chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: was hospitalized for Guillain Barre Syndrome; numbness in her feet; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st December 2019, 6 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced numbness in feet. On an unknown date, the outcome of the guillain barre syndrome and numbness in feet were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome and numbness in feet to be related to Shingrix.  Additional details wee reported as follows: The case was reported by the patient's spouse. The patient received dose of Shingrix at the end of November 2019 and 6 days later, she was hospitalized for Guillain Barre syndrome. The patient was hospitalized and was in rehabilitation for 7 months and that had not resolved. The patient had ongoing numbness in her feet. The lot number and expiration date were unknown at the time of reporting. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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 not reported, batch number: 1805029 and expiry: unknown) dose was not reported, 1 total administered on 12-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021 the patient had suspected clinical vaccination failure and suspected covid-19 infection. The patient underwent laboratory test included: COVID-19 virus test with result positive The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000190583.; Sender's Comments: V0: 20210846305 -Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 66 year old female of unknown race and ethnicity. 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, expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced symptoms such as loss of taste and lethargy. On an unspecified date in APR-2021, the patient underwent COVID-19 virus test which showed positive result (suspected clinical vaccination failure and suspected COVID-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190700. This case, from the same reporter is linked to 20210846926.; Sender's Comments: V0: 20210846583-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Gait disturbance, Headache, Hemiplegia, Hypoaesthesia
Clinical narrative: BECAME PHYSICALLY RIGHT SIDE PARALYZED (COULD NOT FEEL HALF OF HER BODY); CHEST PAIN; BARELY WALK FLUCTUATES BACK AND FORTH; MIGRAINES; TINGLING; NUMBNESS ALL OVER HER BODY; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 28 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported,1 total, administered on 16-AUG-2021 right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient took vaccine on 16-AUG-2021 since then she experienced chest pain, migraine, headache, tingling, numbness all over her body, fever and can barely walk fluctuates back and forth. On 20-AUG-2021, the patient became physically right side paralyzed (could not feel half of her body). Patient went to emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, migraines, headache, became physically right side paralyzed (could not feel half of her body), tingling, numbness all over her body, fever and barely walk fluctuates back and forth was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210848879- covid-19 vaccine ad26.cov2.s - Became physically right side paralyzed (could not feel half of her body). This event(s) is considered unassessable. The event(s) 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(s).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Paraesthesia, Pyrexia
Clinical narrative: BECAME PHYSICALLY RIGHT SIDE PARALYZED (COULD NOT FEEL HALF OF HER BODY); CHEST PAIN; BARELY WALK FLUCTUATES BACK AND FORTH; MIGRAINES; TINGLING; NUMBNESS ALL OVER HER BODY; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 28 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported,1 total, administered on 16-AUG-2021 right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient took vaccine on 16-AUG-2021 since then she experienced chest pain, migraine, headache, tingling, numbness all over her body, fever and can barely walk fluctuates back and forth. On 20-AUG-2021, the patient became physically right side paralyzed (could not feel half of her body). Patient went to emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, migraines, headache, became physically right side paralyzed (could not feel half of her body), tingling, numbness all over her body, fever and barely walk fluctuates back and forth was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210848879- covid-19 vaccine ad26.cov2.s - Became physically right side paralyzed (could not feel half of her body). This event(s) is considered unassessable. The event(s) 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(s).
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: THROMBUS; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. 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 and expiry Unknown) dose, start therapy date were not reported 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced thrombus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombus was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210848879.; Sender's Comments: V0:20210849013-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  thrombus- This event(s) is considered unassessable. The event(s) 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(s).
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 46 year old Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included: was in previous car accident on 26-FEB-2020 which he now gets therapy for, and concurrent conditions included: hypertension, cocaine abuse (uses occasionally but its not an addiction), alcohol user (beer 2 weeks then he wont drink for 5 to 6 months), and cigarette smoker (10 cigarettes per day), and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 310017, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021, the patient had an appointment at the hospital because of previous car accident and did Covid test which came out positive (suspected covid-19 infection and suspected clinical vaccination failure). The reporter only notified the doctor where he goes and gets his therapy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210849124-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Hypertension, Influenza like illness, Injection site nodule
Clinical narrative: THROAT HAS CLOSED; DIFFICULTY BREATHING; FULL BODY RASH BRIGHT RED AND PUFFY (LIKE A BAD CASE OF POISON IVY); FLU-LIKE SYMPTOMS; KNOT AT INJECTION SITE; HIGH BLOOD PRESSURE; This spontaneous report received from a consumer concerned a 42 year old female of unspecified ethnic origin and race. The patient's height, and weight were not reported.  The patient's concurrent conditions included: sulfa allergy, and penicillin allergy.  The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 19-AUG-2021, the patient experienced flu-like symptoms, headache and fever. On 20-AUG-2021, the patient experienced full body rash bright red and puffy (like a bad case of poison ivy).  On 22-AUG-2021, the patient experienced throat has closed and difficulty breathing On AUG-2021, the patient experienced knot at injection site and high blood pressure Laboratory data included: Blood pressure (NR: not provided) 190/120 mmHg. The patient visited hospital and visited emergency room (8 times). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the full body rash bright red and puffy (like a bad case of poison ivy), difficulty breathing, high blood pressure, knot at injection site, flu-like symptoms and throat has closed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210849527-Covid-19 vaccine ad26.cov2.s- High blood pressure. This event(s) is considered unassessable. The event(s) 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(s).
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Throat tightness
Clinical narrative: THROAT HAS CLOSED; DIFFICULTY BREATHING; FULL BODY RASH BRIGHT RED AND PUFFY (LIKE A BAD CASE OF POISON IVY); FLU-LIKE SYMPTOMS; KNOT AT INJECTION SITE; HIGH BLOOD PRESSURE; This spontaneous report received from a consumer concerned a 42 year old female of unspecified ethnic origin and race. The patient's height, and weight were not reported.  The patient's concurrent conditions included: sulfa allergy, and penicillin allergy.  The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 19-AUG-2021, the patient experienced flu-like symptoms, headache and fever. On 20-AUG-2021, the patient experienced full body rash bright red and puffy (like a bad case of poison ivy).  On 22-AUG-2021, the patient experienced throat has closed and difficulty breathing On AUG-2021, the patient experienced knot at injection site and high blood pressure Laboratory data included: Blood pressure (NR: not provided) 190/120 mmHg. The patient visited hospital and visited emergency room (8 times). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the full body rash bright red and puffy (like a bad case of poison ivy), difficulty breathing, high blood pressure, knot at injection site, flu-like symptoms and throat has closed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210849527-Covid-19 vaccine ad26.cov2.s- High blood pressure. This event(s) is considered unassessable. The event(s) 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(s).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: COULD NOT ACHIEVE AN ERECTION; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. As pre-existing medical histories, patient had been an occasional alcohol user and a non-smoker, patient had no known drug allergies and did not have any drug abuse/illicit drug use. No past condition was reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported, 1 total, administered on 20-AUG-2021 at about 9 AM in the left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-AUG-2021, during the evening, the patient could not achieve an erection after vaccination. Patient stated that "not achieving an erection was "killing me". The patient did not have the vaccine card on him but would provide follow-up on product details. At the time of reporting, it was stated that the patient was planning to set an appointment with doctor later that week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from could not achieve an erection. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210849711-covid-19 vaccine ad26.cov2.s-could not achieve an erection. This event(s) is considered unassessable. The event(s) 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(s).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Feeling abnormal, Headache, Impaired driving ability, Mental disorder
Clinical narrative: PAIN IN CALF AND CHECKED CALF AND SAW A LONG DARK VEIN (DESCRIBED IT AS ONE LONG VEIN 80% OF HIS CALF); HEADACHES (DESCRIBED THEM AS HEAVINESS AND FULLNESS); DOUBLE VISION (COULD NOT READ SUBTITLES WHEN WATCHING A MOVIE); MENTALLY OFF CAN NOT PROCESS; FEELS WEIRD; COULD NOT DRIVE HOME; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: migraines, poison oak allergy, alcohol user, and smoker, and other pre-existing medical conditions included: The patient was very healthy. The patient have no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced double vision (could not read subtitles when watching a movie). On AUG-2021, the patient experienced mentally off can not process. On AUG-2021, the patient experienced feels weird. On AUG-2021, the patient experienced could not drive home. On AUG-2021, the patient experienced headaches (described them as heaviness and fullness). Treatment medications included: paracetamol. On 23-AUG-2021, the patient experienced pain in calf and checked calf and saw a long dark vein (described it as one long vein 80% of his calf). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches (described them as heaviness and fullness), and the outcome of double vision (could not read subtitles when watching a movie), mentally off can not process, feels weird, pain in calf and checked calf and saw a long dark vein (described it as one long vein 80% of his calf) and could not drive home was not reported. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN CALF AND CHECKED CALF AND SAW A LONG DARK VEIN (DESCRIBED IT AS ONE LONG VEIN 80% OF HIS CALF); HEADACHES (DESCRIBED THEM AS HEAVINESS AND FULLNESS); DOUBLE VISION (COULD NOT READ SUBTITLES WHEN WATCHING A MOVIE); MENTALLY OFF CAN NOT PROCESS; FEELS WEIRD; COULD NOT DRIVE HOME; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: migraines, poison oak allergy, alcohol user, and smoker, and other pre-existing medical conditions included: The patient was very healthy. The patient have no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced double vision (could not read subtitles when watching a movie). On AUG-2021, the patient experienced mentally off can not process. On AUG-2021, the patient experienced feels weird. On AUG-2021, the patient experienced could not drive home. On AUG-2021, the patient experienced headaches (described them as heaviness and fullness). Treatment medications included: paracetamol. On 23-AUG-2021, the patient experienced pain in calf and checked calf and saw a long dark vein (described it as one long vein 80% of his calf). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches (described them as heaviness and fullness), and the outcome of double vision (could not read subtitles when watching a movie), mentally off can not process, feels weird, pain in calf and checked calf and saw a long dark vein (described it as one long vein 80% of his calf) and could not drive home was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination complication
Clinical narrative: Does not feel like himself; Chills; A spontaneous report was received from a 50-year-old, male, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills and does not feel like himself.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, a few hours later prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 30 Dec 2020, a few hours after receiving the vaccine, the patient had chills. On 31 Dec 2020, the patient felt fine.  On 01 Jan 2021, he had chills again.  On 02 Jan 2021, the patient stated he does not feel like himself and the chills comes and goes.  Treatment for the events included acetaminophen and ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The events, chills and does not feel like himself, were not resolved at the time of this report.; Reporter'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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 09-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Reporter details updated ( Address): Follow-up contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Wheezing. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WHEEZING (Wheezing). At the time of the report, WHEEZING (Wheezing) had resolved. Not Provided          No treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 65-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 effect (No medical history provided).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm was bruised; arm was swollen; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Arm was bruised), VACCINATION SITE SWELLING (arm was swollen) and VACCINATION SITE PAIN (arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced CONTUSION (Arm was bruised), VACCINATION SITE SWELLING (arm was swollen) and VACCINATION SITE PAIN (arm was sore). At the time of the report, CONTUSION (Arm was bruised), VACCINATION SITE SWELLING (arm was swollen) and VACCINATION SITE PAIN (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Muscular weakness, Myalgia, Pain
Clinical narrative: body ache; headache; chills; muscle ache; muscle weakness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), MYALGIA (muscle ache), MUSCULAR WEAKNESS (muscle weakness), PAIN (body ache) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced CHILLS (chills), MYALGIA (muscle ache) and MUSCULAR WEAKNESS (muscle weakness). On 28-Jan-2021, the patient experienced PAIN (body ache) and HEADACHE (headache). At the time of the report, CHILLS (chills), MYALGIA (muscle ache), MUSCULAR WEAKNESS (muscle weakness), PAIN (body ache) and HEADACHE (headache) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment details included OTC Ibuprofen for 2 days.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Handhurt for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Handhurt for a day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Handhurt for a day). At the time of the report, PAIN IN EXTREMITY (Handhurt for a day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever Cough Congestion Chills Body aches
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever Cough Congestion Chills Body aches
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Late-
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: no adverse medical side effect from moderna vaccine patient denied having previous vaccine, however when reporting moderna vaccination to Department of Health it was discovered that patient received COVID-19 Janssen vaccine on 04/05/2021
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: . reported numbness first jaw to elbow left side then top of head to elbow.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: small rash on stomach developed 2days after vaccine-Mild, Additional Details: rash on stomach & pt couldnt think of anything else that he had done/consumed/encountered that could have caused the rash...
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Condition aggravated, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Shortness of breath; Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vision blurred, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: almost fainted-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt came 08/25/2021 to report that he had a reaction to pfizer vaccine 4-5 hrs after receiving it on 08/12/2021. Pt had blurry vision, was light headed and dizzy which lasted for 5 minutes. Pt states that he almost passed out but never lost consciousness. Pt then had a headache that lasted for 30 mins. Pt was better afterwards and was still able to go to the mall.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Flushing, Hyperhidrosis, Pallor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: patient indicated prior to vaccination that she ususally faints when given shots. we discussed what to expect from vaccination and that i would be right in front w her. I administered the vaccine and she seemed relieved that it was painless. i had her sit down in front of the pharmacy and about 5 min later she alerted me that she felt faint. i stood in front of  her and aked her to put her head down when she collapsed in my arms , was sweating, pale and began to shake, possiby a seizure
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: patient indicated prior to vaccination that she ususally faints when given shots. we discussed what to expect from vaccination and that i would be right in front w her. I administered the vaccine and she seemed relieved that it was painless. i had her sit down in front of the pharmacy and about 5 min later she alerted me that she felt faint. i stood in front of  her and aked her to put her head down when she collapsed in my arms , was sweating, pale and began to shake, possiby a seizure
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fungal infection, Injection site erythema, Injection site pruritus, Lethargy
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Had a rash under right breast after 1st dose; PCP diagnosed as fungal infection and prescribed a powder.  Told patient to follow up if she had a reaction after 2nd dose.  itching on injection site arm up to neck and lethargy on day 3 after 2nd dose.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Had a rash under right breast after 1st dose; PCP diagnosed as fungal infection and prescribed a powder.  Told patient to follow up if she had a reaction after 2nd dose.  itching on injection site arm up to neck and lethargy on day 3 after 2nd dose.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza A virus test, Influenza virus test, Nasal congestion, Oropharyngeal pain
Clinical narrative: 1. Cough  2. Sore throat  3. Nasal congestion with rhinorrhea  4. At increased risk of exposure to COVID-19 virus  5. Fever, unspecified fever cause  6. Generalized body aches
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: 1. Cough  2. Sore throat  3. Nasal congestion with rhinorrhea  4. At increased risk of exposure to COVID-19 virus  5. Fever, unspecified fever cause  6. Generalized body aches
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Breast discomfort, Breast induration, Breast swelling, Sciatica
Clinical narrative: 8-8-21 I was up all night with sciatica pain, which I've never had before.  8-9-21 I felt like my breasts were bruised. They swelled up and were as hard as a softball. I also missed my monthly cycle. I still have not started.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: 8-8-21 I was up all night with sciatica pain, which I've never had before.  8-9-21 I felt like my breasts were bruised. They swelled up and were as hard as a softball. I also missed my monthly cycle. I still have not started.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Headache, Migraine
Clinical narrative: Systemic: Headache-Severe, Additional Details: Stated she had a mild headaache for several days post injection but then began experiancing severe migraines. Stated that CT scan run by doctor returned with normal results. States she has never had migraines before receiving covid vaccination.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Nasal congestion, Nausea, Pain
Clinical narrative: cough, nasal congestion, body aches, congestion in my chest, dizziness , nausea etc. at times a little vertigo.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test, Vertigo
Clinical narrative: cough, nasal congestion, body aches, congestion in my chest, dizziness , nausea etc. at times a little vertigo.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Oropharyngeal pain, Pruritus, Pyrexia
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: patient also complained of sore throat, muscle aches, fever and chills which started on Sunday 08/22/21.  On Saturday 08/21; she reported initial signs of rash on both arms and chest area which still has not cleared up.  currently taking Benadryl OTC orally and topically for rash on arms and chest area.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: patient also complained of sore throat, muscle aches, fever and chills which started on Sunday 08/22/21.  On Saturday 08/21; she reported initial signs of rash on both arms and chest area which still has not cleared up.  currently taking Benadryl OTC orally and topically for rash on arms and chest area.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, fever, fatigue
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Rash, Rash erythematous, Rash papular
Clinical narrative: Mom calling Covid vaccine second shot 8/10/21, after first vaccine red patch on butt size of nickel, not worse, watched- not gone,  5 days after 2nd vaccine rash all over abd and back, not worse/better, not too worried, raised, can feel, patches and dots, some light red, not itchy, feels tired, couple days throat hurt didn't complain too much, feels fine not, please note anything to do?
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: swellling and hot to touch at injection site-Mild, Additional Details: Patient stated that when she received the 1st injection she experienced a rash on her arm. As soon as this shot was injection she experienced swelling and the injection site was hot to the touch. Patient was given Benadryl and an ice pack was placed on her arm. I sat and monitored the patient until her parents arrived. She confirmed that she was not light headed or was not experiencing anymore side effects.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: hospitalization (non-ICU) dose #1 on 3/16/21 dose #2 on 4/20/21
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Periodic mild stinging at injection site
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Approximately 2 minutes after injection of JnJ vaccine patient fainted.... patient recovered after approximately 30 seconds
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: hospitalization (non-ICU)
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Echocardiogram, Electrocardiogram ambulatory, Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: Ischemic left thalamic Stroke
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait inability, Paralysis
Clinical narrative: Extreme fatigue. Unable to walk. Essentially paralyzed for 24 hours.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Hypoaesthesia, Pain, Palpitations
Clinical narrative: Patient experienced heart palpitations and irregular heartbeat while resting in chair watching TV.  Patient has no previous history of heart issues. Patient regularly tracks his heartbeat, typical at-rest heartbeat is approx 89 bpm. During event, at-rest heartbeat peaked to 120 bpm. Event lasted approximately 4 hours. Patient took several Tylenol which did help to calm down his heart.  Additional side-effects noticed during this time included pain over his entire body, as well as a numbness in his fingers.  Patient still experiencing mild pain across his entire body as of 8:00 AM on 8/26/2021.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Anorectal disorder
Clinical narrative: Enlarged anus, can't hold up poop.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysphagia, Dyspnoea, Pharyngeal swelling
Clinical narrative: About 15 minutes post injection, difficulty swallowing, throat swelling, lightheadness, weak. Took 50 mg of Benadryl, contacted the nurse for assistance. Was given nebulizer treatment of albuterol and Ipratropium. NP stated my throat was swollen and difficulty passing air in right lower lung base. Vitals stable. Sent to ED for evaluation. 5 days of prednisone, every 8 hour dose of 25 mg Benadryl, and emergency inhaler if needed.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: hospitalization (non-ICU)
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: hospitalization (non-ICU)
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anticoagulant therapy, Computerised tomogram abdomen abnormal, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Patient developed acute left upper quadrant severe abdominal pain several days after his second COVID-19 Moderna vaccine shot. Admitted 7/30/21 for CT Abdomen findings that showed diffuse splenic infarcts. Treated with parenteral blood thinner and transitioned to Eliquis (which he is on as of 8/26/21).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Splenic infarction
Clinical narrative: Patient developed acute left upper quadrant severe abdominal pain several days after his second COVID-19 Moderna vaccine shot. Admitted 7/30/21 for CT Abdomen findings that showed diffuse splenic infarcts. Treated with parenteral blood thinner and transitioned to Eliquis (which he is on as of 8/26/21).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Throat irritation
Clinical narrative: Patient received Pfizer COVID vaccine at 7:23am. Reported headache at 7:35am, at 7:49am reported chest tightness and itching in throat. Benadryl administered at 7:53am. V/S 99%, 125/84, 85, 17, 36.3. Lungs clear all lobes. At 8:00 am pt reports relief of symptoms.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: hospitalization (non-ICU)
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain, Somnolence
Clinical narrative: approx 36 hours had fatigue, achy, headache. at 48 hours still feel bad.  Just want to sleep.
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Dizziness, Nausea, Respiratory tract congestion
Clinical narrative: Breakthrough COVID admission in fully vaccinated patient.  Presented with dizziness, nausea, vomiting, 2 week history of cough and congestion.  SpO2 96% on room air
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection, Vomiting
Clinical narrative: Breakthrough COVID admission in fully vaccinated patient.  Presented with dizziness, nausea, vomiting, 2 week history of cough and congestion.  SpO2 96% on room air
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Echocardiogram, Heart rate increased, Oedema peripheral, Skin warm
Clinical narrative: Patient received one dose of Moderna COVID-19 vaccine on July 20, 2021. Diagnosed with DVT on August 25, 2021 via venous doppler. Patient sought medical care after experiencing left lower extremity edema, warmth, tenderness, and elevated heart rate. Patient is unsure exactly when symptoms began.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Ultrasound Doppler abnormal
Clinical narrative: Patient received one dose of Moderna COVID-19 vaccine on July 20, 2021. Diagnosed with DVT on August 25, 2021 via venous doppler. Patient sought medical care after experiencing left lower extremity edema, warmth, tenderness, and elevated heart rate. Patient is unsure exactly when symptoms began.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Paraesthesia
Clinical narrative: ABOUT 30 MINUTES AFTER MY SECOND VACCINE THE LEFT SIDE OF MY BODY STARTED TO FEEL NUMB, TINGLY, AND WARM. SENSATION IS STILL PRESENT THE NEXT DAY WITHOUT IMPROVEMENT
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest X-ray, Computerised tomogram head, Differential white blood cell count, Full blood count
Clinical narrative: Blood Pressure rapidly started going up and pulse did too.  159/111 pulse 103 on 2/19/21 8:54am, continued 169/120 p96 on 2/20/21 5:48am, 162/105 p76 on 2/2021 7:25pm, 201/119 p 85 8:40am Finally was able to see physician at a local Clinic.  She sent me to the emergency room.  They ran a lot of tests but did not give me any test results.  My normal blood pressure ave is 126/88 p 54.  Since then I have had to be on medication for my blood pressure and it is still high and not stable.  Just for the month of August it averages 151/102 P61, Best is 120/82, and worst is 184/115.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Troponin, Urine analysis
Clinical narrative: Blood Pressure rapidly started going up and pulse did too.  159/111 pulse 103 on 2/19/21 8:54am, continued 169/120 p96 on 2/20/21 5:48am, 162/105 p76 on 2/2021 7:25pm, 201/119 p 85 8:40am Finally was able to see physician at a local Clinic.  She sent me to the emergency room.  They ran a lot of tests but did not give me any test results.  My normal blood pressure ave is 126/88 p 54.  Since then I have had to be on medication for my blood pressure and it is still high and not stable.  Just for the month of August it averages 151/102 P61, Best is 120/82, and worst is 184/115.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Myalgia, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Morbiliform rash on extremities and torso appearing on 08/25/2021 and fading by 08/26/2021 Local erythema below injection site. Muscle aches. Low grade temperature.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Shortness of breath,.  Patient, with history of allergies and asthma, said ""my PCP approved me receiving the Pfizer vaccine and I took 2 Benadryl per advise at 7:30 A.M. (Pfizer vaccine administered around 8:47)  9:13 AM Patient reported feeling some shortness of breath and chest tightness and  took 2 puffs of her Albuterol inhaler. Pulse ox- 99%, Pulse-99, BP 128/74 Lungs clear.  9:20 reports ""SOB and chest tightness ""dissipating, but feels jittery.""  She reports that she has been having to use her Albuterol inhaler more frequently during the past 2 weeks due to seasonal allergies. Observed, symptoms improved 9:42 discharged in stable condition and advised to speak with her MD prior to 2nd vaccine.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Deafness, Tinnitus
Clinical narrative: Already have tinnitus and lose of hearing. After 2 days when I woke up the ringing is louder and I have additional hearing lose. It?s been  4 months and  it is not better. The ringing is almost unbearable.