chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Redness, pain and swelling at injection site, joint and muscle pain, burning eyes, feverish.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness of left arm, mild swelling, full arm from shoulder to hand, pain. Happened same day of vaccine, followed up 2 days after.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Arthralgia, Blood test, Chills, Depression
Clinical narrative: Fever, chills, almost passing out twice (followed by sweating), nausea, pain in joints, skin hurt, injection site sore, depression, heart racing (flip flop feeling); sharp pains in different parts of body miserable for 24 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hyperhidrosis, Injection site pain, Nausea, Pain
Clinical narrative: Fever, chills, almost passing out twice (followed by sweating), nausea, pain in joints, skin hurt, injection site sore, depression, heart racing (flip flop feeling); sharp pains in different parts of body miserable for 24 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Palpitations, Pyrexia
Clinical narrative: Fever, chills, almost passing out twice (followed by sweating), nausea, pain in joints, skin hurt, injection site sore, depression, heart racing (flip flop feeling); sharp pains in different parts of body miserable for 24 hours.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site warmth, Myalgia
Clinical narrative: Worse headache I have ever had. Started about 9 hrs after injection. Acetaminophen and aspirin did not help. Headaches finally went away 14 hrs later. Chills started about 12 hrs later but only lasted a few minutes each time. Leg muscles ached the next day for a few hours. Arm where the injection is still tender to the touch and warm. Has been over 50 hrs. I have never had a reaction to any vaccine like this and I have had many vaccines.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Injection site is red, hard, and warm to touch.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Meningitis viral
Clinical narrative: Viral meningitis 5 weeks after SHINGRIX shot. Hospital attributed this to the shingles vaccine.
Age: 56.0
Sex: F
Vaccine: FLUA3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Symptoms are extreme pain, swelling, limited arm movement.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Bursa injury, Immediate post-injection reaction, Joint range of motion decreased, Loss of personal independence in daily activities, Middle insomnia
Clinical narrative: I received a flu vaccine in the upper left arm on 11/06/2018. Immediately after receiving the shot it hurt, the pain worsened over the next few days and I took ibuprofen to help with pain. My arm became so painful that I thought I would get a frozen shoulder, I immediately started exercises at home for bursa injury(exercises were home exercises that I found on the internet). Gradually over the course of several months, the pain worsened. I did not have any pain or injury to this arm prior to receiving the vaccine. The injection site was high up on the arm, and in my opinion, the placement was too high possibly hitting a structure in my shoulder that caused some damage of some type. I notified my doctor of this continued pain because it is disrupting my sleep, activities of daily living and function of the left arm. My physician took an X-ray and referred me to physical therapy and blew off my idea that the injury was received as a result of vaccine injury. I asked my physician for an MRI, but have, thus far, been denied. Physician wants me to continue with Physical Therapy and possibly have acupuncture. I have been compliant with all prescribed physical therapy and have noticed an increase in range of motion, but the pain continues. The pain awakens me from sleep at night frequently. The pain causes me to not be able to lift as much with my left arm as my unaffected arm (right). I am reporting this because it has been some time, in my opinion, since this injury and I am not healing fully with my current treatment. I have recently messaged my doctor and she now is saying she thinks it is arthritis. I have arthritis in my knees and frankly this pain is much more severe than any arthritis pain the I have felt and it is not alleviated with any current medications that I have been taking (anti inflammatory medications prescribed and over the counter). My doctor recently has prescribed diclofenac and I am awaiting the arrival of this medication. I am hoping that this injury is not permanent, but have decided to report so that there is a record of my injury even though my physician is not admitting that it is a vaccine injury.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal disorder, Pain, Pain in extremity, Sleep disorder, X-ray
Clinical narrative: I received a flu vaccine in the upper left arm on 11/06/2018. Immediately after receiving the shot it hurt, the pain worsened over the next few days and I took ibuprofen to help with pain. My arm became so painful that I thought I would get a frozen shoulder, I immediately started exercises at home for bursa injury(exercises were home exercises that I found on the internet). Gradually over the course of several months, the pain worsened. I did not have any pain or injury to this arm prior to receiving the vaccine. The injection site was high up on the arm, and in my opinion, the placement was too high possibly hitting a structure in my shoulder that caused some damage of some type. I notified my doctor of this continued pain because it is disrupting my sleep, activities of daily living and function of the left arm. My physician took an X-ray and referred me to physical therapy and blew off my idea that the injury was received as a result of vaccine injury. I asked my physician for an MRI, but have, thus far, been denied. Physician wants me to continue with Physical Therapy and possibly have acupuncture. I have been compliant with all prescribed physical therapy and have noticed an increase in range of motion, but the pain continues. The pain awakens me from sleep at night frequently. The pain causes me to not be able to lift as much with my left arm as my unaffected arm (right). I am reporting this because it has been some time, in my opinion, since this injury and I am not healing fully with my current treatment. I have recently messaged my doctor and she now is saying she thinks it is arthritis. I have arthritis in my knees and frankly this pain is much more severe than any arthritis pain the I have felt and it is not alleviated with any current medications that I have been taking (anti inflammatory medications prescribed and over the counter). My doctor recently has prescribed diclofenac and I am awaiting the arrival of this medication. I am hoping that this injury is not permanent, but have decided to report so that there is a record of my injury even though my physician is not admitting that it is a vaccine injury.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Pyrexia
Clinical narrative: Fever, extreme muscle ache, neck stiffness to the point of high pain levels.
Age: 6.0
Sex: M
Vaccine: IPV
Symptoms: Axillary pain, Discomfort, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Described pain in the axilla of the arm that received the vaccination on going to bed. Woke early the next morning saying that his arm hurt worse. There was marked swelling in the axillary region. Swelling and pain increased over the rest of the day. We applied alternating hot and cold compresses to help with the swelling and discomfort. We brought him to immediate care after calling the pediatricians office and they said just bring him to immediate care. Immediate care didn't know what it was but said give him motrin and if it persisted longer than three days, call the pediatrician back. We continued to do alternating hot and cold compresses and the swelling and discomfort slowly resolved over the next three days.
Age: 6.0
Sex: M
Vaccine: IPV
Symptoms: Swelling
Clinical narrative: Described pain in the axilla of the arm that received the vaccination on going to bed. Woke early the next morning saying that his arm hurt worse. There was marked swelling in the axillary region. Swelling and pain increased over the rest of the day. We applied alternating hot and cold compresses to help with the swelling and discomfort. We brought him to immediate care after calling the pediatricians office and they said just bring him to immediate care. Immediate care didn't know what it was but said give him motrin and if it persisted longer than three days, call the pediatrician back. We continued to do alternating hot and cold compresses and the swelling and discomfort slowly resolved over the next three days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient received SHINGRIX vaccine, first dose to the left tricep. The location of the vaccine was not on the deltoid, but the middle back portion of the left arm. Patient supplied picture, displaying erythema, slight swelling, and round reaction site on left tricep. Patient reported painful arm, with swelling that eventually resolved after 3 days.
Age: 81.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Muscular weakness, Myalgia, Nausea, Pyrexia
Clinical narrative: Fatigue, myalgia, muscle weakness, fever, nausea.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Severe flu like symptoms, high fever, achiness for 10+ hours.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Blindness, Deafness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: RIGHT AFTER THE VACCINATION, PATIENT STARTED FEELING WEAK, LOSING VISION, LOSING HEARING, WAS SWEATING AND HAD NAUSEA. PATIENT WAS ALERT AND SITTING UPRIGHT. AFTER 3 MINUTES, THE VISION AND HEARING CAME BACK AND STARTED FEELING BETTER. PULSE WAS 80 AND 5 MINUTES LATER BLOOD PRESSURE WAS 110/70. NO FURTHER TREATMENT WAS NEEDED. PATIENT FEELING FINE.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Nausea
Clinical narrative: RIGHT AFTER THE VACCINATION, PATIENT STARTED FEELING WEAK, LOSING VISION, LOSING HEARING, WAS SWEATING AND HAD NAUSEA. PATIENT WAS ALERT AND SITTING UPRIGHT. AFTER 3 MINUTES, THE VISION AND HEARING CAME BACK AND STARTED FEELING BETTER. PULSE WAS 80 AND 5 MINUTES LATER BLOOD PRESSURE WAS 110/70. NO FURTHER TREATMENT WAS NEEDED. PATIENT FEELING FINE.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site paraesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pain and tingling of entire arm that was vaccinated. I'm not sure the treatment and outcome.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Arthropathy, Chills, Influenza like illness
Clinical narrative: SHE HAD A VERY BAD REACTION TO THE FIRST DOSE OF SHINGRIX (JOINT INFLAMMATION WITH DIFFICULTY MOVING, KNEE WENT OUT WHEN WALKING, CHILLS, GENERAL FEELING OF FLU-LIKE SYMPTOMS FOR A FEW WEEKS). SHE AND HER DOCTOR DECIDED AGAINST THE SECOND DOSE.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dizziness, Dysphagia, Fatigue, Headache
Clinical narrative: Severe joint pain numbness, headache and fever, hyperglycemia, fatigue all within the first 48 hours. Then mental changes and forgetfulness, expressive dysphagia, tremors, numbness, and loss of feeling in extremities. Complete saturating night sweats and dizziness.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperglycaemia, Hyperhidrosis, Hypoaesthesia, Laboratory test, Memory impairment
Clinical narrative: Severe joint pain numbness, headache and fever, hyperglycemia, fatigue all within the first 48 hours. Then mental changes and forgetfulness, expressive dysphagia, tremors, numbness, and loss of feeling in extremities. Complete saturating night sweats and dizziness.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Mental status changes, Night sweats, Pyrexia, Sensory loss, Tremor
Clinical narrative: Severe joint pain numbness, headache and fever, hyperglycemia, fatigue all within the first 48 hours. Then mental changes and forgetfulness, expressive dysphagia, tremors, numbness, and loss of feeling in extremities. Complete saturating night sweats and dizziness.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Urine analysis
Clinical narrative: Severe joint pain numbness, headache and fever, hyperglycemia, fatigue all within the first 48 hours. Then mental changes and forgetfulness, expressive dysphagia, tremors, numbness, and loss of feeling in extremities. Complete saturating night sweats and dizziness.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site nodule
Clinical narrative: Knot in thigh (right).
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 85-year-old female patient who received SHINGRIX for prophylaxis. On 10th July 2018, the patient received SHINGRIX. On 10th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, upset stomach, dizziness and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the upset stomach, dizziness and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain, upset stomach, dizziness and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm and instantly after receiving SHINGRIX the patient experienced pain in her left arm that lasted for a week. At the time of reporting, she still had intermittent pain in her arm. Less than a day after receiving SHINGRIX, the patient became sick on her stomach and was very dizzy. The pain in her arm prevented her from lifting up her left arm passed her waist. The reporter consented to follow up.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Dizziness, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 85-year-old female patient who received SHINGRIX for prophylaxis. On 10th July 2018, the patient received SHINGRIX. On 10th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, upset stomach, dizziness and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the upset stomach, dizziness and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain, upset stomach, dizziness and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm and instantly after receiving SHINGRIX the patient experienced pain in her left arm that lasted for a week. At the time of reporting, she still had intermittent pain in her arm. Less than a day after receiving SHINGRIX, the patient became sick on her stomach and was very dizzy. The pain in her arm prevented her from lifting up her left arm passed her waist. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 1st March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced fever, headache, myalgia, gastrointestinal upset, erythema of extremities, skin warm and swelling. On an unknown date, the outcome of the fever, headache, myalgia and gastrointestinal upset were recovered/resolved and the outcome of the erythema of extremities, skin warm and swelling were not recovered/not resolved. It was unknown if the reporter considered the fever, headache, myalgia, gastrointestinal upset, erythema of extremities, skin warm and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The pediatrician reported that she was the patient and received SHINGRIX and stated that over the weekend she experienced a fever of 102 degrees Fahrenheit, headache, myalgia, and gastrointestinal upset, all of which have resolved. The reporter continued that she was now 5 days since being vaccinated and she has a large local reaction described as big oval of redness that is contiguous, raised, warm to touch, approximately 12 cm in diameter on her left arm in the bicep area but more lateral stating it was below the deltoid of the injection site. The reporter states the local reaction was migrating down her arm, stating that every day she wakes up it was a bit closer to her hand. The reporter consented to follow up. The agent did confirm that consent to follow up was obtained since the reporter was the patient. The patient stated that she could be contacted by safety and provides cell phone number as alternative contact method as the number provided was her office line. Lab Comments: lab test performed on unknown date.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 1st March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced fever, headache, myalgia, gastrointestinal upset, erythema of extremities, skin warm and swelling. On an unknown date, the outcome of the fever, headache, myalgia and gastrointestinal upset were recovered/resolved and the outcome of the erythema of extremities, skin warm and swelling were not recovered/not resolved. It was unknown if the reporter considered the fever, headache, myalgia, gastrointestinal upset, erythema of extremities, skin warm and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The pediatrician reported that she was the patient and received SHINGRIX and stated that over the weekend she experienced a fever of 102 degrees Fahrenheit, headache, myalgia, and gastrointestinal upset, all of which have resolved. The reporter continued that she was now 5 days since being vaccinated and she has a large local reaction described as big oval of redness that is contiguous, raised, warm to touch, approximately 12 cm in diameter on her left arm in the bicep area but more lateral stating it was below the deltoid of the injection site. The reporter states the local reaction was migrating down her arm, stating that every day she wakes up it was a bit closer to her hand. The reporter consented to follow up. The agent did confirm that consent to follow up was obtained since the reporter was the patient. The patient stated that she could be contacted by safety and provides cell phone number as alternative contact method as the number provided was her office line. Lab Comments: lab test performed on unknown date.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Erythema, Headache, Local reaction, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 1st March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced fever, headache, myalgia, gastrointestinal upset, erythema of extremities, skin warm and swelling. On an unknown date, the outcome of the fever, headache, myalgia and gastrointestinal upset were recovered/resolved and the outcome of the erythema of extremities, skin warm and swelling were not recovered/not resolved. It was unknown if the reporter considered the fever, headache, myalgia, gastrointestinal upset, erythema of extremities, skin warm and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The pediatrician reported that she was the patient and received SHINGRIX and stated that over the weekend she experienced a fever of 102 degrees Fahrenheit, headache, myalgia, and gastrointestinal upset, all of which have resolved. The reporter continued that she was now 5 days since being vaccinated and she has a large local reaction described as big oval of redness that is contiguous, raised, warm to touch, approximately 12 cm in diameter on her left arm in the bicep area but more lateral stating it was below the deltoid of the injection site. The reporter states the local reaction was migrating down her arm, stating that every day she wakes up it was a bit closer to her hand. The reporter consented to follow up. The agent did confirm that consent to follow up was obtained since the reporter was the patient. The patient stated that she could be contacted by safety and provides cell phone number as alternative contact method as the number provided was her office line. Lab Comments: lab test performed on unknown date.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 1st March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced fever, headache, myalgia, gastrointestinal upset, erythema of extremities, skin warm and swelling. On an unknown date, the outcome of the fever, headache, myalgia and gastrointestinal upset were recovered/resolved and the outcome of the erythema of extremities, skin warm and swelling were not recovered/not resolved. It was unknown if the reporter considered the fever, headache, myalgia, gastrointestinal upset, erythema of extremities, skin warm and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The pediatrician reported that she was the patient and received SHINGRIX and stated that over the weekend she experienced a fever of 102 degrees Fahrenheit, headache, myalgia, and gastrointestinal upset, all of which have resolved. The reporter continued that she was now 5 days since being vaccinated and she has a large local reaction described as big oval of redness that is contiguous, raised, warm to touch, approximately 12 cm in diameter on her left arm in the bicep area but more lateral stating it was below the deltoid of the injection site. The reporter states the local reaction was migrating down her arm, stating that every day she wakes up it was a bit closer to her hand. The reporter consented to follow up. The agent did confirm that consent to follow up was obtained since the reporter was the patient. The patient stated that she could be contacted by safety and provides cell phone number as alternative contact method as the number provided was her office line. Lab Comments: lab test performed on unknown date.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Throat tightness, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 67-year-old male patient who received SHINGRIX (batch number 7X743, expiry date 22nd May 2021) for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, tremor, throat tightness, injection site discomfort and injection site swelling. On an unknown date, the outcome of the nausea, tremor and throat tightness were recovered/resolved and the outcome of the injection site discomfort and injection site swelling were unknown. It was unknown if the reporter considered the nausea, tremor, throat tightness, injection site discomfort and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The health care professional wanted see how to proceed with giving  the 2nd dose of SHINGRIX to the patient due to the 1st dose reaction. The patient experienced nausea, shaking severely and tightness in the throat, then laid down and stated was fine. The patient experienced normal swelling and discomfort at the site of injection.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discomfort, Injection site swelling, Nausea, Throat tightness, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 67-year-old male patient who received SHINGRIX (batch number 7X743, expiry date 22nd May 2021) for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, tremor, throat tightness, injection site discomfort and injection site swelling. On an unknown date, the outcome of the nausea, tremor and throat tightness were recovered/resolved and the outcome of the injection site discomfort and injection site swelling were unknown. It was unknown if the reporter considered the nausea, tremor, throat tightness, injection site discomfort and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The health care professional wanted see how to proceed with giving  the 2nd dose of SHINGRIX to the patient due to the 1st dose reaction. The patient experienced nausea, shaking severely and tightness in the throat, then laid down and stated was fine. The patient experienced normal swelling and discomfort at the site of injection.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Headache, Pyrexia, Sensory disturbance
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season). On 15th December 2018, the patient received the 2nd dose of SHINGRIX. On 15th December 2018, less than a day after receiving SHINGRIX, the patient experienced headache, fever and shivering. On an unknown date, the patient experienced abnormal physical sensation, cold sores, bumps tongue, bumps lip, loss of voice, tiredness, energy decreased, pallor and burning mouth syndrome. The patient was treated with TYLENOL, Magic Mouthwash, MYLANTA and Multivitamins. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, cold sores, shivering and burning mouth syndrome were unknown and the outcome of the fever, bumps tongue and bumps lip were recovered/resolved and the outcome of the abnormal physical sensation, loss of voice, tiredness, energy decreased and pallor were not recovered/not resolved. It was unknown if the reporter considered the headache, fever, abnormal physical sensation, cold sores, bumps tongue, bumps lip, loss of voice, tiredness, energy decreased, pallor, shivering and burning mouth syndrome to be related to SHINGRIX. Additional details were reported as follows: In the evening of 15th December 2018, the patient developed a torrid headache. The patient went to bed and developed shivering and a fever. The next morning her temperature was 101 degrees F and it increased to 102. The fever broke within 24 hours. Less than a year after vaccination, the patient experienced abnormal physical sensation, cold sores, bumps tongue, bumps lip, loss of voice, tiredness, energy decreased, pallor and burning mouth syndrome. The patient then developed what felt like cold sores in her mouth. The patient's dentist diagnosed her with burning mouth syndrome. The patient tongue and lips were covered with bumps. The bumps were gone at the time of reporting, but the normal sensation was not back till the time of reporting. The patient had now lost her voice since 2 weeks ago from the date of reporting. The patient was still tired, had low energy and was pale. The reporter consented to follow up. The patient had an appointment with a throat specialist at the time of reporting. For tolerance of 1st dose refer linked case US2019042337.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Aphonia, Asthenia, Burning mouth syndrome, Chills, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season). On 15th December 2018, the patient received the 2nd dose of SHINGRIX. On 15th December 2018, less than a day after receiving SHINGRIX, the patient experienced headache, fever and shivering. On an unknown date, the patient experienced abnormal physical sensation, cold sores, bumps tongue, bumps lip, loss of voice, tiredness, energy decreased, pallor and burning mouth syndrome. The patient was treated with TYLENOL, Magic Mouthwash, MYLANTA and Multivitamins. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, cold sores, shivering and burning mouth syndrome were unknown and the outcome of the fever, bumps tongue and bumps lip were recovered/resolved and the outcome of the abnormal physical sensation, loss of voice, tiredness, energy decreased and pallor were not recovered/not resolved. It was unknown if the reporter considered the headache, fever, abnormal physical sensation, cold sores, bumps tongue, bumps lip, loss of voice, tiredness, energy decreased, pallor, shivering and burning mouth syndrome to be related to SHINGRIX. Additional details were reported as follows: In the evening of 15th December 2018, the patient developed a torrid headache. The patient went to bed and developed shivering and a fever. The next morning her temperature was 101 degrees F and it increased to 102. The fever broke within 24 hours. Less than a year after vaccination, the patient experienced abnormal physical sensation, cold sores, bumps tongue, bumps lip, loss of voice, tiredness, energy decreased, pallor and burning mouth syndrome. The patient then developed what felt like cold sores in her mouth. The patient's dentist diagnosed her with burning mouth syndrome. The patient tongue and lips were covered with bumps. The bumps were gone at the time of reporting, but the normal sensation was not back till the time of reporting. The patient had now lost her voice since 2 weeks ago from the date of reporting. The patient was still tired, had low energy and was pale. The reporter consented to follow up. The patient had an appointment with a throat specialist at the time of reporting. For tolerance of 1st dose refer linked case US2019042337.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Headache, Lip disorder, Oral herpes, Pallor, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season). On 15th December 2018, the patient received the 2nd dose of SHINGRIX. On 15th December 2018, less than a day after receiving SHINGRIX, the patient experienced headache, fever and shivering. On an unknown date, the patient experienced abnormal physical sensation, cold sores, bumps tongue, bumps lip, loss of voice, tiredness, energy decreased, pallor and burning mouth syndrome. The patient was treated with TYLENOL, Magic Mouthwash, MYLANTA and Multivitamins. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, cold sores, shivering and burning mouth syndrome were unknown and the outcome of the fever, bumps tongue and bumps lip were recovered/resolved and the outcome of the abnormal physical sensation, loss of voice, tiredness, energy decreased and pallor were not recovered/not resolved. It was unknown if the reporter considered the headache, fever, abnormal physical sensation, cold sores, bumps tongue, bumps lip, loss of voice, tiredness, energy decreased, pallor, shivering and burning mouth syndrome to be related to SHINGRIX. Additional details were reported as follows: In the evening of 15th December 2018, the patient developed a torrid headache. The patient went to bed and developed shivering and a fever. The next morning her temperature was 101 degrees F and it increased to 102. The fever broke within 24 hours. Less than a year after vaccination, the patient experienced abnormal physical sensation, cold sores, bumps tongue, bumps lip, loss of voice, tiredness, energy decreased, pallor and burning mouth syndrome. The patient then developed what felt like cold sores in her mouth. The patient's dentist diagnosed her with burning mouth syndrome. The patient tongue and lips were covered with bumps. The bumps were gone at the time of reporting, but the normal sensation was not back till the time of reporting. The patient had now lost her voice since 2 weeks ago from the date of reporting. The patient was still tired, had low energy and was pale. The reporter consented to follow up. The patient had an appointment with a throat specialist at the time of reporting. For tolerance of 1st dose refer linked case US2019042337.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Sensory disturbance, Tongue disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season). On 15th December 2018, the patient received the 2nd dose of SHINGRIX. On 15th December 2018, less than a day after receiving SHINGRIX, the patient experienced headache, fever and shivering. On an unknown date, the patient experienced abnormal physical sensation, cold sores, bumps tongue, bumps lip, loss of voice, tiredness, energy decreased, pallor and burning mouth syndrome. The patient was treated with TYLENOL, Magic Mouthwash, MYLANTA and Multivitamins. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, cold sores, shivering and burning mouth syndrome were unknown and the outcome of the fever, bumps tongue and bumps lip were recovered/resolved and the outcome of the abnormal physical sensation, loss of voice, tiredness, energy decreased and pallor were not recovered/not resolved. It was unknown if the reporter considered the headache, fever, abnormal physical sensation, cold sores, bumps tongue, bumps lip, loss of voice, tiredness, energy decreased, pallor, shivering and burning mouth syndrome to be related to SHINGRIX. Additional details were reported as follows: In the evening of 15th December 2018, the patient developed a torrid headache. The patient went to bed and developed shivering and a fever. The next morning her temperature was 101 degrees F and it increased to 102. The fever broke within 24 hours. Less than a year after vaccination, the patient experienced abnormal physical sensation, cold sores, bumps tongue, bumps lip, loss of voice, tiredness, energy decreased, pallor and burning mouth syndrome. The patient then developed what felt like cold sores in her mouth. The patient's dentist diagnosed her with burning mouth syndrome. The patient tongue and lips were covered with bumps. The bumps were gone at the time of reporting, but the normal sensation was not back till the time of reporting. The patient had now lost her voice since 2 weeks ago from the date of reporting. The patient was still tired, had low energy and was pale. The reporter consented to follow up. The patient had an appointment with a throat specialist at the time of reporting. For tolerance of 1st dose refer linked case US2019042337.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Anaemia, Aspiration bone marrow, Blood test, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Hospitalization, sever staphylococcus, MRSA, anemia, fever for over 80 days.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Sedation, Staphylococcal infection, Transfusion
Clinical narrative: Hospitalization, sever staphylococcus, MRSA, anemia, fever for over 80 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Extreme fatigue, muscle and joint pain, headache, nausea, pain at injection site, extreme chills. On 3/15/2019 ..I woke up with a rash all over the upper part of my arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Nausea, Rash
Clinical narrative: Extreme fatigue, muscle and joint pain, headache, nausea, pain at injection site, extreme chills. On 3/15/2019 ..I woke up with a rash all over the upper part of my arm.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 14-FEB-2019, the patient inadvertently received a dose of expired M-M-R II (lot # N002337 with expiry date of 20-JAN-2019; dose, frequency and route were unknown) for prophylaxis (expired product administered). No adverse effects were reported.
Age: 57.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse referring to a 57 years old patient of unknown gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided. On 14-FEB-2019, the patient was administered a dose of VAQTA (lot # R025518, expiration date was 15-NOV-2019; strength, dose and route were not reported) for prophylaxis. The VAQTA was too long in transit and deemed not viable by their distributor (Poor quality product administered). No adverse effects were reported. The call was not because of a "data logger" as this was a shipping issue.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient with unknown age and gender. The patient's concomitant drug included sterile diluent. The patient's pertinent medical history, drug reactions or allergies were not reported. On 18-FEB-2019, the patient inadvertently received an expired dose of M-M-R II (lot number: M047302; expiration date: 30-NOV-2018; dose, route were not reported) for prophylaxis. No adverse effects reported.
Age: 23.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: No adverse event, Product storage error, Wrong product administered
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 23 years old female patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided. On 22-FEB-2019 the patient inadvertently received a dose of ZOSTAVAX (lot # R031825, expiration date: 13-JUN-2019, dose details, strength and frequency were unknown) instead of VARIVAX subcutaneous for prophylaxis (wrong product administered). The patient also received a dose of M-M-R II (lot #: N008365, expiration date: 13-MAR-2019, dose details, strength and frequency were unknown) during the same office visit. Both vaccines had experienced a temperature excursion of 82.4 degrees Fahrenheit for 4 hours 30 minutes (product storage error). There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported in the patient.
Age: 39.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 39 years old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided. On 01-MAR-2019, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB lot# M046373 with expiration date was reported as 04-NOV-2018, intramuscular in the left deltoid (dose detail was not reported) for prophylaxis (expired vaccine used). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Drug hypersensitivity
Clinical narrative: This spontaneous report was received from a health professional via Pfizer refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, units, frequency, lot# and expiration date unknown) for prophylaxis. On an unknown date the patient experienced drug hypersensitivity. The outcome of drug hypersensitivity was unknown. The reporter considered drug hypersensitivity to be related to M-M-R II.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Encephalitis autoimmune, Failure to thrive, Malaise, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection
Clinical narrative: This spontaneous report was received from the patient's mother referring to her daughter, currently approximately 10 years old female patient. Concurrent conditions included methylenetetrahydrofolate reductase (MTHFR) gene mutation, gluten sensitive and milk allergy. The patient had no drug allergies. Information about concomitant medication and medical history was not provided. On an unknown date (reported as in infancy), the patient was vaccinated with M-M-R II series (strength, dose, route, lot # and expiration date were not reported) which was reconstituted with sterile diluent (STERILE DILUENT) for prophylaxis. On unknown date in the child stage (also reported as toddler stage (15 to 18 months)), the patient began experiencing failure to thrive and was treated with cyproheptadine hydrochloride(PERIACTIN). It was also reported on an unknown date when the patient was a toddler, she developed paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDA) or autoimmune encephalitis. The reporter stated the condition was not well known at that time, so the patient did see unspecified specialist for unspecified treatment and testing. On an unknown date, patient received PREVNAR 13 and it failed, meaning titers came back negative. The patient kept being sick with high fever that healthcare team stated was viral, so her parents provided comfort treatment like ibuprofen (ADVIL). On an unknown date, the patient did received therapy with montelukast sodium(SINGULAIR) tablet (strength, dose, frequency, lot # and expiration date were not reported) orally for an unknown indication. Action taken with sterile diluent (STERILE DILUENT) and montelukast sodium (SINGULAIR) was unknown. The outcome of failure to thrive, PANDA, autoimmune encephalitis, titers negative, being sick and high fever was reported as recovering. The causality was not reported. Upon internal review, the events failure to thrive and autoimmune encephalitis were determined to be medically significant.
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from the patient's mother referring to her daughter, currently approximately 10 years old female patient. Concurrent conditions included methylenetetrahydrofolate reductase (MTHFR) gene mutation, gluten sensitive and milk allergy. The patient had no drug allergies. Information about concomitant medication and medical history was not provided. On an unknown date (reported as in infancy), the patient was vaccinated with M-M-R II series (strength, dose, route, lot # and expiration date were not reported) which was reconstituted with sterile diluent (STERILE DILUENT) for prophylaxis. On unknown date in the child stage (also reported as toddler stage (15 to 18 months)), the patient began experiencing failure to thrive and was treated with cyproheptadine hydrochloride(PERIACTIN). It was also reported on an unknown date when the patient was a toddler, she developed paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDA) or autoimmune encephalitis. The reporter stated the condition was not well known at that time, so the patient did see unspecified specialist for unspecified treatment and testing. On an unknown date, patient received PREVNAR 13 and it failed, meaning titers came back negative. The patient kept being sick with high fever that healthcare team stated was viral, so her parents provided comfort treatment like ibuprofen (ADVIL). On an unknown date, the patient did received therapy with montelukast sodium(SINGULAIR) tablet (strength, dose, frequency, lot # and expiration date were not reported) orally for an unknown indication. Action taken with sterile diluent (STERILE DILUENT) and montelukast sodium (SINGULAIR) was unknown. The outcome of failure to thrive, PANDA, autoimmune encephalitis, titers negative, being sick and high fever was reported as recovering. The causality was not reported. Upon internal review, the events failure to thrive and autoimmune encephalitis were determined to be medically significant.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-DEC-2010, the patient, at 65 years old, was administered the ZOSTAVAX by a healthcare provider at a medical clinic (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at a medical clinic for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to self, loss of consortium, loss of services and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 13-MAR-2019, the patient was vaccinated with an expired ROTATEQ lot # N030364 with expiration date on 06-MAR-2019, orally for prophylaxis (dose was not reported). However, no adverse effects were reported.