chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Nausea
Clinical narrative: Nausea and shivers for 2 days starting day of vaccination. Redness, swelling, hives, fatigue, headache starting the next morning then rash covering most of the torso the next day lasting for 4+ days.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: Nausea and shivers for 2 days starting day of vaccination. Redness, swelling, hives, fatigue, headache starting the next morning then rash covering most of the torso the next day lasting for 4+ days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash, Rash vesicular, Secretion discharge
Clinical narrative: Pt reported developing a shingles-like rash on her lower left leg beginning 3 days after her vaccination on 6/15/18. Pt described the rash as having a burning sensation and being very painful to the touch. The rash periodically forms vesicles and drains fluid. The rash has been progressing and now wraps around her lower left leg (near the ankle).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Pt reported developing a shingles-like rash on her lower left leg beginning 3 days after her vaccination on 6/15/18. Pt described the rash as having a burning sensation and being very painful to the touch. The rash periodically forms vesicles and drains fluid. The rash has been progressing and now wraps around her lower left leg (near the ankle).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Musculoskeletal disorder
Clinical narrative: Patient reported that she couldn't walk for 24 hours. She said her legs weren't working. It wasn't a numbness and it only last for the day of the vaccine. The next day it was fine.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Antinuclear antibody negative, Arthralgia, Bedridden, Blood test abnormal
Clinical narrative: The first dose I had a small reaction of heart palpitations and faintness that went away shortly after. The second dose, a year later, I had started to get small pains in my stomach and a general feeling of fatigue about a week after. I went downhill in the coming weeks. I had started to have pain in my spine. I had three discs herniated and I also had pain in my Sacroiliac Joint. That lasted for about three months and included a flu-like feeling for a long time. In January 2018, I had gotten worse. I started to get heart palpitations, GI issues, menstruation issues, a body rash(including a butterfly rash on my face) and I was basically bedridden. I am still, in July of 2018, having the same issues.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Borrelia test positive, Butterfly rash, Chest X-ray, Fatigue, Gastrointestinal disorder
Clinical narrative: The first dose I had a small reaction of heart palpitations and faintness that went away shortly after. The second dose, a year later, I had started to get small pains in my stomach and a general feeling of fatigue about a week after. I went downhill in the coming weeks. I had started to have pain in my spine. I had three discs herniated and I also had pain in my Sacroiliac Joint. That lasted for about three months and included a flu-like feeling for a long time. In January 2018, I had gotten worse. I started to get heart palpitations, GI issues, menstruation issues, a body rash(including a butterfly rash on my face) and I was basically bedridden. I am still, in July of 2018, having the same issues.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Influenza like illness, Intervertebral disc protrusion, Menstrual disorder, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: The first dose I had a small reaction of heart palpitations and faintness that went away shortly after. The second dose, a year later, I had started to get small pains in my stomach and a general feeling of fatigue about a week after. I went downhill in the coming weeks. I had started to have pain in my spine. I had three discs herniated and I also had pain in my Sacroiliac Joint. That lasted for about three months and included a flu-like feeling for a long time. In January 2018, I had gotten worse. I started to get heart palpitations, GI issues, menstruation issues, a body rash(including a butterfly rash on my face) and I was basically bedridden. I am still, in July of 2018, having the same issues.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Palpitations, Rash, Sacroiliitis, Spinal pain, Syncope
Clinical narrative: The first dose I had a small reaction of heart palpitations and faintness that went away shortly after. The second dose, a year later, I had started to get small pains in my stomach and a general feeling of fatigue about a week after. I went downhill in the coming weeks. I had started to have pain in my spine. I had three discs herniated and I also had pain in my Sacroiliac Joint. That lasted for about three months and included a flu-like feeling for a long time. In January 2018, I had gotten worse. I started to get heart palpitations, GI issues, menstruation issues, a body rash(including a butterfly rash on my face) and I was basically bedridden. I am still, in July of 2018, having the same issues.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Tilt table test
Clinical narrative: The first dose I had a small reaction of heart palpitations and faintness that went away shortly after. The second dose, a year later, I had started to get small pains in my stomach and a general feeling of fatigue about a week after. I went downhill in the coming weeks. I had started to have pain in my spine. I had three discs herniated and I also had pain in my Sacroiliac Joint. That lasted for about three months and included a flu-like feeling for a long time. In January 2018, I had gotten worse. I started to get heart palpitations, GI issues, menstruation issues, a body rash(including a butterfly rash on my face) and I was basically bedridden. I am still, in July of 2018, having the same issues.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Rash
Clinical narrative: Vaccine was administered incorrectly subcutaneously. Patient complained of rash on arm.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Cold sweat, Dizziness, Nausea
Clinical narrative: After 5 min pt had nausea, lightheadedness and cold sweats. Pt asked to rest, lasted for 30 minutes, then resolved. No vomiting, no difficulty breathing.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Nausea, Pain, Vomiting
Clinical narrative: 7 hours after vaccination, mild headache and weakness, gradually intensifying headache to a very bad, throbbing headache by 11 hours after vaccination, which continued through until 22 hours after vaccination. At 20 hours after vaccination, took 2 extra-strength acetaminophen which helped alleviate headache pain. Additionally, nausea and vomiting began at 17 hours after vaccination, and continued until 22 hours after vaccination. General body aches continued through 57 post-vaccination.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: 5 hours post vaccination, started general body aches, headache, chills, tiredness. By 9 hours post-vaccination, severe headache and body aches, very tired and weak. 15-hours post-vaccination, fever of 99.8, severe chills, sweating, body aches, and severe headache. Took 2 extra-strength acetaminophen. 16-hours post-vaccination, headache, fever, and chills, subsided. General achiness continued through 57 hours post-vaccination.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: 5 hours post vaccination, started general body aches, headache, chills, tiredness. By 9 hours post-vaccination, severe headache and body aches, very tired and weak. 15-hours post-vaccination, fever of 99.8, severe chills, sweating, body aches, and severe headache. Took 2 extra-strength acetaminophen. 16-hours post-vaccination, headache, fever, and chills, subsided. General achiness continued through 57 hours post-vaccination.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Loss of consciousness, Seizure
Clinical narrative: Within a minute of receiving vaccine, pt had a 10 sec seizure, monitored in chair, VS taken, did not remember what happened. 5 minutes later he felt dizzy with semi LOC again, pt placed in supine position with feet elevated, recurrent VS taken which were stable throughout every 5 minutes for 15 more minutes. Pt stable, released with precautions for potential anaphylaxis symptoms. ER precautions discussed.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Redness, hot, tender, swollen - all local. Unknown if cellulitis or vaccine reaction. Rx for cephalexin 500 mg TID x 10 days from covering PCP for Dr.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Pain in extremity
Clinical narrative: Patient received SHINGRIX on left arm. Patient's right arm had a previous injury that she is going to physical therapy for. She states after the shot the pain in the right arm was significantly increased.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Extra dose administered, Fatigue, Pain
Clinical narrative: This spontaneous report was received from the patient's mother, concerning a 17 year old female patient. The patient did not have pertinent medical history or concomitant medications. She is allergic to amoxicillin since she was a baby; it gave her hives and itching. In April, June and November 2012, the patient was vaccinated with GARDASIL, as 3 series injections for prevention of Human Papillomavirus (HPV), the route of administration was reported as injection (lot #, expiration date, strength or anatomical location were not provided). It was stated that after each injection with GARDASIL, the patient developed body aches, fatigue and body weakness that resolved in about a week. On 19-JUN-2018, the patient received an injection of GARDASIL 9 (lot #, expiration date, strength, or anatomical location were not provided) for the same indication, due to an administrative error. After vaccination the patient experienced body aches, muscle weakness and fatigue. The patient did not seek medical attention; so no treatment was given for any of the above reported events and no laboratory diagnostics studies were performed. At the reporting time, the patient was experiencing body aches, muscle weakness and fatigue. The causal relationship between body aches, fatigue, body weakness and muscle weakness with GARDASIL was not provided. The causal relationship between body aches, body weakness and fatigue with onset date in 2012 and GARDASIL 9 was not related, and for the all the above mentioned events from 19-JUN-2018 was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vein disorder
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 10-OCT-2015, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-OCT-2015, the patient was treated at a medical center for the onset of a severe vesicular  rash, which was diagnosed as shingles. The patient was prescribed valacyclovir (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 01-FEB-2010, the patient was inoculated with ZOSTAVAX by a physician for routine adult health maintenance and 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. On or about 10-FEB-2010, the patient was treated by the hospital, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 06-APR-2015, the patient was inoculated with ZOSTAVAX at a healthcare facility/clinic, as recommended for routine adult health maintenance and 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. On or about 18-JUN-2016, the patient was treated by an advanced practice registered nurse (APRN) at a healthcare facility for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 unknown. The reporter considered the events as related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 29-SEP-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-AUG-2013, the patient was treated by a physician at a clinic for a severe vesicular outbreak, which was diagnosed as herpes zoster ophthalmicus. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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. Upon internal review, herpes zoster ophthalmicus was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 05-OCT-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-SEP-2015, the patient was treated at an urgent care and family practice for a blistering vesicular outbreak, which was then diagnosed as or shingles. The patient has been prescribed lidocaine (LIDODERM) patches for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-OCT-2013, the patient was inoculated with ZOSTAVAX at a pharmacy, 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 condition of herpes zoster. On or about 08-APR-2016, the patient was treated by a certified physician's assistant (PA-C) at a healthcare facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 unknown. The reporter considered the events as related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2009, the patient was inoculated with ZOSTAVAX by the healthcare facility/clinic (by unspecified healthcare professional), 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 condition of herpes zoster. In 2015, the patient was treated by the healthcare facility/clinic (by unspecified healthcare professional), for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 unknown.  The reporter considered the events as related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-NOV-2011, the patient was treated at an urgent care for a persistent and severe vesicular rash, which was then diagnosed as herpes zoster. The patient has been prescribed acyclovir and prednisone for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Varicella zoster virus infection
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-MAY-2016, the patient was treated at a clinic for a persistent and severe vesicular rash, which was then diagnosed as varicella zoster. The patient has been prescribed valacyclovir and gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RVX
Symptoms: Rash generalised
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a 4-month-old male patient who received INFANRIX (batch number 2N43Z, expiry date 12th April 2020) for prophylaxis. Concomitant products included HIB VACCINE, PREVNAR 13, POLIO VACCINE and ROTAVIRUS VACCINE. On 12th June 2018, the patient received INFANRIX .5 ml. On 13th June 2018, 1 days after receiving INFANRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovering/resolving. It was unknown if the reporter considered the generalized rash to be related to INFANRIX. Additional information was reported as follows: This case was reported by a Certified Medical Assistant. On 12th June 2018, the patient received Haemophilus influenza B vaccine, PREVNAR 13, Polio vaccine and Rotavirus vaccine. The patient received INFANRIX on the right thigh. On 14th June 2018, the patient was seen for a follow-up doctor visit. On 20th June 2018, the patient was again seen for a follow-up doctor visit, in which it was reported that, his condition was improved. The healthcare professional was however unsure of the patient's current state at the time of reporting. No further information was reported regarding the event. The reported lot number (2943Z) for INFANRIX did not exist and was updated to 2N43Z, according to sales database.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 58-year-old male patient who received SHINGRIX for prophylaxis. On 28th June 2018, the patient received the 2nd dose of SHINGRIX. On 28th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site hemorrhage, accidental underdose and wrong injection technique. On an unknown date, the outcome of the injection site hemorrhage, accidental underdose and wrong injection technique were unknown. It was unknown if the reporter considered the injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: The HCP (healthcare professional) who was also the patient received a dose of SHINGRIX and during administration the patient hit a blood vessel. There was a lot of blood that came out. The patient felt as though he might not have received the full dose, which led to wrong injection technique and accidental underdose. The HCP would like to know if GlaxoSmithKline had data on whether or not he should be revaccinated.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site swelling, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a elderly female patient who received SINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, chills, injection site swelling and general body pain. On an unknown date, the outcome of the headache, chills, injection site swelling and general body pain were recovered/resolved. It was unknown if the reporter considered the headache, chills, injection site swelling and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was the brother in law of the patient. The reporter did not have details of when events started or how long they lasted. This case has been linked with US2018115927, reported by the same reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 78-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 27th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. In May 2018, less than a week after receiving SHINGRIX, the patient experienced swelling. On an unknown date, the patient experienced generalized pruritus. On 30th May 2018, the outcome of the swelling was recovered/resolved. On an unknown date, the outcome of the generalized pruritus was recovered/resolved. It was unknown if the reporter considered the swelling and generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported to GlaxoSmithKline by the pharmacist and the patient reported to the pharmacist on 26th June 2018 about the adverse events. The patient received SHINGRIX in the left arm. The patient experienced some swelling that resolved within a couple of days. Less than a month after vaccination, the patient experienced itching all over her body and that took a couple of weeks to resolve. The reporter did not have exact start and stop dates of the events but all were resolved at the time of reporting. The pharmacist was transferred to medical information for additional assistance. The pharmacist wanted to know whether the patient should proceed with the 2nd dose and if she did not, what type of protection did she have with just one shot.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Lethargy, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX (batch number YE9YL ?, expiry date 6th February 2021,GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 28th June 2018, the patient experienced influenza-like symptoms, muscle pain, tiredness, lethargy, fever and malaise. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the influenza-like symptoms, tiredness and malaise were not recovered/not resolved and the outcome of the muscle pain, lethargy and fever were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, influenza-like symptoms, muscle pain, tiredness, lethargy, fever and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. One day after receiving SHINGRIX, the patient experienced flu like symptoms, clarified as feeling kind of run down, muscle ache, malaise, tiredness, lethargy and a low grade fever. No emergency room or doctor visit, or intervention was required. The symptoms were not considered disabling or life threatening.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX (batch number YE9YL ?, expiry date 6th February 2021,GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 28th June 2018, the patient experienced influenza-like symptoms, muscle pain, tiredness, lethargy, fever and malaise. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the influenza-like symptoms, tiredness and malaise were not recovered/not resolved and the outcome of the muscle pain, lethargy and fever were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, influenza-like symptoms, muscle pain, tiredness, lethargy, fever and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. One day after receiving SHINGRIX, the patient experienced flu like symptoms, clarified as feeling kind of run down, muscle ache, malaise, tiredness, lethargy and a low grade fever. No emergency room or doctor visit, or intervention was required. The symptoms were not considered disabling or life threatening.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pyrexia, Rash generalised, Skin ulcer
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 72-year-old male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a day after receiving SHINGRIX, the patient experienced generalized rash, skin ulcer, influenza-like symptoms, headache and fever. In June 2018, the outcome of the generalized rash, skin ulcer, influenza-like symptoms, headache and fever were recovered/resolved. The reporter considered the generalized rash, influenza-like symptoms, headache and fever to be possibly related to SHINGRIX. It was unknown if the reporter considered the skin ulcer to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the SHINGRIX on an unknown arm. The patient experienced a whole body rash with open sores, flu-like symptoms, headache and fever within 1 day after receiving the SHINGRIX. All the events were resolved within approximately 1 week without treatment. The healthcare professional (HCP) was not in the pharmacy at the time of report, and was not able to provide additional information.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Vaccine positive rechallenge, Viral rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX, ibuprofen and TYLENOL. On 24th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 25th May 2018, 1 days after receiving SHINGRIX and 80 days after receiving SHINGRIX, the patient experienced headache, general body pain and feeling unwell. On 26th May 2018, the patient experienced rash and viral rash. Rechallenge with SHINGRIX was positive. On 26th May 2018, the outcome of the headache and general body pain were recovered/resolved. On 28th May 2018, the outcome of the rash and viral rash were recovered/resolved. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the headache, general body pain, feeling unwell, rash and viral rash to be related to SHINGRIX. Additional information was reported as follows: The reporting pharmacist is the patient herself. On 25th May 2018, next day after receiving SHINGRIX, she experienced headache, and did not felt very good with body aches, which lasted only till Friday, 25th May 2018. On 26th May 2018, Saturday, 2 days after receiving SHINGRIX, she experienced a rash on her torso, which was same rash as she experienced with the 1st dose of SHINGRIX. The pharmacist stated, it looked like a viral rash. She also stated that, she did not experience chills nor fever like she did with the 1st dose of SHINGRIX. For tolerance after 1st dose of SHINGRIX, refer case US2018040164. Follow-up information was reported by the pharmacist on 26th June 2018: The reporter details were updated. The patient demographic details were updated. The patient experienced viral rash on torso region. The VAERS details were updated. Sender's Comments: US2018GSK102500: Previous VAERS submission in paper format.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female 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 headache, general body pain and queasy. On an unknown date, the outcome of the headache, general body pain and queasy were recovered/resolved. It was unknown if the reporter considered the headache, general body pain and queasy to be related to SHINGRIX. Additional details were provided as follows: This case was reported via a live click to chat. The age at vaccination was not reported. But, it could be 63 or 64 years old. The patient experienced headache, body aches (was achy) and general queasiness. For tolerance after the 2nd dose of SHINGRIX, refer US2018GSK115521.
Age: 11.0
Sex: F
Vaccine: MMRV
Symptoms: Fatigue, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: High fever to 103.5 (oral) despite ibuprofen 600 mg and acetaminophen 1000 mg, alternating every 2 1/2-3 hours. Fever began on July 5 and resolved on July 7. There were no symptoms of local infection, only side effects of the high fever: headache, malaise and fatigue, thirst, myalgias.
Age: 11.0
Sex: F
Vaccine: MMRV
Symptoms: Thirst
Clinical narrative: High fever to 103.5 (oral) despite ibuprofen 600 mg and acetaminophen 1000 mg, alternating every 2 1/2-3 hours. Fever began on July 5 and resolved on July 7. There were no symptoms of local infection, only side effects of the high fever: headache, malaise and fatigue, thirst, myalgias.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at shot site.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth, Rash
Clinical narrative: He received DTaP and varicella. Twenty-four hours later he woke with rash on buttocks and inner thigh, pink-red, that spread to sides. Later in day, he was noticed to have raised pink welps under arms and on chest and upper arm as well. Red rash in diaper area and inner thigh faced. He also developed an area of erythema, warm and induration around DTaP in left thigh the size of two fifty-cent pieces.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Rash erythematous, Urticaria
Clinical narrative: He received DTaP and varicella. Twenty-four hours later he woke with rash on buttocks and inner thigh, pink-red, that spread to sides. Later in day, he was noticed to have raised pink welps under arms and on chest and upper arm as well. Red rash in diaper area and inner thigh faced. He also developed an area of erythema, warm and induration around DTaP in left thigh the size of two fifty-cent pieces.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Severe headache - started up the back of my neck and engulfed my entire head for 60 hrs before it started to subside. The headache took 6 days until it was completely gone. My neck was stiff for 3 days, fever of 100 to 101 for 2 days, joints hurt for 2 days when I had the fever. Fatigue.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: About 4 hours after the vaccination I developed significant soreness in my arm, my shoulder was warm to the touch, and I developed a fever and a headache. This lasted for 36 hours, but symptoms were substantially relieved with TYLENOL.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
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 concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (route, dose, and lot # not provided). The vaccine "did" function as intended [considered meant the vaccine did not function as intended] and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a Medical Center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist via Poison and Drug Center (PDC) regarding a currently 14-year-old female patient. The patient's concomitant medications included a prescription for an ear medication. Information on the patient's relevant medical history and concurrent conditions were not reported. On an unknown date in 2016 (also reported as when she was 12-year-old), the patient was vaccinated with the first dose of GARDASIL 9 (strength, frequency, lot# and expiry date was not reported) via intramuscular deltoid, for prevention of cervical cancer. On 05-JUL-2018, the patient was vaccinated with the second dose of GARDASIL 9 (lot # N022583, expiration date: 20-JUN-2020) suspension for intramuscular injection via intramuscular deltoid, for prevention of cervical cancer, 2 years apart. The patient's laboratory data was unknown at the time of report.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Extreme soreness in left arm for 12 hours. Headache off and on for 3 days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: SEVERE RASH ON THE BACK AND THE CHEST THAT THE PATIENT WAS GIVEN PREDNISONE SHOTS AT DR'S OFFICE.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Limb mass, Pain in extremity
Clinical narrative: Right arm very sore and large lump reported.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: SEVERE SWELLING & RASH ON THE ARM THAT MOVED DOWN TO THE ELBOW, THE BACK OF THE ELBOW IS STILL SWOLLEN & HAVING RED RASH 2 MONTHS AFTER THE SHOT.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysuria, Flank pain, Injection site erythema, Injection site swelling, Joint stiffness
Clinical narrative: 7/9/18 Had #2 SHINGRIX on 7/6/18. Reports that on Saturday AM (7/7/18) awoke with difficulty urinating and then as the day progressed, began to have flank pain and although had some urgency during the day, did not void much and this continued throughout the day but then was better on Sunday (7/8/18) and denies those sx today. Also awoke with much "stiffness in my joints" and difficulty performing normal activities but this sx also improved but still some on Sunday and denies today. Also noted that Saturday morning had swelling at injection site with redness. As the day progressed the redness began to move down into some areas of the left arm. Today still has some pink/redness with mild swelling at the injection site and also some down the arm in patchy areas that are raised slightly and red but do not feel warm to touch. This redness extends down to elbow, with a slightly darker redness about a half dollar size just above the elbow on the outside of the arm. C/O itchiness that started on Saturday evening and has continued. Discussed taking an antihistamine maybe and try a topical cream as well. Does have an extensive medical hx with multiple allergies and or reactions to certain medications, so will call Dr. and ask if this is ok. Will continue to monitor.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Micturition urgency, Peripheral swelling, Pruritus
Clinical narrative: 7/9/18 Had #2 SHINGRIX on 7/6/18. Reports that on Saturday AM (7/7/18) awoke with difficulty urinating and then as the day progressed, began to have flank pain and although had some urgency during the day, did not void much and this continued throughout the day but then was better on Sunday (7/8/18) and denies those sx today. Also awoke with much "stiffness in my joints" and difficulty performing normal activities but this sx also improved but still some on Sunday and denies today. Also noted that Saturday morning had swelling at injection site with redness. As the day progressed the redness began to move down into some areas of the left arm. Today still has some pink/redness with mild swelling at the injection site and also some down the arm in patchy areas that are raised slightly and red but do not feel warm to touch. This redness extends down to elbow, with a slightly darker redness about a half dollar size just above the elbow on the outside of the arm. C/O itchiness that started on Saturday evening and has continued. Discussed taking an antihistamine maybe and try a topical cream as well. Does have an extensive medical hx with multiple allergies and or reactions to certain medications, so will call Dr. and ask if this is ok. Will continue to monitor.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: MA, drew up vaccine. Asked for assistant on giving immunizations. RN administered expired Tdap. Tdap was in a box that was transfered to Health Center from family Medicine. This specific Tdap vaccine was the only one in that box with that expiration date.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Mother stated that pt presented with a rash a day prior to being seen in our facility on 7/5/2018. Mother also stated that a family member had just been diagnosed with varicella a few days prior to when patient had presented with symptoms. Rash was located on pt's legs, feet, arms. and face.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination site inflammation, Vaccination site nodule, Vaccination site pain, Vaccination site warmth
Clinical narrative: Vaccine site was inflamed, warm and there was a small nodule below the skin within an hour after recieving the vaccine. No intervention was taken by the patient. 7/9/18 patient came back the the clinic and still had some tenderness but it was reduced.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Atrial fibrillation, Diarrhoea, Erythema, Fatigue, Headache
Clinical narrative: 6 hrs after shot - fever, erythematous arm, headache. 12 hrs after shot - headache, body aches, pain in hands. 24 hrs after shot- headache, extreme fatigue, diarrhea. 2 days after - palpitations, hospitalization, atrial fibrillation.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: 6 hrs after shot - fever, erythematous arm, headache. 12 hrs after shot - headache, body aches, pain in hands. 24 hrs after shot- headache, extreme fatigue, diarrhea. 2 days after - palpitations, hospitalization, atrial fibrillation.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Loss of consciousness, Somnolence, Syncope
Clinical narrative: Event: Vasovagal syncope with mild post-syncopal convulsions - patient caught by parent, no head trauma. Was unconscious for 15 seconds. Drowsy, weak on floor for another 10 minutes. Able to sit up in chair after 10 minutes. Treatment: pulse ox checked - normal. Blood pressure checked - ok. Given cool water to drink, cool washcloth to forehead. Given granola bar to eat. After about 20 minutes was able to carefully walk to the car and go home with parent.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rashes on different parts of my body (neck, wrist, waist, side of knee, buttock, etc.) with accompanying itching. The rash and itch on the neck attracted my attention a day or two after I received the vaccine. Then about 6 days later I noticed itching and rash on other body sites.