chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Syncope
Clinical narrative: Vasovagal Syncope; unauthorized age patient, 17 years of age; This spontaneous case was reported by a nurse and describes the occurrence of SYNCOPE (Vasovagal Syncope) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congenital heart disease NOS since 22-May-2003.    On 01-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021 at 2:30 PM, the patient experienced SYNCOPE (Vasovagal Syncope) (seriousness criterion medically significant) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age patient, 17 years of age). On 01-Mar-2021, SYNCOPE (Vasovagal Syncope) had resolved. On 01-Mar-2021 at 2:30 PM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age patient, 17 years of age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SYNCOPE (Vasovagal Syncope) to be unlikely related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age patient, 17 years of age).    No relevant concomitant medications were reported.   The patient did not receive any treatment. The event, SYNCOPE (vasovagal syncope) was an acute episode and recovered quickly within minutes.  Follow-up received on 06-APR-2021 included additional reporter information, date of vaccine administration, patient's race, ethnicity and other relevant medical history, start and dates of product administered and the events, anatomical location, and reporter causality.  This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated syncope reported. The reporter considered SYNCOPE to be unlikely related.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: additional reporter information, date of vaccine administration, patient's race, ethnicity and concurrent condition, additional event - Syncope, onset and stop dates of the event, - Product administered to patient of inappropriate age, injection site, and reporter causality.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated syncope reported.The reporter considered SYNCOPE to be unlikely related.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Blood test, Chest pain, Computerised tomogram
Clinical narrative: chest pain; Shaking legs/ Tremors in hands; legs buckled; anxiety; Weight loss; fell to ground; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain), TREMOR (Shaking legs/ Tremors in hands) and LIMB DISCOMFORT (legs buckled) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced FALL (fell to ground) and WEIGHT DECREASED (Weight loss). On an unknown date, the patient experienced TREMOR (Shaking legs/ Tremors in hands) (seriousness criterion disability), LIMB DISCOMFORT (legs buckled) (seriousness criterion disability) and ANXIETY (anxiety). On 04-Apr-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, TREMOR (Shaking legs/ Tremors in hands), LIMB DISCOMFORT (legs buckled), FALL (fell to ground), ANXIETY (anxiety) and WEIGHT DECREASED (Weight loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) Normal. In March 2021, Computerised tomogram: normal (normal) Normal. In March 2021, Weight: 148 (Inconclusive) Inconclusive. On 06-Apr-2021, Weight: 125 (Inconclusive) Inconclusive. On an unknown date, Blood pressure measurement: elevated (High) BP Elevated. On an unknown date, Heart rate: elevated (High) Elevated.         The patient underwent CAT scan of the stomach, complete gastro work-up and complete blood work up. All tests were result normal. On 3 Apr 2021 he experienced severe chest pain and was transported to the hospital they concluded it was not heart related but he was hospitalized overnight. His BP and heart rate were also elevated.  Concomitant product use was not provided.Treatment information was unknown.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Heart rate, Limb discomfort, Tremor, Weight
Clinical narrative: chest pain; Shaking legs/ Tremors in hands; legs buckled; anxiety; Weight loss; fell to ground; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain), TREMOR (Shaking legs/ Tremors in hands) and LIMB DISCOMFORT (legs buckled) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced FALL (fell to ground) and WEIGHT DECREASED (Weight loss). On an unknown date, the patient experienced TREMOR (Shaking legs/ Tremors in hands) (seriousness criterion disability), LIMB DISCOMFORT (legs buckled) (seriousness criterion disability) and ANXIETY (anxiety). On 04-Apr-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, TREMOR (Shaking legs/ Tremors in hands), LIMB DISCOMFORT (legs buckled), FALL (fell to ground), ANXIETY (anxiety) and WEIGHT DECREASED (Weight loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) Normal. In March 2021, Computerised tomogram: normal (normal) Normal. In March 2021, Weight: 148 (Inconclusive) Inconclusive. On 06-Apr-2021, Weight: 125 (Inconclusive) Inconclusive. On an unknown date, Blood pressure measurement: elevated (High) BP Elevated. On an unknown date, Heart rate: elevated (High) Elevated.         The patient underwent CAT scan of the stomach, complete gastro work-up and complete blood work up. All tests were result normal. On 3 Apr 2021 he experienced severe chest pain and was transported to the hospital they concluded it was not heart related but he was hospitalized overnight. His BP and heart rate were also elevated.  Concomitant product use was not provided.Treatment information was unknown.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: chest pain; Shaking legs/ Tremors in hands; legs buckled; anxiety; Weight loss; fell to ground; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain), TREMOR (Shaking legs/ Tremors in hands) and LIMB DISCOMFORT (legs buckled) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced FALL (fell to ground) and WEIGHT DECREASED (Weight loss). On an unknown date, the patient experienced TREMOR (Shaking legs/ Tremors in hands) (seriousness criterion disability), LIMB DISCOMFORT (legs buckled) (seriousness criterion disability) and ANXIETY (anxiety). On 04-Apr-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, TREMOR (Shaking legs/ Tremors in hands), LIMB DISCOMFORT (legs buckled), FALL (fell to ground), ANXIETY (anxiety) and WEIGHT DECREASED (Weight loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) Normal. In March 2021, Computerised tomogram: normal (normal) Normal. In March 2021, Weight: 148 (Inconclusive) Inconclusive. On 06-Apr-2021, Weight: 125 (Inconclusive) Inconclusive. On an unknown date, Blood pressure measurement: elevated (High) BP Elevated. On an unknown date, Heart rate: elevated (High) Elevated.         The patient underwent CAT scan of the stomach, complete gastro work-up and complete blood work up. All tests were result normal. On 3 Apr 2021 he experienced severe chest pain and was transported to the hospital they concluded it was not heart related but he was hospitalized overnight. His BP and heart rate were also elevated.  Concomitant product use was not provided.Treatment information was unknown.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Facial bones fracture, Fall, Haemorrhage, Loss of consciousness
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (unconscious), HAEMORRHAGE (bleeding from forehead), EPISTAXIS (bleeding from nose), FACIAL BONES FRACTURE (nose is fractured), FALL (fell down from chair on the face down towards floor) and MALAISE (not feeling well) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (unconscious) (seriousness criteria hospitalization and medically significant), HAEMORRHAGE (bleeding from forehead) (seriousness criterion hospitalization), EPISTAXIS (bleeding from nose) (seriousness criterion hospitalization), FACIAL BONES FRACTURE (nose is fractured) (seriousness criteria hospitalization and medically significant), FALL (fell down from chair on the face down towards floor) (seriousness criterion hospitalization) and MALAISE (not feeling well) (seriousness criterion hospitalization). At the time of the report, LOSS OF CONSCIOUSNESS (unconscious), HAEMORRHAGE (bleeding from forehead), EPISTAXIS (bleeding from nose), FACIAL BONES FRACTURE (nose is fractured), FALL (fell down from chair on the face down towards floor) and MALAISE (not feeling well) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not reported. Treatment includes IV; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (unconscious), HAEMORRHAGE (bleeding from forehead), EPISTAXIS (bleeding from nose), FACIAL BONES FRACTURE (nose is fractured), FALL (fell down from chair on the face down towards floor) and MALAISE (not feeling well) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (unconscious) (seriousness criteria hospitalization and medically significant), HAEMORRHAGE (bleeding from forehead) (seriousness criterion hospitalization), EPISTAXIS (bleeding from nose) (seriousness criterion hospitalization), FACIAL BONES FRACTURE (nose is fractured) (seriousness criteria hospitalization and medically significant), FALL (fell down from chair on the face down towards floor) (seriousness criterion hospitalization) and MALAISE (not feeling well) (seriousness criterion hospitalization). At the time of the report, LOSS OF CONSCIOUSNESS (unconscious), HAEMORRHAGE (bleeding from forehead), EPISTAXIS (bleeding from nose), FACIAL BONES FRACTURE (nose is fractured), FALL (fell down from chair on the face down towards floor) and MALAISE (not feeling well) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not reported. Treatment includes IV; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: UNK
Symptoms: Blood glucose, Diabetic ketoacidosis, Drug interaction, Pain in extremity
Clinical narrative: diabetic ketoacidosis; HCP advised that Inkovana is known to interact with vaccines; Sore arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of DIABETIC KETOACIDOSIS (diabetic ketoacidosis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) from January 2021 to an unknown date for Diabetes.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, the patient experienced DIABETIC KETOACIDOSIS (diabetic ketoacidosis) (seriousness criterion life threatening) and DRUG INTERACTION (HCP advised that Inkovana is known to interact with vaccines). At the time of the report, DIABETIC KETOACIDOSIS (diabetic ketoacidosis), PAIN IN EXTREMITY (Sore arm) and DRUG INTERACTION (HCP advised that Inkovana is known to interact with vaccines) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       Treatment included blood sugar monitoring.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decubitus ulcer, Product dose omission issue
Clinical narrative: COVID and COVID Pneumonia; Developed pressure wound; She was due to get 2nd dose on 15Feb2021 which she did not; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID and COVID Pneumonia) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included METOPROLOL, DULOXETINE, CLOPIDOGREL, ACETYLSALICYLIC ACID (ASPIRIN 81), FAMOTIDINE, VITAMIN D3, CLONAZEPAM, ATORVASTATIN, CICLOSPORIN (RESTASIS), IPRATROPIUM, AIRBORNE and ASCORBIC ACID, COLECALCIFEROL, SAMBUCUS NIGRA FRUIT, TOCOPHEROL, ZINC GLUCONATE (AIRBORNE ELDERBERRY) for an unknown indication.    On 15-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 COVID-19 (COVID and COVID Pneumonia) (seriousness criterion hospitalization). On an unknown date, the patient experienced DECUBITUS ULCER (Developed pressure wound) and PRODUCT DOSE OMISSION ISSUE (She was due to get 2nd dose on 15Feb2021 which she did not). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to COVID-19. On 15-Feb-2021, COVID-19 (COVID and COVID Pneumonia) outcome was unknown. At the time of the report, DECUBITUS ULCER (Developed pressure wound) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She was due to get 2nd dose on 15Feb2021 which she did not) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 07-Feb-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion hospitalization prolonged) which was a part of COVID infection. Treatment for the events included remdesivir, dexamethasone, antibody plasma and trimethoprim/sulfamethoxazole for the pressure wound.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Decreased appetite, Dyspnoea, Facial paralysis
Clinical narrative: drooping face; loss of appetite; shortness of breath; rapid pulse; cold sweat; slightly feverish; fatigue; severe joint pain; slept for 13 hours; calves and thighs hurt for 4 day; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (drooping face) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced HYPERSOMNIA (slept for 13 hours) and PAIN IN EXTREMITY (calves and thighs hurt for 4 day). On 20-Mar-2021 at 4:00 PM, the patient experienced FACIAL PARALYSIS (drooping face) (seriousness criterion medically significant), DECREASED APPETITE (loss of appetite), DYSPNOEA (shortness of breath), HEART RATE INCREASED (rapid pulse), COLD SWEAT (cold sweat), PYREXIA (slightly feverish), FATIGUE (fatigue) and ARTHRALGIA (severe joint pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 21-Mar-2021, FACIAL PARALYSIS (drooping face), DECREASED APPETITE (loss of appetite), DYSPNOEA (shortness of breath), HEART RATE INCREASED (rapid pulse), COLD SWEAT (cold sweat), HYPERSOMNIA (slept for 13 hours), PYREXIA (slightly feverish), FATIGUE (fatigue) and ARTHRALGIA (severe joint pain) had resolved. On 24-Mar-2021, PAIN IN EXTREMITY (calves and thighs hurt for 4 day) had resolved.       No concomitant medications were reported.  Treatment included ibuprofen for the event PAIN IN EXTREMITY (calves and thighs hurt for 4 day).   This case was linked to MOD-2021-074831 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Hypersomnia, Pain in extremity, Pyrexia
Clinical narrative: drooping face; loss of appetite; shortness of breath; rapid pulse; cold sweat; slightly feverish; fatigue; severe joint pain; slept for 13 hours; calves and thighs hurt for 4 day; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (drooping face) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced HYPERSOMNIA (slept for 13 hours) and PAIN IN EXTREMITY (calves and thighs hurt for 4 day). On 20-Mar-2021 at 4:00 PM, the patient experienced FACIAL PARALYSIS (drooping face) (seriousness criterion medically significant), DECREASED APPETITE (loss of appetite), DYSPNOEA (shortness of breath), HEART RATE INCREASED (rapid pulse), COLD SWEAT (cold sweat), PYREXIA (slightly feverish), FATIGUE (fatigue) and ARTHRALGIA (severe joint pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 21-Mar-2021, FACIAL PARALYSIS (drooping face), DECREASED APPETITE (loss of appetite), DYSPNOEA (shortness of breath), HEART RATE INCREASED (rapid pulse), COLD SWEAT (cold sweat), HYPERSOMNIA (slept for 13 hours), PYREXIA (slightly feverish), FATIGUE (fatigue) and ARTHRALGIA (severe joint pain) had resolved. On 24-Mar-2021, PAIN IN EXTREMITY (calves and thighs hurt for 4 day) had resolved.       No concomitant medications were reported.  Treatment included ibuprofen for the event PAIN IN EXTREMITY (calves and thighs hurt for 4 day).   This case was linked to MOD-2021-074831 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Swelling face
Clinical narrative: Shingles right eye; Shingles right side of face; swelling left side of face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OPHTHALMIC HERPES ZOSTER (Shingles right eye) and HERPES ZOSTER (Shingles right side of face) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A29A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced OPHTHALMIC HERPES ZOSTER (Shingles right eye) (seriousness criterion medically significant), HERPES ZOSTER (Shingles right side of face) (seriousness criterion intervention required) and SWELLING FACE (swelling left side of face). At the time of the report, OPHTHALMIC HERPES ZOSTER (Shingles right eye), HERPES ZOSTER (Shingles right side of face) and SWELLING FACE (swelling left side of face) outcome was unknown.            No concomitant medication were reported.  On 27 Mar 2021, the patient reported "face blew up". The patient also mentioned that she had no other adverse reactions. The patient went to see the ophthalmologist and dermatologist on 06-Apr-2021 and was prescribed valaciclovir (Valtrex). On 07-Apr-2021, the patient saw another eye specialist and was prescribed prednisone. Treatment included for the events were valaciclovir and prednisone.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-073451 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Myelitis
Clinical narrative: Guillain Barre; Myelitis; could not walk without assistance; had severe leg pain; lower back pain; numbness in his lower extremities; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of BACK PAIN (lower back pain), GAIT DISTURBANCE (could not walk without assistance), HYPOAESTHESIA (numbness in his lower extremities), PAIN IN EXTREMITY (had severe leg pain), GUILLAIN-BARRE SYNDROME (Guillain Barre) and MYELITIS (Myelitis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Myelitis (admitted in the hospital with Gillian barre or myelitis) since 10-Apr-2021.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced BACK PAIN (lower back pain) (seriousness criterion hospitalization) and HYPOAESTHESIA (numbness in his lower extremities) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced GAIT DISTURBANCE (could not walk without assistance) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (had severe leg pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre) (seriousness criteria hospitalization and medically significant) and MYELITIS (Myelitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 10-Apr-2021 due to BACK PAIN, GUILLAIN-BARRE SYNDROME and MYELITIS. At the time of the report, BACK PAIN (lower back pain), GAIT DISTURBANCE (could not walk without assistance), HYPOAESTHESIA (numbness in his lower extremities), PAIN IN EXTREMITY (had severe leg pain), GUILLAIN-BARRE SYNDROME (Guillain Barre) and MYELITIS (Myelitis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 10apr2021, he could not walk without assistance and had severe leg pain then went to the emergency department. Treatment: IV steroids, and IV immunoglobulin.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Guillain Barre; Myelitis; could not walk without assistance; had severe leg pain; lower back pain; numbness in his lower extremities; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of BACK PAIN (lower back pain), GAIT DISTURBANCE (could not walk without assistance), HYPOAESTHESIA (numbness in his lower extremities), PAIN IN EXTREMITY (had severe leg pain), GUILLAIN-BARRE SYNDROME (Guillain Barre) and MYELITIS (Myelitis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Myelitis (admitted in the hospital with Gillian barre or myelitis) since 10-Apr-2021.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced BACK PAIN (lower back pain) (seriousness criterion hospitalization) and HYPOAESTHESIA (numbness in his lower extremities) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced GAIT DISTURBANCE (could not walk without assistance) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (had severe leg pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre) (seriousness criteria hospitalization and medically significant) and MYELITIS (Myelitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 10-Apr-2021 due to BACK PAIN, GUILLAIN-BARRE SYNDROME and MYELITIS. At the time of the report, BACK PAIN (lower back pain), GAIT DISTURBANCE (could not walk without assistance), HYPOAESTHESIA (numbness in his lower extremities), PAIN IN EXTREMITY (had severe leg pain), GUILLAIN-BARRE SYNDROME (Guillain Barre) and MYELITIS (Myelitis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 10apr2021, he could not walk without assistance and had severe leg pain then went to the emergency department. Treatment: IV steroids, and IV immunoglobulin.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021 at 2:00 PM, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event of facial paralysis, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of facial paralysis, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm was sore; This is a spontaneous report from contactable consumer (caregiver on behalf of her mother). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 24Feb2021 (Batch/Lot number: Unknown) as a single dose for COVID-19 immunisation. Medical history included knee pain (knee hurts a lot because of the cold). Concomitant medications were not reported.  The patient experienced her arm was sore on an unspecified. The patient was due to get her second dose, but her knee hurts a lot and she wants to change her appointment. The caregiver reported that after the first dose, only her arm was sore, the knee pain was something else, because of the cold. The outcome of event sore arm was unknown.  No follow-up attempts possible; no request for batch number will be pursued.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing of ears/tinnitus; This is a spontaneous report received from a male contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, on Mar2021 as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced ringing of ears/tinnitus in Mar2021, 5 days after receiving the BNT162b2 vaccine. The clinical outcome of the ringing of ears/tinnitus was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Blood pressure measurement, Blood pressure systolic, Fatigue, Pain
Clinical narrative: fatigue; achiness; increase in blood pressure; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-086275), for BNT162B2. An 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization; and lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 04Jan2021 to 07Jan2021, at 20 mg, daily, then via an unspecified route of administration from 26Jan2021 at 10 mg, unspecified frequency for uterine cancer. Medical history included: uterine cancer and systolic blood pressure greater than 150. Concomitant medications included: lisinopril and amlodipine besylate taken for systolic blood pressure greater than 150, start and stop date were not reported. The patient previously took pembrolizumab (KEYTRUDA) infusions. Patient stated continues to monitor blood pressure and still sees increase in blood pressure. Patient is now taking lisinopril 20 mg in the morning and 20 mg in the evening. Is also taking amlodipine besylate 5 mg for systolic blood pressure greater than 150. Is scheduled to speak with pharmacist next week, and if blood pressure remains consistently greater than 150, then will increase amlodipine to 7.5 mg. Received second COVID vaccine (Pfizer) two weeks ago. Stated is now feeling better this week. Noted with fatigue and achiness all last week. Patient is also scheduled to see gynecological oncologist next week for follow up appointment. Diagnosis C55 Uterine Cancer, LENVIMA 20 mg once daily, start date 04Jan2021, temporarily stopped medication on 07Jan2021, resumed LENVIMA 10 mg on 26Jan2021. The action taken in response to the events for lenvatinib mesilate was unknown. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pain in extremity
Clinical narrative: Flu symptoms; pain in the arm; This is a spontaneous report from a contactable consumer reporting for her mother.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient experienced pain in the arm on 27Feb2021, and flu symptoms on 28Feb2021. The outcome of the events pain in the arm and flu symptoms was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303395 as same reporter/drug, different AE/patients.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes over her arm, stomach, upper thigh and legs; This is a spontaneous report received from Pfizer sponsored program,  from a contactable consumer (Patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 for COVID-19 immunization as dose 1.  The patient had rashes over her arm, stomach, upper thigh and legs on 16Mar2021. The outcome of had rashes over her arm, stomach, upper thigh and legs was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she is not feeling well; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 24Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient called to reschedule her second dose appointment tomorrow (as of 17Mar2021) because she was not feeling well. The clinical outcome of not feeling well was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: False negative investigation result, HIV test, HIV test negative
Clinical narrative: HIV labs which were all negative/ was given a false negative disposition; HIV labs which were all negative/ was given a false negative disposition; This is a spontaneous report from a contactable other health professional (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Dec2020 at 08:30 (first dose, lot number: EK5730) in the arm left and on 12Jan2021 (second dose, lot number: EL3248) in the arm right; both via  an unspecified route of administration as single dose for COVID-19 immunization. Medical history included false positive HIV. No allergies to medications, food, or other products. Concomitant medications included cetirizine; sertraline; and ethinylestradiol, norgestimate (TRI-SPRINTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 06Jan2021 at 08:00, patient had a reactive screening for HIV. The Infectious Disease Specialist has ordered HIV labs which were all negative. At this point, patient was given a false negative disposition. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage (as reported). The patient received the second dose of vaccine on 12Jan2021. Then on 06Mar2021, patient went for a second HIV testing site and tested negative. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.; Sender's Comments: Based on limited information, there is not a reasonable possibility of a causal relationship between the reported events and suspect drug BNT162B2. The case will be reassessed  on follow up information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Approximately 1 week after my vaccination, I began losing hearing in my right ear.  Coincidentally the same side I received my vaccination; This is a spontaneous report received a contactable consumer, the patient. A 52-year-old adult [non-pregnant] female received a single dose (unspecified dose number) of BNT162b2 (solution for injection; Lot provided as unknown and expiry information not reported) via unspecified route in the right arm on 25Mar2021 at 13:30 (at 52-years-old), for COVID-19 immunisation. Relevant medical history included depression. Concomitant medications sans indication, posology and therapy dates included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN) and sulfamethoxazole/ trimethoprim (BACTRIM). The patient previously received treatment for an unspecified indication with codeine and experienced a drug allergy. The patient denied any COVID diagnosis prior to the vaccine. The patient reported that on 29Mar2021 she began to lose hearing in her right ear. The patient noted that it was coincidentally the same side that she received the vaccine on. The event did not result in any visit to an emergency room, physician office or hospital. It was unknown if any treatment was received. The outcome of the event began to lose hearing in her right ear was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy right side of face; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient (patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number En6208), via an unknown route on 15Mar2021 at 12:00 pm (at the age of 60-years-old) at single dose on the left arm for COVID-19 immunization. Medical history was none. The patient did not have allergies to medications, food, or other products. Relevant concomitant medications patient received within 2 weeks of vaccination included pantoprazole 40mg. On 15Mar2021 at 12:00, the patient had Bells Palsy right side of face. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the event. Outcome of the event Bells Palsy right side of face was recovered in 2021.   Follow up attempts are needed. Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Pharyngitis, SARS-CoV-2 test
Clinical narrative: On Saturday, 27Mar, it was Bell's Palsy paralysis of the right side of my face.; By Tuesday, 23Mar, I had an earache and sore throat.; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 67-year-old female patient (who was not pregnant at the time of vaccination), received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6204 and expiry date was not provided), via an intramuscular route of administration, in left arm on 20Mar2021, at 14:30 as single dose for COVID-19 immunisation. Patient's medical history included breast cancer in 2009, gall bladder disorder in 2020, tonsillectomy in 1965, hysterectomy in 1986 and patient had known allergies to Latex, nail polish remover and sensitivity to fragrances. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number: EN6198, and expiry date was not provided), via an intramuscular route of administration in left arm on 27Feb2021, at 12:30 PM as single dose for COVID-19 immunisation. No other vaccination received in past four weeks and no other medications in past two weeks of vaccination. Patient stated that by Tuesday, 23Mar2021 at 05:00, she had an earache and sore throat. On Saturday, 27Mar2021, it was Bell's Palsy paralysis of the right side of her face. As a result, the patient had to visit Emergency room/department or urgent care and physician office visit. The patient has been tested for COVID, post vaccination, on 27March 2021, which resulted as negative. The patient was treated for the adverse events with Prednisone and antiviral medicine. Outcome of the events was not recovered.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Feeling abnormal, Hypoaesthesia oral
Clinical narrative: Bell's palsy; Foggy brain; Loss of feeling in lips and tongue; This is a spontaneous report from a contactable consumer (patient, self-reported). A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 30Mar2021 at 17:30 (age at vaccination was 56 years), as a single dose for COVID-19 immunisation. Patient's medical history included diabetes and cancer survivor. The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 09Mar2021 at 03:00 PM (age at vaccination was 56 years), as a single dose for Covid-19 immunisation. On 31Mar2021 at 09:00, the patient experienced bell's palsy, foggy brain and loss of feeling in lips and tongue. Patient did not receive other vaccines within 4 weeks or prior vaccination. Patient's treatment medications included unspecified steroid for the adverse events. The patient was hospitalized for the events on an unknown date in 2021 (for two and half days). Seriousness of the events was reported as hospitalization. Outcome of events was not recovered.  Information on the lot/batch number has been requested.