongue, Vision blurred
Clinical narrative: Tongue started swelling; Lips started swelling; Felt Dizzy; Felt Drunk; Blood pressure dropped; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue started swelling), LIP SWELLING (Lips started swelling), DIZZINESS (Felt Dizzy), FEELING DRUNK (Felt Drunk) and BLOOD PRESSURE DECREASED (Blood pressure dropped) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Food allergy (allergic to garlic, strawberry) since an unknown date, Allergy to nuts (peanut) since an unknown date, Allergy to molds since an unknown date, Allergy to animals (dogs, cats) since an unknown date, Pollen allergy since an unknown date, Grass allergy since an unknown date and Dust allergy since an unknown date.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 23-Mar-2021, the patient experienced SWOLLEN TONGUE (Tongue started swelling). 23-Mar-2021, the patient experienced LIP SWELLING (Lips started swelling), DIZZINESS (Felt Dizzy), FEELING DRUNK (Felt Drunk) and BLOOD PRESSURE DECREASED (Blood pressure dropped). On 24-Mar-2021, SWOLLEN TONGUE (Tongue started swelling) and LIP SWELLING (Lips started swelling) had resolved. On 26-Mar-2021, DIZZINESS (Felt Dizzy) and BLOOD PRESSURE DECREASED (Blood pressure dropped) had resolved. Benadryl helped with the reaction.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Blood pressure measurement: unk decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer reached out to her physician and cardiologist, who recommended she does not get the second dose of the vaccine. Consumer inquiring if she should get the 2nd dose of the vaccine. Consumer gave safety consent to follow up via phone  There is no product complaint associated with this case   Reporter did not allow further contact