chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. During 2012, the patient was vaccinated 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, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a medical center, for the onset of a vesicular rash, which was diagnosed as severe 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
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. In 2007 the patient was vaccinated 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, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 03-MAY-2016, the patient was treated at a medical center, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient had been prescribed VALTREX for the management of her painful symptoms. 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: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 09-APR-2018, the patient was vaccinated with improperly stored PROQUAD (dosing details were not reported) (lot # N028444, expiry date: 09-APR-2019) for prophylaxis the vaccine was administered with properly stored sterile diluent (MERCK). The vaccine was stored at a temperature of  14 degree Celsius to -10 Celsius (-9.9 degree Celsius) for 17 hours and 11 minutes. No previous temperature excursions reported. No adverse effects reported. No product quality complaint involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1804USA007886.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation. A female patient, age unspecified, was inoculated with ZOSTAVAX on 05-FEB-2014 at a pharmacy as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain condition of herpes zoster. On or about 24-MAY-2016 the patient was treated by a physician at a medical group for a blistering vesicular outbreak which was then diagnosed as herpes zoster, shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Gait disturbance, Inflammation, Injection site pain
Clinical narrative: Symptoms from 4/10 to 4/6: Fatigue  late morning and afternoon of 4/10; slept four hours; Pain at injection site, left arm; Pain and inflammation  along left leg and  knee.  Difficulty walking. Hives over front and back of torso.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Somnolence, Urticaria
Clinical narrative: Symptoms from 4/10 to 4/6: Fatigue  late morning and afternoon of 4/10; slept four hours; Pain at injection site, left arm; Pain and inflammation  along left leg and  knee.  Difficulty walking. Hives over front and back of torso.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: At 8:00 am the morning after I felt nauseous. About noon I started feeling extreme fatigue and a headache. By 2:00 pm I felt body aches, fever and chills.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: At 8:00 am the morning after I felt nauseous. About noon I started feeling extreme fatigue and a headache. By 2:00 pm I felt body aches, fever and chills.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Large circular welt on upper arm where vaccinated. Red, about 6 inches in diameter, and warm to the touch.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Lip swelling, Urticaria
Clinical narrative: EMPLOYEE HAD VACCINE IN R DELTOID, 1mL- Per employee appx 4 days after vaccine she awoke with hives localized to her back, arms, and side of breasts with some swelling to her lips. Employee states that she has been treating her hives with OTC Benadryl for two days now.
Age: 19.0
Sex: F
Vaccine: FLU4, MNQ, PPV, RAB
Symptoms: Arthralgia, Chest X-ray normal, Chills, Dehydration, Dizziness
Clinical narrative: 19 yo female presents with swelling and pain in R arm after getting several vaccines 4 days ago. Also had severe GI sx very quickly after vaccinations, had to go to ED for IVF and treatment, released yesterday afternoon. 4 days ago had rabies vaccine, influenza, pneumococcal and meningococcal. Unsure which arm got which vaccine (Rabies and pneumococcal vaccine given in L deltoid, Influenza and MENVEO in R per records). 5 hours later started to note lightheadedness and nausea, and left arm pain. Started to have joint pain and sensitivity of skin on soles of feet. Tossing and turning all night due to discomfort in back and hips. Woke up with sweats. The next day felt day felt better when awoke, but then quickly started to feel myalgias/arthralgias and nausea again. Unable to eat due to nausea. Having shaking chills and fever which persisted throughout the night. The next day mother came down and brought her ibuprofen/acetaminophen and ginger ale. But nausea getting worse, started to vomit. Vomited multiple times. Went to ED due to vomiting and dehydration. At that time was noting some pain in left arm, and red bump left deltoid area. Had labs done (influenza negative, noted to have elevated WBC of 24). Got IVF, nausea medicine, and sent home; told likely reaction to vaccine. Nausea and vomiting now improved. Ate bagel yesterday and small bowl of cereal this am. Last ZOFRAN just prior to coming in. Arm has been sore since vaccinations, then over past 2 days left arm getting more swollen, with a few scattered areas of erythema. This morning arm more swollen, feeling a little "numb". Yesterday was more painful, today more swollen and "numb" over lateral arm in area of swelling. No more chills. Did have sweats last night. Generally feeling much better, other than left arm swelling and blotchy rash. No myalgias or arthralgias. Immunizations reviewed: no hx of prior rabies vaccines (this was first), no hx of prior pneumococcal vaccine.
Age: 19.0
Sex: F
Vaccine: FLU4, MNQ, PPV, RAB
Symptoms: Erythema, Feeding disorder, Hyperaesthesia, Hyperhidrosis, Hypoaesthesia
Clinical narrative: 19 yo female presents with swelling and pain in R arm after getting several vaccines 4 days ago. Also had severe GI sx very quickly after vaccinations, had to go to ED for IVF and treatment, released yesterday afternoon. 4 days ago had rabies vaccine, influenza, pneumococcal and meningococcal. Unsure which arm got which vaccine (Rabies and pneumococcal vaccine given in L deltoid, Influenza and MENVEO in R per records). 5 hours later started to note lightheadedness and nausea, and left arm pain. Started to have joint pain and sensitivity of skin on soles of feet. Tossing and turning all night due to discomfort in back and hips. Woke up with sweats. The next day felt day felt better when awoke, but then quickly started to feel myalgias/arthralgias and nausea again. Unable to eat due to nausea. Having shaking chills and fever which persisted throughout the night. The next day mother came down and brought her ibuprofen/acetaminophen and ginger ale. But nausea getting worse, started to vomit. Vomited multiple times. Went to ED due to vomiting and dehydration. At that time was noting some pain in left arm, and red bump left deltoid area. Had labs done (influenza negative, noted to have elevated WBC of 24). Got IVF, nausea medicine, and sent home; told likely reaction to vaccine. Nausea and vomiting now improved. Ate bagel yesterday and small bowl of cereal this am. Last ZOFRAN just prior to coming in. Arm has been sore since vaccinations, then over past 2 days left arm getting more swollen, with a few scattered areas of erythema. This morning arm more swollen, feeling a little "numb". Yesterday was more painful, today more swollen and "numb" over lateral arm in area of swelling. No more chills. Did have sweats last night. Generally feeling much better, other than left arm swelling and blotchy rash. No myalgias or arthralgias. Immunizations reviewed: no hx of prior rabies vaccines (this was first), no hx of prior pneumococcal vaccine.
Age: 19.0
Sex: F
Vaccine: FLU4, MNQ, PPV, RAB
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Injection site erythema, Injection site swelling
Clinical narrative: 19 yo female presents with swelling and pain in R arm after getting several vaccines 4 days ago. Also had severe GI sx very quickly after vaccinations, had to go to ED for IVF and treatment, released yesterday afternoon. 4 days ago had rabies vaccine, influenza, pneumococcal and meningococcal. Unsure which arm got which vaccine (Rabies and pneumococcal vaccine given in L deltoid, Influenza and MENVEO in R per records). 5 hours later started to note lightheadedness and nausea, and left arm pain. Started to have joint pain and sensitivity of skin on soles of feet. Tossing and turning all night due to discomfort in back and hips. Woke up with sweats. The next day felt day felt better when awoke, but then quickly started to feel myalgias/arthralgias and nausea again. Unable to eat due to nausea. Having shaking chills and fever which persisted throughout the night. The next day mother came down and brought her ibuprofen/acetaminophen and ginger ale. But nausea getting worse, started to vomit. Vomited multiple times. Went to ED due to vomiting and dehydration. At that time was noting some pain in left arm, and red bump left deltoid area. Had labs done (influenza negative, noted to have elevated WBC of 24). Got IVF, nausea medicine, and sent home; told likely reaction to vaccine. Nausea and vomiting now improved. Ate bagel yesterday and small bowl of cereal this am. Last ZOFRAN just prior to coming in. Arm has been sore since vaccinations, then over past 2 days left arm getting more swollen, with a few scattered areas of erythema. This morning arm more swollen, feeling a little "numb". Yesterday was more painful, today more swollen and "numb" over lateral arm in area of swelling. No more chills. Did have sweats last night. Generally feeling much better, other than left arm swelling and blotchy rash. No myalgias or arthralgias. Immunizations reviewed: no hx of prior rabies vaccines (this was first), no hx of prior pneumococcal vaccine.
Age: 19.0
Sex: F
Vaccine: FLU4, MNQ, PPV, RAB
Symptoms: Metabolic function test normal, Musculoskeletal discomfort, Myalgia, Nausea, Neutrophil count increased
Clinical narrative: 19 yo female presents with swelling and pain in R arm after getting several vaccines 4 days ago. Also had severe GI sx very quickly after vaccinations, had to go to ED for IVF and treatment, released yesterday afternoon. 4 days ago had rabies vaccine, influenza, pneumococcal and meningococcal. Unsure which arm got which vaccine (Rabies and pneumococcal vaccine given in L deltoid, Influenza and MENVEO in R per records). 5 hours later started to note lightheadedness and nausea, and left arm pain. Started to have joint pain and sensitivity of skin on soles of feet. Tossing and turning all night due to discomfort in back and hips. Woke up with sweats. The next day felt day felt better when awoke, but then quickly started to feel myalgias/arthralgias and nausea again. Unable to eat due to nausea. Having shaking chills and fever which persisted throughout the night. The next day mother came down and brought her ibuprofen/acetaminophen and ginger ale. But nausea getting worse, started to vomit. Vomited multiple times. Went to ED due to vomiting and dehydration. At that time was noting some pain in left arm, and red bump left deltoid area. Had labs done (influenza negative, noted to have elevated WBC of 24). Got IVF, nausea medicine, and sent home; told likely reaction to vaccine. Nausea and vomiting now improved. Ate bagel yesterday and small bowl of cereal this am. Last ZOFRAN just prior to coming in. Arm has been sore since vaccinations, then over past 2 days left arm getting more swollen, with a few scattered areas of erythema. This morning arm more swollen, feeling a little "numb". Yesterday was more painful, today more swollen and "numb" over lateral arm in area of swelling. No more chills. Did have sweats last night. Generally feeling much better, other than left arm swelling and blotchy rash. No myalgias or arthralgias. Immunizations reviewed: no hx of prior rabies vaccines (this was first), no hx of prior pneumococcal vaccine.
Age: 19.0
Sex: F
Vaccine: FLU4, MNQ, PPV, RAB
Symptoms: Pain in extremity, Peripheral swelling, Pregnancy test negative, Pyrexia, Rash macular
Clinical narrative: 19 yo female presents with swelling and pain in R arm after getting several vaccines 4 days ago. Also had severe GI sx very quickly after vaccinations, had to go to ED for IVF and treatment, released yesterday afternoon. 4 days ago had rabies vaccine, influenza, pneumococcal and meningococcal. Unsure which arm got which vaccine (Rabies and pneumococcal vaccine given in L deltoid, Influenza and MENVEO in R per records). 5 hours later started to note lightheadedness and nausea, and left arm pain. Started to have joint pain and sensitivity of skin on soles of feet. Tossing and turning all night due to discomfort in back and hips. Woke up with sweats. The next day felt day felt better when awoke, but then quickly started to feel myalgias/arthralgias and nausea again. Unable to eat due to nausea. Having shaking chills and fever which persisted throughout the night. The next day mother came down and brought her ibuprofen/acetaminophen and ginger ale. But nausea getting worse, started to vomit. Vomited multiple times. Went to ED due to vomiting and dehydration. At that time was noting some pain in left arm, and red bump left deltoid area. Had labs done (influenza negative, noted to have elevated WBC of 24). Got IVF, nausea medicine, and sent home; told likely reaction to vaccine. Nausea and vomiting now improved. Ate bagel yesterday and small bowl of cereal this am. Last ZOFRAN just prior to coming in. Arm has been sore since vaccinations, then over past 2 days left arm getting more swollen, with a few scattered areas of erythema. This morning arm more swollen, feeling a little "numb". Yesterday was more painful, today more swollen and "numb" over lateral arm in area of swelling. No more chills. Did have sweats last night. Generally feeling much better, other than left arm swelling and blotchy rash. No myalgias or arthralgias. Immunizations reviewed: no hx of prior rabies vaccines (this was first), no hx of prior pneumococcal vaccine.
Age: 19.0
Sex: F
Vaccine: FLU4, MNQ, PPV, RAB
Symptoms: Tremor, Vaccination complication, Vomiting, White blood cell count increased
Clinical narrative: 19 yo female presents with swelling and pain in R arm after getting several vaccines 4 days ago. Also had severe GI sx very quickly after vaccinations, had to go to ED for IVF and treatment, released yesterday afternoon. 4 days ago had rabies vaccine, influenza, pneumococcal and meningococcal. Unsure which arm got which vaccine (Rabies and pneumococcal vaccine given in L deltoid, Influenza and MENVEO in R per records). 5 hours later started to note lightheadedness and nausea, and left arm pain. Started to have joint pain and sensitivity of skin on soles of feet. Tossing and turning all night due to discomfort in back and hips. Woke up with sweats. The next day felt day felt better when awoke, but then quickly started to feel myalgias/arthralgias and nausea again. Unable to eat due to nausea. Having shaking chills and fever which persisted throughout the night. The next day mother came down and brought her ibuprofen/acetaminophen and ginger ale. But nausea getting worse, started to vomit. Vomited multiple times. Went to ED due to vomiting and dehydration. At that time was noting some pain in left arm, and red bump left deltoid area. Had labs done (influenza negative, noted to have elevated WBC of 24). Got IVF, nausea medicine, and sent home; told likely reaction to vaccine. Nausea and vomiting now improved. Ate bagel yesterday and small bowl of cereal this am. Last ZOFRAN just prior to coming in. Arm has been sore since vaccinations, then over past 2 days left arm getting more swollen, with a few scattered areas of erythema. This morning arm more swollen, feeling a little "numb". Yesterday was more painful, today more swollen and "numb" over lateral arm in area of swelling. No more chills. Did have sweats last night. Generally feeling much better, other than left arm swelling and blotchy rash. No myalgias or arthralgias. Immunizations reviewed: no hx of prior rabies vaccines (this was first), no hx of prior pneumococcal vaccine.
Age: 21.0
Sex: F
Vaccine: HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: Client described large amount of swelling, redness and hives of left arm.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: To left thigh, local reaction. Area was red, raised and warm to touch. Instructed to give Tylenol for pain/discomfort. Cool bath, warm/cool compress to area, movement such as walking. Contacted mom on 04/17/18 and mom stated she was doing much better.
Age: 53.0
Sex: M
Vaccine: YF
Symptoms: Acute kidney injury, Blood creatinine increased, Confusional state, Diarrhoea, Encephalopathy
Clinical narrative: Patient with high fevers to 103, confused/encephalopathic, nausea, vomiting, diarrhea, thrombocytopenia, AKI.
Age: 53.0
Sex: M
Vaccine: YF
Symptoms: Nausea, Platelet count decreased, Pyrexia, Thrombocytopenia, Vomiting
Clinical narrative: Patient with high fevers to 103, confused/encephalopathic, nausea, vomiting, diarrhea, thrombocytopenia, AKI.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased, Body mass index increased, Chills, Pyrexia
Clinical narrative: Presented to clinic with Fever temperature 104.1, chills, body aches, activated EMS, taken to hospital.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed a raised/swelling w/ redness over annular patch 8.5cm x 6.5cm over left deltoid, with mild warmth and pain whether sedentary or use of left arm where Meningococcal Vaccine was administered.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient presented with large 2.5 x 2 inch swollen rash approximately two inches under the site of injection. She said it itched her but it did not feel hot. I advised patient to use cold compress, antihistamine (BENADRYL), and ADVIL or TYLENOL.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Patient presented with large 2.5 x 2 inch swollen rash approximately two inches under the site of injection. She said it itched her but it did not feel hot. I advised patient to use cold compress, antihistamine (BENADRYL), and ADVIL or TYLENOL.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Swelling, Urticaria
Clinical narrative: Patient presented with large 2.5 x 2 inch swollen rash approximately two inches under the site of injection. She said it itched her but it did not feel hot. I advised patient to use cold compress, antihistamine (BENADRYL), and ADVIL or TYLENOL.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: As per patient, arm felt sore immediately after shot and for the next few days. Soreness disappated, but began to feel pain on the injection site (lower deltoid area)  whenever she lifts her arm past her chest. She says that due to the pain, she can no longer take her daily yoga classes. This has been ongoing for the past month since receiving the injection. Did not have any other external trauma or injury to the arm.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: A minute after injection patient had a tonic clonic seizure. Myself and the nursing staff were able to grab him and lay him on the ground without any injury to body or head. The seizure was less then a minute.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Pt received 3 vaccines, Tdap, MCV4P, and HPV. Tdap and MCV4P were administered first on L arm and HPV was administered last on R arm. Pt fainted right after HPV was administered. Per mother pt had fainted previously with blood drawn but never with vaccines. Pt was kept on observation for 20 minutes with normal BP, respiration, and pulse. Pt had a fast and successful recovery.
Age: 74.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Left arm became warm, red, swollen on inside of arm on upper arm and extending down about 2 inches below elbow.
Age: 74.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Skin warm
Clinical narrative: Left arm became warm, red, swollen on inside of arm on upper arm and extending down about 2 inches below elbow.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Poor quality sleep, Tenderness
Clinical narrative: She has had severe pain from her shoulder all the way down to her hand. It is sore to the touch and she has not had a good night sleep since the shot because of the pain. She has done physical therapy and nothing has helped so she is now going to go see a MD.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Significant body aches, tiredness, chills -- resolving within a day.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Blood test normal, Erythema, Full blood count, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediately following site injection-his site injection- his face became red and blotchy. His arm had a huge bump and swollen. A few hours later the swelling went down and his face cleared up. Fast forward to day 5 - He started off with fevers and red watery eyes. He had fevers ranging from 102-104.7 for 5 days. I took patient to the doctor on 4/10/18, they claimed it might have just been a cold or something viral. Upon examining him no ear infection was present, they advised me to keep an eye  on him and call them if his symptoms worsen. 2 days later, on 4/12/18) I call them back to let them know his fever was at 104.7 (This was around 7PM), they advised me if his fever doesn't break after an hour or if he becomes lethargic to take him to the emergency room or  bring him in the following morning. On 4/13/18 (DAY 10) his fever was finally lowering to 101.5 but he was developing pox/red dots on his face and his arm where the injection site is, was red as well.  He was beginning to develop pox all over his body. They did bloodwork and attempted to take a urine sample to rule out sepsis or a UTI. All which resulted in negative labs. Per the doctor, her suspicions were that he had roseola. Upon checking on the CDC.gov website, I realized he had an adverse reaction which was a mild case of the measles. His arm still has a red lump surrounded by a few red lump surrounded buy a few red bumps. It looks like a big bug bite where the site is now.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Injection site mass, Injection site reaction, Lacrimation increased, Limb mass, Measles post vaccine
Clinical narrative: Immediately following site injection-his site injection- his face became red and blotchy. His arm had a huge bump and swollen. A few hours later the swelling went down and his face cleared up. Fast forward to day 5 - He started off with fevers and red watery eyes. He had fevers ranging from 102-104.7 for 5 days. I took patient to the doctor on 4/10/18, they claimed it might have just been a cold or something viral. Upon examining him no ear infection was present, they advised me to keep an eye  on him and call them if his symptoms worsen. 2 days later, on 4/12/18) I call them back to let them know his fever was at 104.7 (This was around 7PM), they advised me if his fever doesn't break after an hour or if he becomes lethargic to take him to the emergency room or  bring him in the following morning. On 4/13/18 (DAY 10) his fever was finally lowering to 101.5 but he was developing pox/red dots on his face and his arm where the injection site is, was red as well.  He was beginning to develop pox all over his body. They did bloodwork and attempted to take a urine sample to rule out sepsis or a UTI. All which resulted in negative labs. Per the doctor, her suspicions were that he had roseola. Upon checking on the CDC.gov website, I realized he had an adverse reaction which was a mild case of the measles. His arm still has a red lump surrounded by a few red lump surrounded buy a few red bumps. It looks like a big bug bite where the site is now.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Ocular hyperaemia, Peripheral swelling, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Immediately following site injection-his site injection- his face became red and blotchy. His arm had a huge bump and swollen. A few hours later the swelling went down and his face cleared up. Fast forward to day 5 - He started off with fevers and red watery eyes. He had fevers ranging from 102-104.7 for 5 days. I took patient to the doctor on 4/10/18, they claimed it might have just been a cold or something viral. Upon examining him no ear infection was present, they advised me to keep an eye  on him and call them if his symptoms worsen. 2 days later, on 4/12/18) I call them back to let them know his fever was at 104.7 (This was around 7PM), they advised me if his fever doesn't break after an hour or if he becomes lethargic to take him to the emergency room or  bring him in the following morning. On 4/13/18 (DAY 10) his fever was finally lowering to 101.5 but he was developing pox/red dots on his face and his arm where the injection site is, was red as well.  He was beginning to develop pox all over his body. They did bloodwork and attempted to take a urine sample to rule out sepsis or a UTI. All which resulted in negative labs. Per the doctor, her suspicions were that he had roseola. Upon checking on the CDC.gov website, I realized he had an adverse reaction which was a mild case of the measles. His arm still has a red lump surrounded by a few red lump surrounded buy a few red bumps. It looks like a big bug bite where the site is now.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash pustular
Clinical narrative: Immediately following site injection-his site injection- his face became red and blotchy. His arm had a huge bump and swollen. A few hours later the swelling went down and his face cleared up. Fast forward to day 5 - He started off with fevers and red watery eyes. He had fevers ranging from 102-104.7 for 5 days. I took patient to the doctor on 4/10/18, they claimed it might have just been a cold or something viral. Upon examining him no ear infection was present, they advised me to keep an eye  on him and call them if his symptoms worsen. 2 days later, on 4/12/18) I call them back to let them know his fever was at 104.7 (This was around 7PM), they advised me if his fever doesn't break after an hour or if he becomes lethargic to take him to the emergency room or  bring him in the following morning. On 4/13/18 (DAY 10) his fever was finally lowering to 101.5 but he was developing pox/red dots on his face and his arm where the injection site is, was red as well.  He was beginning to develop pox all over his body. They did bloodwork and attempted to take a urine sample to rule out sepsis or a UTI. All which resulted in negative labs. Per the doctor, her suspicions were that he had roseola. Upon checking on the CDC.gov website, I realized he had an adverse reaction which was a mild case of the measles. His arm still has a red lump surrounded by a few red lump surrounded buy a few red bumps. It looks like a big bug bite where the site is now.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy red swollen patch near the injection site lasting for 5 days post injection. Recommended cold compress. TYLENOL for pain. Antihistamine for itching. If no improvement or gets worse follow up with MD.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Mouth swelling, Pain, Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Noise in ear; prickly skin; blurred vision; fever; swollen mouth; "ball" swelling under arm; pain.  Patient visited doctor and was given antihistamine prescription to help with reaction.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Noise in ear; prickly skin; blurred vision; fever; swollen mouth; "ball" swelling under arm; pain.  Patient visited doctor and was given antihistamine prescription to help with reaction.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness on the top half of left arm with a little bit of swelling.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Staring
Clinical narrative: Swelling and erythema (L) thigh noted this AM. Immunizations given 4/16/18. Pt also had blank stare x 45 min at school. During that time he was not interacting with anyone until Dad arrived - At which time he "snapped out of it" and is now ok. Dad made question of actions related to pt wanting his helicopter which he referred to when father arrived (as stated per father). No family Hx of seizures. To follow up with Dr. (Peds Neurology) 4/19/18.
Age: 1.33
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap given in error instead of DTaP. Mother was notified.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, Eye irritation, Ocular hyperaemia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of eye red in a adult male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced eye red, eye irritation, inadvertent exposure to vaccine, exposure via skin contact and exposure via eye contact. On an unknown date, the outcome of the eye red, eye irritation, inadvertent exposure to vaccine, exposure via skin contact and exposure via eye contact were unknown. The reporter considered the eye red and eye irritation to be related SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was preparing the SHINGRIX product for administration. When he went to throw away the syringe that he had used to withdraw the adjuvant suspension, as he threw it, residual suspension splashed in his face and into his right eye, which led to inadvertent exposure to vaccine, exposure via skin contact and exposure via eye contact. He reported that his right eye was irritated and red in the outside corner.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received SHINGRIX. On 7th April 2018 11:35, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. In April 2018, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporting nurse was the patient's wife. The patient received SHINGRIX vaccine on his left deltoid and experienced a sore arm. The patient had denied permission to contact their physician. This case was linked with US2018063411 (wife's case), reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a adult patient who received SHINGRIX. 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 injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. The reporter considered the injection site rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient went to get her 2nd SHINGRIX vaccination and she informed the reporter that she developed a rash at the injection site after her 1st vaccination.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received SHINGRIX. On 7th April 2018 11:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, injection site warmth and injection site erythema. On 9th April 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site warmth and injection site erythema were not recovered/not resolved. The reporter considered the pain in arm, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The reporting nurse was the patient. The patient received SHINGRIX vaccine on her left deltoid and experienced a sore arm, redness and warmth at the injection site. The patient still had the redness and warmth at the injection site and described the red area as approximately three inches wide and two inches tall with irregular borders. The patient has denied permission to contact their physician. This case was linked with US2018063412 (husband's case), reported by the same reporter.
Age: 37.0
Sex: F
Vaccine: TYP
Symptoms: Hypersensitivity, Lip swelling, Malaise, Swollen tongue
Clinical narrative: Called clinic 11/2 hr after receiving vaccine complaint of allergic reaction -felt like her lips and tongue swelling, generally not feeling well. Sent to local ER. Stable in ER. VSS. No swelling noted anywhere, no hives or rash, no SOB, no nausea or vomiting, no lightheadedness. Treated for subjective symptoms with IV BENADRYL, PEPCID, SOLU MEDROL and observe for 11/2 hr. Complete resolution of symptoms and discharged with prednisone for three days. No further symptoms.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Oropharyngeal pain, Rash generalised, Sneezing, Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fatigue in a 53-year-old female patient who received SHINGRIX. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd April 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue, sore throat and sneezing. On 8th April 2018, the patient experienced generalized rash, rash urticaria-like and raised rash. On an unknown date, the outcome of the fatigue, sore throat, sneezing, generalized rash, rash urticaria-like and raised rash were unknown. it was unknown if the reporter considered the fatigue, sore throat, sneezing, generalized rash, rash urticaria-like and raised rash to be related to SHINGRIX. Additional details were reported as follows: Six day after vaccination, the patient experienced rash which was described as full-body, hive-like and raised.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Fatigue, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Tired, headache, fever, sweating. Arm red at injection site and a little swollen, and pain at site. 4/18/18 Pt called during the day with ADR issues. I said that she should contact her M.D. and also go to the hospital to get checked out. She said that she would try her M.D. first. I called back 3x during the day and finally was able to catch her at 7:20 pm. She said that she saw Dr. and he said reaction happens often. He said it should be fine. He prescribed ABX for her too. At 7:20 pm she stated that she felt much better and took a walk plus did some shopping. I told her to call pharmacy and her doctor if she has any more issues.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Tired, headache, fever, sweating. Arm red at injection site and a little swollen, and pain at site. 4/18/18 Pt called during the day with ADR issues. I said that she should contact her M.D. and also go to the hospital to get checked out. She said that she would try her M.D. first. I called back 3x during the day and finally was able to catch her at 7:20 pm. She said that she saw Dr. and he said reaction happens often. He said it should be fine. He prescribed ABX for her too. At 7:20 pm she stated that she felt much better and took a walk plus did some shopping. I told her to call pharmacy and her doctor if she has any more issues.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 60-year-old female patient who received SHINGRIX. Concomitant products included magnesium. On 10th April 2018, the patient received SHINGRIX. On 10th April 2018, less than a day after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving. The reporter considered the rash to be probably related to SHINGRIX. Additional information was received as follows: The patient reported that she started to feel the onset of the rash at bedtime the day of the vaccination. In the next morning, the rash was presented on the back of her legs, trunk and little on both shoulders. It was more pronounced on the trunk and legs than the shoulders. The patient took Multivitamins.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 10th April 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. In April 2018, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site erythema and influenza-like symptoms were unknown. The reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. The reporter considered the influenza-like symptoms to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In April 2018, less than a week after receiving SHINGRIX, the patient experienced redness and swelling at the injection site and began to develop flu-like symptoms. The reporter was unable to provide additional details at the time of the call.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Mother stated pt. developed fever after vaccines were given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pruritus, Skin discolouration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX. Concurrent medical conditions included asthma. On 5th April 2018 18:00, the patient received the 1st dose of SHINGRIX. On 5th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 6th April 2018, the patient experienced injection site swelling. In April 2018, the patient experienced skin discoloration and pruritus. The patient was treated with antihistamine. On an unknown date, the outcome of the injection site pain, injection site swelling, skin discoloration and pruritus were recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site swelling and skin discoloration to be related to SHINGRIX. The reporter considered the pruritus to be related to SHINGRIX. Additional details were provided as follows: The caller was physician, who was good family friend to the patient. The patient received SHINGRIX in left arm and experienced pain at the injection site the first evening, but nothing too significant. The next day 1 day after receiving SHINGRIX, the patient experienced large swelling of the full deltoid muscle. Less than a week after receiving SHINGRIX, the patient experienced a 4cm x 3.5cm area that was pink in color and itching. The pain was worsened. The patient was directed by physician to take an antihistamine and he notes the swelling was decreasing. The physician was not aware of the dose or how the product was given or the lot number she had received. The patient called for inquiring if she should receive the second dose or not based on her localized reaction. The patient was transferred to the Medical Information Scientist to discuss.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pruritus
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pruritus in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, several hours after receiving SHINGRIX, the patient experienced pruritus and intramuscular formulation administered by other route. On an unknown date, the outcome of the pruritus was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the pruritus to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional reported that his wife received a dose of SHINGRIX subcutaneously, which led to inappropriate route of vaccination. He also reported that she experienced extreme itching that lasted up to 10 days after receipt of vaccine.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoacusis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hard of hearing in a 72-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date January 2020). Previously administered products included CRESTOR (received generic CRESTOR a year before the reporting date). On 22nd March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 2 days after receiving SHINGRIX, the patient experienced hard of hearing. On an unknown date, the outcome of the hard of hearing was unknown. It was unknown if the reporter considered the hard of hearing to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in his left arm, and 2 to 3 days later experienced difficulty hearing in his right ear. The reporter stated that the patient was not sure if the condition had worsened, and was not certain of causality in relation to SHINGRIX. This case has been linked with case US2018063434 reported by same reporter.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Flushing, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold in a 72-year-old male patient who received SHINGRIX. Concomitant products included amlodipine and Baby Aspirin. On 11th April 2018 16:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th April 2018, less than a day after receiving SHINGRIX, the patient experienced cold. On 12th April 2018, the patient experienced myalgia, flushing, fatigue, headache and shivering. On an unknown date, the outcome of the cold, myalgia, flushing, fatigue, headache and shivering were not recovered/not resolved. The reporter considered the cold, myalgia, flushing, fatigue, headache and shivering to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. On 11th April 2018, the patient felt cold later the night of the vaccination and the next morning he developed shivering and other side effects.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold in a 72-year-old male patient who received SHINGRIX. Concomitant products included amlodipine and Baby Aspirin. On 11th April 2018 16:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th April 2018, less than a day after receiving SHINGRIX, the patient experienced cold. On 12th April 2018, the patient experienced myalgia, flushing, fatigue, headache and shivering. On an unknown date, the outcome of the cold, myalgia, flushing, fatigue, headache and shivering were not recovered/not resolved. The reporter considered the cold, myalgia, flushing, fatigue, headache and shivering to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. On 11th April 2018, the patient felt cold later the night of the vaccination and the next morning he developed shivering and other side effects.