chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX, PPV, TDAP
Symptoms: ACTH stimulation test abnormal, Abdominal pain, Adrenocortical insufficiency acute, Antibody test positive, Blood corticotrophin increased
Clinical narrative: The following is the abstract from the article: A 32-year-old man 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. This case involves a 32-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Lot number, expiry date, route and site of administration were not reported), also received DIPHTHERIA AND TETANUS TOXOIDS and PNEUMOCOCCAL VACCINE (Lot number, expiry date, route and site of administration were not reported), on an unknown date. The patient had a medical history of autoimmune Addison disease. Concomitant medications included 20 mg of hydrocortisone in the morning and 5 mg at night and 0.05 mg fludrocortisone daily. On an unknown date, 6 hours following the vaccination, the patient experienced fever, myalgias, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 Celsius and hypotension of 88/54, with hyponatraemia and hyperkalaemia, that resulted in adrenal crisis and the existing disorder aggravated. Upon admission to the intensive care unit for adrenal crisis, the patient received 4 L of normal saline and stress-dose IV hydrocortisone for 24 h. Patient was discharged on his home steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The patient's laboratory data included renin level of 3.0 ng/ml/h. The patient was treated with 4 L of normal saline and stress-dose iv hydrocortisone for 24 h for adrenal crisis. It was reported that, the patient's gastrointestinal symptoms, Abdominal pain, Vomiting, hypotension of 88/54, hyponatraemia, hyperkalaemia, quickly resolved after steroid administration and his sodium and potassium normalized. The outcome of adrenal crisis, myalgia, aggravation of existing disorder and fever of 39.5 Celsius was unknown. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient with pre-existing adrenal insufficiency disease who developed an aggravation of his disorder after vaccination with Influenza, Tdap and Pneumococcal vaccines. The time to onset is compatible with the role of vaccines. However, the disease aggravation is clinically judged to be due to a stressful situation (simultaneous vaccination), concurrent stoppage of steroid therapy temporarily or a possible co-incidental infection. Based upon the reported information, the direct role of the vaccine components is unlikely.
Sex: M
Vaccine: FLUX, PPV, TDAP
Symptoms: Condition aggravated, Dehydroepiandrosterone decreased, Hyperkalaemia, Hyponatraemia, Hypophagia
Clinical narrative: The following is the abstract from the article: A 32-year-old man 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. This case involves a 32-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Lot number, expiry date, route and site of administration were not reported), also received DIPHTHERIA AND TETANUS TOXOIDS and PNEUMOCOCCAL VACCINE (Lot number, expiry date, route and site of administration were not reported), on an unknown date. The patient had a medical history of autoimmune Addison disease. Concomitant medications included 20 mg of hydrocortisone in the morning and 5 mg at night and 0.05 mg fludrocortisone daily. On an unknown date, 6 hours following the vaccination, the patient experienced fever, myalgias, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 Celsius and hypotension of 88/54, with hyponatraemia and hyperkalaemia, that resulted in adrenal crisis and the existing disorder aggravated. Upon admission to the intensive care unit for adrenal crisis, the patient received 4 L of normal saline and stress-dose IV hydrocortisone for 24 h. Patient was discharged on his home steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The patient's laboratory data included renin level of 3.0 ng/ml/h. The patient was treated with 4 L of normal saline and stress-dose iv hydrocortisone for 24 h for adrenal crisis. It was reported that, the patient's gastrointestinal symptoms, Abdominal pain, Vomiting, hypotension of 88/54, hyponatraemia, hyperkalaemia, quickly resolved after steroid administration and his sodium and potassium normalized. The outcome of adrenal crisis, myalgia, aggravation of existing disorder and fever of 39.5 Celsius was unknown. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient with pre-existing adrenal insufficiency disease who developed an aggravation of his disorder after vaccination with Influenza, Tdap and Pneumococcal vaccines. The time to onset is compatible with the role of vaccines. However, the disease aggravation is clinically judged to be due to a stressful situation (simultaneous vaccination), concurrent stoppage of steroid therapy temporarily or a possible co-incidental infection. Based upon the reported information, the direct role of the vaccine components is unlikely.
Sex: M
Vaccine: FLUX, PPV, TDAP
Symptoms: Hypotension, Intensive care, Myalgia, Pyrexia, Renin normal
Clinical narrative: The following is the abstract from the article: A 32-year-old man 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. This case involves a 32-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Lot number, expiry date, route and site of administration were not reported), also received DIPHTHERIA AND TETANUS TOXOIDS and PNEUMOCOCCAL VACCINE (Lot number, expiry date, route and site of administration were not reported), on an unknown date. The patient had a medical history of autoimmune Addison disease. Concomitant medications included 20 mg of hydrocortisone in the morning and 5 mg at night and 0.05 mg fludrocortisone daily. On an unknown date, 6 hours following the vaccination, the patient experienced fever, myalgias, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 Celsius and hypotension of 88/54, with hyponatraemia and hyperkalaemia, that resulted in adrenal crisis and the existing disorder aggravated. Upon admission to the intensive care unit for adrenal crisis, the patient received 4 L of normal saline and stress-dose IV hydrocortisone for 24 h. Patient was discharged on his home steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The patient's laboratory data included renin level of 3.0 ng/ml/h. The patient was treated with 4 L of normal saline and stress-dose iv hydrocortisone for 24 h for adrenal crisis. It was reported that, the patient's gastrointestinal symptoms, Abdominal pain, Vomiting, hypotension of 88/54, hyponatraemia, hyperkalaemia, quickly resolved after steroid administration and his sodium and potassium normalized. The outcome of adrenal crisis, myalgia, aggravation of existing disorder and fever of 39.5 Celsius was unknown. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient with pre-existing adrenal insufficiency disease who developed an aggravation of his disorder after vaccination with Influenza, Tdap and Pneumococcal vaccines. The time to onset is compatible with the role of vaccines. However, the disease aggravation is clinically judged to be due to a stressful situation (simultaneous vaccination), concurrent stoppage of steroid therapy temporarily or a possible co-incidental infection. Based upon the reported information, the direct role of the vaccine components is unlikely.
Sex: M
Vaccine: FLUX, PPV, TDAP
Symptoms: Vomiting
Clinical narrative: The following is the abstract from the article: A 32-year-old man 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. This case involves a 32-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Lot number, expiry date, route and site of administration were not reported), also received DIPHTHERIA AND TETANUS TOXOIDS and PNEUMOCOCCAL VACCINE (Lot number, expiry date, route and site of administration were not reported), on an unknown date. The patient had a medical history of autoimmune Addison disease. Concomitant medications included 20 mg of hydrocortisone in the morning and 5 mg at night and 0.05 mg fludrocortisone daily. On an unknown date, 6 hours following the vaccination, the patient experienced fever, myalgias, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 Celsius and hypotension of 88/54, with hyponatraemia and hyperkalaemia, that resulted in adrenal crisis and the existing disorder aggravated. Upon admission to the intensive care unit for adrenal crisis, the patient received 4 L of normal saline and stress-dose IV hydrocortisone for 24 h. Patient was discharged on his home steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The patient's laboratory data included renin level of 3.0 ng/ml/h. The patient was treated with 4 L of normal saline and stress-dose iv hydrocortisone for 24 h for adrenal crisis. It was reported that, the patient's gastrointestinal symptoms, Abdominal pain, Vomiting, hypotension of 88/54, hyponatraemia, hyperkalaemia, quickly resolved after steroid administration and his sodium and potassium normalized. The outcome of adrenal crisis, myalgia, aggravation of existing disorder and fever of 39.5 Celsius was unknown. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient with pre-existing adrenal insufficiency disease who developed an aggravation of his disorder after vaccination with Influenza, Tdap and Pneumococcal vaccines. The time to onset is compatible with the role of vaccines. However, the disease aggravation is clinically judged to be due to a stressful situation (simultaneous vaccination), concurrent stoppage of steroid therapy temporarily or a possible co-incidental infection. Based upon the reported information, the direct role of the vaccine components is unlikely.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who receive SHINGRIX (batch number XC534, expiry date 4th July 2020). On 5th March 2018, the patient received SHINGRIX. On 5th March 2018, less than a day after receiving SHINGRIX, the patient experienced chills, injection site pain and general body pain. In March 2018, the patient experienced fever, nocturnal awakening, muscle pain, fatigability generalized, headache and injection site erythema. In March 2018, the outcome of the nocturnal awakening, fatigability generalized and headache were recovered/resolved. On an unknown date, the outcome of the fever, chills, muscle pain, injection site erythema, injection site pain and general body pain were unknown. It was unknown if the reporter considered the fever, chills, nocturnal awakening, muscle pain, fatigability generalized, headache, injection site erythema, injection site pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX vaccine, the patient experienced the fever fluctuating from normal to 101 and back, severe chills with intense shivering that awoke the patient several times during 3 nights, body and muscle aching, general fatigue and mild headache for 72 plus hours and redness, soreness and mild pain at the injection site. The patient commented that it was okay if she developed immunity to shingles but that that left her with two questions. One was what should she expect as side effects from the second dose and what counselling they should give to their patients. They did not want to alarm them but the reporter was a little frightened by her side effects She further asked if they just warn them of the probable side effects and suggest mild acetaminophen dosing and what if any warnings should they make prior to the second dose especially for herself. The patient also mentioned that if the first available shingle vaccine was any indication they, as pharmacist, would be giving a great many of these vaccines. The patient called medical information requesting information about how to proceed. The patient's husband, also a pharmacist experienced the same side effects but much less severe (US2018GSK046333).
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who receive SHINGRIX (batch number XC534, expiry date 4th July 2020). On 5th March 2018, the patient received SHINGRIX. On 5th March 2018, less than a day after receiving SHINGRIX, the patient experienced chills, injection site pain and general body pain. In March 2018, the patient experienced fever, nocturnal awakening, muscle pain, fatigability generalized, headache and injection site erythema. In March 2018, the outcome of the nocturnal awakening, fatigability generalized and headache were recovered/resolved. On an unknown date, the outcome of the fever, chills, muscle pain, injection site erythema, injection site pain and general body pain were unknown. It was unknown if the reporter considered the fever, chills, nocturnal awakening, muscle pain, fatigability generalized, headache, injection site erythema, injection site pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX vaccine, the patient experienced the fever fluctuating from normal to 101 and back, severe chills with intense shivering that awoke the patient several times during 3 nights, body and muscle aching, general fatigue and mild headache for 72 plus hours and redness, soreness and mild pain at the injection site. The patient commented that it was okay if she developed immunity to shingles but that that left her with two questions. One was what should she expect as side effects from the second dose and what counselling they should give to their patients. They did not want to alarm them but the reporter was a little frightened by her side effects She further asked if they just warn them of the probable side effects and suggest mild acetaminophen dosing and what if any warnings should they make prior to the second dose especially for herself. The patient also mentioned that if the first available shingle vaccine was any indication they, as pharmacist, would be giving a great many of these vaccines. The patient called medical information requesting information about how to proceed. The patient's husband, also a pharmacist experienced the same side effects but much less severe (US2018GSK046333).
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal pain, Rash, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 69-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 19th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st March 2018, 2 days after receiving SHINGRIX, the patient experienced erythematous rash, injection site erythema, injection site pain and shoulder pain. On an unknown date, the outcome of the erythematous rash was unknown and the outcome of the injection site erythema, injection site pain and shoulder pain were not reported. The reporter considered the erythematous rash, injection site erythema and injection site pain to be possibly related to SHINGRIX. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional details were provide as follows: The patient received SHINGRIX on the right arm on Monday. On the reporting date, the patient returned to the pharmacy to report soreness in right arm and shoulder, redness about 6 inches below the injection site and raised slightly red spots on right arm and abdomen that are not itchy or painful. The patient confirmed that the red raised spots appeared after the SHINGRIX vaccination but he was not certain of the timing. The pharmacist called the agency to inquire whether the red spots might be due to the SHINGRIX and referred pharmacist to the Product information and to Medical information representative for further discussion.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (light case of shingles 10 years before the date of reporting). Previously administered products included Flu shot with an associated reaction of pain in extremity and Tetanus shot with an associated reaction of pain in extremity (the patient was hardly sore after receiving Tetanus and Flu shots the present year). On 29th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. But, it could be 61 or 62 years old. The patient was in good health condition with no serious underlying health problems. The patient received SHINGRIX on an unknown arm. The patient's arm was so sore that she could not sleep and could not find any pain reliever that helped much at all and asked to suggest one. The patient asked how long would this pain last, do any physicians or pharmacies give the shot in the rear, would her 2nd dose be as painful and should she decide to not get the 2nd dose and does her 1st dose give any immunity. The patient was not sure if she can go through this pain again. Since she wasn't prepared for how sore her arm would be after a shingles a shot, she did not know what pain relieve would work or what to try. She thought that, people should be warned just how painful it could be. Her pain was terrible for 3 days. Luckily she did not had to go to work. So, she waited a couple of days for a reply and no suggestions from GlaxoSmithKline experts on what to do were received. She would not recommend the shingles shot to anyone as she did not want them to hate her. This case has been linked to case US2018GSK060750, reported for the same patient.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Middle insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient said at the time of shot and next day no pain but maybe a week after and since he has had arm, shoulder pain. Wakes him up at night and radiating.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: 07/26/17 Pt. c/o redness, tenderness, and a "knot" at injection site per pt's mother. 07/28/17 Spoke with pt's mother and she reports that redness is improving. 07/31/17 Spoke with pt's mother and symptoms were resolved on 07/29/17 - Pt. took loratadine and ibuprofen.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Injection site bruising, Injection site induration, Injection site pain
Clinical narrative: Patient received vaccine Monday 4/9/18 in the morning. Reports temp 99.5 F in the evening as well as arm tenderness. On Tuesday 4/10/18 she noted arm swelling and two red spots on right arm. As of today 4/11/18, noted swelling in right upper arm. Area is hard and tender. Small bruise approximately the size of eraser head at injection site. A couple inches below the injection site are two red, flat spots, approximately quarter sized. These areas are more tender. Additionally under right armpit there is a large area of swelling. No palpable lymph nodes. Provider feels localized lymphatic reaction.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Oedema peripheral, Peripheral swelling, Tenderness
Clinical narrative: Patient received vaccine Monday 4/9/18 in the morning. Reports temp 99.5 F in the evening as well as arm tenderness. On Tuesday 4/10/18 she noted arm swelling and two red spots on right arm. As of today 4/11/18, noted swelling in right upper arm. Area is hard and tender. Small bruise approximately the size of eraser head at injection site. A couple inches below the injection site are two red, flat spots, approximately quarter sized. These areas are more tender. Additionally under right armpit there is a large area of swelling. No palpable lymph nodes. Provider feels localized lymphatic reaction.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Immediately upon receiving the shot in the upper left arm, pain began to travel directly down the arm and triggered fairly substantial pain within the elbow joint and further to the hand. The pain and a hot sensation also traveled up the arm and spread throughout the body. Within several hours, the pain had concentrated in joints and involved muscle aches and slight weakness/stiffness in all extremities. Ten to eighteen hours after the shot, the pain was accompanied by a moderate headache and moderate hot/sweating/fever. 24 hours after the shot, joint pain has subsided to mild, however muscle aches remain moderate in the back and in extremities. A general malaise and moderate to substantial fatigue is present. Movement/work exacerbates the remaining symptoms, but I am able to continue since it is office work.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Malaise, Muscular weakness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Immediately upon receiving the shot in the upper left arm, pain began to travel directly down the arm and triggered fairly substantial pain within the elbow joint and further to the hand. The pain and a hot sensation also traveled up the arm and spread throughout the body. Within several hours, the pain had concentrated in joints and involved muscle aches and slight weakness/stiffness in all extremities. Ten to eighteen hours after the shot, the pain was accompanied by a moderate headache and moderate hot/sweating/fever. 24 hours after the shot, joint pain has subsided to mild, however muscle aches remain moderate in the back and in extremities. A general malaise and moderate to substantial fatigue is present. Movement/work exacerbates the remaining symptoms, but I am able to continue since it is office work.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Immediately upon receiving the shot in the upper left arm, pain began to travel directly down the arm and triggered fairly substantial pain within the elbow joint and further to the hand. The pain and a hot sensation also traveled up the arm and spread throughout the body. Within several hours, the pain had concentrated in joints and involved muscle aches and slight weakness/stiffness in all extremities. Ten to eighteen hours after the shot, the pain was accompanied by a moderate headache and moderate hot/sweating/fever. 24 hours after the shot, joint pain has subsided to mild, however muscle aches remain moderate in the back and in extremities. A general malaise and moderate to substantial fatigue is present. Movement/work exacerbates the remaining symptoms, but I am able to continue since it is office work.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient developed redness and swelling in arm and was treated with antibiotic for cellulitis.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Extensive swelling of vaccinated limb, Injection site erythema, Insomnia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 70-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received 5 years ago. On 28th March 2018, the patient received the 1st dose of SHINGRIX. On 28th march 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, pain, bone pain and sleeplessness. The patient was treated with ibuprofen and non-drug therapy (Hot Compresses). On an unknown date, the outcome of the pain and bone pain were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, pain and bone pain to be related to SHINGRIX. It was unknown if the reporter considered the sleeplessness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm and in evening of the injection, the patient experienced extensive swelling of vaccinated limb (swelling down her right arm from her shoulder to her hand), redness down her right arm. She had body and bones hurt and could not sleep for 2 nights due to the pain. She received ibuprofen and that seemed to help. The pain was gone and hot compresses helped the redness and swelling. The patient does not plan to get the 2nd dose. She states she got the shot at her local pharmacy in her right shoulder area. When she was asked about the dose given she noted 50mcg or 50 cc. The reporter was not sure of the dose or lot number of the product. The reporter's husband was a physician and she had only consulted him for care. The patient has denied permission to contact their physician. The caller had requested reimbursement for out of pocket cost for the product of $160.23. She was provided the reimbursement address and process.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that he wanted to receive the SHINGRIX vaccine and looked for a provider all over. The reporter found a provider who stated that they administered 40 doses thus far. Within a week and half of vaccination, the patient experienced shingles. The case of Shingles was moderate. The consumer stated that the provider informed him that they submitted these adverse events to GlaxoSmithKline. This case has been linked with case US2018056979, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast ulceration, Nasal ulcer, Ulcer
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of ulcer in a 64-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 7th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, 2 days after receiving SHINGRIX, the patient experienced ulcer, breast ulceration and nasal ulcer. In March 2018, the outcome of the ulcer, breast ulceration and nasal ulcer were recovered/resolved. The reporter considered the ulcer, breast ulceration and nasal ulcer to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. On 7th March 2018, at 4:20 pm, the patient received the SHINGRIX vaccine. The pharmacist reported that the patient experienced sores on one breast and in her left ear and nostril after receiving the SHINGRIX vaccine. The patient reported the sores started with 2 to 3 days after the vaccination and they resolved in one week.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 53-year-old female patient who received SHINGRIX (batch number T5242, expiry date March 2020). On 2nd April 2018 14:00, the patient received the 1st dose of SHINGRIX (subcutaneous). In April 2018, less than a week after receiving SHINGRIX, the patient experienced muscle pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the muscle pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient inadvertently received a dose of SHINGRIX via subcutaneous route, which led to incorrect route of administration. The health care professional did not have any further details regarding the muscle pain. No further information was reported.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX. On 7th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site itching, injection site inflammation and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site itching, injection site inflammation and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site itching, injection site inflammation and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced injection site burning. The health care professional stated that the pharmacy had already reported the adverse event. The call center representative did not collect patient initials or vaccine lot number or expiry date. It was reported that the pharmacy had already reported this case, however, the duplicate case could not be found.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Mouth swelling, Pruritus, Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 69-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date unknown). On 6th February 2018, the patient received the 1st dose of SHINGRIX. On 7th February 2018, 1 days after receiving SHINGRIX, the patient experienced fever, swollen tongue, swollen mouth and pruritus. On 8th February 2018, the patient experienced rash. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the fever, swollen tongue, swollen mouth, pruritus and rash were recovered/resolved and the outcome of the influenza-like symptoms was unknown. The reporter considered the fever, swollen tongue, swollen mouth, pruritus and rash to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: Two days after receiving SHINGRIX, the patient experienced a rash which went down her arm. Less than a year after receiving SHINGRIX, the patient experienced flu-like symptoms. The patient required to visit emergency room.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 69-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date unknown). On 6th February 2018, the patient received the 1st dose of SHINGRIX. On 7th February 2018, 1 days after receiving SHINGRIX, the patient experienced fever, swollen tongue, swollen mouth and pruritus. On 8th February 2018, the patient experienced rash. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the fever, swollen tongue, swollen mouth, pruritus and rash were recovered/resolved and the outcome of the influenza-like symptoms was unknown. The reporter considered the fever, swollen tongue, swollen mouth, pruritus and rash to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: Two days after receiving SHINGRIX, the patient experienced a rash which went down her arm. Less than a year after receiving SHINGRIX, the patient experienced flu-like symptoms. The patient required to visit emergency room.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX. Concurrent medical conditions included oral herpes. 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 shingles. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. During the call, the patient mentioned 2 occurrences of shingles. The 1st outbreak was managed with valacyclovir which did not work. The patient, sounded as if she had not received SHINGRIX but at end of the call, the patient stated that, she received 1st dose of SHINGRIX. Unable to clarify the timeline of shingles outbreaks in regards to the SHINGRIX administration. No further details were provided.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old female patient who received FLUARIX QUADRIVALENT. The patient's past medical history included cold (prior to receiving the vaccine the patient felt like she was coming down with a cold). Concomitant products included PROLIA. On 11th December 2017, the patient received FLUARIX QUADRIVALENT (intramuscular). On 11th December 2017, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced pain, fever and worn out. In December 2017, the outcome of the pain, fever and worn out were recovered/resolved. It was unknown if the reporter considered the pain, fever and worn out to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The reporter was not sure which flu vaccine the patient received. In the evening of the same day of vaccination, the patient experienced aches, pain, low grade fever and feeling wipe out. The patient recovered in approximately 2 days. The patient was not running a fever prior to receiving the flu shot and they were not sure if she was coming down with a cold anyway or if it was the flu vaccine that caused these events. The caller was reporting adverse events on behalf of his wife (patient).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Painful respiration
Clinical narrative: 3/28/28 approximately 3PM -> shortness of breath, kept getting worse. Felt pain when inhaling on sternum. No symptoms related to heart. 3/29/18 -took TUMS, thought it was heartburn, but did not work -took COQ10 shortly after shot. Approximately 10/11AM -> pain wore off.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen left arm, extending from shoulder to elbow, redness, hot and painful for 4 days. Used ice packs and resolved within 4 days.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Myalgia, Urticaria
Clinical narrative: Large red welt about 2 inches from injection site on upper right arm. Warm to the touch. Injection area warm after shot. Localized back muscle pain in upper right back. Her trigger point area for her normal back pain.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Myalgia, Urticaria
Clinical narrative: Large red welt about 2 inches from injection site on upper right arm. Warm to the touch. Injection area warm after shot. Localized back muscle pain in upper right back. Her trigger point area for her normal back pain.
Age: 20.0
Sex: F
Vaccine: FLUR3
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms, no treatment. Noted expiration date when entering data.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter stated that, he advised the person with the question. The patient had all the side effects.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain
Clinical narrative: Chest pain underneath left breast. Improved with laying down.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Culture throat, Oropharyngeal pain, Streptococcus test
Clinical narrative: Patient received MCV-4 vaccination on 4-4-18 in our office between 3:25 and 3:40 pm. Within a few minutes of leaving office, she developed sore throat. Did not report it to her mom until later that evening. Came back to office at 7:51 pm per doctor's request for exam. No other symptoms. Form was completed on 4/5/18 by staff.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site warmth, Insomnia, Pain in extremity
Clinical narrative: Right arm pain since flu injection in right arm. Keeping her awake at night. Unable to reach above the head. Seen in urgent care on 4/2/2018, provider noted the skin at the site of injection, mild warmth, redness. Decreased ROM to Right arm. She was prescribed a 10 day course of BACTRIM antibiotics and FLEXERIL 5mg every 8 hours as needed.
Age: 70.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pruritus
Clinical narrative: Patient developed systemic itching to hands, under chin, face, and back of head. No change in diet. No new soap or laundry detergent. No contact with known allergens.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Bacterial test negative, Gram stain negative, Incisional drainage, Injection site cellulitis, Injection site erythema
Clinical narrative: Cellulitis at the injection site that occurred 1 day after the injection was given. Mom proceeded to the ED on Sunday 4/8/18 due to guarding of the left leg and redness at the injection site but denied warmth to touch. He was treated with topical lidocaine and aN I&D was performed. Patient was started on SEPTRA antibiotics as well as topical Mupirocin. Follow up today in clinic with PCP he is showing much improvement.
Age: 74.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Headache, Injection site pain, Neck pain, Pain, Skin burning sensation
Clinical narrative: Injection of SHINGRIX 50 Mcg Inj - rt. shoulder injection, intramuscular. Painful within 30 min and continued to be very painful at site. By next AM I suffered severe pain including: headaches, neck pain and pain continues from head to mid-calf equal to plus 10. Pain was like severe burning on the skin. Pain was exactly like I suffered from actually having shingles. Dr. prescribed strong pain medication and the pain subsided after 4 days. No redness or rash was visible with the pain.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, RVX
Symptoms: Crying, Diet refusal, Screaming
Clinical narrative: Inconsolable crying/screaming, high pitched in nature for more than 4 continuous hours. Refusal to eat (breastfeed) during that time.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching around injection site. Started 2 days after receiving the immunization and has since improved some but still some redness and itching.
Age: 0.17
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Drug prescribing error
Clinical narrative: Vaccine was ordered by Physician in error. I gave vaccine as ordered. Too early for child to have Hep A.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: Patient received BOOSTRIX vaccine on 4/10/18 in left arm. Patient called today 4/11/18 and stated he had a fever of 101 and chills and TYLENOL and MOTRIN did not bring the fever down. Advised pt to seek medical attention.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Redness and heat at site of injection, knot in muscle at injection site, muscle aches, fatigue, chills, slight fever, slight upset stomach, headache.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Redness and heat at site of injection, knot in muscle at injection site, muscle aches, fatigue, chills, slight fever, slight upset stomach, headache.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shivering, chills, fever, muscle aches, tiredness redness and swelling and fever at the injection site 5 hours after the injection.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Shivering, chills, fever, muscle aches, tiredness redness and swelling and fever at the injection site 5 hours after the injection.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Received Recombinant Vaccine. Extreme headache, Chills, Fever, Pain in joints. For 24 hours. Second of two SHINGRIX Zoster shots.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Loss of personal independence in daily activities, Renal transplant, Soft tissue necrosis, Wound
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable consumer who reported about herself. An adult female patient of an unspecified race and ethnicity received, on 01Apr2016, at the age of 52 years, PREVNAR 13 at single dose. Relevant medical history included splenectomy on an unspecified date (spleen was removed because of benign tumor in Sep2010); body aches and chills from 31Dec2015 (12 hours later she was in hospital in sepsis); septic pneumococcal pneumonia diagnosed on 01Jan2016; multi organ failure; renal failure, dialysis (she had kidney transplant on 06Dec2017). The patient previously, on an unspecified date, in Aug2010, received PNEUMOVAX 23, FLU VACCINE and meningococcal vaccine. Concomitant medications were unknown. The patient was usual going to gym exercising (ran), and yoga. On an unspecified date, the patient experienced vascular necrosis in her feet so much that she was not able to run. She did spin classes and yoga. Subsequently the patient received PNEUMOVAX 23 on an unspecified date, in Jan2017. At time of this report, the patient recovered (all wounds healed). No follow-up attempts are possible, information about lot number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's husband). A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history included pneumonia (hospitalized with pneumonia several times). Concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The patient was hospitalized due to the event. Outcome of the event was unknown. No follow-up attempts are possible, information about lot number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 76-years-old female patient of unknown race/ethnicity received in Mar2018 a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. After vaccination, in Apr2018, patient experiences skin rashes. Outcome was unknown. Information on the batch number has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal pain
Clinical narrative: Persistent shoulder pain after injection.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Flushing, Injection site erythema, Injection site warmth
Clinical narrative: Patient received SHINGRIX 3/20/18 and on Wednesday and Thursday (3/21 and 3/22) patient noted a firm red area, warm at site of vaccine. Since then, redness resolved, but on Saturday (3/24) patient noted redness, swelling of forearm, ipsilateral side. Patient reports feeling flushed, not sure if fever or chills. Left forearm is red, swollen and tender. Redness seems to be tracking down her arm, following gravity. Clearing from more proximal areas per her pen marks and extending distally. Patient diagnoses with cellulitis and prescribed Amoxicillin/Clavulanate 875/125mg to treat.