chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 82-year-old female patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th March 2019, 1 days after receiving SHINGRIX, the patient experienced erythema, rash, pruritus, injection site warmth, upset stomach, tiredness, shivering and fever. On an unknown date, the outcome of the erythema, rash, upset stomach, shivering and fever were recovered/resolved and the outcome of the pruritus, injection site warmth and tiredness were not recovered/not resolved. It was unknown if the reporter considered the erythema, rash, pruritus, injection site warmth, upset stomach, tiredness, shivering and fever to be related to SHINGRIX. Additional details were provided as follows: The next day post vaccination, the patient had redness, rash, itching and heat at the injection site. She also had fever, upset stomach, tiredness and shivering. The patient was mostly feeling better at the time of reporting, but she was still a tired and has some itching and warmth at the injection site. The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain
Clinical narrative: Red spot at area of injection site. Pain at injection site. Severe joint pain for 48 hours.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Activated partial thromboplastin time, Angiogram, Anti factor V antibody, Anti factor VIII antibody test, Antiphospholipid antibodies
Clinical narrative: 1-2 weeks prior to event noted lightheadedness, palpitations. Had cardiology evaluation with normal chest x-ray, ECG, Echocardiogram with bubble study. On morning of event, awoke and felt off with noted right arm/leg weakness. Taken to ER where stroke protocol activated. CT, CT angiogram, IR arteriogram and MRI obtained. CT angiogram initially concerning for sigmoid sinus thrombosis. IR arteriogram by interventional neurologist noted sluggish flow in portions of middle cerebral artery and TPA administered. MRI ultimately noted ischemia in areas supplied by posterior cerebral artery.  Prolonged weakness and dyskinesia as sequelae of event. Follow-up MRI by neurology noted: At the site of previously seen acute (diffusion-restricting) infarction of LEFT PCA territory including LEFT thalamus, posterior hippocampus, and calcarine cortex, there is now a small (9 mm) cavity of the dorsal lateral LEFT thalamus, with adjacent mild gliosis extending into the PLIC and centrum semiovale, and sclerosis/encephalomalacia (severe volume loss) of the posteriormost LEFT hippocampus.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Antithrombin III, Arteriogram, Beta-2 glycoprotein antibody, C-reactive protein, Cardiolipin antibody
Clinical narrative: 1-2 weeks prior to event noted lightheadedness, palpitations. Had cardiology evaluation with normal chest x-ray, ECG, Echocardiogram with bubble study. On morning of event, awoke and felt off with noted right arm/leg weakness. Taken to ER where stroke protocol activated. CT, CT angiogram, IR arteriogram and MRI obtained. CT angiogram initially concerning for sigmoid sinus thrombosis. IR arteriogram by interventional neurologist noted sluggish flow in portions of middle cerebral artery and TPA administered. MRI ultimately noted ischemia in areas supplied by posterior cerebral artery.  Prolonged weakness and dyskinesia as sequelae of event. Follow-up MRI by neurology noted: At the site of previously seen acute (diffusion-restricting) infarction of LEFT PCA territory including LEFT thalamus, posterior hippocampus, and calcarine cortex, there is now a small (9 mm) cavity of the dorsal lateral LEFT thalamus, with adjacent mild gliosis extending into the PLIC and centrum semiovale, and sclerosis/encephalomalacia (severe volume loss) of the posteriormost LEFT hippocampus.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Cerebral ischaemia, Chest X-ray normal, Coagulation test, Computerised tomogram, Dizziness
Clinical narrative: 1-2 weeks prior to event noted lightheadedness, palpitations. Had cardiology evaluation with normal chest x-ray, ECG, Echocardiogram with bubble study. On morning of event, awoke and felt off with noted right arm/leg weakness. Taken to ER where stroke protocol activated. CT, CT angiogram, IR arteriogram and MRI obtained. CT angiogram initially concerning for sigmoid sinus thrombosis. IR arteriogram by interventional neurologist noted sluggish flow in portions of middle cerebral artery and TPA administered. MRI ultimately noted ischemia in areas supplied by posterior cerebral artery.  Prolonged weakness and dyskinesia as sequelae of event. Follow-up MRI by neurology noted: At the site of previously seen acute (diffusion-restricting) infarction of LEFT PCA territory including LEFT thalamus, posterior hippocampus, and calcarine cortex, there is now a small (9 mm) cavity of the dorsal lateral LEFT thalamus, with adjacent mild gliosis extending into the PLIC and centrum semiovale, and sclerosis/encephalomalacia (severe volume loss) of the posteriormost LEFT hippocampus.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Drug screen, Dyskinesia, Echocardiogram normal, Electrocardiogram normal, Encephalomalacia
Clinical narrative: 1-2 weeks prior to event noted lightheadedness, palpitations. Had cardiology evaluation with normal chest x-ray, ECG, Echocardiogram with bubble study. On morning of event, awoke and felt off with noted right arm/leg weakness. Taken to ER where stroke protocol activated. CT, CT angiogram, IR arteriogram and MRI obtained. CT angiogram initially concerning for sigmoid sinus thrombosis. IR arteriogram by interventional neurologist noted sluggish flow in portions of middle cerebral artery and TPA administered. MRI ultimately noted ischemia in areas supplied by posterior cerebral artery.  Prolonged weakness and dyskinesia as sequelae of event. Follow-up MRI by neurology noted: At the site of previously seen acute (diffusion-restricting) infarction of LEFT PCA territory including LEFT thalamus, posterior hippocampus, and calcarine cortex, there is now a small (9 mm) cavity of the dorsal lateral LEFT thalamus, with adjacent mild gliosis extending into the PLIC and centrum semiovale, and sclerosis/encephalomalacia (severe volume loss) of the posteriormost LEFT hippocampus.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal, Fibrin D dimer, Full blood count, Metabolic function test, Muscular weakness
Clinical narrative: 1-2 weeks prior to event noted lightheadedness, palpitations. Had cardiology evaluation with normal chest x-ray, ECG, Echocardiogram with bubble study. On morning of event, awoke and felt off with noted right arm/leg weakness. Taken to ER where stroke protocol activated. CT, CT angiogram, IR arteriogram and MRI obtained. CT angiogram initially concerning for sigmoid sinus thrombosis. IR arteriogram by interventional neurologist noted sluggish flow in portions of middle cerebral artery and TPA administered. MRI ultimately noted ischemia in areas supplied by posterior cerebral artery.  Prolonged weakness and dyskinesia as sequelae of event. Follow-up MRI by neurology noted: At the site of previously seen acute (diffusion-restricting) infarction of LEFT PCA territory including LEFT thalamus, posterior hippocampus, and calcarine cortex, there is now a small (9 mm) cavity of the dorsal lateral LEFT thalamus, with adjacent mild gliosis extending into the PLIC and centrum semiovale, and sclerosis/encephalomalacia (severe volume loss) of the posteriormost LEFT hippocampus.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Palpitations, Protein C, Protein S, Prothrombin level
Clinical narrative: 1-2 weeks prior to event noted lightheadedness, palpitations. Had cardiology evaluation with normal chest x-ray, ECG, Echocardiogram with bubble study. On morning of event, awoke and felt off with noted right arm/leg weakness. Taken to ER where stroke protocol activated. CT, CT angiogram, IR arteriogram and MRI obtained. CT angiogram initially concerning for sigmoid sinus thrombosis. IR arteriogram by interventional neurologist noted sluggish flow in portions of middle cerebral artery and TPA administered. MRI ultimately noted ischemia in areas supplied by posterior cerebral artery.  Prolonged weakness and dyskinesia as sequelae of event. Follow-up MRI by neurology noted: At the site of previously seen acute (diffusion-restricting) infarction of LEFT PCA territory including LEFT thalamus, posterior hippocampus, and calcarine cortex, there is now a small (9 mm) cavity of the dorsal lateral LEFT thalamus, with adjacent mild gliosis extending into the PLIC and centrum semiovale, and sclerosis/encephalomalacia (severe volume loss) of the posteriormost LEFT hippocampus.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Prothrombin time, Red blood cell sedimentation rate, Ultrasound Doppler, Urine analysis, Venogram
Clinical narrative: 1-2 weeks prior to event noted lightheadedness, palpitations. Had cardiology evaluation with normal chest x-ray, ECG, Echocardiogram with bubble study. On morning of event, awoke and felt off with noted right arm/leg weakness. Taken to ER where stroke protocol activated. CT, CT angiogram, IR arteriogram and MRI obtained. CT angiogram initially concerning for sigmoid sinus thrombosis. IR arteriogram by interventional neurologist noted sluggish flow in portions of middle cerebral artery and TPA administered. MRI ultimately noted ischemia in areas supplied by posterior cerebral artery.  Prolonged weakness and dyskinesia as sequelae of event. Follow-up MRI by neurology noted: At the site of previously seen acute (diffusion-restricting) infarction of LEFT PCA territory including LEFT thalamus, posterior hippocampus, and calcarine cortex, there is now a small (9 mm) cavity of the dorsal lateral LEFT thalamus, with adjacent mild gliosis extending into the PLIC and centrum semiovale, and sclerosis/encephalomalacia (severe volume loss) of the posteriormost LEFT hippocampus.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Developed maculopapular rash on day 11 post-vaccination. Visit to Pediatrician the same morning. No definitive diagnosis or treatment given. Benadryl given with no improvement of rash. No fever or other obvious signs of illness at the time. Rash still persists day 2.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated at the same medical office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not recovered/not resolved. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pruritus, Rash, Varicella zoster virus infection
Clinical narrative: This initial spontaneous case was received from a lawyer regarding a case in litigation concerning a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 04-JAN-2018, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (dose, route, and lot # not provided). Shortly after receiving ZOSTAVAX, the patient suffered severe, intractable back pain, itchy skin, and skin rash.  On 07-APR-2018, the patient presented to a hospital (considered an Emergency Room (ER) visit until follow-up is received) and was diagnosed with varicella zoster. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered/not resolved. Causality assessment was related. Varicella zoster was considered to be disabling. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes simplex, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpes simplex keratitis in a 67-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included herpes simplex keratitis (usually affected patient's right eye). On 8th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a month after receiving SHINGRIX, the patient experienced herpes simplex keratitis (serious criteria GSK medically significant) and rash. The patient was treated with acyclovir. On an unknown date, the outcome of the herpes simplex keratitis was recovering/resolving and the outcome of the rash was unknown. It was unknown if the reporter considered the herpes simplex keratitis and rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient received a dose of SHINGRIX on the left side. The patient had history of herpes simplex keratitis that usually affects her right eye. After receiving the SHINGRIX vaccine, she developed very similar symptoms of the same but affecting her left eye. The patient also experienced rash break out on her scalp on the top of her head on the left side, the same side she had received her vaccine. The patient did not contact the physician for the adverse events. The reporter stated that on the day of reporting, the patient began taking Acyclovir orally per a previously prescribed from her physician, and the symptoms in her left eye were improving. The reporter was advised to contact the physician to let him know what had occurred with the first SHINGRIX vaccine. The reporter wanted to know, if this was a expected side effect.
Sex: F
Vaccine: VARZOS
Symptoms: Seborrhoeic dermatitis
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of seborrheic dermatitis in a 80-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced seborrheic dermatitis. On an unknown date, the outcome of the seborrheic dermatitis was unknown. It was unknown if the reporter considered the seborrheic dermatitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was 80 years old at the time of reporting. The patient experienced seborrheic dermatitis. The reporter was agreed to follow up from GlaxoSmithKline (GSK).
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of local swelling in a 55-year-old male patient who received SHINGRIX for prophylaxis. 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 local swelling and induration. On an unknown date, the outcome of the local swelling and induration were unknown. It was unknown if the reporter considered the local swelling and induration to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who himself was a nurse. The age at vaccination was not reported. The patient experienced red hard lump after receiving 1st dose of SHINGRIX vaccine. The reporter wanted to know if he could take the 2nd dose of SHINGRIX when it was due or not. The patient agreed to be followed up, however he said if he is with patients he could not answer, but if the safety department leaves a message for him, he could call back.
Sex: M
Vaccine: MENB
Symptoms: Headache, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of headache in a male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced headache (serious criteria hospitalization) and fever (serious criteria hospitalization). BEXSERO was discontinued. On an unknown date, the outcome of the headache and fever were recovered/resolved. It was unknown if the reporter considered the headache and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported by the medical assistant. The age at vaccination was not reported. In 2015, the patient received 1st dose of BEXSERO. The patient expereinced severe headache and high fever. The patient was hospitalized for the events. The patient did not receive 2nd dose of BEXSERO because of headache.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX (batch number 9349T, expiry date 7th March 2021) for prophylaxis. The patient's past medical history included shingles (multiple times previously and it lasts about 6 weeks). On 9th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year 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 provided as follows: The patient received the 1st dose of SHINGRIX on left arm. Three to four weeks ago from the reporting date, the patient experienced Shingles. The patient had shingles multiple times previously and mentioned from start to finish, it lasted about 6 weeks. This time it cleared about 3 to 4 weeks ago. The pharmacist stated that the patient needs their 2nd shot of SHINGRIX. No further specific information regarding event was available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 17th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain, fever and chills. On an unknown date, the outcome of the injection site pain, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she received SHINGRIX in the left arm on the day before reporting date and she developed intense pain at the injection site. The patient was also experiencing fever and chills. The reporter gave consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 11th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced rash. The patient was treated with VALTREX. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The pharmacist reporting that his sister developed a rash after receiving SHINGRIX vaccinated from the reporter. The patient sought medical treatment at a walk-in clinic and was given a prescription for VALTREX. The pharmacist said he was off work on the reporting day, and did not have information related to product lot number, expiration date, or other details that would be at his pharmacy.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX (batch number LL552, expiry date 8th June 2021) for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included INFUSION (MEDICATION UNKNOWN). On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient's concomitant medications were unspecified Rheumatoid Arthritis infusion drug. The patient experienced continued arm soreness in the left shoulder where the injection was given. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 78-year-old male patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 1st November 2018, 62 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the patient experienced product supply issue. On 24th November 2018, the outcome of the ophthalmic herpes zoster was recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown. It was unknown if the reporter considered the ophthalmic herpes zoster to be related to SHINGRIX. Additional details were provided as follows: About two months after receiving SHINGRIX, the patient experienced herpes zoster in his left eye. The emergency room visit was required. The patient visited his doctor and was treated with drops, medication and it was resolved. The patient stated that he was unable to get the 2nd dose but had been notified by his pharmacy that they had got it. The reporter did not consent to follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lip swelling
Clinical narrative: Upper Lip Swelling without restriction of airway. Arm swelling from injection site to the elbow. No direct corrective measures were taken. Symptoms resolved spontaneously within a few days of onset.
Age: 1.33
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: The Product Must Be Received On or By 02/12/2019 date printed on the packing slip, vaccine was received 02/13/2019, the vaccine was not delivered within the allowable time. Vaccines were stored and administered. Parents were been notified that they have received expired or non-viable vaccine will need doses repeated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, flu like symptoms on day 2 thru 4. Extreme pain at injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disturbance in attention, Fatigue, Feeling abnormal, Headache
Clinical narrative: Starting at approx 15 hour post, severe chills and fatigue, over the following several hours my temp was 102 degrees. I took ibuprofen and TYLENOL but it did nothing to reduce the fever. I had severe body pain, on a 1-10 scale it was 9 for almost 12 hours. Headache that lasted 3 days even with ibuprofen. I could not get up from my bed. I started to feel better at approx 48 hours post. It was five full days before the symptoms subsided, I still feel fatigued and am having trouble concentrating as if my brain is foggy.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Starting at approx 15 hour post, severe chills and fatigue, over the following several hours my temp was 102 degrees. I took ibuprofen and TYLENOL but it did nothing to reduce the fever. I had severe body pain, on a 1-10 scale it was 9 for almost 12 hours. Headache that lasted 3 days even with ibuprofen. I could not get up from my bed. I started to feel better at approx 48 hours post. It was five full days before the symptoms subsided, I still feel fatigued and am having trouble concentrating as if my brain is foggy.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Hypersomnia, Irritability, Muscle rigidity, Pyrexia, Tremor
Clinical narrative: Patient was given vaccines approximately 3PM on 3/25/19. Per mother, patient slept a total of 15 hours. He woke up on 3/26/19 at 9:30AM. Had a slight fever, fussy, having off and on shaky and is rigid. Advised to take patient to ER ASAP.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a child dose of Hep B. Patient is 50 years old and needed adult Hep B.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypersensitivity, Rash
Clinical narrative: Patient presents to clinic with mother approx. 40 minutes after onset of symptoms, mom reports patient was "a little fussy" the night before (3/20/19), mom gave TYLENOL prior to bed. Mom also states she gave two bites of mashed banana for the first time. Rash initially started on right side of anterior chest spreading to posterior and anterior trunk as well as some areas of bilateral lower extremities. Area of injections do not look inflamed. BENADRYL prescribed as needed for itching or irritation of rash. Prednisolone prescribed for allergic reaction and rash. Treatment discussed with patient's PCP, Dr., who is in agreement with course of treatment. Patient is to follow up with PCP early in the next week. Follow up contact initiated on 3/22/2019 by clinic nurse, with no contact made due to call being unable to be completed due to restrictions being placed on patient's mother phone. Contact attempted again on 3/25/2019 and 3/26/2019 with no contact being made due to restrictions placed on mothers phone. Patient has follow up appointment scheduled on 3/26/2019 with PCP, Dr.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Anal incontinence, Back pain, Blood bicarbonate normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Following injection had first four days of body aches, chills and fever. Twelve days following injection - Patient describes pain in his cervical spine that radiates down his right upper extremity into his hand causing numbness and tingling on his fingertips, upper right sided back pain mid scapula, and a band across his lumbar spine that causes pain down one or both of his lower extremities via his buttocks and can shoot all the way to his toes. He has been diagnosed with sciatica in the past. Patient denies preceding injury but did "overdo it" by lifting up wood and fallen branches from the backyard followed by the next day with vigorous vacuuming. He has not had any difficulty holding his bladder or bowel. He denies fever, chills, night sweats, constitutional symptoms. Patient states he has tried ibuprofen and last took it at about 11:00 this morning and it "did nothing". He has not tried any topical medications. He has not tried ice or heat. Patient was unsure whether the pain in his right shoulder be coming from his heart and he does have a history of coronary artery disease so he took 2 nitroglycerin spaced 15 minutes apart just prior to arrival here in the emergency room. The nitroglycerin had no reported effect. Pain suddenly resolved about seven weeks later.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatinine normal, Blood electrolytes normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Following injection had first four days of body aches, chills and fever. Twelve days following injection - Patient describes pain in his cervical spine that radiates down his right upper extremity into his hand causing numbness and tingling on his fingertips, upper right sided back pain mid scapula, and a band across his lumbar spine that causes pain down one or both of his lower extremities via his buttocks and can shoot all the way to his toes. He has been diagnosed with sciatica in the past. Patient denies preceding injury but did "overdo it" by lifting up wood and fallen branches from the backyard followed by the next day with vigorous vacuuming. He has not had any difficulty holding his bladder or bowel. He denies fever, chills, night sweats, constitutional symptoms. Patient states he has tried ibuprofen and last took it at about 11:00 this morning and it "did nothing". He has not tried any topical medications. He has not tried ice or heat. Patient was unsure whether the pain in his right shoulder be coming from his heart and he does have a history of coronary artery disease so he took 2 nitroglycerin spaced 15 minutes apart just prior to arrival here in the emergency room. The nitroglycerin had no reported effect. Pain suddenly resolved about seven weeks later.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood urea normal, Chills, Computerised tomogram spine, Full blood count normal, Haematocrit increased
Clinical narrative: Following injection had first four days of body aches, chills and fever. Twelve days following injection - Patient describes pain in his cervical spine that radiates down his right upper extremity into his hand causing numbness and tingling on his fingertips, upper right sided back pain mid scapula, and a band across his lumbar spine that causes pain down one or both of his lower extremities via his buttocks and can shoot all the way to his toes. He has been diagnosed with sciatica in the past. Patient denies preceding injury but did "overdo it" by lifting up wood and fallen branches from the backyard followed by the next day with vigorous vacuuming. He has not had any difficulty holding his bladder or bowel. He denies fever, chills, night sweats, constitutional symptoms. Patient states he has tried ibuprofen and last took it at about 11:00 this morning and it "did nothing". He has not tried any topical medications. He has not tried ice or heat. Patient was unsure whether the pain in his right shoulder be coming from his heart and he does have a history of coronary artery disease so he took 2 nitroglycerin spaced 15 minutes apart just prior to arrival here in the emergency room. The nitroglycerin had no reported effect. Pain suddenly resolved about seven weeks later.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Haemoglobin increased, Hypoaesthesia, International normalised ratio increased, Intervertebral disc degeneration, Intervertebral disc space narrowing
Clinical narrative: Following injection had first four days of body aches, chills and fever. Twelve days following injection - Patient describes pain in his cervical spine that radiates down his right upper extremity into his hand causing numbness and tingling on his fingertips, upper right sided back pain mid scapula, and a band across his lumbar spine that causes pain down one or both of his lower extremities via his buttocks and can shoot all the way to his toes. He has been diagnosed with sciatica in the past. Patient denies preceding injury but did "overdo it" by lifting up wood and fallen branches from the backyard followed by the next day with vigorous vacuuming. He has not had any difficulty holding his bladder or bowel. He denies fever, chills, night sweats, constitutional symptoms. Patient states he has tried ibuprofen and last took it at about 11:00 this morning and it "did nothing". He has not tried any topical medications. He has not tried ice or heat. Patient was unsure whether the pain in his right shoulder be coming from his heart and he does have a history of coronary artery disease so he took 2 nitroglycerin spaced 15 minutes apart just prior to arrival here in the emergency room. The nitroglycerin had no reported effect. Pain suddenly resolved about seven weeks later.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Following injection had first four days of body aches, chills and fever. Twelve days following injection - Patient describes pain in his cervical spine that radiates down his right upper extremity into his hand causing numbness and tingling on his fingertips, upper right sided back pain mid scapula, and a band across his lumbar spine that causes pain down one or both of his lower extremities via his buttocks and can shoot all the way to his toes. He has been diagnosed with sciatica in the past. Patient denies preceding injury but did "overdo it" by lifting up wood and fallen branches from the backyard followed by the next day with vigorous vacuuming. He has not had any difficulty holding his bladder or bowel. He denies fever, chills, night sweats, constitutional symptoms. Patient states he has tried ibuprofen and last took it at about 11:00 this morning and it "did nothing". He has not tried any topical medications. He has not tried ice or heat. Patient was unsure whether the pain in his right shoulder be coming from his heart and he does have a history of coronary artery disease so he took 2 nitroglycerin spaced 15 minutes apart just prior to arrival here in the emergency room. The nitroglycerin had no reported effect. Pain suddenly resolved about seven weeks later.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Radiculopathy, Sciatica, Shift to the left, Spinal pain, Spondylolisthesis
Clinical narrative: Following injection had first four days of body aches, chills and fever. Twelve days following injection - Patient describes pain in his cervical spine that radiates down his right upper extremity into his hand causing numbness and tingling on his fingertips, upper right sided back pain mid scapula, and a band across his lumbar spine that causes pain down one or both of his lower extremities via his buttocks and can shoot all the way to his toes. He has been diagnosed with sciatica in the past. Patient denies preceding injury but did "overdo it" by lifting up wood and fallen branches from the backyard followed by the next day with vigorous vacuuming. He has not had any difficulty holding his bladder or bowel. He denies fever, chills, night sweats, constitutional symptoms. Patient states he has tried ibuprofen and last took it at about 11:00 this morning and it "did nothing". He has not tried any topical medications. He has not tried ice or heat. Patient was unsure whether the pain in his right shoulder be coming from his heart and he does have a history of coronary artery disease so he took 2 nitroglycerin spaced 15 minutes apart just prior to arrival here in the emergency room. The nitroglycerin had no reported effect. Pain suddenly resolved about seven weeks later.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Urinary incontinence, White blood cell count normal
Clinical narrative: Following injection had first four days of body aches, chills and fever. Twelve days following injection - Patient describes pain in his cervical spine that radiates down his right upper extremity into his hand causing numbness and tingling on his fingertips, upper right sided back pain mid scapula, and a band across his lumbar spine that causes pain down one or both of his lower extremities via his buttocks and can shoot all the way to his toes. He has been diagnosed with sciatica in the past. Patient denies preceding injury but did "overdo it" by lifting up wood and fallen branches from the backyard followed by the next day with vigorous vacuuming. He has not had any difficulty holding his bladder or bowel. He denies fever, chills, night sweats, constitutional symptoms. Patient states he has tried ibuprofen and last took it at about 11:00 this morning and it "did nothing". He has not tried any topical medications. He has not tried ice or heat. Patient was unsure whether the pain in his right shoulder be coming from his heart and he does have a history of coronary artery disease so he took 2 nitroglycerin spaced 15 minutes apart just prior to arrival here in the emergency room. The nitroglycerin had no reported effect. Pain suddenly resolved about seven weeks later.
Age: 36.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Contusion, Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: The night of the administration date, patient reported pain on both arms, induration at vaccination site, red and bruising on the left arm, warm to touch, and fever at night. Patient was evaluated by doctor in ER and was given treatment (IM DECADRON 8 mg).
Age: 36.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Vaccination site induration
Clinical narrative: The night of the administration date, patient reported pain on both arms, induration at vaccination site, red and bruising on the left arm, warm to touch, and fever at night. Patient was evaluated by doctor in ER and was given treatment (IM DECADRON 8 mg).
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient contacted pharmacy 3.26.19 - Patient reported redness spreading from elbow to shoulder, warm to the touch, itchy. Patient has tried applying an ice pack with no relief. RpH on duty advised the patient to contact their PCP, no further info reported as of 3.26.19 at 1140.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Injection site erythema, Injection site haematoma, Malaise, Pyrexia
Clinical narrative: Patient developed malaise, fever, bruise, swelling, redness the size of her hand with a hematoma at the site. It has lasted 1 week. Redness is starting to get better.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Patient developed malaise, fever, bruise, swelling, redness the size of her hand with a hematoma at the site. It has lasted 1 week. Redness is starting to get better.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Peripheral swelling, Skin warm
Clinical narrative: Swollen arm, warm to touch, diagnosed cellulitis.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Impaired work ability, Pain, Pain in extremity
Clinical narrative: Sore arm, chills, severe aching body, no energy, unable to go to work.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Nasopharyngitis, Vaccination failure
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of suspected vaccination failure in a adult male patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included abacavir sulphate, dolutegravir, lamivudine (Triumeq) tablet for hiv infection. Concomitant products included ascorbic acid (Vitamin C). On an unknown date, the patient received Flu vaccine at an unknown dose and Triumeq (oral) at an unknown dose and frequency. On an unknown date, less than a year after receiving Flu vaccine and unknown after starting Triumeq, the patient experienced vaccination failure (serious criteria GSK medically significant), flu symptoms and cold symptoms. On an unknown date, the outcome of the vaccination failure, flu symptoms and cold symptoms were unknown. It was unknown if the reporter considered the vaccination failure, flu symptoms and cold symptoms to be related to Flu vaccine. The reporter considered the vaccination failure, flu symptoms and cold symptoms to be unrelated to Triumeq. Additional details were provided as follows: The patient's concomitant medications included Dayquil and Nyquil. The age at vaccination was not reported. About 2 to 3 years ago, the patient started taking Triumeq at dose of 600/50/300 mg. The patient reported that he and his co-workers were having cold or flu symptoms. The patient was not feeling that bad. The patient was surprised to be experiencing this because he received a flu shot. This case was considered as suspected vaccination failure case as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting. This case was linked with US2019AMR051611, reported for the same patient.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 68-year-old male patient who received SHINGRIX (batch number MX2LT, expiry date 29th May 2021) for prophylaxis. On 19th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced general body pain and injection site erythema. On an unknown date, the outcome of the general body pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the general body pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The caller reported that the patient had red patch at injection site and body aches lasting 3-4 days after receiving SHINGRIX vaccination series.
Sex: F
Vaccine: MENB
Symptoms: Memory impairment
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A female patient of an unspecified age received TRUMENBA; (lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced forgetfulness occurring about 1 week after vaccination on an unspecified date after the use of the product. The outcome of the event was unknown. Information on the batch number has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Eye swelling, Eyelid rash, Pruritus, Rash
Clinical narrative: Swelling of eyes & face with rash, burning & itching, also on my neck.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Swelling of eyes & face with rash, burning & itching, also on my neck.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chest discomfort, Dysphagia, Flushing, Hypoaesthesia
Clinical narrative: Per the patient she felt flushing in face, difficulty swallowing, chest tightness, upset stomach and numbness in neck. These symptoms occurred approximately 1-2 minutes post administration and resolved approximately 5 minutes after they began.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Anger, Anxiety, Asthenia, Borrelia test, C-reactive protein
Clinical narrative: She became sick with tired and weak symptoms along with some sinus type issues by early December. Then early January she had a headache (first ever in her life). Initially it was missed on a CT scan, but several MRIs later there proved to be a dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis. All presumed due to the vaccine, because she was fine before it. The treatment has been antibiotics (which don't work), Occupational therapy, therapy. The adverse event has caused weakness, dizziness, headaches, neck pain, tingling sensations, fatigue, school regression, OCD, anxiety, worry, fear, PTSD, anger and of course as listed above -  dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head normal, Dizziness, Educational problem, Encephalitis, Encephalopathy
Clinical narrative: She became sick with tired and weak symptoms along with some sinus type issues by early December. Then early January she had a headache (first ever in her life). Initially it was missed on a CT scan, but several MRIs later there proved to be a dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis. All presumed due to the vaccine, because she was fine before it. The treatment has been antibiotics (which don't work), Occupational therapy, therapy. The adverse event has caused weakness, dizziness, headaches, neck pain, tingling sensations, fatigue, school regression, OCD, anxiety, worry, fear, PTSD, anger and of course as listed above -  dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Enlarged cerebral perivascular spaces, Epstein-Barr virus test, Fatigue, Fear, Full blood count
Clinical narrative: She became sick with tired and weak symptoms along with some sinus type issues by early December. Then early January she had a headache (first ever in her life). Initially it was missed on a CT scan, but several MRIs later there proved to be a dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis. All presumed due to the vaccine, because she was fine before it. The treatment has been antibiotics (which don't work), Occupational therapy, therapy. The adverse event has caused weakness, dizziness, headaches, neck pain, tingling sensations, fatigue, school regression, OCD, anxiety, worry, fear, PTSD, anger and of course as listed above -  dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Malaise, Metabolic function test, Mononucleosis heterophile test, Neck pain
Clinical narrative: She became sick with tired and weak symptoms along with some sinus type issues by early December. Then early January she had a headache (first ever in her life). Initially it was missed on a CT scan, but several MRIs later there proved to be a dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis. All presumed due to the vaccine, because she was fine before it. The treatment has been antibiotics (which don't work), Occupational therapy, therapy. The adverse event has caused weakness, dizziness, headaches, neck pain, tingling sensations, fatigue, school regression, OCD, anxiety, worry, fear, PTSD, anger and of course as listed above -  dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis.