chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Loss of consciousness
Clinical narrative: The patient had a black out within 10 minutes of taking vaccine for both doses. The black out lasted for about 2 minutes. In the first case, the patient fell on the carpet since he was standing. Paramedics attended, observed for 15 minutes and declared that he was doing alright and we took him to a physical examination after that and found everything was normal. After the second shot ensured the patient was sitting on the chair after the shot and he experienced a black out and recovered. In both instances, he complained of heart pain.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pallor
Clinical narrative: client reported nausea after receiving 1st Janssen Covid vaccine. At 1540 RN  assisted client who was pale and nauseous to sit down in observation room. Client reported he had just received Janssen Covid vaccine and was feeling nauseous. RN gave client emesis bag. PHN joined RN at 1543 with vital supplies. Upon arrival client sitting in chair, leaning forward holding emesis bag. Client appeared pale. Vitals: blood pressure 103/56, pulse 61, oxygen 96%. PHN  and RN  assisted client to transfer from chair to anti-gravity chair. Per client only had nausea. Declined headache, blurry vision, chest pain, shortness of breath. Per client had arrived to site and ate snack quickly prior to vaccine, last meal was breakfast. RN provided client water and juice at 1545. Per client no relevant medical history, medications and no known allergies. Vitals at 1548: blood pressure 135/75, pulse 59, oxygen 96%. Per client nausea improving, skin color improving. RN stayed with client remaining time in observation. Vitals at 1553: blood pressure 131/78, pulse 68, oxygen 97%. Per client all symptoms resolved, skin color normal for ethnicity. Vitals at 1603: blood pressure 136/79, pulse 58, oxygen 100%. No complaints. Client finished juice. Last vitals at 1613: blood pressure 140/81, pulse 56, oxygen 99%. Per client feeling fine, no nausea. Client left facility with steady gait at 1620.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pharmacy intern accidentally administered an expired vaccine that was drawn up on June 1, 2021. We believe it is Moderna COVID-19 vaccine, but we are not absolutely certain. Father of patient said patient did not have any adverse effects and will return with the patient to be revaccinated with the correct vaccine.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Injection site hypoaesthesia, Muscle spasms
Clinical narrative: Within a minute of administering the vaccine, the patient felt her arm where the injection was administered go numb. She also felt sporadic muscle spasms going down her feet. She said she started to feel dizzy, so we laid her down on the floor with her 2 feet up on a chair. She laid there for few minutes after which she said she felt better. She sat up on the floor and her B.P reading was taken. Her B.P reading read 88/68 mmHg. On further investigation she stated that she has a history of anemia, but hasn't been to a doctor in a few years. On the floor (concrete), her body started to shiver, so we moved her to a chair and she was given water to drink and a granola bar to eat. She was also given a blanket and some hot chocolate to drink. 15 minutes later, her B.P reading was checked again and it was 111/78mmHg. We monitored her for 30-40 minutes and after she felt back to normal she was asked to take some rest at home and follow up with a physician to make sure her Hemoglobin levels.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis microscopic, Defaecation urgency, Diarrhoea, Nausea, Prostatomegaly
Clinical narrative: After 2nd covid shot on Feb 26th, starting  March 1st,  watery Stools 1 to 3 sometimes 4 a day(once 5 times)  stools were 5 to 7 on Bristol stool chart !  most were with nausea and urgency!  lasted  for two months before slowing.   Self treated with Imodium ad, pepto bismol.   PCP  tested for Covid, flu A and B, and C-diff.(all three negative)   referred to  have colonoscopy.  was clear.  tested for  wheat allergy, negative,  but diagnosed with microscopic colitis  from colonoscopy's test on 5/11.  but since that day symptoms have subsided.    with maybe one or two episodes of watery stools.     I kept a journal each day of covid contacts (for contact tracing just in case) and also kept notes of when and what kind of bowel movement I had!
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol normal, Cerebrovascular accident, Headache, Transient ischaemic attack, Vertigo
Clinical narrative: 48 hours after the shot began experiencing Vertigo and a dryness headache. 8 Days after the shot had a TIA and Stroke.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure increased, Chest pain, Constipation, Decreased appetite
Clinical narrative: Chest pains, sore left arm where shot was given,  painful swollen lymph nodes under left arm pit, bad head pain, eye pain from the head pain, elevated blood pressure (even after medication), body pain everywhere, diarrhea, nausea, lost of appetite, neck pain from the head pain, constipation, left/right side  stomach pain, left/right muscle spasms in both calves, dry mouth, thirsty, dry nostrils, and ear drainage from right ear.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dry mouth, Eye pain, Headache, Injection site pain
Clinical narrative: Chest pains, sore left arm where shot was given,  painful swollen lymph nodes under left arm pit, bad head pain, eye pain from the head pain, elevated blood pressure (even after medication), body pain everywhere, diarrhea, nausea, lost of appetite, neck pain from the head pain, constipation, left/right side  stomach pain, left/right muscle spasms in both calves, dry mouth, thirsty, dry nostrils, and ear drainage from right ear.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle spasms, Nasal dryness, Nausea, Neck pain
Clinical narrative: Chest pains, sore left arm where shot was given,  painful swollen lymph nodes under left arm pit, bad head pain, eye pain from the head pain, elevated blood pressure (even after medication), body pain everywhere, diarrhea, nausea, lost of appetite, neck pain from the head pain, constipation, left/right side  stomach pain, left/right muscle spasms in both calves, dry mouth, thirsty, dry nostrils, and ear drainage from right ear.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Otorrhoea, Pain, Thirst
Clinical narrative: Chest pains, sore left arm where shot was given,  painful swollen lymph nodes under left arm pit, bad head pain, eye pain from the head pain, elevated blood pressure (even after medication), body pain everywhere, diarrhea, nausea, lost of appetite, neck pain from the head pain, constipation, left/right side  stomach pain, left/right muscle spasms in both calves, dry mouth, thirsty, dry nostrils, and ear drainage from right ear.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Pharmacy intern accidentally administered an expired vaccine that was drawn up on June 1, 2021. We believe it is Moderna COVID-19 vaccine, but we are not absolutely certain. Patient did not have any adverse effects other than sore arm and will return to be revaccinated with the correct vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Lymphadenitis, Pain in extremity
Clinical narrative: Serious arm pain that radiated to hand and across my back with inflamed lymph nodes on left side of my body. Inflammation of lymph nodes  lasted for 2 weeks arm pain continues almost 3 months later.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest X-ray, Differential white blood cell count, Full blood count, Musculoskeletal chest pain
Clinical narrative: Extreme pain on right side under the lower ribs necessitating a visit to Primary Care Physician. Felt like my organs were too big for my torso. Pain began Saturday or Sunday (I don't remember which) after vaccination Friday afternoon. Saw PCP on Monday.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound abdomen, Urine analysis
Clinical narrative: Extreme pain on right side under the lower ribs necessitating a visit to Primary Care Physician. Felt like my organs were too big for my torso. Pain began Saturday or Sunday (I don't remember which) after vaccination Friday afternoon. Saw PCP on Monday.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hot flush, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: About 8 minutes after shot felt a very very fast heartbeat and left side of face started feeling numb and hot.  Fast heart beat luckily went down, numbness lasted a couple hours.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pharmacy intern accidentally administered an expired vaccine that was drawn up on June 1, 2021. We believe it is Moderna COVID-19 vaccine, but we are not absolutely certain. Patient could not be reached to let her know of the incident. We left her voice messages to come back to get the correct vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, CD4/CD8 ratio, CD4/CD8 ratio increased, Illness, Inflammation
Clinical narrative: Nausea, pins and needles, extreme aches, migraine over the course of 4 weeks since first shot.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain, Paraesthesia, White blood cell count
Clinical narrative: Nausea, pins and needles, extreme aches, migraine over the course of 4 weeks since first shot.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Nausea, pins and needles, extreme aches, migraine over the course of 4 weeks since first shot.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Sevrve Rash under right knee started approximately 5 hours after shot.  Applied deximethasone ointment  to affected area it helped
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Around  May  2021,  I?ve been having intermittent lt arm pain around the location of the shot area.  NEVER BELOW THE LT ELBOW  OR AT THE LT ELBOW.  Experience approx  3 times.  It fades w/in 30min.  Also, had swollen lymph nodes  but in RT armpit area in May  2021 too.  Schedule appt. w/my primary doctor.   Appt date in June.  :(.   Swelling went away 1-2  days later.   Hasn?t returned.  Little worried due to having had breast cancer- rt breast.  Just thought you should be aware.  Haven?t had any arm pain in June- yet.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer
Clinical narrative: About a week after receiving, second dose I noticed a canker sore on my inner lip. It healed and another one appeared. Now, more than 2 weeks later, I have multiple mouth sores inside my lips and underneath my tongue.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Heart rate irregular, Pain, Palpitations, Pyrexia
Clinical narrative: Fever, aches and pain all over body, heart beating irregularly and beating hard with pain.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Long term joint pain
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram abnormal, Heart rate increased, Loss of consciousness
Clinical narrative: Went on a walk on 6/8/21.  Had high heart rate about 178 BPM) the entire time.  After the walk, I could not breath well, the chest hurt, and I lost consciousness.  Went to the ER.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: Went on a walk on 6/8/21.  Had high heart rate about 178 BPM) the entire time.  After the walk, I could not breath well, the chest hurt, and I lost consciousness.  Went to the ER.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Pounding heart and shortness of breath; particularly at night. I?ve been woken from sleep with the sensation of a pounding heart.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Deep vein thrombosis, Limb discomfort, Mass, Pain in extremity
Clinical narrative: Right calf pain with leg swelling and heaviness over a couple of days then right medial calf pain with what appeared to be a bruise the size of my fist and a small central painful lump. Urgent Care appt.  US done and found a medial distal thigh venous clot.  started Aspirin 325mg once daily. On day 4 of taking this medication, my right leg completely resolved of the swelling and heaviness and the "bruise" completely resolved without any discoloration.  This makes me think the "bruise" was engorged capillary vessels that were not flowing due to the clot.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: Right calf pain with leg swelling and heaviness over a couple of days then right medial calf pain with what appeared to be a bruise the size of my fist and a small central painful lump. Urgent Care appt.  US done and found a medial distal thigh venous clot.  started Aspirin 325mg once daily. On day 4 of taking this medication, my right leg completely resolved of the swelling and heaviness and the "bruise" completely resolved without any discoloration.  This makes me think the "bruise" was engorged capillary vessels that were not flowing due to the clot.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Echocardiogram abnormal, Electrocardiogram abnormal, Full blood count, Heart rate abnormal
Clinical narrative: I started feeling that my heart rate is not steady and it?s very irregular. I had trouble sleeping from my heart beata for 2 weeks and I thought it was stress or anxiety. I went to see a doctor, they drew blood and then called me after 2 days and said I had to go to the ER because Troponin level was so high. I went to the ER and they kelt me at the hospital for 30 hours to monitor my Troponin level and they did and ECG and Echocardiogram. They said it was Pericardial effusion and Pericarditis. They prescribed me Ibuprofen 400 tid and my doctor have me Propranolol 20mg qd.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Insomnia, Pericardial effusion, Stress, Troponin increased
Clinical narrative: I started feeling that my heart rate is not steady and it?s very irregular. I had trouble sleeping from my heart beata for 2 weeks and I thought it was stress or anxiety. I went to see a doctor, they drew blood and then called me after 2 days and said I had to go to the ER because Troponin level was so high. I went to the ER and they kelt me at the hospital for 30 hours to monitor my Troponin level and they did and ECG and Echocardiogram. They said it was Pericardial effusion and Pericarditis. They prescribed me Ibuprofen 400 tid and my doctor have me Propranolol 20mg qd.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Facial paralysis, Heart rate increased, Magnetic resonance imaging
Clinical narrative: Rapid heart rate, face drooping (Bell?s palsy).  Given MRI, stroke test, and monitored form5 hours.  Prescribed steroids for Bell?s palsy.  Referred to cardiologist for tachycardia.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Rapid heart rate, face drooping (Bell?s palsy).  Given MRI, stroke test, and monitored form5 hours.  Prescribed steroids for Bell?s palsy.  Referred to cardiologist for tachycardia.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pustular
Clinical narrative: Rash and pustules beginning on left hand and spreading to hands, arms, trunk, thighs, and legs, persisting to current date, but improving.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Burning sensation, Herpes zoster, Neuralgia, Pustule
Clinical narrative: Diagnosis of disseminated shingles. Burning, nerve pain 6 inches below left axillary that 2 days later developed painful and itchy red dots and pustules. These also developed across upper chest bilaterally and right side of neck. This occurred 7 days status post ALIF Lumbar Fusion L5 - S1 and 18 days post Covid 19 Moderna vaccine #1. Symptoms dissipated within 3 weeks.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Spinal fusion surgery
Clinical narrative: Diagnosis of disseminated shingles. Burning, nerve pain 6 inches below left axillary that 2 days later developed painful and itchy red dots and pustules. These also developed across upper chest bilaterally and right side of neck. This occurred 7 days status post ALIF Lumbar Fusion L5 - S1 and 18 days post Covid 19 Moderna vaccine #1. Symptoms dissipated within 3 weeks.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain, Vomiting
Clinical narrative: It started as a mild pain in the center of my chest that was made much worse by leaning forward or laying down. Felt I could only stand. I vomited, I believe from the pain after I tried getting on my hands and knees. Once, I realized I could only stand upright I did. Pain lasted for about an hour. Also, I chewed an aspirin but not sure if that helped. I felt fine after standing for a while and continue to feel fine more than 24 hrs later. Also, I'll add that I've had acid reflux before and this wasn't that.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Musculoskeletal chest pain
Clinical narrative: BAD CHEST PAIN , UPPER CHEST LEFT SIDE , FEELS LIKE I GOT HIT IN CHEST , LIKE A BIG BRUISE TYPE PAIN WHEN I TOUCH IT . TODAY IS JUNE 11 2021 AND STILL HAVE PAIN .
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Heart rate increased
Clinical narrative: Heart problem
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram normal, Fibrin D dimer normal, Metabolic function test normal, Myalgia
Clinical narrative: Chest pain, arm pain, muscle aches.  Visit to ER.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Troponin normal
Clinical narrative: Chest pain, arm pain, muscle aches.  Visit to ER.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Lymphadenopathy, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: First shot: visible swelling in arm & painful to the touch. Swollen lymph nodes 5 hours after administration of pfizer vaccine. Duration of about 2 days  Second shot: slight arm stiffness after administration of pfizer vaccine. Around 4 PM throat became dry & scratchy. Around 5:30 sore throat. Duration is 3 days and counting.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: First shot: visible swelling in arm & painful to the touch. Swollen lymph nodes 5 hours after administration of pfizer vaccine. Duration of about 2 days  Second shot: slight arm stiffness after administration of pfizer vaccine. Around 4 PM throat became dry & scratchy. Around 5:30 sore throat. Duration is 3 days and counting.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Large round rash around injection site. Left arm. Looks like "Covid arm" as seen online search.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Nausea,vomiting,fatigue
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersensitivity, Pain, Sleep disorder
Clinical narrative: Headaches aches fatigue since shot, headaches more severe at night, can?t sleep   Severe allergic reaction with trip to ER following excederin 6/5  Headaches continue trying Tylenol and imitrex
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: I got a bump ( lymph nodes) on my left side of my neck , the area is swollen and is painful
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Cough, Dyspnoea, Neck pain, Pain
Clinical narrative: pain on the left side that appeared after 5 days Pain in the whole left side of the torso; wich intensified at the level of the neck (parasympathetic ganglion) and spleen area; wich intensified at the level of the neck (parasympathetic ganglion) and spleen area; in the spleen area when breathing, talking, coughing and moving; in the spleen area when breathing, talking, coughing and moving; This is a spontaneous report from a contactable consumer or other non hcp. A patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, in arm left on 07May2021 09:00  as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 07Apr2021 09:00 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation and aspirin. On 10May2021, the patient experienced pain on the left side that appeared after 5 days pain in the whole left side of the torso, which intensified at the level of the neck (parasympathetic ganglion) and spleen area and in the spleen area when breathing, talking, coughing and moving. The patient underwent lab tests and procedures which included covid test: negative on 28May2021. The outcome of the events was unknown.  Follow-up attempts are possible. Further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: pain on the left side that appeared after 5 days Pain in the whole left side of the torso; wich intensified at the level of the neck (parasympathetic ganglion) and spleen area; wich intensified at the level of the neck (parasympathetic ganglion) and spleen area; in the spleen area when breathing, talking, coughing and moving; in the spleen area when breathing, talking, coughing and moving; This is a spontaneous report from a contactable consumer or other non hcp. A patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, in arm left on 07May2021 09:00  as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 07Apr2021 09:00 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation and aspirin. On 10May2021, the patient experienced pain on the left side that appeared after 5 days pain in the whole left side of the torso, which intensified at the level of the neck (parasympathetic ganglion) and spleen area and in the spleen area when breathing, talking, coughing and moving. The patient underwent lab tests and procedures which included covid test: negative on 28May2021. The outcome of the events was unknown.  Follow-up attempts are possible. Further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Pulmonary embolism; Unprovoked dvt; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2ec5g) for COVID-19 vaccination.     The patient was non smoker. No medical history was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Unprovoked dvt) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) had not resolved.            Concomitant medication was not reported. Treatment medication included anticoagulants  Action taken with mRNA-1273 in response to the event was Not Applicable  This is a report of a 35-years non-smoker male, whose medical history was unremarkable; who presented DVT and pulmonary embolism, 102  days after receiving the second dose of the product. The patient required hospitalization  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Pulmonary embolism, Ultrasound Doppler
Clinical narrative: Pulmonary embolism; Unprovoked dvt; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2ec5g) for COVID-19 vaccination.     The patient was non smoker. No medical history was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Unprovoked dvt) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) had not resolved.            Concomitant medication was not reported. Treatment medication included anticoagulants  Action taken with mRNA-1273 in response to the event was Not Applicable  This is a report of a 35-years non-smoker male, whose medical history was unremarkable; who presented DVT and pulmonary embolism, 102  days after receiving the second dose of the product. The patient required hospitalization  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Groin pain, Pain, Positron emission tomogram normal
Clinical narrative: Pulmonary embolism; Unprovoked dvt; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2ec5g) for COVID-19 vaccination.     The patient was non smoker. No medical history was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Unprovoked dvt) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) had not resolved.            Concomitant medication was not reported. Treatment medication included anticoagulants  Action taken with mRNA-1273 in response to the event was Not Applicable  This is a report of a 35-years non-smoker male, whose medical history was unremarkable; who presented DVT and pulmonary embolism, 102  days after receiving the second dose of the product. The patient required hospitalization  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Prothrombin time normal, Pulmonary embolism
Clinical narrative: Pulmonary embolism; Unprovoked dvt; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2ec5g) for COVID-19 vaccination.     The patient was non smoker. No medical history was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Unprovoked dvt) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) had not resolved.            Concomitant medication was not reported. Treatment medication included anticoagulants  Action taken with mRNA-1273 in response to the event was Not Applicable  This is a report of a 35-years non-smoker male, whose medical history was unremarkable; who presented DVT and pulmonary embolism, 102  days after receiving the second dose of the product. The patient required hospitalization  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse reaction; patient was given an expired dose of MMR II; This spontaneous report as received from a medical assistant and refers to a 12 month old female patient. On 07-MAY-2021, the patient was vaccinated with an expired first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (lot # S013683 exp date 05-MAY-2021) subcutaneously. The medical assistant reported that after vaccine was administered, it was discovered that the vaccine had expired. No adverse reaction was reported.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, HIBV, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored administered vaccine with ROTATEQ; no additional AEs; This spontaneous report was received from an licenced practiotioner nurse via office manager and refers to a currently 3-months-old male patient. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 26-APR-2021, the patient was administered improperly stored vaccine with rotavirus vaccine, live, oral, pentavalent rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml dose, lot number: 1691302, expiration date: 23-JAN-2022, orally for prophylaxis, which was supported by temperature stability evaluation. Other company product hib vaccine conj (tet tox) (HIBERIX) (exact dose, route of administration, exact dose and route of administration were not provided) was also reported as improperly stored and administered. Other vaccines given to a patient on the same day included: haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number: T001206, expiration date: 03-JUN-2022, intramuscularly, in right anterolateral thigh (RAT) for prophylaxis (exact dose was not provided), diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) lot number: 23yl4, expiration date: 04-APR-2022, intramuscularly, left anterolateral thigh (LAT) (exact dose wand insication were not provided), pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) lot number: cy4777, expiration date: 26-AUG-2022, intramuscularly, LAT (exact dose and indication were not provided).  The vaccine was experienced temperature excursion of 35.2 degree Farenheit for 480 hours. Previous temperature excursion was not detected. The digital data logger was involved.  The reporter stated, that the unit (refrigerator) with the vaccines was making a noise, therefore to prevent a loss of vaccines, on 09-APR-2021, they were transferred to a unit, which had insulin samples in it. Due to the amount of products in the unit, the temperature got down to 35.2 degree Fahrenheit (F) on one day (unspecified) (product storage error temperature too low). When a new unit was available and the temperature was at acceptable level, vaccines were put in the new unit on 04-MAY-2021. The reporter attached the temperature logs. The vaccines were stored at the temperature below 36 (F) (lowest registered temperature was of 35.2 F) for 480 hours (no previous temperature excursion reported). Adverse event and the patient's response were reported as none (0) (no adverse event). The vaccines was not available for return/evaluation due to the single dose. Operator was trained healthcare professional. All vaccines were used according to the instruction leaflet.  This is one of the six linked reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002859: US-009507513-2105USA002668: US-009507513-2105USA002966: US-009507513-2105USA002665: US-009507513-2105USA002516:
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Per caller all patients, asymptomatic/ No additional AE's/PQC's reported.; Caller reported a temperature excursion for frozen products. Caller notes PROQUAD administered to (3) patients; This spontaneous report was received from a nurse (vaccine provider), referring to a 4 years old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant therapy were not provided.  On 29-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # T010288 has been verified to be a valid lot number, expiration date reported as 20-SEP-2021) (strength not reported) at a dose of 1 (unit not provided), subcutaneous in the left arm for prophylaxis (incorrect product storage), which was the second dose and was administered by a healthcare professional from the reporter's institution. The healthcare professional was trained, and the vaccine was used according to the instruction leaflet. It was reported that when ordering the vaccine for state doses, digital data logger noted on 15-MAR-2021 an temperature excursion occurred at 16:58 for 3 hours and 54 minutes resulting in an elevation of temperature to - 6.8 degree Celsius. Data logger temperature was within normal limits (WNL) on 16-MAR-2021 when daily temperature was checked. There was no previous temperature excursion. The reporter called for viability and reported that the patient was asymptomatic, and there's no adverse reaction. No additional adverse event (AE) or product quality complaints (PQC) were reported.   This is one of several reports received from the same reporter.
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: Per caller all patients, asymptomatic/ No additional AE's/PQC's reported.; Date of vaccination: 04/16/2021 / Was the vaccine resumed? Yes/ 5/12/2021; Caller reported a temperature excursion for frozen products. Caller notes PROQUAD administered to (3) patients; This spontaneous report was received from a nurse (vaccine provider), referring to a 1 year old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant therapy were not provided.  On 16-APR-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # T010288 has been verified to be a valid lot number, expiration date reported as 20-SEP-2021) (strength not reported) at a dose of 1 (unit not provided), subcutaneous in the left arm for prophylaxis (incorrect product storage), which was the first dose and was administered by a healthcare professional from the reporter's institution. The healthcare professional was trained, and the vaccine was used according to the instruction leaflet. It was reported that when ordering the vaccine for state doses, digital data logger noted on 15-MAR-2021 an temperature excursion occurred at 16:58 for 3 hours and 54 minutes resulting in an elevation of temperature to - 6.8 degree Celsius. Data logger temperature was within normal limits (WNL) on 16-MAR-2021 when daily temperature was checked. There was no previous temperature excursion. On 12-MAY-2021, the vaccine was resumed (inappropriate schedule of vaccine administered). The reporter called for viability and reported that the patient was asymptomatic, and there's no adverse reaction. No additional adverse event (AE) or product quality complaints (PQC) were reported.   This is one of several reports received from the same reporter.
Sex: F
Vaccine: HPV9
Symptoms: Accidental exposure to product, Injury associated with device, Skin laceration, Syringe issue
Clinical narrative: received a small cut due to finger flange breaking during administration; received a small cut due to finger flange breaking during administration; received a small cut due to finger flange breaking during administration; This spontaneous report was received from a nurse, concerning a female employee of unknown age. Information regarding the employee's pertinent medical history, concomitant medications and previous drug reactions or allergies was unknown by the reporter.  On 13-MAY-2021, the employee while administering hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (lot number T025370, which was verified to be a valid lot number, expiration date reported as 05-DEC-2022 and upon internal validation established as 01-DEC-2022) (dose, frequency, route of administration, vaccination scheme and anatomical location were not reported), as vaccination to a patient, received a small cut due to the finger flange breaking during administration (injury associated with device, accidental exposure to product and occupational exposure to product). It was unknown by the reporter if the employee received a treatment for the event. Furthermore, the nurse stated the cut was small and the employee was fully recovered.  Causality assessment was not provided by the reporter.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025370; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2105USA003646:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, Pyrexia
Clinical narrative: fever of 99.9F; patient received expired Rotateq; This spontaneous report was received from an office manager and refers to a patient of unknowage and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported. The patient's concomitant vaccines included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 7v (crm197) (PREVNAR) and hepatitis b vaccine rhbsag (yeast) (ENGERIX-B).  On 20-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, orally, for prophylaxis, (lot # 1660999 was verified to be valid, expiration date reported and established as 03-MAY-2021).  On 21-MAY-2021 (reported as a day after the vaccination), the patient's family sought medical attention and called to the office to inform that the patient developed fever of 99.9 Fahrenheit degrees. It was unknown if there was any treatment given for the adverse event. The healthcare provided told the patient's family to call back if the fever did not go down. Since they did not call back, the office manager though that on an unspecified date in May 2021 the patient did recover from the fever.   The causality assessment between the event of fever and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered herpes zoster and postherpetic neuralgia. As a result of those symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster and postherpetic neuralgia were considered as disabling events by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccine breakthrough infection
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the vaccine, the pt suffered herpes zoster. As a result of these symptoms, the pt was seen and treated by health care providers (reported as medical providers) and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt' condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The event herpes zoster was considered to be disabling by the lawyer.
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Nerve injury, Physical disability
Clinical narrative: nerve damage; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. In or around June 2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered nerve damage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The event nerve damage was considered to be disabling by the lawyer.