chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Perforated ulcer, Peripheral swelling, Vasodilatation, Vision blurred
Clinical narrative: bleeding perforated ulcers in my stomach; eyes became blurry; left arm became swollen with 2 red lines going up arm, the swelling was in left arm and got the shot in right arm; left arm became swollen with 2 red lines going up arm, the swelling was in left arm and got the shot in right arm; chest pains at night; veins was popped up in (left) arm; wake up gasping for air; not sleeping; stomach pains; This is a spontaneous report from a contactable consumer. This 63-year-old female consumer (patient) reported that: A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 63 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included chronic obstructive pulmonary disease (COPD) because she had smoked since she was 16. The patient was not sleeping before she got the shot. It was all reported on an unspecified date. The patient's concomitant medications included steroid inhalers for COPD. She was a pretty healthy girl. She drinks turmeric tea every day. On an unspecified date, bleeding perforated ulcers in my stomach, eyes became blurry, left arm became swollen with 2 red lines going up arm, the swelling was in left arm and got the shot in right arm, chest pains at night, veins was popped up in (left) arm, wake up gasping for air, not sleeping and stomach pains. It was reported that, the patient stated that she received her first dose of the Pfizer COVID-19 vaccine, and reported the following: (soon after the shot) the patient stated her eyes became blurry and then she goes out to her truck after about 25 minutes and her left arm became swollen with 2 red lines (redness) going up her arm which doesn't even make sense because she got the shot in her right arm. The patient also stated she had bleeding perforated ulcers in her stomach, chest pains at night, her veins were popped up in her left arm and she was not sleeping. She woke up gasping for air because of the chest pains and the stomach pains that are not subsiding. She didn't do that before all of this. She was made to get this vaccine or else she was going to lose her job of 40 years. The patient also stated she wasn't sleeping before she got the shot because of this stupid mandate. She had so much anxiety over this second shot because she was terrified something is going to happen to her. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Chest pain, Dizziness, Dyspnoea, Oxygen saturation decreased
Clinical narrative: ADMITTED TO HOSPITAL 11/4/2021 - 11/7/2021 WITH BILATERAL PULMONARY EMBOLISM WITH LARGE CLOT BURDEN
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: ADMITTED TO HOSPITAL 11/4/2021 - 11/7/2021 WITH BILATERAL PULMONARY EMBOLISM WITH LARGE CLOT BURDEN
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: ADMITTED TO HOSPITAL 11/4/2021 - 11/7/2021 WITH BILATERAL PULMONARY EMBOLISM WITH LARGE CLOT BURDEN
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Cardiac telemetry, Catheterisation cardiac normal, Chest pain, Electrocardiogram
Clinical narrative: Severe pain in Left Shoulder, moved to heart and down left arm - started approximately 10:15pm on 11/8/2021
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: Severe pain in Left Shoulder, moved to heart and down left arm - started approximately 10:15pm on 11/8/2021
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Arthralgia, Catheterisation cardiac, Chest X-ray, Echocardiogram
Clinical narrative: Severe pain in Left Shoulder, moved to heart and down left arm - started approximately 10:15pm on 11/8/2021
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pericarditis
Clinical narrative: Severe pain in Left Shoulder, moved to heart and down left arm - started approximately 10:15pm on 11/8/2021
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Swelling face
Clinical narrative: Employee reports: Employee received first pfizer covid vaccine today. Reports allergic reaction. She went to where she had shot and they treated her with benadryl and she was sent home. Employee reports improvement at time of call on 11/11/21 at 1345 Timeline of events: 10:00- began to feel " itchy ".  11:00- Reports she had whelp on her back. Her eyes began to water. Increased itchy feeling over entire body. Reports her face swelled; including her eyes, lips and chin. Reports she felt slight shortness of breath. 12:30- Employee went to Pharmacy at hospital where she obtained shot this morning. They administered Benadryl. 1345- Employee called to report situation. Was sent home for the remainder of the day. States her symptoms have improved. Denied shortness of breath or difficulty breathing. 1735- Spoke with employee to how she was feeling. Reports she laid down and took a nap. Woke up about 1500 and felt jittery. Was able to go back to sleep and woke up without complaints. Reports arm pain 5/10 where shot was administered. Denies fever or chills.   Instructed her to follow-up with her primary care physician. Speak with her about second vaccine. States she will   Result or outcome of adverse event(s) Was treated with po benadryl at the pharmacy where she received the shot. Complaints resolved.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lacrimation increased, Lip swelling, Periorbital swelling, Pruritus, Swelling face
Clinical narrative: Employee reports: Employee received first pfizer covid vaccine today. Reports allergic reaction. She went to where she had shot and they treated her with benadryl and she was sent home. Employee reports improvement at time of call on 11/11/21 at 1345 Timeline of events: 10:00- began to feel " itchy ".  11:00- Reports she had whelp on her back. Her eyes began to water. Increased itchy feeling over entire body. Reports her face swelled; including her eyes, lips and chin. Reports she felt slight shortness of breath. 12:30- Employee went to Pharmacy at hospital where she obtained shot this morning. They administered Benadryl. 1345- Employee called to report situation. Was sent home for the remainder of the day. States her symptoms have improved. Denied shortness of breath or difficulty breathing. 1735- Spoke with employee to how she was feeling. Reports she laid down and took a nap. Woke up about 1500 and felt jittery. Was able to go back to sleep and woke up without complaints. Reports arm pain 5/10 where shot was administered. Denies fever or chills.   Instructed her to follow-up with her primary care physician. Speak with her about second vaccine. States she will   Result or outcome of adverse event(s) Was treated with po benadryl at the pharmacy where she received the shot. Complaints resolved.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Employee reports: Employee received first pfizer covid vaccine today. Reports allergic reaction. She went to where she had shot and they treated her with benadryl and she was sent home. Employee reports improvement at time of call on 11/11/21 at 1345 Timeline of events: 10:00- began to feel " itchy ".  11:00- Reports she had whelp on her back. Her eyes began to water. Increased itchy feeling over entire body. Reports her face swelled; including her eyes, lips and chin. Reports she felt slight shortness of breath. 12:30- Employee went to Pharmacy at hospital where she obtained shot this morning. They administered Benadryl. 1345- Employee called to report situation. Was sent home for the remainder of the day. States her symptoms have improved. Denied shortness of breath or difficulty breathing. 1735- Spoke with employee to how she was feeling. Reports she laid down and took a nap. Woke up about 1500 and felt jittery. Was able to go back to sleep and woke up without complaints. Reports arm pain 5/10 where shot was administered. Denies fever or chills.   Instructed her to follow-up with her primary care physician. Speak with her about second vaccine. States she will   Result or outcome of adverse event(s) Was treated with po benadryl at the pharmacy where she received the shot. Complaints resolved.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Eye swelling, Hypersensitivity, Lacrimation increased, Lip swelling
Clinical narrative: Employee reports: Employee received first pfizer covid vaccine today. Reports allergic reaction. She went to where she had shot and they treated her with benadryl and she was sent home. Employee reports improvement at time of call on 11/11/21 at 1345 Timeline of events: 10:00- began to feel " itchy ".  11:00- Reports she had whelp on her back. Her eyes began to water. Increased itchy feeling over entire body. Reports her face swelled; including her eyes, lips and chin. Reports she felt slight shortness of breath. 12:30- Employee went to Pharmacy at hospital where she obtained shot this morning. They administered Benadryl. 1345- Employee called to report situation. Was sent home for the remainder of the day. States her symptoms have improved. Denied shortness of breath or difficulty breathing. 1735- Spoke with employee to how she was feeling. Reports she laid down and took a nap. Woke up about 1500 and felt jittery. Was able to go back to sleep and woke up without complaints. Reports arm pain 5/10 where shot was administered. Denies fever or chills.   Instructed her to follow-up with her primary care physician. Speak with her about second vaccine. States she will   Result or outcome of adverse event(s) Was treated with po benadryl at the pharmacy where she received the shot. Complaints resolved.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Employee reports: Employee received first pfizer covid vaccine today. Reports allergic reaction. She went to where she had shot and they treated her with benadryl and she was sent home. Employee reports improvement at time of call on 11/11/21 at 1345 Timeline of events: 10:00- began to feel " itchy ".  11:00- Reports she had whelp on her back. Her eyes began to water. Increased itchy feeling over entire body. Reports her face swelled; including her eyes, lips and chin. Reports she felt slight shortness of breath. 12:30- Employee went to Pharmacy at hospital where she obtained shot this morning. They administered Benadryl. 1345- Employee called to report situation. Was sent home for the remainder of the day. States her symptoms have improved. Denied shortness of breath or difficulty breathing. 1735- Spoke with employee to how she was feeling. Reports she laid down and took a nap. Woke up about 1500 and felt jittery. Was able to go back to sleep and woke up without complaints. Reports arm pain 5/10 where shot was administered. Denies fever or chills.   Instructed her to follow-up with her primary care physician. Speak with her about second vaccine. States she will   Result or outcome of adverse event(s) Was treated with po benadryl at the pharmacy where she received the shot. Complaints resolved.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Activated partial thromboplastin time, Blood test, C-reactive protein, Cardiac monitoring
Clinical narrative: Moderna COVID-19 Vaccine EUA: Pericarditis / Myocarditis Patient with latent TB s/p 9 mths INH tx with persistent GI symptoms, received Moderna Vaccines on 3/3/2021,  3/31/2021, and 11/05/2021. On 11/6/2021 patient began to have chills, fatigue, & fever as high as 101.0.  Early on the morning of 11/8/2021 around 2 a.m. she began diarrhea, vomitiing and chest pain which was made worse by lying down. Persistent fevers as well as sweats prompted to come to the ER. EKG was abnormal (diffuse ST elevation), echocardiogram obtained which was stable. Patient began to improve over the next few hours and was discharged in stable condition on 11/9/2021. Covid test negative.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest X-ray abnormal, Chest pain, Diarrhoea, Echocardiogram, Electrocardiogram
Clinical narrative: Moderna COVID-19 Vaccine EUA: Pericarditis / Myocarditis Patient with latent TB s/p 9 mths INH tx with persistent GI symptoms, received Moderna Vaccines on 3/3/2021,  3/31/2021, and 11/05/2021. On 11/6/2021 patient began to have chills, fatigue, & fever as high as 101.0.  Early on the morning of 11/8/2021 around 2 a.m. she began diarrhea, vomitiing and chest pain which was made worse by lying down. Persistent fevers as well as sweats prompted to come to the ER. EKG was abnormal (diffuse ST elevation), echocardiogram obtained which was stable. Patient began to improve over the next few hours and was discharged in stable condition on 11/9/2021. Covid test negative.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Full blood count, Headache, Human chorionic gonadotropin, Inflammation
Clinical narrative: Moderna COVID-19 Vaccine EUA: Pericarditis / Myocarditis Patient with latent TB s/p 9 mths INH tx with persistent GI symptoms, received Moderna Vaccines on 3/3/2021,  3/31/2021, and 11/05/2021. On 11/6/2021 patient began to have chills, fatigue, & fever as high as 101.0.  Early on the morning of 11/8/2021 around 2 a.m. she began diarrhea, vomitiing and chest pain which was made worse by lying down. Persistent fevers as well as sweats prompted to come to the ER. EKG was abnormal (diffuse ST elevation), echocardiogram obtained which was stable. Patient began to improve over the next few hours and was discharged in stable condition on 11/9/2021. Covid test negative.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lipase, Metabolic function test, Muscle injury, Myocarditis, Nausea
Clinical narrative: Moderna COVID-19 Vaccine EUA: Pericarditis / Myocarditis Patient with latent TB s/p 9 mths INH tx with persistent GI symptoms, received Moderna Vaccines on 3/3/2021,  3/31/2021, and 11/05/2021. On 11/6/2021 patient began to have chills, fatigue, & fever as high as 101.0.  Early on the morning of 11/8/2021 around 2 a.m. she began diarrhea, vomitiing and chest pain which was made worse by lying down. Persistent fevers as well as sweats prompted to come to the ER. EKG was abnormal (diffuse ST elevation), echocardiogram obtained which was stable. Patient began to improve over the next few hours and was discharged in stable condition on 11/9/2021. Covid test negative.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pericarditis, Prothrombin time, Red blood cell sedimentation rate, Respiratory viral panel, Sleep disorder
Clinical narrative: Moderna COVID-19 Vaccine EUA: Pericarditis / Myocarditis Patient with latent TB s/p 9 mths INH tx with persistent GI symptoms, received Moderna Vaccines on 3/3/2021,  3/31/2021, and 11/05/2021. On 11/6/2021 patient began to have chills, fatigue, & fever as high as 101.0.  Early on the morning of 11/8/2021 around 2 a.m. she began diarrhea, vomitiing and chest pain which was made worse by lying down. Persistent fevers as well as sweats prompted to come to the ER. EKG was abnormal (diffuse ST elevation), echocardiogram obtained which was stable. Patient began to improve over the next few hours and was discharged in stable condition on 11/9/2021. Covid test negative.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin I, Troponin increased, Urine analysis, Vomiting
Clinical narrative: Moderna COVID-19 Vaccine EUA: Pericarditis / Myocarditis Patient with latent TB s/p 9 mths INH tx with persistent GI symptoms, received Moderna Vaccines on 3/3/2021,  3/31/2021, and 11/05/2021. On 11/6/2021 patient began to have chills, fatigue, & fever as high as 101.0.  Early on the morning of 11/8/2021 around 2 a.m. she began diarrhea, vomitiing and chest pain which was made worse by lying down. Persistent fevers as well as sweats prompted to come to the ER. EKG was abnormal (diffuse ST elevation), echocardiogram obtained which was stable. Patient began to improve over the next few hours and was discharged in stable condition on 11/9/2021. Covid test negative.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Chest pain, Chills, Diarrhoea, Echocardiogram normal
Clinical narrative: Moderna COVID-19 Vaccine EUA: Pericarditis / Myocarditis Patient with latent TB s/p 9 mths INH tx with persistent GI symptoms, received Moderna Vaccines on 3/3/2021,  3/31/2021, and 11/05/2021. On 11/6/2021 patient began to have chills, fatigue, & fever as high as 101.0.  Early on the morning of 11/8/2021 around 2 a.m. she began diarrhea, vomitiing and chest pain which was made worse by lying down. Persistent fevers as well as sweats prompted to come to the ER. EKG was abnormal (diffuse ST elevation), echocardiogram obtained which was stable. Patient began to improve over the next few hours and was discharged in stable condition on 11/9/2021. Covid test negative.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Fatigue, Hyperhidrosis, Myocarditis
Clinical narrative: Moderna COVID-19 Vaccine EUA: Pericarditis / Myocarditis Patient with latent TB s/p 9 mths INH tx with persistent GI symptoms, received Moderna Vaccines on 3/3/2021,  3/31/2021, and 11/05/2021. On 11/6/2021 patient began to have chills, fatigue, & fever as high as 101.0.  Early on the morning of 11/8/2021 around 2 a.m. she began diarrhea, vomitiing and chest pain which was made worse by lying down. Persistent fevers as well as sweats prompted to come to the ER. EKG was abnormal (diffuse ST elevation), echocardiogram obtained which was stable. Patient began to improve over the next few hours and was discharged in stable condition on 11/9/2021. Covid test negative.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pericarditis, Pyrexia, SARS-CoV-2 test negative, Troponin I increased, Viral test negative
Clinical narrative: Moderna COVID-19 Vaccine EUA: Pericarditis / Myocarditis Patient with latent TB s/p 9 mths INH tx with persistent GI symptoms, received Moderna Vaccines on 3/3/2021,  3/31/2021, and 11/05/2021. On 11/6/2021 patient began to have chills, fatigue, & fever as high as 101.0.  Early on the morning of 11/8/2021 around 2 a.m. she began diarrhea, vomitiing and chest pain which was made worse by lying down. Persistent fevers as well as sweats prompted to come to the ER. EKG was abnormal (diffuse ST elevation), echocardiogram obtained which was stable. Patient began to improve over the next few hours and was discharged in stable condition on 11/9/2021. Covid test negative.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Moderna COVID-19 Vaccine EUA: Pericarditis / Myocarditis Patient with latent TB s/p 9 mths INH tx with persistent GI symptoms, received Moderna Vaccines on 3/3/2021,  3/31/2021, and 11/05/2021. On 11/6/2021 patient began to have chills, fatigue, & fever as high as 101.0.  Early on the morning of 11/8/2021 around 2 a.m. she began diarrhea, vomitiing and chest pain which was made worse by lying down. Persistent fevers as well as sweats prompted to come to the ER. EKG was abnormal (diffuse ST elevation), echocardiogram obtained which was stable. Patient began to improve over the next few hours and was discharged in stable condition on 11/9/2021. Covid test negative.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Nausea, Paraesthesia
Clinical narrative: Pt. states that after receiving the 1st dose of J&J 11/08/2021, started experiencing symptoms 11/09/2021 of sharp "nerve" pain shooting throughout the body. Primary visit 11/17/2021 recommended Reporting, Blood Work. Still experiencing symptoms.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Neuralgia, Pain
Clinical narrative: Pt. states that after receiving the 1st dose of J&J 11/08/2021, started experiencing symptoms 11/09/2021 of sharp "nerve" pain shooting throughout the body. Primary visit 11/17/2021 recommended Reporting, Blood Work. Still experiencing symptoms.
Age: 28.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion measurement
Clinical narrative: Left shoulder impingement, sever left shoulder pain upon vaccine administration in left arm. Received vaccine on 10/29/21. Symptoms occurred that night and gradually worsened each day. Went to NP at minute clinic on 11/12 as symptoms continued. They indicated shoulder impingement/bursitis/neuropathic entrapment syndrome and recommended I schedule an orthopedic appointment for imaging and physical therapy. Orthopedic appointment is scheduled for 11/19/21 for further tests and imaging.
Age: 28.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Arthralgia, Bursitis, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Left shoulder impingement, sever left shoulder pain upon vaccine administration in left arm. Received vaccine on 10/29/21. Symptoms occurred that night and gradually worsened each day. Went to NP at minute clinic on 11/12 as symptoms continued. They indicated shoulder impingement/bursitis/neuropathic entrapment syndrome and recommended I schedule an orthopedic appointment for imaging and physical therapy. Orthopedic appointment is scheduled for 11/19/21 for further tests and imaging.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye contusion, Eyelid oedema
Clinical narrative: at the 24 hour mark, noted w bruising above his left upper eyelid
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion
Clinical narrative: at the 24 hour mark, noted w bruising above his left upper eyelid
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was given a COVID 19 Vaccine Booster dose that had expired past its expiration time. No treatment was giving and the patient was doing well.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was given a COVID 19 Vaccine Booster dose that had expired past its expiration time. No treatment was giving and the patient was doing well.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Eye swelling, Hypersensitivity, Oropharyngeal discomfort, Swelling
Clinical narrative: Anaphylaxis- facial swelling, trouble breathing- treated in ER with epinephrine, prednisone, Benadryl and antihistamine-resolved Left facial droop affecting her smile only- ASA 81mg started-persisted
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue discomfort
Clinical narrative: Anaphylaxis- facial swelling, trouble breathing- treated in ER with epinephrine, prednisone, Benadryl and antihistamine-resolved Left facial droop affecting her smile only- ASA 81mg started-persisted
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Facial paralysis, Magnetic resonance imaging, Swelling face
Clinical narrative: Anaphylaxis- facial swelling, trouble breathing- treated in ER with epinephrine, prednisone, Benadryl and antihistamine-resolved Left facial droop affecting her smile only- ASA 81mg started-persisted
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site hypoaesthesia, Joint range of motion decreased, Muscular weakness
Clinical narrative: Within 24 hours of second Pfizer Covid vaccine, patient lost all strength in the left hand even today, eight days later, left hand is severely weak and cannot fully close the hand or hold objects.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Muscular weakness
Clinical narrative: Within 24 hours of second Pfizer Covid vaccine, patient lost all strength in the left hand even today, eight days later, left hand is severely weak and cannot fully close the hand or hold objects.
Sex: M
Vaccine: COVID19, PPV
Symptoms: Peripheral swelling
Clinical narrative: arm swelling; This spontaneous report was received from a pharmacist and refers to a male patient of an unknown age. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On an unspecified date, the patient received unspecified Coronavirus disease (COVID) vaccine (exact dose, route of administration, lot number and expiration date were not provided) and on an unknown date (reported as at least a month later), the patient had a pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided).   On an unknown date, the patient experienced arm swelling after his pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown).  The outcome of the event was unknown. The causality assessment was not provided.  This is one of three reports from the same reporter.; Sender's Comments:  US-009507513-2110USA006332: US-009507513-2110USA006333:
Sex: M
Vaccine: COVID19, PPV
Symptoms: Limb mass
Clinical narrative: lump develop on his arm that has not gone away; This spontaneous report was received from a pharmacist and refers to a male patient of an unknown age. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On an unspecified date, the patient received unspecified Coronavirus disease (COVID) vaccine (exact dose, route of administration, lot number and expiration date were not provided) and on an unknown date (reported as at least a month later), the patient had a pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided).   On an unknown date, the patient had a lump develop on his arm that has not gone away. This occurred after his pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown).  The outcome of the event was unknown. The causality assessment was not provided.  This is one of three reports from the same reporter.; Sender's Comments:  US-009507513-2110USA006319: US-009507513-2110USA006333:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: She denied further AE; VAQTA was administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 13-OCT-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, lot # T013204, expiration date 13-DEC-2021 for prophylaxis (anatomical location and route of administration were not reported).   The vaccine was stored at the temperature that was reported as 50.5 degrees of Fahrenheit for 0 hours and 30 minutes. There was no previous temperature excursion reported.  The reporter denied further adverse events.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2110USA007269: US-009507513-2110USA007275: US-009507513-2110USA007379: US-009507513-2110USA007316: US-009507513-2110USA007310: US-009507513-2110USA007288: US-009507513-2110USA006972: US-009507513-2110USA007007: US-009507513-2110USA007272:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE.; VAQTA was administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 11-OCT-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, lot # T013204, expiration date reported as 13-DEC-2021 but under internal validation established as 03-DEC-2021 for prophylaxis (anatomical location and route of administration were not reported).   The vaccine was stored at the temperature that was reported as 50.5 degrees of Fahrenheit for 0 hours and 30 minutes. There was no previous temperature excursion reported.  The reporter denied further adverse events.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2110USA007275: US-009507513-2110USA007269: US-009507513-2110USA007379: US-009507513-2110USA007310: US-009507513-2110USA007288: US-009507513-2110USA006972: US-009507513-2110USA007007: US-009507513-2110USA007272:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported by HCP; an expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from a pharmacist and refers to a 67-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 22-OCT-2021, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) formulation vial, dose/frequency reporter as 0.5 ml (miilliliter) one time, lot # T021329, expiration date 03-OCT-2021 (dose number and route of administration were not reported) for prophylaxis (expired product administered).  The vaccine had not experienced a temperature excursion. No other adverse events was reported by the pharmacist (no adverse event). The pharmacist additionally inquired how long after expiration the product was good for.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: a dose of improperly stored dose of PROQUAD was administered; no adverse event; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unspecified date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T034614 exp date 10-APR-2022) (0.5 mL and route not reported) that was stored during a temperature excursion found supported on 16-SEP-2021. The temperature of excursion was 6°F to 14°F (8.5 °F) for 18 minutes and 6°F to 14°F (11.9 °F) for 1 hour. Cumulative timeframe was 1 hour and 18 minutes. There was no previous temperature excursion.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Adverse recation: None; administered on 10/2019 and 10/2020; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 66-year-old female patient (pt). There was no information about the patient's concurrent conditions, allergies, drug reactions or medical history provided. The pt's historical vaccines included unspecified influenza vaccine administered on an unknown date in October 2018. On unknown date, in October 2019 and on unknown date in October 2020, the patient was vaccinated with unspecified pneumococcal vaccine (manufacturer unknown) for prophylaxis (exact dose, lot #, expiration date, route of administration and anatomical location were not reported) (inappropriate schedule of product administration). Concomitant vaccines included unspecified influenza vaccine . The pt had none of adverse reaction. The outcome of inappropriate schedule of product administration was unknown.  This is one of two reports regarding the same patient.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Blindness unilateral, Herpes zoster, Injury corneal
Clinical narrative: vision loss; damage to cornea of right eye; herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 26-DEC-2014(at approximately 60 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a health care provider (HCP) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, damage to cornea of right eye and vision loss. The outcome of all events was unknown.   Upon internal review, vision loss was determined to be medically significant.
Sex: F
Vaccine: MMR, UNK, VARCEL
Symptoms: Accidental exposure to product, Limb injury, Product container issue, Speech disorder
Clinical narrative: there was broken glass and she was punctured by a sliver of glass in her right index and middle finger; Accidental exposure to product; circumstance or information capable of leading to medication error; now has a Bump on her right middle finger.; Caller had rambled, pressured during call; Caller had rambled, pressured during call; there was broken glass and she was punctured by a sliver of glass in her right index and middle finger/ PQC Present?: Yes; This spontaneous report was received from a female patient of unknown age, referring to herself. The patient was not pregnant. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  In approximately 04-NOV-2021 (reported as on 04-NOV-2021 or 05-NOV-2021), the patient found vials of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U019905, expiration date reported as 21-JUN-2023, but upon internal validation established as 24-JUN-2023), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot# T034380, expiration date reported as 08-OCT-2022, but upon internal validation established as 08-JAN-2022) and sterile diluent (MERCK STERILE DILUENT) (all suspects strength, dose detail were not reported, indication for vaccines was captured as prophylaxis) in a dumpster while looking through the dumpster and there was broken glass (product container issue). She was not looking for the vial and found them by accident. The patient was punctured by a sliver of glass in her right index and middle finger (accidental exposure to product and circumstance or information capable of leading to medication error). On an unknown date in November 2021, she had a bump on her right middle finger. The patient had rambled, pressured speech during call (onset date unspecified, captured as unknown dates in November 2021). No treatment was given to the patient. The patient didn't seek medical attention. The patient was suggested to take vials to closest pharmacy and request them to dispose of vials. It was reported that the products were unable to return. The outcome of the events was unknown. The causality assessment was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.       On 07-OCT-2021, the patient was vaccinated with the improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA) (PROQUAD) (lot # U019287, expiration date: 15-DEC-2022) 0.5 ml/once (strength and route were not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 5.7 Fahrenheit (F) for 6 minutes. There was no previous temperature excursion. No additional adverse events (AEs) were reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported; multiple temperature excursion that occurred on 26/OCT/2021. VAQTA was administered to patients after the excursion occurred.; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, or concomitant therapies were not reported.   It was reported a multiple temperature excursion that occurred on 26-OCT-2021. On 28-OCT-2021, the patient was vaccinated with  hepatitis a vaccine, inactivated(VAQTA)  1 dosage form, lot # T031201 and expiration date 14-JUN-2022 (strength, route not provided) for prophylaxis after the excursion occurred. The excursion was at 35.0 °F, 35.1 °F, 35.3 °F, 35.2 °F, and 34.9 °F in a time frame of 53 minutes ( cumulative). There were no previous temperature excursion. No signs or symptoms reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Accidental underdose, Infantile spitting up
Clinical narrative: regurgitated "possibly 1/3 to 1/2" of the oral vaccine following administration; regurgitated "possibly 1/3 to 1/2" of the oral vaccine following administration; This spontaneous report was received from a physician referring to a 6-month-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On an unknown date, the patient was vaccinated with the final dose in the 3-dose series of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 ml; strength, lot# and expiration date were not reported) orally (PO) for prophylaxis, and the patient regurgitated possibly 1/3 to 1/2 of the oral vaccine following administration (infantile spitting up and accidental underdose). The patient sought medical attention and no treatment was given for both events. The outcome of infantile spitting up was unknown.     The causality between infantile spitting up and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a solicited report. PSP-Eliquis-Lash-CW2891702, received from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-116774), license party for apixaban (ELIQUIS). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), unknown on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; apixaban (ELIQUIS), unknown from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for embolism venous. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced THROMBOSIS (seriousness criterion medically significant). The action taken with APIXABAN(Unknown) was unknown. At the time of the report, THROMBOSIS outcome was unknown. The patient developed blood clots in his Leg (venous thromboembolism) and was prescribed Eliquis. The patient got the Covid-19 vaccine and developed another blood clot. The action taken with Covid-19 vaccine was unknown and causality was not provided for the same. For APIXABAN(Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Medical Evaluation Comment: This patient who was on apixaban therapy had blood clot. Based on the limited information regarding the suspect therapy details, event onset details, medical history it cannot be ascertained with reasonable possibility that apixaban contributed to the reported event. Pfizer comment: Based on the limited available information and temporal relationship, the causal relationship between thrombosis and bnt162b2 use  cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: U
Vaccine: ANTH
Symptoms: Abdominal pain, Frequent bowel movements, Haematochezia
Clinical narrative: Frequent abdominal pains; Frequent bowel movements; Frequent bloody stools; On 27OCT2021, a spontaneous report was received from a patient.  A male patient of unknown age reported experiencing "frequent bowel movements" (PT: Frequent bowel movements), "frequent bloody stools" (PT: Haematochezia), and "frequent abdominal pains" (PT: Abdominal pain) approximately 10 weeks after receiving BioThrax (anthrax vaccine) on an unknown date (date not reported). The patient inquired if these symptoms are "serious adverse effects of the Anthrax Vaccine?" Any treatments received for the events was not reported. The outcome of the events was not reported.  Medical history and concomitant medication use was not reported.  No additional information with regards to this event was reported.  Company comment:  The AEs reported are not a known phenomenon to occur of BioThrax, the expression of frequency means repetition of the events that may explain other plausible causes and ten weeks after injection, there is no temporal relationship. Therefore, the Company considers the AEs as not related to BioThrax.; Sender's Comments: The AEs reported are not a known phenomenon to occur of BioThrax, the expression of frequency means repetition of the events that may explain other plausible causes and ten weeks after injection, there is no temporal relationship. Therefore, the Company considers the AEs as not related to BioThrax.
Sex: U
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Chest discomfort, Condition aggravated, Headache, Herpes zoster, Pain
Clinical narrative: they came out with the two shots/ suspected vaccination failure; shingles on the top of my head and forehead almost got in my eyes; worst headache; someone setting on my chest; sleep setting up because it made my head hurt worse to lay down; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and morphine for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and morphine at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache, chest discomfort and sleep disorder. The action taken with morphine was unknown. On an unknown date, the outcome of the vaccination failure, shingles, headache, chest discomfort and sleep disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, headache, chest discomfort and sleep disorder to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the 1st shot of Shingles only needed one, 4 years later had the shingles. The patient came out with two shots of Shingles. The patient stated he/she had the shingles on the top of head and forehead almost got in eyes. It was the worst headache ever and went to the emergency room and gave morphine, it helped with pain but felt like someone setting on chest, hated it. The patient stated he/she had to sleep setting up because it made head hurt worse to lay down. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Sleep disorder, Vaccination failure
Clinical narrative: they came out with the two shots/ suspected vaccination failure; shingles on the top of my head and forehead almost got in my eyes; worst headache; someone setting on my chest; sleep setting up because it made my head hurt worse to lay down; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and morphine for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and morphine at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache, chest discomfort and sleep disorder. The action taken with morphine was unknown. On an unknown date, the outcome of the vaccination failure, shingles, headache, chest discomfort and sleep disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, headache, chest discomfort and sleep disorder to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the 1st shot of Shingles only needed one, 4 years later had the shingles. The patient came out with two shots of Shingles. The patient stated he/she had the shingles on the top of head and forehead almost got in eyes. It was the worst headache ever and went to the emergency room and gave morphine, it helped with pain but felt like someone setting on chest, hated it. The patient stated he/she had to sleep setting up because it made head hurt worse to lay down. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Constipation, Gastric dilatation, Gastrointestinal disorder, Gastrooesophageal reflux disease
Clinical narrative: Gastroesophageal reflux disease; fever; chills; stomach issues; numbness, elbow and thigh; constipation; severe stomach distension; This case was reported by a consumer and described the occurrence of gastroesophageal reflux disease in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced gastroesophageal reflux disease, fever, chills, gastrointestinal disorder, numbness, constipation and distended stomach. On an unknown date, the outcome of the gastroesophageal reflux disease, fever, chills, gastrointestinal disorder, numbness and constipation were unknown and the outcome of the distended stomach was not recovered/not resolved.   It was unknown if the reporter considered the gastroesophageal reflux disease, fever, chills, gastrointestinal disorder, numbness, constipation and distended stomach to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced fever, chills, stomach issues, numbness, constipation, severe stomach distention, numbness in elbow and thigh as well as GERD symptoms. The patient had none of these issues before taking the vaccine. It's almost a year later and not one doctor can help the patient with his/her severe stomach distention and I had spent countless monies on seeing almost every doctor on Island. The reporter consented to follow-up.