chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concurrent medical conditions included Parkinson's disease. Concomitant products included carbidopa with levodopa. On 21st March 2018, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced worn out. On 21st March 2018, the patient experienced injection site swelling, injection site pain, injection site inflammation and injection site erythema. On 22nd March 2018, the patient experienced general body pain, neck pain, shoulder pain and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, general body pain, worn out, neck pain, shoulder pain, injection site pain and injection site inflammation were recovering/resolving and the outcome of the injection site erythema and influenza-like symptoms were unknown. The reporter considered the injection site swelling, general body pain, worn out, neck pain, injection site pain and injection site inflammation to be related to SHINGRIX. It was unknown if the reporter considered the shoulder pain, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient received pain medication as concomitant drug. The pharmacist reported that she administered the SHINGRIX to a patient at 2:30 pm and the patient reported that her upper arm turned bright red and swollen and was sore immediately after injection. The patient experienced severe pain in her shoulder and neck but the pain subsided when the inflammation form the injection site went down. The patient had flu like symptoms that made her bed ridden and she had body aches the following day after injection. The pharmacist described her side effects as exaggerated side effects.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concurrent medical conditions included Parkinson's disease. Concomitant products included carbidopa with levodopa. On 21st March 2018, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced worn out. On 21st March 2018, the patient experienced injection site swelling, injection site pain, injection site inflammation and injection site erythema. On 22nd March 2018, the patient experienced general body pain, neck pain, shoulder pain and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, general body pain, worn out, neck pain, shoulder pain, injection site pain and injection site inflammation were recovering/resolving and the outcome of the injection site erythema and influenza-like symptoms were unknown. The reporter considered the injection site swelling, general body pain, worn out, neck pain, injection site pain and injection site inflammation to be related to SHINGRIX. It was unknown if the reporter considered the shoulder pain, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient received pain medication as concomitant drug. The pharmacist reported that she administered the SHINGRIX to a patient at 2:30 pm and the patient reported that her upper arm turned bright red and swollen and was sore immediately after injection. The patient experienced severe pain in her shoulder and neck but the pain subsided when the inflammation form the injection site went down. The patient had flu like symptoms that made her bed ridden and she had body aches the following day after injection. The pharmacist described her side effects as exaggerated side effects.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 51-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 28th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th March 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, general body pain, fever, vomiting, nausea and headache. On an unknown date, the outcome of the muscle pain, general body pain, fever, vomiting, nausea and headache were recovering/resolving. The reporter considered the muscle pain, general body pain, fever, vomiting, nausea and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient said he was better but not 100 percent yet. The registered pharmacist reported adverse events to VAERS. This case is 1 of 4 cases reported by same reporter.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 51-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 28th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th March 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, general body pain, fever, vomiting, nausea and headache. On an unknown date, the outcome of the muscle pain, general body pain, fever, vomiting, nausea and headache were recovering/resolving. The reporter considered the muscle pain, general body pain, fever, vomiting, nausea and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient said he was better but not 100 percent yet. The registered pharmacist reported adverse events to VAERS. This case is 1 of 4 cases reported by same reporter.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 51-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 28th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th March 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, general body pain, fever, vomiting, nausea and headache. On an unknown date, the outcome of the muscle pain, general body pain, fever, vomiting, nausea and headache were recovering/resolving. The reporter considered the muscle pain, general body pain, fever, vomiting, nausea and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient said he was better but not 100 percent yet. The registered pharmacist reported adverse events to VAERS. This case is 1 of 4 cases reported by same reporter.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 51-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 28th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th March 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, general body pain, fever, vomiting, nausea and headache. On an unknown date, the outcome of the muscle pain, general body pain, fever, vomiting, nausea and headache were recovering/resolving. The reporter considered the muscle pain, general body pain, fever, vomiting, nausea and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient said he was better but not 100 percent yet. The registered pharmacist reported adverse events to VAERS. This case is 1 of 4 cases reported by same reporter.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Pain at injection site, nausea, increased thirst, joint pain, muscle pain, fever, headache. Ibuprofen and fluids.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Thirst
Clinical narrative: Pain at injection site, nausea, increased thirst, joint pain, muscle pain, fever, headache. Ibuprofen and fluids.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Asthenia, Blood creatine phosphokinase normal, Bronchitis, Cytomegalovirus test negative
Clinical narrative: Flu vacc 1-27-18. Started with sinus symptoms. Diagnosed with Flu 02-05-2018. Suffered 5 days with flu/ bronchitis/ fever x 5 days. Began feeling really ill 02-09-2018. Trouble walking, swallowing, severe stomach pain, hot cold flashes, irritable, lost interest drinking and eating, trouble brushing teeth, urinating, showering ( to painful) insomnia due to pain, extreme fatigue, deep excruciating pain that was much worse at night, unable to concentrate, to weak to get out of bed.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Disturbance in attention, Dysphagia, Epstein-Barr virus test negative, Fatigue
Clinical narrative: Flu vacc 1-27-18. Started with sinus symptoms. Diagnosed with Flu 02-05-2018. Suffered 5 days with flu/ bronchitis/ fever x 5 days. Began feeling really ill 02-09-2018. Trouble walking, swallowing, severe stomach pain, hot cold flashes, irritable, lost interest drinking and eating, trouble brushing teeth, urinating, showering ( to painful) insomnia due to pain, extreme fatigue, deep excruciating pain that was much worse at night, unable to concentrate, to weak to get out of bed.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling of body temperature change, Full blood count normal, Gait disturbance, Hot flush, Influenza
Clinical narrative: Flu vacc 1-27-18. Started with sinus symptoms. Diagnosed with Flu 02-05-2018. Suffered 5 days with flu/ bronchitis/ fever x 5 days. Began feeling really ill 02-09-2018. Trouble walking, swallowing, severe stomach pain, hot cold flashes, irritable, lost interest drinking and eating, trouble brushing teeth, urinating, showering ( to painful) insomnia due to pain, extreme fatigue, deep excruciating pain that was much worse at night, unable to concentrate, to weak to get out of bed.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Insomnia, Irritability, Loss of personal independence in daily activities, Malaise, Mononucleosis heterophile test negative
Clinical narrative: Flu vacc 1-27-18. Started with sinus symptoms. Diagnosed with Flu 02-05-2018. Suffered 5 days with flu/ bronchitis/ fever x 5 days. Began feeling really ill 02-09-2018. Trouble walking, swallowing, severe stomach pain, hot cold flashes, irritable, lost interest drinking and eating, trouble brushing teeth, urinating, showering ( to painful) insomnia due to pain, extreme fatigue, deep excruciating pain that was much worse at night, unable to concentrate, to weak to get out of bed.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging normal, Pain, Pyrexia, Sinus disorder, Swallow study
Clinical narrative: Flu vacc 1-27-18. Started with sinus symptoms. Diagnosed with Flu 02-05-2018. Suffered 5 days with flu/ bronchitis/ fever x 5 days. Began feeling really ill 02-09-2018. Trouble walking, swallowing, severe stomach pain, hot cold flashes, irritable, lost interest drinking and eating, trouble brushing teeth, urinating, showering ( to painful) insomnia due to pain, extreme fatigue, deep excruciating pain that was much worse at night, unable to concentrate, to weak to get out of bed.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Sex: M
Vaccine: CHOL, TYP
Symptoms: Drug administered to patient of inappropriate age, Wrong technique in product usage process
Clinical narrative: This spontaneous case report was received from a nurse (PVX2018-169) on 18-Jan-2018. The report describes male consumer (older than 64 years) who "ate 15 minutes after taking VAXCHORA". The consumer was receiving oral VAXCHROA for cholera protection. Also the consumer was above the approved age for VAXCHORA. It was reported that the consumer ate 15 minutes after taking VAXCHORA. VAXCHORA is indicated for patients up to 64 years old, but the consumer was above this age group as indicated his date of birth. The action taken with VIVOTIF with respect to the events "ate 15 minutes after taking VAXCHORA" and consumer was above the approved age for VAXCHORA was not applicable. The clinical outcome of the events "ate 15 minutes after taking VAXCHORA" and consumer was above the approved age for VAXCHORA was unknown. Sender's Comments: Company's comment: The causality of the events "ate 15 minutes after taking VAXCHORA" and "consumer was above the approved age for VAXCHORA" was considered as not applicable.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a medical assistant, and refers to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, (lot # N021101 with an expiration date 28-FEB-2019), for prophylaxis, (dose, frequency and strength were not provided), that underwent a temperature excursion of 34 degrees Fahrenheit during a time frame of 2 hours and 30 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect were reported and no product quality complaint (PQC) was involved. Follow up information has been received from the physician on 15-MAR-2018 referring to a 2 months old male patient. On 12-FEB-2018, the patient was vaccinated with the second dose of improperly stored ROTATEQ (lot# N021099 with expiration date 02-FEB-2019 (previously reported as lot # N021101 with an expiration date 28-FEB-2019)). The patient had no illness at time of vaccination. No reaction noted.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Maternal exposure before pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a female patient, who was medical assistant, reporting on 17-year-old herself. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in 2008, the patient was vaccinated with 3 doses of GARDASIL injection (dose, route of administration, lot # and expiry date were not reported) for prophylaxis (reported as "adolescent vaccine"). On an unknown date in 2010, (reported as "at age 17"), the patient delivered a baby (details unknown). Follow-up information has been received from a registered nurse in physician's office on 02-APR-2018. The registered nurse wanted to know where this report came from because it was totally wrong. It was reported that, the patient had not been seen in this office since 2009 and the office had no information on any vaccinations or pregnancies the patient in this report had received. This is one of two reports concerning the same patient. Sender's Comments: US-009507513-1803USA004631.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a male patient of unknown age. The patient was allergic to penicillin and sulfa. The patient's concurrent condition and concomitant therapy information was not provided. On 14-MAR-2018 the patient was vaccinated with PNEUMOVAX 23 (0.5ml, once) (lot# N034512, expiration date: 13-SEP-2019) intramuscularly for prophylaxis. On an unknown date the patient experienced pain at the injection site. The injection site pain radiated to the inner portion of the patient's arm, after patient took his blood pressure in the same unspecified arm, over the injection site. The pharmacist advised the patient to use of over-the-counter drug (OTC) analgesic medicines, however the patient declined the use of an OTC analgesic medicines. The outcome of the events was unknown. The causality between the events and PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report as received from a nurse and refers to multiple patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patient were vaccinated with improperly stored doses of VAQTA (lot # N028743, expiration date: 23-NOV-2018, dose and route of administration were not reported) or M-M-R II (lot# N013867, expiration date: 04-MAY-2019, dose and route of administration were not reported) both for prophylaxis. Both vaccines were reconstituted with improperly stored sterile diluent (MRK) (lot#, expiration date, dose and route of administration were not reported). Reporter stated that the vaccines were stored between 32° degrees Fahrenheit  to 35° degrees Fahrenheit (also reported as 32.9 Fahrenheit) for 23 hours prior to administration. There was previous temperature excursions reported as between 47° degrees Fahrenheit to 77° degrees Fahrenheit (also reported as 53.5 Fahrenheit) for 1 hour. The digital data logger was used. The patients did not experienced any adverse events. Product quality complaint was not involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent. On an unknown date the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route were not reported) (lot # N029632 expiry date: 23-OCT-2019) for prophylaxis. The VARIVAX was stored in temperature of 15 degree Fahrenheit (F) to 46 F (31.1 F) for 1 hour. There was previous temperature excursion reported 6 F to 14 F (10 F). A digital data logger was not involved. No adverse effects were reported. No product quality complaint was involved. Lot number [N029632] has been verified to be a valid lot number for VARIVAX.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were unknown. Concomitant therapy included sterile diluent (MRK INJ). On 10-JAN-2018 the patient was vaccinated with improperly stored dose of ZOSTAVAX vial 19400 PFU (dose, units and frequency were unknown) (lot # N021170 and expiration date 27-OCT-2018) and properly stored sterile diluent (MRK INJ) (lot number and expiration date unknown by reporter). The temperature excursion was from 6°F to 14°F for 3 hours and 45 minutes. The previous excursion was from 15°F to 46°F for 8 hours. The digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a nurse referring to multiple patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # N021572, expiration date: 01-MAY-2020 and, lot # N014470, expiration date: 17-JUN-2019, lot# N017833, expiration date: 16-NOV-2019, dose and route of administration were not provided) for prophylaxis. The doses were exposed to a temperature excursion of 9 degrees Celsius to 25 degrees Celsius during unknown period of time. The temperature excursion was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. Product quality complaint (PQC) was not reported.
Sex: M
Vaccine: FLUX, PPV, TDAP
Symptoms: ACTH stimulation test abnormal, Abdominal pain, Adrenocortical insufficiency acute, Antibody test positive, Blood corticotrophin increased
Clinical narrative: Information has been received from a literature article, referring to a 32-year-old man. The patient with recurrent idiopathic pericarditis was admitted with persistent hypotension. Workup revealed elevated ACTH, low DHEA-S, positive ACTH stimulation test and positive 21-hydroxylase antibody consistent with autoimmune Addison disease. Maintenance hydrocortisone, 20 mg in the morning and 5 mg at night, as well as fludrocortisone 0.05 mg daily, were started. He was counseled on the use of emergency dexamethasone injection pens. One month after discharge, he had normal sodium and potassium levels and a renin level of 3.0 ng/mL/h. During a follow-up primary care appointment, the patient was administered routine influenza virus vaccine (unspecified), Tdap and pneumococcal vaccine, polyvalent (23-valent) (manufacturer, dose, lot# and route unknown). Six hours after immunisations, the patient developed fever, myalgias, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 centigrade and hypotension of 88/54, with hyponatraemia and hyperkalaemia. Upon admission to the intensive care unit for adrenal crisis, he received 4 L of normal saline and stress-dose IV hydrocortisone for 24 h. The patient's gastrointestinal symptoms quickly resolved after steroid administration and his sodium and potassium normalised. He was discharged on his home steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The author considered the event adrenal crisis to be related to influenza virus vaccine (unspecified), diphtheria toxoid, pertussis acellular vaccine (unspecified), Tdap and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Upon internal review, the event adrenal crisis was determined to be medically significant.
Sex: M
Vaccine: FLUX, PPV, TDAP
Symptoms: Blood potassium increased, Blood sodium decreased, Condition aggravated, Dehydroepiandrosterone decreased, Hyperkalaemia
Clinical narrative: Information has been received from a literature article, referring to a 32-year-old man. The patient with recurrent idiopathic pericarditis was admitted with persistent hypotension. Workup revealed elevated ACTH, low DHEA-S, positive ACTH stimulation test and positive 21-hydroxylase antibody consistent with autoimmune Addison disease. Maintenance hydrocortisone, 20 mg in the morning and 5 mg at night, as well as fludrocortisone 0.05 mg daily, were started. He was counseled on the use of emergency dexamethasone injection pens. One month after discharge, he had normal sodium and potassium levels and a renin level of 3.0 ng/mL/h. During a follow-up primary care appointment, the patient was administered routine influenza virus vaccine (unspecified), Tdap and pneumococcal vaccine, polyvalent (23-valent) (manufacturer, dose, lot# and route unknown). Six hours after immunisations, the patient developed fever, myalgias, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 centigrade and hypotension of 88/54, with hyponatraemia and hyperkalaemia. Upon admission to the intensive care unit for adrenal crisis, he received 4 L of normal saline and stress-dose IV hydrocortisone for 24 h. The patient's gastrointestinal symptoms quickly resolved after steroid administration and his sodium and potassium normalised. He was discharged on his home steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The author considered the event adrenal crisis to be related to influenza virus vaccine (unspecified), diphtheria toxoid, pertussis acellular vaccine (unspecified), Tdap and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Upon internal review, the event adrenal crisis was determined to be medically significant.
Sex: M
Vaccine: FLUX, PPV, TDAP
Symptoms: Hyponatraemia, Hypotension, Intensive care, Myalgia, Pyrexia
Clinical narrative: Information has been received from a literature article, referring to a 32-year-old man. The patient with recurrent idiopathic pericarditis was admitted with persistent hypotension. Workup revealed elevated ACTH, low DHEA-S, positive ACTH stimulation test and positive 21-hydroxylase antibody consistent with autoimmune Addison disease. Maintenance hydrocortisone, 20 mg in the morning and 5 mg at night, as well as fludrocortisone 0.05 mg daily, were started. He was counseled on the use of emergency dexamethasone injection pens. One month after discharge, he had normal sodium and potassium levels and a renin level of 3.0 ng/mL/h. During a follow-up primary care appointment, the patient was administered routine influenza virus vaccine (unspecified), Tdap and pneumococcal vaccine, polyvalent (23-valent) (manufacturer, dose, lot# and route unknown). Six hours after immunisations, the patient developed fever, myalgias, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 centigrade and hypotension of 88/54, with hyponatraemia and hyperkalaemia. Upon admission to the intensive care unit for adrenal crisis, he received 4 L of normal saline and stress-dose IV hydrocortisone for 24 h. The patient's gastrointestinal symptoms quickly resolved after steroid administration and his sodium and potassium normalised. He was discharged on his home steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The author considered the event adrenal crisis to be related to influenza virus vaccine (unspecified), diphtheria toxoid, pertussis acellular vaccine (unspecified), Tdap and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Upon internal review, the event adrenal crisis was determined to be medically significant.
Sex: M
Vaccine: FLUX, PPV, TDAP
Symptoms: Vomiting
Clinical narrative: Information has been received from a literature article, referring to a 32-year-old man. The patient with recurrent idiopathic pericarditis was admitted with persistent hypotension. Workup revealed elevated ACTH, low DHEA-S, positive ACTH stimulation test and positive 21-hydroxylase antibody consistent with autoimmune Addison disease. Maintenance hydrocortisone, 20 mg in the morning and 5 mg at night, as well as fludrocortisone 0.05 mg daily, were started. He was counseled on the use of emergency dexamethasone injection pens. One month after discharge, he had normal sodium and potassium levels and a renin level of 3.0 ng/mL/h. During a follow-up primary care appointment, the patient was administered routine influenza virus vaccine (unspecified), Tdap and pneumococcal vaccine, polyvalent (23-valent) (manufacturer, dose, lot# and route unknown). Six hours after immunisations, the patient developed fever, myalgias, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 centigrade and hypotension of 88/54, with hyponatraemia and hyperkalaemia. Upon admission to the intensive care unit for adrenal crisis, he received 4 L of normal saline and stress-dose IV hydrocortisone for 24 h. The patient's gastrointestinal symptoms quickly resolved after steroid administration and his sodium and potassium normalised. He was discharged on his home steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The author considered the event adrenal crisis to be related to influenza virus vaccine (unspecified), diphtheria toxoid, pertussis acellular vaccine (unspecified), Tdap and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Upon internal review, the event adrenal crisis was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Chest discomfort, Conjunctivitis, Drug administered to patient of inappropriate age, Dysarthria
Clinical narrative: This spontaneous report as received from a 39 year old non-pregnant female patient regarding herself. She did not have any pertinent medical history. Concomitant therapies included MICROGESTIN, folic acid, and methotrexate (manufacturer unknown). On 04-DEC-2014, the patient was vaccinated with ZOSTAVAX (1 dose, lot # J013137, expiration date: 17-JAN-2015) (route not reported) diluted with sterile diluent (manufacturer unknown) as recommended vaccine per her rheumatologist's recommendation. The patient received the vaccine prior to age 50 (inappropriate schedule of drug administration). On 10-JUN-2015, the patient's face became slack and she was slurring her words. On an unknown date in June 2015 (reported as about 6 months later after receiving ZOSTAVAX, the patient was taken to a hospital due to face becoming slack and slurring words. The patient sought medical attention. At the emergency room, the medical staff on duty performed many unspecified labs and test. She was later diagnosed with Bell's Palsy. On unknown dates (reported as since then), the patient had gained 40 pounds, developed high blood pressure, sleep apnea, and conjunctivitis. The patient confirmed that she did not have these issues prior to receiving ZOSTAVAX. Since receiving ZOSTAVAX, the patient was prescribed and treated with XIIDRA, PROZAC unspecified steroids, doxycycline, prednisone, acyclovir, TOPAMAX, carbamazepine, rizatriptan and sumatriptan (doses, frequencies, routes, lot#s, and expiration dates unknown) for the adverse events. On an unknown date, the patient experienced "too many side effects" due to which she stopped TOPAMAX. On an unknown date, the patient stopped sumatriptan due to the fact that it made her chest feel tight. The events did not cause hospitalization. Action taken with TOPAMAX was withdrawn for adverse event and sumatriptan (manufacturer unknown) was withdrawn for chest discomfort. The outcome of chest discomfort and adverse event was unknown and the outcome of other events was not recovered/not resolved. The patient considered the chest discomfort to be related to sumatriptan. The patient did not assess the causality of adverse event with TOPAMAX. The patient did not assess causality of all events with ZOSTAVAX. Product quality complaint was not involved. Upon internal review, the event facial paralysis was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Hypertension, Laboratory test, Sleep apnoea syndrome, Weight increased
Clinical narrative: This spontaneous report as received from a 39 year old non-pregnant female patient regarding herself. She did not have any pertinent medical history. Concomitant therapies included MICROGESTIN, folic acid, and methotrexate (manufacturer unknown). On 04-DEC-2014, the patient was vaccinated with ZOSTAVAX (1 dose, lot # J013137, expiration date: 17-JAN-2015) (route not reported) diluted with sterile diluent (manufacturer unknown) as recommended vaccine per her rheumatologist's recommendation. The patient received the vaccine prior to age 50 (inappropriate schedule of drug administration). On 10-JUN-2015, the patient's face became slack and she was slurring her words. On an unknown date in June 2015 (reported as about 6 months later after receiving ZOSTAVAX, the patient was taken to a hospital due to face becoming slack and slurring words. The patient sought medical attention. At the emergency room, the medical staff on duty performed many unspecified labs and test. She was later diagnosed with Bell's Palsy. On unknown dates (reported as since then), the patient had gained 40 pounds, developed high blood pressure, sleep apnea, and conjunctivitis. The patient confirmed that she did not have these issues prior to receiving ZOSTAVAX. Since receiving ZOSTAVAX, the patient was prescribed and treated with XIIDRA, PROZAC unspecified steroids, doxycycline, prednisone, acyclovir, TOPAMAX, carbamazepine, rizatriptan and sumatriptan (doses, frequencies, routes, lot#s, and expiration dates unknown) for the adverse events. On an unknown date, the patient experienced "too many side effects" due to which she stopped TOPAMAX. On an unknown date, the patient stopped sumatriptan due to the fact that it made her chest feel tight. The events did not cause hospitalization. Action taken with TOPAMAX was withdrawn for adverse event and sumatriptan (manufacturer unknown) was withdrawn for chest discomfort. The outcome of chest discomfort and adverse event was unknown and the outcome of other events was not recovered/not resolved. The patient considered the chest discomfort to be related to sumatriptan. The patient did not assess the causality of adverse event with TOPAMAX. The patient did not assess causality of all events with ZOSTAVAX. Product quality complaint was not involved. Upon internal review, the event facial paralysis was determined to be medically significant.
Sex: F
Vaccine: FLUX, HPV9, MEN, TDAP
Symptoms: Generalised tonic-clonic seizure, Immediate post-injection reaction, Seizure, Tonic clonic movements
Clinical narrative: This spontaneous report was received from a physician via company representative, referring to a currently 11 year old female patient. The patient's historical drugs and medical history were not reported. The patient's concurrent conditions included asthma. The patient's concomitant therapies included influenza virus vaccine (unspecified) (reported as "Flu"), meningoccal vaccine unspecified and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as "tdap"). On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, for prevention of human papillomavirus infection (HPV) (strength, dose, frequency, lot# and expiration date were not reported). On the same date, immediately after withdrawal the needle used for the GARDASIL 9 injection, the patient experienced clonic, tonic movements, described as a seizure. The patient was in doctor's office and did not receive any treatment. Diagnostic laboratories were not performed. The patient recovered from the event on the same day, within one minute. Additionally, the causality assessment between generalised tonic-clonic seizure and GARDASIL 9 was not provided. Upon internal review generalised tonic-clonic seizure was determined to be a medically significant event.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder
Clinical narrative: This spontaneous report was received from a consumer refers to unspecified female patients of unknown age. Information on patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with  GARDASIL injection (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis. The reporter enquired where in the public literature, was the percentage of girls/young women who had ended up with an autoimmune disease disclosed. The outcome and causality of autoimmune disorder were not reported. Upon internal review, autoimmune disorder was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX lot # N022980 (dose, frequency and route of administration were not provided) for prophylaxis which was reconstituted with a properly stored dose of sterile diluent (manufacturer unknown). The vaccine was stored at a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 48 hours and, 15 degree Fahrenheit to 46 degree Fahrenheit for 9 hours with no previous temperature excursion. Digital Data logger was involved.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Blood glucose increased, Malaise
Clinical narrative: Initial unsolicited report received from consumer (Patient) on 28 Mar 2018. This case involves 62 years old male patient who was vaccinated with dose of Influenza vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On unspecified date post vaccination patient was weak and beats him down and blood glucose increased. On an unspecified date in 2010, patient got his first flu shot in 2010 and since then he got sick with every flu shot. Other laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Blood glucose increased, Feeling abnormal
Clinical narrative: Initial unsolicited report received from consumer (Patient) on 28 Mar 2018. This case involves 62 years old male patient who was vaccinated with dose of Influenza vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On unspecified date post vaccination patient was weak and beats him down and blood glucose increased. On an unspecified date in 2010, patient got his first flu shot in 2010 and since then he got sick with every flu shot. Other laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Paraesthesia, Pruritus, Swelling
Clinical narrative: Noticed redness and swelling almost immediate. Arm was very itchy. Took BENADRYL with some relief but the redness, swelling has continued to increase in size. Arm is sore. Has FROM of shoulder and elbow. Denies numbness in arm. Slightly tingling. Denies fevers, feeling poorly. Denies difficulty breathing, shortness of breath. Was seen back in office on 04/03/18 and given SOLU-MEDROL injection here as well as a prescription for prednisone.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Lymph node pain
Clinical narrative: Day 4 after injection swelling of anterior deltoid palm sized associated with 1 cm tender non-red, mobile left supraclavicular lymph node.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site papule
Clinical narrative: Anterior L thigh with two areas of erythema. More proximal had two small papules within it, no pustules. Both had firm nodules underlying them. No warmth or discharge.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Dizziness, Ear congestion, Headache, Nasal congestion, Pain
Clinical narrative: Congestion, headache, dizzy, whole body soreness, nose swelling, ears stuffed gave cough med with antihistamine and symptoms resolved by morning.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Respiratory tract congestion
Clinical narrative: Congestion, headache, dizzy, whole body soreness, nose swelling, ears stuffed gave cough med with antihistamine and symptoms resolved by morning.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pyrexia, Sweating fever
Clinical narrative: The patient indicated by phone that she had fever, headache, tiredness, and "fever sweats". Patient took acetaminophen. She felt relieved and symptoms disappear.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: Insomnia - unable to sleep the entire night of 3/30/2018 - 3/31/2018.
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Haematochezia, Rectal examination normal, Stool analysis normal
Clinical narrative: I took the 4 doses of VIVOTIF every other day from March 6th-March 12th. I kept the pills refrigerated and took them on an empty stomach, 1 hour before or 2 hours after a meal, as instructed. However, the night of my last dosage (March 12th), I began to notice episodes of bright red bloody stool. Because the stool was non-painful and regular (solid, brown) and I had no other symptoms, I made a mental note of the event and didn't think much of it. However, when the bloody stool episodes persisted every day from March 12th-March 20th, I decided to call Health Clinic to see if this was possibly an unlisted side effect of the pills. The nurse denied any association of the bloody stool with the VIVOTIF vaccine and suggested that I make an appointment with my primary care physician.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Upper respiratory tract infection
Clinical narrative: Temp to 101.9 (R) after vaccines Temp 100.4 next day. Seen in office for URI Sx 4-5-2018.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis of arm in a female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received prior to 2016). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis of arm (serious criteria GSK medically significant), swelling arm and injected limb mobility decreased. The patient was treated with Antibiotics (Brand Name Not Known). On an unknown date, the outcome of the cellulitis of arm, swelling arm and injected limb mobility decreased were unknown. It was unknown if the reporter considered the cellulitis of arm, swelling of arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the cellulitis in the arm that was vaccinated was treated with 2 antibiotics. The patient also reported arm swelling, and inability to lift her arm. The HCP stated that, this case was reported to Vaccine Adverse Event Reporting System (VAERS), however she was unsure if this had previously been reported to the company. The HCP was reluctant to provide further information as she was not involved in previous interactions. No specifics were provided relative to the development or treatment of the adverse event.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Hives and swelling R thigh at inj site improved with BENADRYL.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. The patient was vaccinated with yellow fever vaccine, and subsequently, 5 days later, the patient was vaccinated with M-M-R II (dose, units, frequency and route not reported) (lot# and expiration date not reported) subcutaneously. No adverse symptoms were reported. No product quality complaint was involved.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a child patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PEDVAXHIB (dose, units, frequency and route not reported) (lot# and expiration date not reported). Reporter stated that, on an unknown date, dose of PEDVAXHIB was administered too soon to an unspecified child. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant via physician refers to identifiable patient. The patient received improperly stored VARIVAX on unspecified date in time period between 31-MAR-2018 to 02-APR-2018 from lot N017395 expiry date 07-JUN-2019 for prophylaxis. The sterile diluent (lot number and expiration date was unknown by reporter) was stored properly. No adverse effects were reported. Temperature and time frame was reported as -14 degree Celsius to -10 degree Celsius (-11.7 degree Celsius) for 1 hour and 8 minutes. No previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product quality issue, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse via field representative refers to a 12 year old patient. On 02-APR-2018 or 03-APR-2018, the patient was vaccinated with GARDASIL 9 from lot N021732 expiry date 01-FEB-2018 dose 1 by intramuscular route for prophylaxis. Nurse reported that while administering GARDASIL 9, the dose appeared to leak out of the syringe. No adverse effect reported. Product quality complaint (Product quality issue) has been filed. The outcome of Product quality issue was unknown. Causality assessment was not provided.
Sex: F
Vaccine: HPV4, MENB
Symptoms: Back pain, Chills, Gait disturbance, Hypoaesthesia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother). A female patient of unknown age, race/ethnicity received on 03Apr2018 a single dose of TRUMENBA and single dose of GARDASIL, both for immunization. Medical history and concomitant medications were not reported. Patient had vaccinations on 03Apr2018 and she is having very severe side effects: chills, backache, she "feels like the needle is still in her arm", her back and feet are hurting and are preventing her to walk too fast, and her body is numb from the shoulders down (Apr2018). Outcome was not reported.
Sex: F
Vaccine: HPV4, MENB
Symptoms: Sensation of foreign body
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother). A female patient of unknown age, race/ethnicity received on 03Apr2018 a single dose of TRUMENBA and single dose of GARDASIL, both for immunization. Medical history and concomitant medications were not reported. Patient had vaccinations on 03Apr2018 and she is having very severe side effects: chills, backache, she "feels like the needle is still in her arm", her back and feet are hurting and are preventing her to walk too fast, and her body is numb from the shoulders down (Apr2018). Outcome was not reported.