chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Lumbar puncture, Magnetic resonance imaging, Mobility decreased, Muscle twitching
Clinical narrative: Initially mild numbness and tingling in arms and legs following first dose of vaccine on 12/17/2020, followed by progressive weakness in legs. On January 19, 2021 developed severe back and leg pain resulting in spinal fusion surgery January 25. Postoperatively developed spastic twitching in thighs on approximately January 31, 2021. On February 7 awoke with weakness and clumsiness in left hand. At post op check for spinal surgery on February 10 neurosurgeon recommended another MRI and mentioned possibility of Transverse Myelitis. Following this MRI on February 15, 2021 was again admitted to hospital for more extensive workup. Diagnosis made of Transverse Myelitis. Was started on high dose steroid treatment. Discharged to home February 17. Completed 5-day course of 1000 mg Methylprednisolone per day as an outpatient on February 20, 2021. Since then have had profound leg weakness, right side greater than left, which impairs mobility, prevents driving, and necessitates use of both handrails to ascend and descend a set of stairs. Currently undergoing physical therapy twice per week accompanied by extensive home exercise regimen. Improvement has been very slow and it is impossible to predict when I will be able to return to work.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Myelitis transverse, Pain in extremity, Paraesthesia, Spinal fusion surgery
Clinical narrative: Initially mild numbness and tingling in arms and legs following first dose of vaccine on 12/17/2020, followed by progressive weakness in legs. On January 19, 2021 developed severe back and leg pain resulting in spinal fusion surgery January 25. Postoperatively developed spastic twitching in thighs on approximately January 31, 2021. On February 7 awoke with weakness and clumsiness in left hand. At post op check for spinal surgery on February 10 neurosurgeon recommended another MRI and mentioned possibility of Transverse Myelitis. Following this MRI on February 15, 2021 was again admitted to hospital for more extensive workup. Diagnosis made of Transverse Myelitis. Was started on high dose steroid treatment. Discharged to home February 17. Completed 5-day course of 1000 mg Methylprednisolone per day as an outpatient on February 20, 2021. Since then have had profound leg weakness, right side greater than left, which impairs mobility, prevents driving, and necessitates use of both handrails to ascend and descend a set of stairs. Currently undergoing physical therapy twice per week accompanied by extensive home exercise regimen. Improvement has been very slow and it is impossible to predict when I will be able to return to work.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Initially mild numbness and tingling in arms and legs following first dose of vaccine on 12/17/2020, followed by progressive weakness in legs. On January 19, 2021 developed severe back and leg pain resulting in spinal fusion surgery January 25. Postoperatively developed spastic twitching in thighs on approximately January 31, 2021. On February 7 awoke with weakness and clumsiness in left hand. At post op check for spinal surgery on February 10 neurosurgeon recommended another MRI and mentioned possibility of Transverse Myelitis. Following this MRI on February 15, 2021 was again admitted to hospital for more extensive workup. Diagnosis made of Transverse Myelitis. Was started on high dose steroid treatment. Discharged to home February 17. Completed 5-day course of 1000 mg Methylprednisolone per day as an outpatient on February 20, 2021. Since then have had profound leg weakness, right side greater than left, which impairs mobility, prevents driving, and necessitates use of both handrails to ascend and descend a set of stairs. Currently undergoing physical therapy twice per week accompanied by extensive home exercise regimen. Improvement has been very slow and it is impossible to predict when I will be able to return to work.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Eructation, Feeling hot, Malaise, Nausea
Clinical narrative: Patient received vaccine at local health department clinic on 2/18 and started experiencing itching and a rash during the monitoring period.  Also complained of nausea.  Patient has h/o autoimmune disorder and rosacea.  Took 50mg diphenhydramine prior to arrival in this reporters facility ED.  patient states very anxious about receiving vaccine.  symptoms resolving discharged home from ED
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Patient received vaccine at local health department clinic on 2/18 and started experiencing itching and a rash during the monitoring period.  Also complained of nausea.  Patient has h/o autoimmune disorder and rosacea.  Took 50mg diphenhydramine prior to arrival in this reporters facility ED.  patient states very anxious about receiving vaccine.  symptoms resolving discharged home from ED
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Nausea, Pruritus, Rash
Clinical narrative: Patient received vaccine at local health department clinic on 2/18 and started experiencing itching and a rash during the monitoring period.  Also complained of nausea.  Patient has h/o autoimmune disorder and rosacea.  Took 50mg diphenhydramine prior to arrival in this reporters facility ED.  patient states very anxious about receiving vaccine.  symptoms resolving discharged home from ED
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye irritation, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Patient stated she got covid arm.  Itching, redness, and swelling down the arm.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Patient stated she got covid arm.  Itching, redness, and swelling down the arm.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient stated she got covid arm.  Itching, redness, and swelling down the arm.
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dyspnoea, Respiratory distress, Use of accessory respiratory muscles, Wheezing
Clinical narrative: Became incoherent and disoriented and remained that way till death 5 days later
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine increased, Blood urea increased, Death, Dyspnoea, Wheezing
Clinical narrative: Became incoherent and disoriented and remained that way till death 5 days later
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Disorientation, Incoherent
Clinical narrative: Became incoherent and disoriented and remained that way till death 5 days later
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Peripheral swelling, Pruritus
Clinical narrative: Started with Hives like rash on left elbow and left knee. Progressed to Angioedema affecting upper area over lips, left palm and left foot sole.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Rash, Urticaria
Clinical narrative: Started with Hives like rash on left elbow and left knee. Progressed to Angioedema affecting upper area over lips, left palm and left foot sole.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Dyspnoea, Lethargy, Paraesthesia, Swelling face
Clinical narrative: Face swelling, throat  closing, rash, headache, rapid heartbeat, weak, dizziness. Having an anaphylactic reaction
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Face swelling, throat  closing, rash, headache, rapid heartbeat, weak, dizziness. Having an anaphylactic reaction
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Dizziness, Headache, Heart rate increased
Clinical narrative: Face swelling, throat  closing, rash, headache, rapid heartbeat, weak, dizziness. Having an anaphylactic reaction
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face, Throat tightness
Clinical narrative: Face swelling, throat  closing, rash, headache, rapid heartbeat, weak, dizziness. Having an anaphylactic reaction
Age: 18.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Chest pain, Death, Fatigue, Headache, Pain
Clinical narrative: Fire Dept responded to home address and found patient in cardiac arrest.  Family stated to ambulance crew that all (including patient) family members had received first dose of CoVid vaccine on March 03.  Family also stated to ambulance crew that patient had been complaining of chest pain for approximately 2 hours prior to his collapse.     Further, family informed ambulance that patient was CoVid (-).  Family did not report any medical history or other symptoms to ambulance crew.   Resuscitation efforts were terminated in the field on March 5, 2021 at approximately 11:20 am.  was unable to insert in box 21
Age: 18.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Unresponsive to stimuli
Clinical narrative: Fire Dept responded to home address and found patient in cardiac arrest.  Family stated to ambulance crew that all (including patient) family members had received first dose of CoVid vaccine on March 03.  Family also stated to ambulance crew that patient had been complaining of chest pain for approximately 2 hours prior to his collapse.     Further, family informed ambulance that patient was CoVid (-).  Family did not report any medical history or other symptoms to ambulance crew.   Resuscitation efforts were terminated in the field on March 5, 2021 at approximately 11:20 am.  was unable to insert in box 21
Age: 18.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Cardiac arrest, Chest pain, Electrocardiogram abnormal
Clinical narrative: Fire Dept responded to home address and found patient in cardiac arrest.  Family stated to ambulance crew that all (including patient) family members had received first dose of CoVid vaccine on March 03.  Family also stated to ambulance crew that patient had been complaining of chest pain for approximately 2 hours prior to his collapse.     Further, family informed ambulance that patient was CoVid (-).  Family did not report any medical history or other symptoms to ambulance crew.   Resuscitation efforts were terminated in the field on March 5, 2021 at approximately 11:20 am.  was unable to insert in box 21
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Immediate post-injection reaction, Nausea
Clinical narrative: Throat and chest tightness.  Dizziness and nausea.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Throat and chest tightness.  Dizziness and nausea.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alpha tumour necrosis factor increased, Chest discomfort, Complement factor C3, Complement factor C4, Complement factor normal
Clinical narrative: Throat and chest tightness.  Dizziness and nausea.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Interleukin level, Interleukin level increased, Laboratory test normal, Nausea
Clinical narrative: Throat and chest tightness.  Dizziness and nausea.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Tryptase
Clinical narrative: Throat and chest tightness.  Dizziness and nausea.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Headache, Hypertension, Nausea, Pain in jaw
Clinical narrative: Patient developed chills and body aches on the day of the vaccination.  The following day she developed left sided jaw pain, tingling sensation, nausea, and jerky movements of her legs.  She cam to ED where she was found to have a BP of 180/102 which rose to 235/135.  This was followed by a seizure.   She required aggressive BP management and a hospital stay of 6 days
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Cerebral small vessel ischaemic disease, Chills, Dyskinesia, Low density lipoprotein increased
Clinical narrative: Patient developed chills and body aches on the day of the vaccination.  The following day she developed left sided jaw pain, tingling sensation, nausea, and jerky movements of her legs.  She cam to ED where she was found to have a BP of 180/102 which rose to 235/135.  This was followed by a seizure.   She required aggressive BP management and a hospital stay of 6 days
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging abnormal, Nausea, Pain, Pain in jaw, Paraesthesia
Clinical narrative: Patient developed chills and body aches on the day of the vaccination.  The following day she developed left sided jaw pain, tingling sensation, nausea, and jerky movements of her legs.  She cam to ED where she was found to have a BP of 180/102 which rose to 235/135.  This was followed by a seizure.   She required aggressive BP management and a hospital stay of 6 days
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Patient developed chills and body aches on the day of the vaccination.  The following day she developed left sided jaw pain, tingling sensation, nausea, and jerky movements of her legs.  She cam to ED where she was found to have a BP of 180/102 which rose to 235/135.  This was followed by a seizure.   She required aggressive BP management and a hospital stay of 6 days
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Paranasal sinus discomfort, Rash
Clinical narrative: Patient was vaccinated on 03MAR21 @ 1700 and returned to the vaccine room on 09MAR21@ 1822.  She presented with a rash on her chest, stomach and right deltoid area (injection site).  She was evaluated by one of our registered nurses and given Benadryl @ 1827.  She was instructed to follow-up as needed.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: Patient was vaccinated on 03MAR21 @ 1700 and returned to the vaccine room on 09MAR21@ 1822.  She presented with a rash on her chest, stomach and right deltoid area (injection site).  She was evaluated by one of our registered nurses and given Benadryl @ 1827.  She was instructed to follow-up as needed.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling cold, Headache, Paraesthesia
Clinical narrative: Pt had pernio noted on her bilateral toes which started 2 days after vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Blister, Blood test, Breast pain, Chillblains
Clinical narrative: Pt had pernio noted on her bilateral toes which started 2 days after vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Contusion, Echocardiogram, Erythema, Eye pain
Clinical narrative: Pt had pernio noted on her bilateral toes which started 2 days after vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Fibrin D dimer, Headache, Magnetic resonance imaging head, Nausea
Clinical narrative: Pt had pernio noted on her bilateral toes which started 2 days after vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sleep disorder, Ultrasound breast abnormal, Urine analysis, Vein disorder
Clinical narrative: Pt had pernio noted on her bilateral toes which started 2 days after vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody negative, Chest pain, Chillblains, Dizziness, Fibrin D dimer normal
Clinical narrative: Pt had pernio noted on her bilateral toes which started 2 days after vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count normal, Headache, Influenza, Nausea, Pain
Clinical narrative: Pt had pernio noted on her bilateral toes which started 2 days after vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Thyroid function test normal, Troponin normal
Clinical narrative: Pt had pernio noted on her bilateral toes which started 2 days after vaccination.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea, Pregnancy test negative, Urine analysis normal
Clinical narrative: Had vaccine at local health department clinic at 9am and presented to this reporters facility ED around lunchtime with reports of nausea and dizziness.  given Zofran in ED.  symptoms resolved, discharged to home
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Had vaccine at local health department clinic at 9am and presented to this reporters facility ED around lunchtime with reports of nausea and dizziness.  given Zofran in ED.  symptoms resolved, discharged to home
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, Joint Pain, Muscle Pain, Headache, Nauseated.  Injection site hot, red and sore
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm, Swelling
Clinical narrative: Fever, Joint Pain, Muscle Pain, Headache, Nauseated.  Injection site hot, red and sore
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Fever, Joint Pain, Muscle Pain, Headache, Nauseated.  Injection site hot, red and sore
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, Joint Pain, Muscle Pain, Headache, Nauseated.  Injection site hot, red and sore
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: Ten minutes after shot  I went into a seizure, was taken to hospital  admitted over night for observation.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure like phenomena
Clinical narrative: Ten minutes after shot  I went into a seizure, was taken to hospital  admitted over night for observation.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Pt was being monitored post vaccination and reported feeling faint, throat tightening, itchy neck/mouth, palpitations, sweating and chest tightness. Epi 0.4mg was given IM and pt was transported to Hospital.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Hyperhidrosis, Oral pruritus, Palpitations, Pruritus
Clinical narrative: Pt was being monitored post vaccination and reported feeling faint, throat tightening, itchy neck/mouth, palpitations, sweating and chest tightness. Epi 0.4mg was given IM and pt was transported to Hospital.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Throat tightness
Clinical narrative: Pt was being monitored post vaccination and reported feeling faint, throat tightening, itchy neck/mouth, palpitations, sweating and chest tightness. Epi 0.4mg was given IM and pt was transported to Hospital.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: nothing to report
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: nothing to report
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: About 3 minutes after the injection, I blacked out and started convulsing.  The event I was told lasted approximately 5 minutes in duration in the clinic before I regained consciousness.    The clinic called an ambulance and I was transferred to a larger hospital.  In route to the hospital my heartrate dropped and I was given atropine to stabilize my heart rate and was taken to the Emergency Room at Hospital.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Echocardiogram, Heart rate decreased, Loss of consciousness
Clinical narrative: About 3 minutes after the injection, I blacked out and started convulsing.  The event I was told lasted approximately 5 minutes in duration in the clinic before I regained consciousness.    The clinic called an ambulance and I was transferred to a larger hospital.  In route to the hospital my heartrate dropped and I was given atropine to stabilize my heart rate and was taken to the Emergency Room at Hospital.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: About 3 minutes after the injection, I blacked out and started convulsing.  The event I was told lasted approximately 5 minutes in duration in the clinic before I regained consciousness.    The clinic called an ambulance and I was transferred to a larger hospital.  In route to the hospital my heartrate dropped and I was given atropine to stabilize my heart rate and was taken to the Emergency Room at Hospital.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Cough, Dizziness, Dry throat, Dysphagia
Clinical narrative: She had been over at the vaccine center getting the second dosage of the Pfizer COVID-19 vaccination and had gotten the vaccine and was sitting afterwards when she started feeling that her throat became tight and she was having a hard time breathing so she alerted the staff who quickly evaluated her and gave her an injection of epinephrine.  At that point she was transported over to our urgent care for me to evaluate her.  While in the urgent care she stated that she still felt that there was some tightness but generally felt better.  As I was examining her she said she started feeling that her throat was tightening up again and so we did give her an additional injection of epinephrine and within 5 minutes she again states that she is feeling tremendously better.  She never did have any wheezing or swelling of her tongue or her lips.  She has never had any prior reaction like this to a vaccination or injection
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Headache, Oropharyngeal pain, Pruritus
Clinical narrative: She had been over at the vaccine center getting the second dosage of the Pfizer COVID-19 vaccination and had gotten the vaccine and was sitting afterwards when she started feeling that her throat became tight and she was having a hard time breathing so she alerted the staff who quickly evaluated her and gave her an injection of epinephrine.  At that point she was transported over to our urgent care for me to evaluate her.  While in the urgent care she stated that she still felt that there was some tightness but generally felt better.  As I was examining her she said she started feeling that her throat was tightening up again and so we did give her an additional injection of epinephrine and within 5 minutes she again states that she is feeling tremendously better.  She never did have any wheezing or swelling of her tongue or her lips.  She has never had any prior reaction like this to a vaccination or injection
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: She had been over at the vaccine center getting the second dosage of the Pfizer COVID-19 vaccination and had gotten the vaccine and was sitting afterwards when she started feeling that her throat became tight and she was having a hard time breathing so she alerted the staff who quickly evaluated her and gave her an injection of epinephrine.  At that point she was transported over to our urgent care for me to evaluate her.  While in the urgent care she stated that she still felt that there was some tightness but generally felt better.  As I was examining her she said she started feeling that her throat was tightening up again and so we did give her an additional injection of epinephrine and within 5 minutes she again states that she is feeling tremendously better.  She never did have any wheezing or swelling of her tongue or her lips.  She has never had any prior reaction like this to a vaccination or injection
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: She had been over at the vaccine center getting the second dosage of the Pfizer COVID-19 vaccination and had gotten the vaccine and was sitting afterwards when she started feeling that her throat became tight and she was having a hard time breathing so she alerted the staff who quickly evaluated her and gave her an injection of epinephrine.  At that point she was transported over to our urgent care for me to evaluate her.  While in the urgent care she stated that she still felt that there was some tightness but generally felt better.  As I was examining her she said she started feeling that her throat was tightening up again and so we did give her an additional injection of epinephrine and within 5 minutes she again states that she is feeling tremendously better.  She never did have any wheezing or swelling of her tongue or her lips.  She has never had any prior reaction like this to a vaccination or injection
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dizziness, Dysphagia, Dyspnoea, Exposure during pregnancy
Clinical narrative: She had been over at the vaccine center getting the second dosage of the Pfizer COVID-19 vaccination and had gotten the vaccine and was sitting afterwards when she started feeling that her throat became tight and she was having a hard time breathing so she alerted the staff who quickly evaluated her and gave her an injection of epinephrine.  At that point she was transported over to our urgent care for me to evaluate her.  While in the urgent care she stated that she still felt that there was some tightness but generally felt better.  As I was examining her she said she started feeling that her throat was tightening up again and so we did give her an additional injection of epinephrine and within 5 minutes she again states that she is feeling tremendously better.  She never did have any wheezing or swelling of her tongue or her lips.  She has never had any prior reaction like this to a vaccination or injection
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: She had been over at the vaccine center getting the second dosage of the Pfizer COVID-19 vaccination and had gotten the vaccine and was sitting afterwards when she started feeling that her throat became tight and she was having a hard time breathing so she alerted the staff who quickly evaluated her and gave her an injection of epinephrine.  At that point she was transported over to our urgent care for me to evaluate her.  While in the urgent care she stated that she still felt that there was some tightness but generally felt better.  As I was examining her she said she started feeling that her throat was tightening up again and so we did give her an additional injection of epinephrine and within 5 minutes she again states that she is feeling tremendously better.  She never did have any wheezing or swelling of her tongue or her lips.  She has never had any prior reaction like this to a vaccination or injection
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Cough, Dizziness, Dry throat, Dysphagia
Clinical narrative: Patient began to have full body itching, felt like she was going to pass out, difficulty breathing and swallowing, and cough.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Headache, Oropharyngeal pain, Pruritus
Clinical narrative: Patient began to have full body itching, felt like she was going to pass out, difficulty breathing and swallowing, and cough.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Patient began to have full body itching, felt like she was going to pass out, difficulty breathing and swallowing, and cough.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Patient began to have full body itching, felt like she was going to pass out, difficulty breathing and swallowing, and cough.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dizziness, Dysphagia, Dyspnoea, Exposure during pregnancy
Clinical narrative: Patient began to have full body itching, felt like she was going to pass out, difficulty breathing and swallowing, and cough.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Patient began to have full body itching, felt like she was going to pass out, difficulty breathing and swallowing, and cough.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Anxiety, Erythema, Feeling abnormal
Clinical narrative: Weakness, fast heart rate, rash, flushed face, throat swelling
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Asthenia, Flushing, Heart rate increased, Pharyngeal swelling, Rash
Clinical narrative: Weakness, fast heart rate, rash, flushed face, throat swelling
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; improperly stored administered VARIVAX; 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 12-FEB-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) dose 0.5 milliliter, lot # T024283; expiration date: 15-JUL-2022 (route of administration and anatomical location were not provided) for prophylaxis. The temperature was between 6 and 14 Fahrenheit degrees for 87 hours. There were no previous temperature excursions. The event was reported due to digital data logger. No additional adverse event (AE) was reported.
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: some excursions were discovered with ROTATEQ; No other adverse events reported; This spontaneous report as received from a physician and his clinical research coordinator and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history.      On an unspecified date, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) single dose, orally, lot # 1661000, expiration date on 13-MAY-2021 as prophylaxis (strength, dose, and frequency were not reported).        On unspecified dates, the administered dose of vaccine experienced the following temperatures of excursion: 1.6 degrees Celsius above the recommended storage for a maximum of 19 hours and 31 minutes; on a separate occasion it was exposed to 1.3 degrees Celsius above for a maximum of 16 hours and 49 minutes;  0.6 degrees Celsius above for a maximum of 22 hours and 56 minutes; and 0.6 degrees Celsis above for 22 hours and 56 minutes (Incorrect product storage). There was previous temperature excursion however it was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: A patient received a Gardasil 9 that underwent an unevaluated temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided.  On 03-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error) injection, at a dose of 0.5 milliliter (ml), lot number S028738, expiration date reported and validated as 03-APR-2022 (route of administration, anatomical site of vaccination, and vaccination scheme frequency were not reported)  as prophylaxis.   The vaccine underwent an unevaluated temperature excursion on an unspecified date, the excursion was supported. The vaccine was stored at 35.8 degrees Fahrenheit (F) for 14 hours and 0 minutes. There was a previous temperature excursion on an unspecified date, and the storage temperature was: 35.4 F for 15 hours and 10 minutes. The call was due to a digital data logger.  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: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA002215:
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: some excursions were discovered with ROTATEQ; No other adverse events reported; This spontaneous report as received from a physician and his clinical research coordinator and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history.      On an unspecified date, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) single dose, orally, lot # 1661000, expiration date on 13-MAY-2021 as prophylaxis (strength, dose, and frequency were not reported).        On unspecified dates, the administered dose of vaccine experienced the following temperatures of excursion: 1.6 degrees Celsius above the recommended storage for a maximum of 19 hours and 31 minutes and on a separate occasion it was exposed to 1.3 degrees Celsius above for a maximum of 16 hours and 49 minutes. (Incorrect product storage). There was previous temperature excursion however it was not reported.
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: some excursions were discovered with ROTATEQ; No other adverse events reported; This spontaneous report as received from a physician and his clinical research coordinator and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history.      On an unspecified date, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) single dose, orally, lot # 1661000, expiration date on 13-MAY-2021 as prophylaxis (strength, dose, and frequency were not reported).        On unspecified dates, the administered dose of vaccine experienced the following temperatures of excursion: 1.6 degrees Celsius above the recommended storage for a maximum of 19 hours and 31 minutes and on a separate occasion it was exposed to 1.3 degrees Celsius above for a maximum of 16 hours and 49 minutes (Incorrect product storage). There was previous temperature excursion however it was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Swollen tongue
Clinical narrative: Body rash; Swollen tongue reaction; This case was reported by a consumer via and described the occurrence of generalized rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized rash and swollen tongue. On an unknown date, the outcome of the generalized rash and swollen tongue were unknown.   It was unknown if the reporter considered the generalized rash and swollen tongue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient received 1st dose of shingrix and experienced body rash and swollen tongue reaction. No other information was not available. The information regarding consent to follow up was not reported.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Incorrect dose administered, Injection site pain, Pain
Clinical narrative: injection sight was  slightly sore; had temperature of 100.5; body aches; Chills / shivering / slight chills; received the adjuvant of the Shingrix vaccine without the antigen; received the adjuvant of the Shingrix vaccine without the antigen; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on Novemebr 2020,refer case US2021055855).   On 4th February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 4th February 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, fever, general body pain, chills, inappropriate reconstitution technique and inappropriate dose of vaccine administered. Rechallenge with Shingrix was positive. On 5th February 2021, the outcome of the injection site pain, fever, general body pain and chills were recovered/resolved. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain, fever, general body pain and chills to be related to Shingrix.  Additional details provided were as follows: Lot number not available for both the vaccines. Patient received 2nd dose of shingrix in right deltoid and felt injection sight was slightly sore. Later in the day at bedtime he had temperature of 100.5 degree F, chills, body aches, and shivering and next day morning he was still not well with slight chills and the day after that he was fine. Customer had received a call from his doctor's office on 22nd February 2021 and stated that they think the customer only received the adjuvant of the Shingrix vaccine without the antigen, which led to Inappropriate reconstitution technique and Inappropriate dose of vaccine administered. Reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021055855:same reporter
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: injection sight was  slightly sore; had temperature of 100.5; body aches; Chills / shivering / slight chills; received the adjuvant of the Shingrix vaccine without the antigen; received the adjuvant of the Shingrix vaccine without the antigen; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on Novemebr 2020,refer case US2021055855).   On 4th February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 4th February 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, fever, general body pain, chills, inappropriate reconstitution technique and inappropriate dose of vaccine administered. Rechallenge with Shingrix was positive. On 5th February 2021, the outcome of the injection site pain, fever, general body pain and chills were recovered/resolved. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain, fever, general body pain and chills to be related to Shingrix.  Additional details provided were as follows: Lot number not available for both the vaccines. Patient received 2nd dose of shingrix in right deltoid and felt injection sight was slightly sore. Later in the day at bedtime he had temperature of 100.5 degree F, chills, body aches, and shivering and next day morning he was still not well with slight chills and the day after that he was fine. Customer had received a call from his doctor's office on 22nd February 2021 and stated that they think the customer only received the adjuvant of the Shingrix vaccine without the antigen, which led to Inappropriate reconstitution technique and Inappropriate dose of vaccine administered. Reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021055855:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles outbreak; Suspected vaccination failure; This case was reported by a lawyer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced shingles and vaccination failure (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the shingles and vaccination failure were unknown.   It was unknown if the reporter considered the shingles and vaccination failure to be related to Shingrix.  Additional information: The age at vaccination was not reported. The patient received Shingrix and experienced shingles outbreak. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak; This case was reported by a lawyer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intravenous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles. The action taken with Shingrix was unknown. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information:The patient had Shingrix and experienced shingles outbreak.
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Bell's palsy, Benign salivary gland neoplasm, Dysphagia, Facial nerve disorder
Clinical narrative: Bell's palsy; Parkinson's disease; Multiple sclerosis; secondary Parkinsonism; Aphasia; dysphasia; benign parotid neoplasm; facial nerve disorder; Down syndrome; mosaicism; This case was reported by a lawyer and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), parkinson's disease (serious criteria GSK medically significant), multiple sclerosis (serious criteria GSK medically significant), secondary parkinsonism, aphasia, dysphasia, benign parotid tumor and facial nerve disorder. The action taken with Shingrix was unknown. On an unknown date, the outcome of the bell's palsy, parkinson's disease, multiple sclerosis, secondary parkinsonism, aphasia, dysphasia, benign parotid tumor and facial nerve disorder were unknown.   It was unknown if the reporter considered the bell's palsy, parkinson's disease, multiple sclerosis, secondary parkinsonism, aphasia, dysphasia, benign parotid tumor and facial nerve disorder to be related to Shingrix.  The initial information was received on 24 Feb 2021 via medical record (case is now medically confirmed). On 1 Oct 2015, the patient assessed for Parkinson's disease, secondary Parkinsonism, Multiple sclerosis, Aphasia, dysphasia, Aphonia,Down's syndrome, mosaicism. The patient had benign parotid neoplasm, facial nerve disorder. Therapy for a Dysphagia evaluated. Patient has a past medical history significant for parotid tumor with parotidectomy on June 17, 2014. As per pharmacy record, on 19 August 2020, patient had used Shnigrix vial Kit.
Sex: F
Vaccine: VARZOS
Symptoms: Multiple sclerosis, Parkinson's disease, Parkinsonism
Clinical narrative: Bell's palsy; Parkinson's disease; Multiple sclerosis; secondary Parkinsonism; Aphasia; dysphasia; benign parotid neoplasm; facial nerve disorder; Down syndrome; mosaicism; This case was reported by a lawyer and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), parkinson's disease (serious criteria GSK medically significant), multiple sclerosis (serious criteria GSK medically significant), secondary parkinsonism, aphasia, dysphasia, benign parotid tumor and facial nerve disorder. The action taken with Shingrix was unknown. On an unknown date, the outcome of the bell's palsy, parkinson's disease, multiple sclerosis, secondary parkinsonism, aphasia, dysphasia, benign parotid tumor and facial nerve disorder were unknown.   It was unknown if the reporter considered the bell's palsy, parkinson's disease, multiple sclerosis, secondary parkinsonism, aphasia, dysphasia, benign parotid tumor and facial nerve disorder to be related to Shingrix.  The initial information was received on 24 Feb 2021 via medical record (case is now medically confirmed). On 1 Oct 2015, the patient assessed for Parkinson's disease, secondary Parkinsonism, Multiple sclerosis, Aphasia, dysphasia, Aphonia,Down's syndrome, mosaicism. The patient had benign parotid neoplasm, facial nerve disorder. Therapy for a Dysphagia evaluated. Patient has a past medical history significant for parotid tumor with parotidectomy on June 17, 2014. As per pharmacy record, on 19 August 2020, patient had used Shnigrix vial Kit.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event following immunisation
Clinical narrative: Unspecified adverse event; This case was reported by a lawyer and described the occurrence of adverse event in a male patient who received Herpes zoster (Shingrix) (batch number 3JK5K, expiry date 11th September 2022) for prophylaxis.   On 14th September 2020, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced adverse event. The action taken with Shingrix was unknown. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  The initial information was received on 24 Feb 2021 via medical record (case is now medically confirmed). The patient had ingested Shnigrix vial Kit 0.5 ml by intramuscular route on 19 August 2020.