chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS IN LEG; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had blood clots in leg and was in and out of the hospital but still had the clot (at the time of this report).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210644769-JANSSEN COVID-19 VACCINE-Blood clots in leg. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Computerised tomogram, Headache
Clinical narrative: STOMACH ACHE; HEADACHE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient did not take any medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced stomach ache. On 14-MAR-2021, the subject experienced headache. On 14-APR-2021, Laboratory data included: CT scan (NR: not provided) Not reported, Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: ANXIETY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anxiety was not reported. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Drooling
Clinical narrative: EXCESSIVE DROOLING/SLOBBERING; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes, lisinopril for high blood pressure, and tamsulosin. On JUN-2021, the subject experienced excessive drooling/slobbering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from excessive drooling/slobbering. This report was non-serious.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE GIVEN TO PATIENT 17 YEARS OF AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 20-JUN-2021, the subject experienced vaccine given to subject 17 years of age. On 20-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given to patient 17 years of age and off label use was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pruritus, Pyrexia, Swelling face, Urticaria
Clinical narrative: SWELLING OF THE FACE; GENERALIZED ITCHING; HIVES ALL OVER HER BODY; FEVER; CHILLS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 15-MAY-2021, the subject experienced hives all over her body. On 19-JUN-2021, the subject experienced swelling of the face. On 19-JUN-2021, the subject experienced generalized itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 10-APR-2021, and had not recovered from hives all over her body, swelling of the face, and generalized itching. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered at inappropriate site, Product temperature excursion issue
Clinical narrative: VACCINE FROM A TEMPERATURE EXCURSION WAS ADMINISTERED; VACCINE WAS ADMINISTERED AT A DIFFERENT SITE; TEMPERATURE EXCURSION OF VACCINE PRODUCT; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccine from a temperature excursion was administered, vaccine was administered at a different site, and temperature excursion of vaccine product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion of vaccine product, vaccine from a temperature excursion was administered and vaccine was administered at a different site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site hypoaesthesia, Pain in extremity
Clinical narrative: THE INJECTION SITE FEELS NUMB WHEN RUBBED; WHEN STRETCHES ARM BACK GETS A SHARP NEEDLE LIKE PAIN; RED DOT AT INJECTION SITE; This spontaneous report received from a health care professional concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 07-AUG-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced the injection site feels numb when rubbed, when stretches arm back gets a sharp needle like pain, and red dot at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the red dot at injection site, the injection site feels numb when rubbed and when stretches arm back gets a sharp needle like pain was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Pain in extremity
Clinical narrative: RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non alcohol use, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201ALIA expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced right arm pain. On 21-JUN-2021, Laboratory data included: Pain scale (NR: not provided) 8/10. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Pyrexia
Clinical narrative: FELT HORRIBLE; BODY ON FIRE; MASSIVE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced felt horrible, body on fire, and massive fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt horrible, massive fever and body on fire was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Chest pain, Chills, Heart rate
Clinical narrative: BODY ACHE; CHEST PAIN; ANXIETY; 88 BPM HEART RATE; BODY CHILLS; MUSCLE ACHE; FEVER 102; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-JUN-2021 16:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-JUN-2021, the subject experienced body ache. On 21-JUN-2021, the subject experienced chest pain. On 21-JUN-2021, the subject experienced anxiety. On 21-JUN-2021, the subject experienced 88 bpm heart rate. On 21-JUN-2021, the subject experienced body chills. On 21-JUN-2021, the subject experienced muscle ache. On 21-JUN-2021, the subject experienced fever 102. Laboratory data included: Body temperature (NR: not provided) fever 102, and Heart rate (NR: not provided) 88 BPM heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 102, body ache, chest pain, anxiety, 88 bpm heart rate, body chills and muscle ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHEST PAIN; ANXIETY; 88 BPM HEART RATE; BODY CHILLS; MUSCLE ACHE; FEVER 102; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-JUN-2021 16:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-JUN-2021, the subject experienced body ache. On 21-JUN-2021, the subject experienced chest pain. On 21-JUN-2021, the subject experienced anxiety. On 21-JUN-2021, the subject experienced 88 bpm heart rate. On 21-JUN-2021, the subject experienced body chills. On 21-JUN-2021, the subject experienced muscle ache. On 21-JUN-2021, the subject experienced fever 102. Laboratory data included: Body temperature (NR: not provided) fever 102, and Heart rate (NR: not provided) 88 BPM heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 102, body ache, chest pain, anxiety, 88 bpm heart rate, body chills and muscle ache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Throat irritation
Clinical narrative: ITCHY THROAT/SCRATCHY THROAT (VERY UNCOMFORTABLE); ANXIETY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 22-JUN-2021, the subject experienced itchy throat/scratchy throat (very uncomfortable). On 22-JUN-2021, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy throat/scratchy throat (very uncomfortable), and the outcome of anxiety was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED TO PATIENTS AT 4 HOURS 55 MINUTES, 5 HOURS AND 5 HOURS 20 MINUTES RESPECTIVELY , WHICH WAS STORED OUT AT ROOM TEMPERATURE FOR 5 HOURS; VACCINE WAS STORED OUT FOR 5 HOURS AT ROOM TEMPERATURE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-JUN-2021, the subject experienced vaccine administered to subjects at 4 hours 55 minutes, 5 hours and 5 hours 20 minutes respectively, which was stored out at room temperature for 5 hours. On 22-JUN-2021, the subject experienced vaccine was stored out for 5 hours at room temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patients at 4 hours 55 minutes, 5 hours and 5 hours 20 minutes respectively , which was stored out at room temperature for 5 hours and vaccine was stored out for 5 hours at room temperature was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Tremor
Clinical narrative: CHEST FELT TIGHTER, UNCOMFORTABLE; SHAKING IN BOTH ARMS/HANDS; SHORTNESS OF BREATH; CHEST PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced shortness of breath. On 22-JUN-2021, the subject experienced chest pain. On 22-JUN-2021, the subject experienced chest felt tighter, uncomfortable. On 22-JUN-2021, the subject experienced shaking in both arms/hands. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, chest pain, shaking in both arms/hands, and chest felt tighter, uncomfortable. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS KEPT AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-JUN-2021, the subject experienced vaccine was kept at room temperature for more than 2 hours. On 12-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was kept at room temperature for more than 2 hours and poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210648291 and 20210417942.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Dizziness, Dysphagia
Clinical narrative: Anaphylactic reaction; Heartbeat fast; Hands were shaking; Dizzy and lightheaded; Could not swallow; Flushed; This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rhinitis (She did have severe sinusitis 2 years ago) and Sinuplasty (This responded well to sinuplasty). Concomitant products included BIOTIN, KERATIN (BIOTIN PLUS KERATIN), COLLAGEN BOVINE and LINACLOTIDE (LINZESS) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), TACHYCARDIA (Heartbeat fast), TREMOR (Hands were shaking), DIZZINESS (Dizzy and lightheaded), DYSPHAGIA (Could not swallow) and FLUSHING (Flushed). The patient was treated with EPINEPHRINE 14-Jan-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) 14-Jan-2021 at a dose of 1 dosage form. On 14-Jan-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction), TACHYCARDIA (Heartbeat fast), TREMOR (Hands were shaking), DIZZINESS (Dizzy and lightheaded), DYSPHAGIA (Could not swallow) and FLUSHING (Flushed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood pressure measurement: 106/71 (normal) 106/71. On 14-Jan-2021, Body temperature: 36.6 (normal) 36.6. On 14-Jan-2021, Heart rate: 87 (normal) Temporal pulse 87. On 14-Jan-2021, Oxygen saturation: 98 (normal) 98%. On 14-Jan-2021, Respiratory rate: 18 (Inconclusive) 18 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taken to ER, treated with IV fluid and also IV steroid. Patient was observed for 4 hours, improved completely and discharged form the ER. She was recommended to take epi-pen, vitamin D, vitamin C and zinc.  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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Added medical history, lab data, concomitant medications and new event; updated patient demography and event stop date.; 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate, Oxygen saturation, Respiratory rate, Tachycardia
Clinical narrative: Anaphylactic reaction; Heartbeat fast; Hands were shaking; Dizzy and lightheaded; Could not swallow; Flushed; This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rhinitis (She did have severe sinusitis 2 years ago) and Sinuplasty (This responded well to sinuplasty). Concomitant products included BIOTIN, KERATIN (BIOTIN PLUS KERATIN), COLLAGEN BOVINE and LINACLOTIDE (LINZESS) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), TACHYCARDIA (Heartbeat fast), TREMOR (Hands were shaking), DIZZINESS (Dizzy and lightheaded), DYSPHAGIA (Could not swallow) and FLUSHING (Flushed). The patient was treated with EPINEPHRINE 14-Jan-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) 14-Jan-2021 at a dose of 1 dosage form. On 14-Jan-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction), TACHYCARDIA (Heartbeat fast), TREMOR (Hands were shaking), DIZZINESS (Dizzy and lightheaded), DYSPHAGIA (Could not swallow) and FLUSHING (Flushed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood pressure measurement: 106/71 (normal) 106/71. On 14-Jan-2021, Body temperature: 36.6 (normal) 36.6. On 14-Jan-2021, Heart rate: 87 (normal) Temporal pulse 87. On 14-Jan-2021, Oxygen saturation: 98 (normal) 98%. On 14-Jan-2021, Respiratory rate: 18 (Inconclusive) 18 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taken to ER, treated with IV fluid and also IV steroid. Patient was observed for 4 hours, improved completely and discharged form the ER. She was recommended to take epi-pen, vitamin D, vitamin C and zinc.  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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Added medical history, lab data, concomitant medications and new event; updated patient demography and event stop date.; 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Anaphylactic reaction; Heartbeat fast; Hands were shaking; Dizzy and lightheaded; Could not swallow; Flushed; This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rhinitis (She did have severe sinusitis 2 years ago) and Sinuplasty (This responded well to sinuplasty). Concomitant products included BIOTIN, KERATIN (BIOTIN PLUS KERATIN), COLLAGEN BOVINE and LINACLOTIDE (LINZESS) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), TACHYCARDIA (Heartbeat fast), TREMOR (Hands were shaking), DIZZINESS (Dizzy and lightheaded), DYSPHAGIA (Could not swallow) and FLUSHING (Flushed). The patient was treated with EPINEPHRINE 14-Jan-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) 14-Jan-2021 at a dose of 1 dosage form. On 14-Jan-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction), TACHYCARDIA (Heartbeat fast), TREMOR (Hands were shaking), DIZZINESS (Dizzy and lightheaded), DYSPHAGIA (Could not swallow) and FLUSHING (Flushed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood pressure measurement: 106/71 (normal) 106/71. On 14-Jan-2021, Body temperature: 36.6 (normal) 36.6. On 14-Jan-2021, Heart rate: 87 (normal) Temporal pulse 87. On 14-Jan-2021, Oxygen saturation: 98 (normal) 98%. On 14-Jan-2021, Respiratory rate: 18 (Inconclusive) 18 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taken to ER, treated with IV fluid and also IV steroid. Patient was observed for 4 hours, improved completely and discharged form the ER. She was recommended to take epi-pen, vitamin D, vitamin C and zinc.  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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Added medical history, lab data, concomitant medications and new event; updated patient demography and event stop date.; 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: U
Vaccine: COVID19
Symptoms: Deafness, Tinnitus, Vaccination complication
Clinical narrative: Almost 2000 people had a similar reaction (not the redness)/hearing loss response; Almost 2000 people had a similar reaction (not the redness)/tinnitus; similar reaction; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021. The most recent information was received on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Almost 2000 people had a similar reaction (not the redness)/hearing loss response) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Almost 2000 people had a similar reaction (not the redness)/hearing loss response) (seriousness criterion medically significant), TINNITUS (Almost 2000 people had a similar reaction (not the redness)/tinnitus) and VACCINATION COMPLICATION (similar reaction). At the time of the report, DEAFNESS (Almost 2000 people had a similar reaction (not the redness)/hearing loss response), TINNITUS (Almost 2000 people had a similar reaction (not the redness)/tinnitus) and VACCINATION COMPLICATION (similar reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.  Very limited information regarding these events have been provided at this time.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow- up received  added new events which upgraded the case to serious.; Sender's Comments: Very limited information regarding these events have been provided at this time.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Scleroderma
Clinical narrative: erythematous palms; anxiety; hands swelling; Itchiness; joint pain; muscle aches; Rheumatoid Arthritis; slight elevation of Scleroderma; This spontaneous case was reported by an other health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) and SCLERODERMA (slight elevation of Scleroderma) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Seasonal allergy since 19-May-2021. Concomitant products included AMLODIPINE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced SCLERODERMA (slight elevation of Scleroderma) (seriousness criterion medically significant). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) (seriousness criterion medically significant), PALMAR ERYTHEMA (erythematous palms), ANXIETY (anxiety), PERIPHERAL SWELLING (hands swelling), PRURITUS (Itchiness), ARTHRALGIA (joint pain) and MYALGIA (muscle aches). The patient was treated with PREDNISONE at a dose of 20mg; BUSPIRONE HYDROCHLORIDE (BUSPAR) at a dose of 15mg bid; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and OMEPRAZOLE at a dose of 5mg OD. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis), SCLERODERMA (slight elevation of Scleroderma), PALMAR ERYTHEMA (erythematous palms), ANXIETY (anxiety), PERIPHERAL SWELLING (hands swelling) and MYALGIA (muscle aches) outcome was unknown and PRURITUS (Itchiness) and ARTHRALGIA (joint pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Blood immunoglobulin E: increased (abnormal) Consultation with the Allergist on 19th Mar 2021 recorded high Ig E of 161 and mentioned as seasonal Allergies. On 24-May-2021, Antinuclear antibody: positive ana (Positive) Positive. On 24-May-2021, Rheumatoid factor quantitative: low (Low) low titer level, slight elevation of Scleroderma.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.  The past history of Rheumatoid arthritis is a confounder..   This case was linked to MOD-2021-116524 (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.  The past history of Rheumatoid arthritis is a confounder.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criteria hospitalization and medically significant). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  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-2021-137907 (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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Somnolence, Unresponsive to stimuli
Clinical narrative: Non responsive; Slept the rest of the day; Chills; Extremely fatigued; Fever; She vomitted and totally incapacinated.; This spontaneous case was reported by a consumer and describes the occurrence of UNRESPONSIVE TO STIMULI (Non responsive) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included LISINOPRIL, INSULIN and ATORVASTATIN for an unknown indication.    On 26-May-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNRESPONSIVE TO STIMULI (Non responsive) (seriousness criterion medically significant), SOMNOLENCE (Slept the rest of the day), CHILLS (Chills), FATIGUE (Extremely fatigued), PYREXIA (Fever) and VOMITING (She vomitted and totally incapacinated.). On 27-May-2021, VOMITING (She vomitted and totally incapacinated.) had resolved. At the time of the report, UNRESPONSIVE TO STIMULI (Non responsive), SOMNOLENCE (Slept the rest of the day), CHILLS (Chills), FATIGUE (Extremely fatigued) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  This case concerns a 38-year-old female with a serious unexpected event of unresponsive to stimuli, and nonserious somnolence, chills, fatigue, pyrexia and vomiting. Event latency within 24 hours after mRNA-1273. Based on 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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Added patient demographics height 4'6'' inches, weight 100 pounds, race, ethnic group. Added new medical history diabetic, high blood pressure. Added drug information's start date, dose number, batch number, body site. Added concomitant medications Lisinopril ,Insulin in siding scale, Atorvastatin. Added events were non responsive,extremely fatigued, she slept the rest of the day, vomited. Added event out come recovered.; Sender's Comments: This case concerns a 38-year-old female with a serious unexpected event of unresponsive to stimuli, and nonserious somnolence, chills, fatigue, pyrexia and vomiting. Event latency within 24 hours after mRNA-1273. Based on 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Non responsive; Slept the rest of the day; Chills; Extremely fatigued; Fever; She vomitted and totally incapacinated.; This spontaneous case was reported by a consumer and describes the occurrence of UNRESPONSIVE TO STIMULI (Non responsive) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included LISINOPRIL, INSULIN and ATORVASTATIN for an unknown indication.    On 26-May-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNRESPONSIVE TO STIMULI (Non responsive) (seriousness criterion medically significant), SOMNOLENCE (Slept the rest of the day), CHILLS (Chills), FATIGUE (Extremely fatigued), PYREXIA (Fever) and VOMITING (She vomitted and totally incapacinated.). On 27-May-2021, VOMITING (She vomitted and totally incapacinated.) had resolved. At the time of the report, UNRESPONSIVE TO STIMULI (Non responsive), SOMNOLENCE (Slept the rest of the day), CHILLS (Chills), FATIGUE (Extremely fatigued) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  This case concerns a 38-year-old female with a serious unexpected event of unresponsive to stimuli, and nonserious somnolence, chills, fatigue, pyrexia and vomiting. Event latency within 24 hours after mRNA-1273. Based on 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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Added patient demographics height 4'6'' inches, weight 100 pounds, race, ethnic group. Added new medical history diabetic, high blood pressure. Added drug information's start date, dose number, batch number, body site. Added concomitant medications Lisinopril ,Insulin in siding scale, Atorvastatin. Added events were non responsive,extremely fatigued, she slept the rest of the day, vomited. Added event out come recovered.; Sender's Comments: This case concerns a 38-year-old female with a serious unexpected event of unresponsive to stimuli, and nonserious somnolence, chills, fatigue, pyrexia and vomiting. Event latency within 24 hours after mRNA-1273. Based on 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Seizure
Clinical narrative: convulsions; Uncontrollable movement on her face / Uncontrollable movement of entire body; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsions) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 648B21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant) and DYSKINESIA (Uncontrollable movement on her face / Uncontrollable movement of entire body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 mg. At the time of the report, SEIZURE (convulsions) and DYSKINESIA (Uncontrollable movement on her face / Uncontrollable movement of entire body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that the patient started experiencing uncontrollable movement on her face and entire body, it like convulsions almost. The pharmacist was not sure what she could use to help it but she was told to use Benadryl 25mg. She is still having the symptoms bad.  This case concerns a 26-year-old female with a serious unexpected event of seizure, and non-serious dyskinesia. Event latency 7 days after second dose mRNA-1273. Based on 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: This case concerns a 26-year-old female with a serious unexpected event of seizure, and nonserious dyskinesia. Event latency 7 days after second dose mRNA-1273. Based on 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: M
Vaccine: COVID19
Symptoms: C-reactive protein, Cardiac failure, Ejection fraction
Clinical narrative: Heart failure; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart failure) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Aortic stenosis.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (Heart failure) (seriousness criterion medically significant). At the time of the report, CARDIAC FAILURE (Heart failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, C-reactive protein: 12.1 (High) 12.1 (Normal Level, < 0.5). In June 2021, Ejection fraction: 60 percent (Inconclusive) 60 % in September and 30 percent (Inconclusive) Now 30%.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Very limited information regarding this event has been provided at this time. Further information has been requested. Of note, the patient's medical history of Aortic Stenosis is a confounding factor that may play a possible contributory role.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Of note, the patient's medical history of Aortic Stenosis is a confounding factor that may play a possible contributory role.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Pain in jaw, Rheumatoid arthritis, Swelling
Clinical narrative: RA flares horrible; Pain over her entire body; Swelling over her entire body; Jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA flares horrible) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product SARILUMAB (KEVZARA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 15-Jul-2019, the patient started SARILUMAB (KEVZARA) (Subcutaneous) 200 milligram. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced RHEUMATOID ARTHRITIS (RA flares horrible) (seriousness criterion medically significant), PAIN (Pain over her entire body), SWELLING (Swelling over her entire body) and PAIN IN JAW (Jaw pain). The patient was treated with PREDNISONE at a dose of titrating Prednisone dose like before. At the time of the report, RHEUMATOID ARTHRITIS (RA flares horrible), PAIN (Pain over her entire body), SWELLING (Swelling over her entire body) and PAIN IN JAW (Jaw pain) had resolved.            No concomitant products use was provided.  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. History of rheumatoid arthritis is a known confounder.   This case was linked to MOD-2021-219899 (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. History of rheumatoid arthritis is a known confounder.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Back pain, Hypoaesthesia, Rheumatoid arthritis, Spinal disorder
Clinical narrative: rheumatoid arthritis flare up; hand got numb; issues in spine and collar area; back pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis flare up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and NAPROXEN SODIUM (ALEVE) for an unknown indication.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and NAPROXEN SODIUM (ALEVE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis flare up) (seriousness criterion medically significant), HYPOAESTHESIA (hand got numb), SPINAL DISORDER (issues in spine and collar area) and BACK PAIN (back pain). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis flare up) and HYPOAESTHESIA (hand got numb) had not resolved and SPINAL DISORDER (issues in spine and collar area) and BACK PAIN (back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.  Action taken with co-suspects ADALIMUMAB (HUMIRA) (Subcutaneous) and NAPROXEN SODIUM (ALEVE) (unknown route) was unknown.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.