chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Anti-thyroid antibody negative, Anti-thyroid antibody positive, Atypical pneumonia, Blood follicle stimulating hormone increased, Blood luteinising hormone increased
Clinical narrative: Started vomiting several times a day starting 8/24/2016-12/2016. Received 2nd dose GARDASIL 9/1/16. Continued ER visit 9/11/16 with severe abdominal pain. Returned to emergency department 9/14/2016. Admitted to hospital 9/15/2016 with pancreatitis, abdominal pain, constipation, and post-viral Ileus. Released from hospital 9/22/16. Continued vomiting, abdominal pain, and gastrointestinal distress. Started seeing GI specialist 9/26/16-1/16/17. Started contracting Strep Throat 11/2016. Developed walking Pneumonia after Strep Throat 11/2016. February 2017-Strep Throat, Urgent Care. June 2017-Strep Throat, Urgent Care. October 2017-Strep Throat, Urgent Care, Developed Walking Pneumonia. January 2018-Strep Throat, Urgent Care. October 4, 2016-Seeing GI specialist for Post Viral Gastroparesis and Visceral Hyperalgesia. January 5, 2017- 3rd dose GARDASIL 9. January 2018-Started seeing a pulmonologist for Reactive Airway Disease. October 13, 2016-ER visit for distended abdomen, extreme constipation. November 2016- ER visit for difficulty breathing and cough. October 21, 2017-ER visit for persistent difficulty breathing. November 17, 2017-Left arm pain (mimicking heart attack)-Thoracic Outlet Syndrome. January 23, 2018-Continued treatment for Thoracic Outlet Syndrome. September 7, 2017-Diagnosed Chronic Regional Pain Syndrome. March 2018-Amenorrhea. September 2018-Suspected Premature Ovarian Failure. January 2019-Confirmed Diagnosis Premature Ovarian Failure, treatment is estrogen therapy. Given antibiotics for Strep Throat. Given an Albuterol and steroid inhalers for Walking Pneumonia.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Bronchial hyperreactivity, Constipation, Cough, Dyspnoea, Hyperaesthesia
Clinical narrative: Started vomiting several times a day starting 8/24/2016-12/2016. Received 2nd dose GARDASIL 9/1/16. Continued ER visit 9/11/16 with severe abdominal pain. Returned to emergency department 9/14/2016. Admitted to hospital 9/15/2016 with pancreatitis, abdominal pain, constipation, and post-viral Ileus. Released from hospital 9/22/16. Continued vomiting, abdominal pain, and gastrointestinal distress. Started seeing GI specialist 9/26/16-1/16/17. Started contracting Strep Throat 11/2016. Developed walking Pneumonia after Strep Throat 11/2016. February 2017-Strep Throat, Urgent Care. June 2017-Strep Throat, Urgent Care. October 2017-Strep Throat, Urgent Care, Developed Walking Pneumonia. January 2018-Strep Throat, Urgent Care. October 4, 2016-Seeing GI specialist for Post Viral Gastroparesis and Visceral Hyperalgesia. January 5, 2017- 3rd dose GARDASIL 9. January 2018-Started seeing a pulmonologist for Reactive Airway Disease. October 13, 2016-ER visit for distended abdomen, extreme constipation. November 2016- ER visit for difficulty breathing and cough. October 21, 2017-ER visit for persistent difficulty breathing. November 17, 2017-Left arm pain (mimicking heart attack)-Thoracic Outlet Syndrome. January 23, 2018-Continued treatment for Thoracic Outlet Syndrome. September 7, 2017-Diagnosed Chronic Regional Pain Syndrome. March 2018-Amenorrhea. September 2018-Suspected Premature Ovarian Failure. January 2019-Confirmed Diagnosis Premature Ovarian Failure, treatment is estrogen therapy. Given antibiotics for Strep Throat. Given an Albuterol and steroid inhalers for Walking Pneumonia.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Ileus, Impaired gastric emptying, Oestrogen therapy, Pain in extremity, Pancreatitis
Clinical narrative: Started vomiting several times a day starting 8/24/2016-12/2016. Received 2nd dose GARDASIL 9/1/16. Continued ER visit 9/11/16 with severe abdominal pain. Returned to emergency department 9/14/2016. Admitted to hospital 9/15/2016 with pancreatitis, abdominal pain, constipation, and post-viral Ileus. Released from hospital 9/22/16. Continued vomiting, abdominal pain, and gastrointestinal distress. Started seeing GI specialist 9/26/16-1/16/17. Started contracting Strep Throat 11/2016. Developed walking Pneumonia after Strep Throat 11/2016. February 2017-Strep Throat, Urgent Care. June 2017-Strep Throat, Urgent Care. October 2017-Strep Throat, Urgent Care, Developed Walking Pneumonia. January 2018-Strep Throat, Urgent Care. October 4, 2016-Seeing GI specialist for Post Viral Gastroparesis and Visceral Hyperalgesia. January 5, 2017- 3rd dose GARDASIL 9. January 2018-Started seeing a pulmonologist for Reactive Airway Disease. October 13, 2016-ER visit for distended abdomen, extreme constipation. November 2016- ER visit for difficulty breathing and cough. October 21, 2017-ER visit for persistent difficulty breathing. November 17, 2017-Left arm pain (mimicking heart attack)-Thoracic Outlet Syndrome. January 23, 2018-Continued treatment for Thoracic Outlet Syndrome. September 7, 2017-Diagnosed Chronic Regional Pain Syndrome. March 2018-Amenorrhea. September 2018-Suspected Premature Ovarian Failure. January 2019-Confirmed Diagnosis Premature Ovarian Failure, treatment is estrogen therapy. Given antibiotics for Strep Throat. Given an Albuterol and steroid inhalers for Walking Pneumonia.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pharyngitis streptococcal, Premature menopause, Thoracic outlet syndrome, Viral infection, Vomiting
Clinical narrative: Started vomiting several times a day starting 8/24/2016-12/2016. Received 2nd dose GARDASIL 9/1/16. Continued ER visit 9/11/16 with severe abdominal pain. Returned to emergency department 9/14/2016. Admitted to hospital 9/15/2016 with pancreatitis, abdominal pain, constipation, and post-viral Ileus. Released from hospital 9/22/16. Continued vomiting, abdominal pain, and gastrointestinal distress. Started seeing GI specialist 9/26/16-1/16/17. Started contracting Strep Throat 11/2016. Developed walking Pneumonia after Strep Throat 11/2016. February 2017-Strep Throat, Urgent Care. June 2017-Strep Throat, Urgent Care. October 2017-Strep Throat, Urgent Care, Developed Walking Pneumonia. January 2018-Strep Throat, Urgent Care. October 4, 2016-Seeing GI specialist for Post Viral Gastroparesis and Visceral Hyperalgesia. January 5, 2017- 3rd dose GARDASIL 9. January 2018-Started seeing a pulmonologist for Reactive Airway Disease. October 13, 2016-ER visit for distended abdomen, extreme constipation. November 2016- ER visit for difficulty breathing and cough. October 21, 2017-ER visit for persistent difficulty breathing. November 17, 2017-Left arm pain (mimicking heart attack)-Thoracic Outlet Syndrome. January 23, 2018-Continued treatment for Thoracic Outlet Syndrome. September 7, 2017-Diagnosed Chronic Regional Pain Syndrome. March 2018-Amenorrhea. September 2018-Suspected Premature Ovarian Failure. January 2019-Confirmed Diagnosis Premature Ovarian Failure, treatment is estrogen therapy. Given antibiotics for Strep Throat. Given an Albuterol and steroid inhalers for Walking Pneumonia.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Muscle spasms, Myalgia, Paraesthesia
Clinical narrative: Severe muscle pain upper left shoulder and neck followed by muscle spasms. These were followed by tingling of neck and upper shoulder, recurring cycles of spasms.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Nausea, Pallor, Syncope
Clinical narrative: Pt received the ADACEL vaccine in his right arm. He was pleasant, and alert after vaccination. I sat with him in vaccination room with his mother as well and we talked about his trip and and went over how we would take his VIVOTIF. So we were probably sitting for 3 to 4 minutes. There were no signs that he was not feeling well. He even stated "that was way easier than I expected". Then we got up to go get his VIVOTIF and the receipts. After about a minute after standing the patient fainted. The security guard was nearby and she immediately 911. I turned pt on his side, and he regained consciousness about 15 seconds after fainting. He was able to walk to a chair and he said he was feeling ok but a little nauseous and he appeared a little pale. I asked if he felt he had his his head and if it hurt, he said no. I provided him with a bottle of water and some mini snickers as snacks. EMS came and examined him. After about 10 minutes they deemed he did not need emergent care and left him in the care of his mother.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient originally returned to pharmacy on or around 03/15/19 and spoke to another pharmacist to report his arm pain. Patient was advised by other pharmacist to use OTC pain relievers and check back in a few days. I spoke to patient 03/19/19. He states he had a lot of pain when the vaccine was administered and has continued to have pain in the left arm ever since. States he will sometimes has limited range of motion in the left arm if he sleeps on the left side. Patient reports a hard lump at the injection site and states has difficulty with certain activities such as pushing with arm to get out of chair.
Age: 2.0
Sex: F
Vaccine: TD
Symptoms: Abnormal behaviour, Decreased eye contact, Pyrexia
Clinical narrative: Not her normal bubbly self not as talkative not making eye contact as usual and not playing as much also running a low grade fever sometime will just act as if she is just out of it.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chills, Rash
Clinical narrative: Patient developed extreme back pain. Was placed in room and vitals all normal. Then developed rash on arms and back and abdomen still have back pain. Was given 2 ES TYLENOL and BENADRYL 25 mg. Back pain started to diminish. Then started to get chills. Back pain resolved vitals were monitored as well as patient for her symptoms totally went away. Spoke to patient day after and had no symptoms. Pt was able to ambulate without difficulty prior to discharge and lower extremity strength was 5/5. She had no shortness of breath tongue or lip swelling, no wheezing.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: My daughter had a fever which lasted 3 days and ranged from 99 to 103. This began 9 days after receiving a MMR vaccination after an exam where the provider stated that my daughter was perfectly well. My daughter had no other symptoms.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Side effects included rash near injection area, muscle pain, felt tired/weak, headache, shivering, fever. Lasted about 2 days.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Side effects included rash near injection area, muscle pain, felt tired/weak, headache, shivering, fever. Lasted about 2 days.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 1 week after the injection, the patients daughter reported that she had heat and a large area of redness, from the injection site to the elbow from the day of the injection to present. No SOB, nausea, headache reported.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Biopsy skin normal, Ear infection, Injection site abscess, Injection site cyst, Injection site discharge
Clinical narrative: Patient developed a lump at the injection site on her left that continued to grow and fill with fluid. We noticed the swelling about a week after the shot was given. It looked like an abscess or cyst and grew about the size of a pea until it popped and the fluid drained out like a pimple. We took her back to provider and had a culture done. Provider prescribed Mupirocin while we waited for the results. We applied the ointment a couple times a day. It did not help reduce the redness or swelling. Results came back from the culture as non bacterial. The site would drain a little bit periodically for about a month. Then it continued to improve slightly until the site eventually scarred. 8/9/18 We took patient see another provider for an ear infection. While we were there we showed her the lump from the vaccine reaction. We had her next dose of the PENTACEL on 8/16/18 in her right thigh. Lot number C5550A - Sanofi. We had the same reaction. This time the lump grew bigger at a faster rate and seemed to be more tender when the site was touched. This one grew to about the size of a quarter. We had an ultrasound on both lumps and it came back as "inflammation". This was after the first injection site was almost healed and the second injection was just starting to flare up. We saw another provider on 9/18/18. She said it was inflammation, and that we should wait and see what happens. It drained more and left a scar. We saw a Dermatologist, and he said that it is one of the worse vaccine skin reactions he has seem. He recommended seeing an Allergist. Dermatologist prescribed Triamcinolone ointment. We put that on her leg twice a day. This seemed to bring the fluid to the surface and it explode with creamy discharge. We called the dermatologist and he said it was the inflamed fat cells draining. We then went to see an Allergist, on 11/13/18 for an initial consultation. He applied a patch test on 12/10/18. We went back on 12/12 for allergist to look at the test site, and again on 12/14 to remove the patch test. Everything came back as negative for allergies. He recommended not doing any future doses of the PENTACEL until we figure out what is causing the reactions. At our check up with provider on 1/22/19 provider recommended calling the CDC to see if they had any other information. Today 3/7/19 I called CDC and they told us to report to VAERS. 3/19/19 I have the report put together and submitted.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site scar, Injection site swelling
Clinical narrative: Patient developed a lump at the injection site on her left that continued to grow and fill with fluid. We noticed the swelling about a week after the shot was given. It looked like an abscess or cyst and grew about the size of a pea until it popped and the fluid drained out like a pimple. We took her back to provider and had a culture done. Provider prescribed Mupirocin while we waited for the results. We applied the ointment a couple times a day. It did not help reduce the redness or swelling. Results came back from the culture as non bacterial. The site would drain a little bit periodically for about a month. Then it continued to improve slightly until the site eventually scarred. 8/9/18 We took patient see another provider for an ear infection. While we were there we showed her the lump from the vaccine reaction. We had her next dose of the PENTACEL on 8/16/18 in her right thigh. Lot number C5550A - Sanofi. We had the same reaction. This time the lump grew bigger at a faster rate and seemed to be more tender when the site was touched. This one grew to about the size of a quarter. We had an ultrasound on both lumps and it came back as "inflammation". This was after the first injection site was almost healed and the second injection was just starting to flare up. We saw another provider on 9/18/18. She said it was inflammation, and that we should wait and see what happens. It drained more and left a scar. We saw a Dermatologist, and he said that it is one of the worse vaccine skin reactions he has seem. He recommended seeing an Allergist. Dermatologist prescribed Triamcinolone ointment. We put that on her leg twice a day. This seemed to bring the fluid to the surface and it explode with creamy discharge. We called the dermatologist and he said it was the inflamed fat cells draining. We then went to see an Allergist, on 11/13/18 for an initial consultation. He applied a patch test on 12/10/18. We went back on 12/12 for allergist to look at the test site, and again on 12/14 to remove the patch test. Everything came back as negative for allergies. He recommended not doing any future doses of the PENTACEL until we figure out what is causing the reactions. At our check up with provider on 1/22/19 provider recommended calling the CDC to see if they had any other information. Today 3/7/19 I called CDC and they told us to report to VAERS. 3/19/19 I have the report put together and submitted.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Skin test negative, Ultrasound scan abnormal
Clinical narrative: Patient developed a lump at the injection site on her left that continued to grow and fill with fluid. We noticed the swelling about a week after the shot was given. It looked like an abscess or cyst and grew about the size of a pea until it popped and the fluid drained out like a pimple. We took her back to provider and had a culture done. Provider prescribed Mupirocin while we waited for the results. We applied the ointment a couple times a day. It did not help reduce the redness or swelling. Results came back from the culture as non bacterial. The site would drain a little bit periodically for about a month. Then it continued to improve slightly until the site eventually scarred. 8/9/18 We took patient see another provider for an ear infection. While we were there we showed her the lump from the vaccine reaction. We had her next dose of the PENTACEL on 8/16/18 in her right thigh. Lot number C5550A - Sanofi. We had the same reaction. This time the lump grew bigger at a faster rate and seemed to be more tender when the site was touched. This one grew to about the size of a quarter. We had an ultrasound on both lumps and it came back as "inflammation". This was after the first injection site was almost healed and the second injection was just starting to flare up. We saw another provider on 9/18/18. She said it was inflammation, and that we should wait and see what happens. It drained more and left a scar. We saw a Dermatologist, and he said that it is one of the worse vaccine skin reactions he has seem. He recommended seeing an Allergist. Dermatologist prescribed Triamcinolone ointment. We put that on her leg twice a day. This seemed to bring the fluid to the surface and it explode with creamy discharge. We called the dermatologist and he said it was the inflamed fat cells draining. We then went to see an Allergist, on 11/13/18 for an initial consultation. He applied a patch test on 12/10/18. We went back on 12/12 for allergist to look at the test site, and again on 12/14 to remove the patch test. Everything came back as negative for allergies. He recommended not doing any future doses of the PENTACEL until we figure out what is causing the reactions. At our check up with provider on 1/22/19 provider recommended calling the CDC to see if they had any other information. Today 3/7/19 I called CDC and they told us to report to VAERS. 3/19/19 I have the report put together and submitted.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Inflammation, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Mild redness swelling at the injection site/(L) deltoid muscle, no systemic signs. Improved with icing, pain medication. 03/13/2019 patient got 1 shot yesterday on left delta for TDaP, redness and swelling and sore noted after shot given. Here for F.U. Localized reaction to TDaP; ok to use ibuprofen to decreased inflammation.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 09-JUL-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered a painful rash on back and was diagnosed with shingles. The patient continued to suffer from pain and/or burning sensations on her back following the outbreak requiring additional care and treatment. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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, the patient has 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 to be not recovered. Shingles was considered disabling. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Atrioventricular block complete, Bradycardia, Cardiac monitoring, Cardiac pacemaker insertion
Clinical narrative: Initial information received on 14-Mar-2019 regarding an unsolicited valid serious case received from a consumer. This case involves a 58 years old male patient who experienced complete heart block, chronic occlusive thrombosis, pulmonary embolism, deep vein thrombosis (DVTs) in right arm, got a little sick and never regained energy, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Sep-2017, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5899NA via intramuscular route in the right arm. On an unknown date, the patient (non-serious) got a little sick (malaise) and never regained energy (asthenia), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 25-Sep-2017 he went to PCP. On an unknown date, the patient was diagnosed with serious complete heart block (atrioventricular block complete) with bradycardia and heart rate was 38 (heart rate decreased), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. He was fitted with a heart monitor for 2 weeks. After the 2 weeks he sent in his results from the monitor and was told to go immediately ER as he needed a pacemaker. Pacemaker was placed on 13-Oct-2017. After that he went home and was fine. Then he ended up with a Pulmonary embolism (PE) on 25-Oct-2017, 1 month 19 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. He said he had to have a pacemaker revision as it was not working properly. That revision on done on 26-Oct-2017. Since then he had been suffering from  deep vein thrombosis (DVTs) in right arm where pacemaker was placed and he never got his strength back. On an unknown date, the patient was also developed serious chronic occlusive thrombosis (thrombosis), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The events: atrioventricular block complete, deep vein thrombosis, chronic occlusive thrombosis and Pulmonary embolism were assessed as medically significant. Relevant laboratory test results included: Heart rate - On an unknown date: 38 beats/min. Final diagnosis was atrioventricular block complete, deep vein thrombosis, malaise, asthenia, chronic occlusive thrombosis and Pulmonary embolism. It was not reported if the patient received a corrective treatment. The outcome for the events was not reported. List of documents held by sender: none.; Sender's Comments: This case concerns a 58 years old male patient who experienced atrioventricular block complete, deep vein thrombosis, bradycardia, heart rate decreased, malaise and asthenia after vaccination with FLUZONE QUADRIVALENT. The time to onset was unknown. Lab test included heart rate- 38 beats/min. However, there is no information regarding patient's medical condition at time of vaccination, concomitant medication, medical history, family history and risk factors. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Deep vein thrombosis, Heart rate decreased, Malaise, Pulmonary embolism, Thrombosis
Clinical narrative: Initial information received on 14-Mar-2019 regarding an unsolicited valid serious case received from a consumer. This case involves a 58 years old male patient who experienced complete heart block, chronic occlusive thrombosis, pulmonary embolism, deep vein thrombosis (DVTs) in right arm, got a little sick and never regained energy, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Sep-2017, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5899NA via intramuscular route in the right arm. On an unknown date, the patient (non-serious) got a little sick (malaise) and never regained energy (asthenia), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 25-Sep-2017 he went to PCP. On an unknown date, the patient was diagnosed with serious complete heart block (atrioventricular block complete) with bradycardia and heart rate was 38 (heart rate decreased), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. He was fitted with a heart monitor for 2 weeks. After the 2 weeks he sent in his results from the monitor and was told to go immediately ER as he needed a pacemaker. Pacemaker was placed on 13-Oct-2017. After that he went home and was fine. Then he ended up with a Pulmonary embolism (PE) on 25-Oct-2017, 1 month 19 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. He said he had to have a pacemaker revision as it was not working properly. That revision on done on 26-Oct-2017. Since then he had been suffering from  deep vein thrombosis (DVTs) in right arm where pacemaker was placed and he never got his strength back. On an unknown date, the patient was also developed serious chronic occlusive thrombosis (thrombosis), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The events: atrioventricular block complete, deep vein thrombosis, chronic occlusive thrombosis and Pulmonary embolism were assessed as medically significant. Relevant laboratory test results included: Heart rate - On an unknown date: 38 beats/min. Final diagnosis was atrioventricular block complete, deep vein thrombosis, malaise, asthenia, chronic occlusive thrombosis and Pulmonary embolism. It was not reported if the patient received a corrective treatment. The outcome for the events was not reported. List of documents held by sender: none.; Sender's Comments: This case concerns a 58 years old male patient who experienced atrioventricular block complete, deep vein thrombosis, bradycardia, heart rate decreased, malaise and asthenia after vaccination with FLUZONE QUADRIVALENT. The time to onset was unknown. Lab test included heart rate- 38 beats/min. However, there is no information regarding patient's medical condition at time of vaccination, concomitant medication, medical history, family history and risk factors. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Acute kidney injury, Acute left ventricular failure, Acute respiratory failure, Asthenia, Bacteraemia
Clinical narrative: Shortness of breath, weak, acute respiratory failure, HCC, septic shock, acute kidney injury (HCC). Acute encephalopathy, acute systolic heart failure. (HCC) Bacteremia, pneumonia, thrombocytopenia. HCC, shock liver, sepsis (HCC). Constipation.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Constipation, Dyspnoea, Encephalopathy, Hepatocellular carcinoma, Ischaemic hepatitis
Clinical narrative: Shortness of breath, weak, acute respiratory failure, HCC, septic shock, acute kidney injury (HCC). Acute encephalopathy, acute systolic heart failure. (HCC) Bacteremia, pneumonia, thrombocytopenia. HCC, shock liver, sepsis (HCC). Constipation.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pneumonia, Sepsis, Septic shock, Thrombocytopenia
Clinical narrative: Shortness of breath, weak, acute respiratory failure, HCC, septic shock, acute kidney injury (HCC). Acute encephalopathy, acute systolic heart failure. (HCC) Bacteremia, pneumonia, thrombocytopenia. HCC, shock liver, sepsis (HCC). Constipation.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old female patient who was vaccinated with FLUBLOK QIV, lot number QFAA1814, via intramuscular route in the left deltoid on 18-Oct-2018 while she was pregnant. The date of last menstrual period was 28-Nov-2016. The estimated due date was 05-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No information regarding concomitant medication premedication or previous therapy was provided. It was actual medication error due to Inappropriate age at vaccine administration. It was a case of vaccine exposure during pregnancy. Patient did not experience any adverse reaction after the injection. Additionally, at time of reporting, the outcome of the pregnancy is unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Additional information was received on 18-Mar-2019 from a nurse. Additional information received on 18-Mar-2019, this case initially considered as non-case was upgraded to valid-case: as FLUBLOK QIV coded with (529). List of documents held by sender- none.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Antinuclear antibody negative, Asthenia, C-reactive protein normal, Electromyogram abnormal, Fatigue
Clinical narrative: He states the anthrax was to his left arm, per his specific request and the typhoid was in his right arm, although the documentation in his medical record is opposite. He experienced onset of tremor, neurologic weakness followed by progressing pain over a period of days to months. He presented to ER on 04 DEC 17 (day 6) and neurology evaluation was 08 Dec 2017 (day 10). He was ultimately diagnosed with Parsonage-Turner Syndrome (PTS), and obtained two additional neurology referrals with same dx. conclusion.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Headache, Tremor
Clinical narrative: He states the anthrax was to his left arm, per his specific request and the typhoid was in his right arm, although the documentation in his medical record is opposite. He experienced onset of tremor, neurologic weakness followed by progressing pain over a period of days to months. He presented to ER on 04 DEC 17 (day 6) and neurology evaluation was 08 Dec 2017 (day 10). He was ultimately diagnosed with Parsonage-Turner Syndrome (PTS), and obtained two additional neurology referrals with same dx. conclusion.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Antiacetylcholine receptor antibody, Antinuclear antibody negative, Blood calcium decreased, Blood chloride normal, Blood creatinine normal
Clinical narrative: He states the anthrax was to his left arm, per his specific request and the typhoid was in his right arm, although the documentation in his medical record is opposite. He experienced onset of tremor, neurologic weakness followed by progressing pain over a period of days to months. He presented to ER on 04 DEC 17 (day 6) and neurology evaluation was 08 Dec 2017 (day 10). He was ultimately diagnosed with Parsonage-Turner Syndrome (PTS), and obtained two additional neurology referrals with same dx. conclusion.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Blood culture negative, Blood folate normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: He states the anthrax was to his left arm, per his specific request and the typhoid was in his right arm, although the documentation in his medical record is opposite. He experienced onset of tremor, neurologic weakness followed by progressing pain over a period of days to months. He presented to ER on 04 DEC 17 (day 6) and neurology evaluation was 08 Dec 2017 (day 10). He was ultimately diagnosed with Parsonage-Turner Syndrome (PTS), and obtained two additional neurology referrals with same dx. conclusion.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Blood thyroid stimulating hormone normal, Blood urea normal, Borrelia test negative, C-reactive protein normal, Carbon dioxide normal
Clinical narrative: He states the anthrax was to his left arm, per his specific request and the typhoid was in his right arm, although the documentation in his medical record is opposite. He experienced onset of tremor, neurologic weakness followed by progressing pain over a period of days to months. He presented to ER on 04 DEC 17 (day 6) and neurology evaluation was 08 Dec 2017 (day 10). He was ultimately diagnosed with Parsonage-Turner Syndrome (PTS), and obtained two additional neurology referrals with same dx. conclusion.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Full blood count normal, Glycosylated haemoglobin normal, Haematocrit normal, Haemoglobin normal, Intervertebral disc degeneration
Clinical narrative: He states the anthrax was to his left arm, per his specific request and the typhoid was in his right arm, although the documentation in his medical record is opposite. He experienced onset of tremor, neurologic weakness followed by progressing pain over a period of days to months. He presented to ER on 04 DEC 17 (day 6) and neurology evaluation was 08 Dec 2017 (day 10). He was ultimately diagnosed with Parsonage-Turner Syndrome (PTS), and obtained two additional neurology referrals with same dx. conclusion.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Lumbar puncture, Metabolic function test normal, Muscular weakness, Nerve conduction studies abnormal, Neuralgic amyotrophy
Clinical narrative: He states the anthrax was to his left arm, per his specific request and the typhoid was in his right arm, although the documentation in his medical record is opposite. He experienced onset of tremor, neurologic weakness followed by progressing pain over a period of days to months. He presented to ER on 04 DEC 17 (day 6) and neurology evaluation was 08 Dec 2017 (day 10). He was ultimately diagnosed with Parsonage-Turner Syndrome (PTS), and obtained two additional neurology referrals with same dx. conclusion.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Osteoarthritis, Pain
Clinical narrative: He states the anthrax was to his left arm, per his specific request and the typhoid was in his right arm, although the documentation in his medical record is opposite. He experienced onset of tremor, neurologic weakness followed by progressing pain over a period of days to months. He presented to ER on 04 DEC 17 (day 6) and neurology evaluation was 08 Dec 2017 (day 10). He was ultimately diagnosed with Parsonage-Turner Syndrome (PTS), and obtained two additional neurology referrals with same dx. conclusion.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Platelet count normal, Red blood cell count normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Tremor
Clinical narrative: He states the anthrax was to his left arm, per his specific request and the typhoid was in his right arm, although the documentation in his medical record is opposite. He experienced onset of tremor, neurologic weakness followed by progressing pain over a period of days to months. He presented to ER on 04 DEC 17 (day 6) and neurology evaluation was 08 Dec 2017 (day 10). He was ultimately diagnosed with Parsonage-Turner Syndrome (PTS), and obtained two additional neurology referrals with same dx. conclusion.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Treponema test negative, Vitamin B12 normal, White blood cell count decreased
Clinical narrative: He states the anthrax was to his left arm, per his specific request and the typhoid was in his right arm, although the documentation in his medical record is opposite. He experienced onset of tremor, neurologic weakness followed by progressing pain over a period of days to months. He presented to ER on 04 DEC 17 (day 6) and neurology evaluation was 08 Dec 2017 (day 10). He was ultimately diagnosed with Parsonage-Turner Syndrome (PTS), and obtained two additional neurology referrals with same dx. conclusion.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 75-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose in June 2018 and had no side effects). On 14th February 2019, the patient received the 2nd dose of SHINGRIX. On 14th February 2019, less than a day after receiving SHINGRIX, the patient experienced pruritus and drug dose administration interval too long. On 15th February 2019, the patient experienced erythromacular rash, blistery rash and burning skin. The patient was treated with mupirocin (Mupirocine) and prednisone. On an unknown date, the outcome of the pruritus was recovered/resolved and the outcome of the erythromacular rash, blistery rash and burning skin were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. The reporter considered the pruritus, erythromacular rash, blistery rash and burning skin to be related to SHINGRIX. Additional details were provided as follows: The patient received his 2nd dose in February of 2019 when he was able to find a pharmacy that had it, which led to drug dose administration interval too long. On the same night he started to feel itchy and by the next morning he was broken out in red spots all over including his neck, back and now around his left eye. The spots kept growing and blistering up so the skin was now raw and was burning. The patient consulted to physician, who said it was just a reaction to the shot and should go away in 3 to 4 days. The patient had been given Mupirocin and prednisone but the rash remained. The patient went to dermatologist and had a biopsy done on 11th March 2019, and was awaiting the results. It was reported that, the patient never had shingles before and his physician were adamant this was not shingles.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Inappropriate schedule of product administration, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 75-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose in June 2018 and had no side effects). On 14th February 2019, the patient received the 2nd dose of SHINGRIX. On 14th February 2019, less than a day after receiving SHINGRIX, the patient experienced pruritus and drug dose administration interval too long. On 15th February 2019, the patient experienced erythromacular rash, blistery rash and burning skin. The patient was treated with mupirocin (Mupirocine) and prednisone. On an unknown date, the outcome of the pruritus was recovered/resolved and the outcome of the erythromacular rash, blistery rash and burning skin were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. The reporter considered the pruritus, erythromacular rash, blistery rash and burning skin to be related to SHINGRIX. Additional details were provided as follows: The patient received his 2nd dose in February of 2019 when he was able to find a pharmacy that had it, which led to drug dose administration interval too long. On the same night he started to feel itchy and by the next morning he was broken out in red spots all over including his neck, back and now around his left eye. The spots kept growing and blistering up so the skin was now raw and was burning. The patient consulted to physician, who said it was just a reaction to the shot and should go away in 3 to 4 days. The patient had been given Mupirocin and prednisone but the rash remained. The patient went to dermatologist and had a biopsy done on 11th March 2019, and was awaiting the results. It was reported that, the patient never had shingles before and his physician were adamant this was not shingles.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Rash vesicular, Skin burning sensation, Skin erosion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 75-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose in June 2018 and had no side effects). On 14th February 2019, the patient received the 2nd dose of SHINGRIX. On 14th February 2019, less than a day after receiving SHINGRIX, the patient experienced pruritus and drug dose administration interval too long. On 15th February 2019, the patient experienced erythromacular rash, blistery rash and burning skin. The patient was treated with mupirocin (Mupirocine) and prednisone. On an unknown date, the outcome of the pruritus was recovered/resolved and the outcome of the erythromacular rash, blistery rash and burning skin were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. The reporter considered the pruritus, erythromacular rash, blistery rash and burning skin to be related to SHINGRIX. Additional details were provided as follows: The patient received his 2nd dose in February of 2019 when he was able to find a pharmacy that had it, which led to drug dose administration interval too long. On the same night he started to feel itchy and by the next morning he was broken out in red spots all over including his neck, back and now around his left eye. The spots kept growing and blistering up so the skin was now raw and was burning. The patient consulted to physician, who said it was just a reaction to the shot and should go away in 3 to 4 days. The patient had been given Mupirocin and prednisone but the rash remained. The patient went to dermatologist and had a biopsy done on 11th March 2019, and was awaiting the results. It was reported that, the patient never had shingles before and his physician were adamant this was not shingles.
Age: 49.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Sharp pain followed by redness swelling and firm lump in area of vaccination on left arm.
Age: 49.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Inflammation, Injection site erythema, Ultrasound scan abnormal, Vaccination site mass, Vaccination site pain
Clinical narrative: Sharp pain followed by redness swelling and firm lump in area of vaccination on left arm.
Age: 49.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Vaccination site swelling
Clinical narrative: Sharp pain followed by redness swelling and firm lump in area of vaccination on left arm.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Tenderness
Clinical narrative: 3 days after vaccination patient started developing sores on her forehead. She said it was not painful at first but is now tender to the touch. Patient will follow up with a doctor or hospital in the morning if she is not feeling better. Told patient that if she gets signs and symptoms like swelling of the mouth or tongue, go directly to emergency room. Told patient she should follow up with a doctor because this is not a common side effect with SHINGRIX.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Anaemia, Asthenia, Blood test, Dermatitis, Fatigue
Clinical narrative: 6 months after receiving the last and 3rd of the series of the HPV, GARDASIL vaccine I suddenly experienced full body fatigue, malaise, skin discoloration, low energy levels, trouble with food absorption, IBS, food sensitivities, dermatitis, low iron levels which quickly led to severe anemia that I had never experienced before.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Food intolerance, Gastritis, Gastroenteritis, Iron deficiency, Irritable bowel syndrome
Clinical narrative: 6 months after receiving the last and 3rd of the series of the HPV, GARDASIL vaccine I suddenly experienced full body fatigue, malaise, skin discoloration, low energy levels, trouble with food absorption, IBS, food sensitivities, dermatitis, low iron levels which quickly led to severe anemia that I had never experienced before.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Skin discolouration
Clinical narrative: 6 months after receiving the last and 3rd of the series of the HPV, GARDASIL vaccine I suddenly experienced full body fatigue, malaise, skin discoloration, low energy levels, trouble with food absorption, IBS, food sensitivities, dermatitis, low iron levels which quickly led to severe anemia that I had never experienced before.
Age: 1.33
Sex: M
Vaccine: UNK
Symptoms: Cyanosis, Febrile convulsion, Postictal state, Tremor
Clinical narrative: Febrile Seizure- parents describe 5-6 minute episode of generalized shaking, perioral cyanosis, postictal afterwards.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Patient woke morning after injection with flu like symptoms. Muscle aches, chills, headache, fatigue, low grade fever.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient woke morning after injection with flu like symptoms. Muscle aches, chills, headache, fatigue, low grade fever.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 month and 10 days old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. On 19-FEB-2019, the patient was vaccinated with the forth dose of ROTATEQ orally (lot # R016271 with an expiration date on 25-APR-2020) for prophylaxis (strength, dose, lot number and expiration date were not reported). No adverse effects reported.
Age: 4.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 4 year old unknown gender patient. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On 19-FEB-2019, the patient was vaccinated with 1 dose of M-M-R II(lot # R024903, Expiration date: 30-AUG-2020 dose, frequency, route were not reported) and 1 dose of PROQUAD(lot #: R023499, expiration date: 13-FEB-2020, dose, frequency and route were not reported) for prophylaxis(incorrect dose administered). No adverse effects. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided.