chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related conditions. In January 2017, the patient was treated by a Nurse Practitioner for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 16-DEC-2015, a pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related conditions. In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 17-DEC-2008, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related conditions. On or about 09-JAN-2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2017, a healthcare provider at a healthcare facility administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider (at an eye surgery and laser center/surgical center)(treatment not further specified) for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the zoster vaccine live (ZOSTAVAX) vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 28-SEP-2016, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 01-DEC-2016, the patient was treated by a physician/MD at medical office for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-DEC-2018, the patient was vaccinated with M-M-R II, for prophylaxis (dose, lot number and expiration date were not reported). The reporter stated that the vaccine was accidentally administered intramuscularly instead of subcutaneously (incorrect route of product administration).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In September 2016, a healthcare provider at a medical center administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 24-DEC-2016, the patient was treated by a healthcare provider at the same medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dehydration, Dizziness
Clinical narrative: Dizzy, dehydrated.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Aggression, Emotional distress, Pyrexia
Clinical narrative: Says had fever as high as 102. 10 days after injection and developed temper tantrums and not consolable.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Arm was a little sore shortly after having received the shot, but soreness increased over time. As of 12/18/18, her arm was still sore and couldn't raise her left arm as high as she used to. She refused to get the second shot due to the soreness.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Pain
Clinical narrative: Redness/rash/warmth from just below the injection site down to the elbow. No fever. Some soreness.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Pain, Pyrexia
Clinical narrative: Patient returned to clinic on 12/14/2018 for c/o redness, pain and subjective fever X 3 days.  Patient was diagnosed with cellulitis and was prescribed cephalexin 500 mg BID X 10 days and ibuprofen 600 mg TID prn fever/pain. Patient's condition worsened overnight and was advised to go to nearest emergency department.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Insomnia, Pain in extremity
Clinical narrative: A lot of pain when shot given and it only increased. Also heat and a little raised area all the way to the elbow. Today the heat is still there and raised area not as bad. She could not sleep on that arm for the first few days due to the pain.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Headache
Clinical narrative: Patient reported he had the "worst headache" of his life after receiving pneumonia shot.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Strong flu-like symptoms. Chills, fever, body ache, nausea. Not responsive to 1000 mg TYLENOL.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Dermatitis diaper, Diarrhoea
Clinical narrative: Diarrhea x1 week since administration resulting in diaper rash. Probiotic and Diaper cream prescribed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Sore arm, headache and muscle aches beginning the evening of the vaccination; next day chills, headache and muscle aches, still sore arm, slight nausea.
Age: 58.0
Sex: M
Vaccine: HEPA
Symptoms: Seizure
Clinical narrative: AFTER RECEIVED VACCINATION, PATIENT DEVELOPED CONVULSION ONLY LEFT SIDE OF BODY. HOWEVER DURING THE ENTIRE EPISODE PATIENT REMAIN CONSCIOUSNESS, ORIENTED TO DATE, PLACE.
Age: 55.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Red swelling of left arm, hot to the touch, ran fever of 101.4, body aches. Received TORADOL in the right hip from Med stop on 12/14/2018. Steroid shot in right arm on 12/16/2018 from Medical Center. Also received Amox-clav 500mg. On the same day I received the Pneumonia shot, I got the Flu shot lot number EB7J7, Glaxo Smith Kline. Flu shot site was clear.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Abnormal behaviour, Aggression, Anger, Condition aggravated, Injection site erythema
Clinical narrative: Patient got the flu shot at around 11am on 12/17/18. By 130pm he was having terrible behavior changes. (He does have preexisting behavior diagnosis that he takes medicine for) we were at a restaurant and he was trying to put a toy together and became so enraged that he threw it down. I threw it away then he proceeded to go into a rage biting me hitting and kicking me trying to throw the chair and table slapped my phone out of my hand. This behavior is not normal for him and prior to this he had an almost perfect day. Then the next day he is fine normal and happy and all the sudden starts raging and body slamming his back pack on the couch .. after it was over he was calm and normal. These events are not his normal behavior. Also on 12/18/18 I noticed a large red hot area on his right arm where he got the flu shot. Up until now I am pretty sure he has always had the preservative free prefilled syringes but this one was not it was in a regular syringe. I am unsure of the make or lot number or anything.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site warmth
Clinical narrative: Patient got the flu shot at around 11am on 12/17/18. By 130pm he was having terrible behavior changes. (He does have preexisting behavior diagnosis that he takes medicine for) we were at a restaurant and he was trying to put a toy together and became so enraged that he threw it down. I threw it away then he proceeded to go into a rage biting me hitting and kicking me trying to throw the chair and table slapped my phone out of my hand. This behavior is not normal for him and prior to this he had an almost perfect day. Then the next day he is fine normal and happy and all the sudden starts raging and body slamming his back pack on the couch .. after it was over he was calm and normal. These events are not his normal behavior. Also on 12/18/18 I noticed a large red hot area on his right arm where he got the flu shot. Up until now I am pretty sure he has always had the preservative free prefilled syringes but this one was not it was in a regular syringe. I am unsure of the make or lot number or anything.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Heated rash with itching developed on arm around the injection site about 2 inches in diameter and had a fever of about 101. Patient took ibuprofen for the fever and temperature returned to normal the next day. Patient also used cortizone cream for the itch.
Age: 65.0
Sex: F
Vaccine: YF
Symptoms: Headache, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Very strong flu like symptoms including fever, body aches, head ache, and slight nausea.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Blood pressure increased, Hyperhidrosis, Painful respiration, Pallor
Clinical narrative: Patient was pale, sweating, stated that she was experiencing back pain, she was having discomfort when breathing, but not difficulty breathing. Blood pressure was 135/72, patient stated that was slight higher than normal. Patient rested in the pharmacy for 10 minutes than stated she felt fine. Patient declined any emergency type of service.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dizziness, Dyspnoea, Dysstasia, Gait inability
Clinical narrative: Body ache fever severe headache shortness of breath arm back and chest pain dizziness nausea Unable to stand or walk more than a few steps
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Body ache fever severe headache shortness of breath arm back and chest pain dizziness nausea Unable to stand or walk more than a few steps
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Middle insomnia
Clinical narrative: Patient states that she woke up in the middle of the night and was shivering and had chills and upon waking up she noticed a blister near her eye.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Fever 101.1, severe headache, malaise, myalgias, severe pain at injection site, moderate redness and induration and warmth at injection site extending.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Fever 101.1, severe headache, malaise, myalgias, severe pain at injection site, moderate redness and induration and warmth at injection site extending.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Skin warm
Clinical narrative: PATIENT PRESENTED WITH A CELLULITIS TYPE RASH (RED AND CIRCULAR) ON 12/18/2018--PATIENT STATED DOES NOT ITCH OR HURT- SLIGHT WARMTH TO THE TOUCH--PATIENT WAS ALARMED BY THE RASH LASTING AND GETTING BIGGER.
Age: 63.0
Sex: M
Vaccine: FLU3, TDAP, VARZOS
Symptoms: CSF test abnormal, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram abnormal, Facial paralysis, Facial paresis
Clinical narrative: Patient developed chronic inflammatory demyelinating polyneuropathy. The first symptom of this condition was right Bell's palsy (right facial weakness) that started on 3/10/2017.
Age: 63.0
Sex: M
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Nerve conduction studies abnormal
Clinical narrative: Patient developed chronic inflammatory demyelinating polyneuropathy. The first symptom of this condition was right Bell's palsy (right facial weakness) that started on 3/10/2017.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Erythema, Local reaction, Secretion discharge, Swelling
Clinical narrative: Large local reaction with redness and swelling as well as blistering and serous oozing.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cough, Febrile convulsion, Throat irritation, Tic, Underdose
Clinical narrative: Dtap on 8/23/18 is only 1/4 dose as family history severe rxn to Td and Dtap. Mom understands that this will not "count". 8/23 1/4 dose dtap, 8/24 noticed throat clearing/cough tic with facial tic, several times per day, lasted 3 weeks, then tapered off. Also had febrile seizure on 12/2/18 (first one) but doubt that is related.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: PATIENT HAS HAD HISTORY OF FAINTING IN THE PAST FROM MEDICAL PROCEDURES, INCLUDING VACCINATIONS. PATIENT SEEMED OK AFTER VACCINE, WAS ADVISED TO SIT FOR A WHILE, BEFORE COMING BACK TO PHARMACY/WORK (PT IS A PHARMACY TECHNICIAN) SHE RETURNED AFTER ABOUT 5 MINUTES, AND SEEMED OK. WAS TALKING AND SMILING, AND THEN ABOUT 5 MINUTES LATER SAID SHE WAS FEELING WOOZY. SHE WAS ADVISED TO SIT DOWN AGAIN, BUT WHILE SHE WAS IN PROCESS OF SITTING DOWN, SHE PASSED OUT VERY BRIEFLY... JUST FOR A FEW SECONDS. A SECOND PHARMACY TECHNICIAN CAUGHT HER ON HER WAY DOWN, AVOIDING ANY INJURY TO VACCINATED TECHNICIAN.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: CSF test normal, Guillain-Barre syndrome, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: AIDP (Guillain-Barre) shortly after influenza vaccine. N.B. Do NOT know the exact influenza shot type -- just picked the first option on drop down menu.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Shoulder injury related to vaccine administration, Sleep disorder
Clinical narrative: Pt thought this vaccine was administered much higher than other flu vaccines that she had received in the past. Two days after the vaccine she reported that her arm hurt really bad, especially at the joint. The pain was so bad that it prevented her from getting a full nights sleep for awhile. She went to her Dr. who diagnosed her with SIRVA (shoulder injury related to vaccine administration). She was referred to a physical therapist and states that she has been getting better since PT.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema
Clinical narrative: Patient's face turned red after receiving vaccination. She had trouble breathing and asked for a BENADRYL. She was given an epinephrine shot and immediately felt better.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Musculoskeletal disorder, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Patient began to become paralyzed on Mon, Nov 5th. He was diagnosed with acute inflammatory demyelinating neuropathy (AIPD), a form of Guillain Barre Syndrome. He spent three weeks in the hospital. He is currently undergoing PT to regain full use of his legs.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm pain, redness, swelling. Went to ED, had cellulitis arm unknown, tried to call patient to verify.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Aspartate aminotransferase increased, Blood bilirubin normal, Blood creatinine normal, Blood glucose normal, Blood lactic acid normal
Clinical narrative: After coming to clinic in stable state on 11/23 and receiving flu vaccine, she went home and prior to making any of the minor adjustments planned to her LANTUS, levothyroxine and Buspirone, she went to bed and reportedly did not get up for 8 days. Family did witness her going to the bathroom, eating, taking medications. Patients recollection of the day symptoms started is fuzzy (doesn't remember coming to my office, thinks she went for an MRI) and she does not recall many details from her week in bed. Family report that she was not unconscious and would respond to them if the spoke to her but resisted their attempts to get her up or to have her eat. She was taken to the ER on 12/1 where she had unremarkable work up but was offered admission which she declined. Since returning home, she continues to be fatigues and desire to spend most of her time in bed. She took her medication on 12/2 but not on 12/3. She has eaten some at urging of family. She has exhibited confusion regarding how to operate a TV remote and her computer. At the time of her visit with me on 12/4, she was speaking slowly in response to questions as if she had a delay processing the question and formulating the answers. She did not have any other significant neurologic findings, and the rest of her exam was benign. I have diagnosed her with encephalopathy.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Blood thyroid stimulating hormone increased, Blood urea increased, Carbon dioxide decreased, Chest X-ray normal, Cholelithiasis
Clinical narrative: After coming to clinic in stable state on 11/23 and receiving flu vaccine, she went home and prior to making any of the minor adjustments planned to her LANTUS, levothyroxine and Buspirone, she went to bed and reportedly did not get up for 8 days. Family did witness her going to the bathroom, eating, taking medications. Patients recollection of the day symptoms started is fuzzy (doesn't remember coming to my office, thinks she went for an MRI) and she does not recall many details from her week in bed. Family report that she was not unconscious and would respond to them if the spoke to her but resisted their attempts to get her up or to have her eat. She was taken to the ER on 12/1 where she had unremarkable work up but was offered admission which she declined. Since returning home, she continues to be fatigues and desire to spend most of her time in bed. She took her medication on 12/2 but not on 12/3. She has eaten some at urging of family. She has exhibited confusion regarding how to operate a TV remote and her computer. At the time of her visit with me on 12/4, she was speaking slowly in response to questions as if she had a delay processing the question and formulating the answers. She did not have any other significant neurologic findings, and the rest of her exam was benign. I have diagnosed her with encephalopathy.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram head normal, Computerised tomogram pelvis abnormal, Confusional state, Encephalopathy
Clinical narrative: After coming to clinic in stable state on 11/23 and receiving flu vaccine, she went home and prior to making any of the minor adjustments planned to her LANTUS, levothyroxine and Buspirone, she went to bed and reportedly did not get up for 8 days. Family did witness her going to the bathroom, eating, taking medications. Patients recollection of the day symptoms started is fuzzy (doesn't remember coming to my office, thinks she went for an MRI) and she does not recall many details from her week in bed. Family report that she was not unconscious and would respond to them if the spoke to her but resisted their attempts to get her up or to have her eat. She was taken to the ER on 12/1 where she had unremarkable work up but was offered admission which she declined. Since returning home, she continues to be fatigues and desire to spend most of her time in bed. She took her medication on 12/2 but not on 12/3. She has eaten some at urging of family. She has exhibited confusion regarding how to operate a TV remote and her computer. At the time of her visit with me on 12/4, she was speaking slowly in response to questions as if she had a delay processing the question and formulating the answers. She did not have any other significant neurologic findings, and the rest of her exam was benign. I have diagnosed her with encephalopathy.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Full blood count normal, Glycosylated haemoglobin increased, Hepatic steatosis, Lipase normal
Clinical narrative: After coming to clinic in stable state on 11/23 and receiving flu vaccine, she went home and prior to making any of the minor adjustments planned to her LANTUS, levothyroxine and Buspirone, she went to bed and reportedly did not get up for 8 days. Family did witness her going to the bathroom, eating, taking medications. Patients recollection of the day symptoms started is fuzzy (doesn't remember coming to my office, thinks she went for an MRI) and she does not recall many details from her week in bed. Family report that she was not unconscious and would respond to them if the spoke to her but resisted their attempts to get her up or to have her eat. She was taken to the ER on 12/1 where she had unremarkable work up but was offered admission which she declined. Since returning home, she continues to be fatigues and desire to spend most of her time in bed. She took her medication on 12/2 but not on 12/3. She has eaten some at urging of family. She has exhibited confusion regarding how to operate a TV remote and her computer. At the time of her visit with me on 12/4, she was speaking slowly in response to questions as if she had a delay processing the question and formulating the answers. She did not have any other significant neurologic findings, and the rest of her exam was benign. I have diagnosed her with encephalopathy.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Metabolic function test normal, Mobility decreased, Red cell distribution width increased, Scan with contrast abnormal
Clinical narrative: After coming to clinic in stable state on 11/23 and receiving flu vaccine, she went home and prior to making any of the minor adjustments planned to her LANTUS, levothyroxine and Buspirone, she went to bed and reportedly did not get up for 8 days. Family did witness her going to the bathroom, eating, taking medications. Patients recollection of the day symptoms started is fuzzy (doesn't remember coming to my office, thinks she went for an MRI) and she does not recall many details from her week in bed. Family report that she was not unconscious and would respond to them if the spoke to her but resisted their attempts to get her up or to have her eat. She was taken to the ER on 12/1 where she had unremarkable work up but was offered admission which she declined. Since returning home, she continues to be fatigues and desire to spend most of her time in bed. She took her medication on 12/2 but not on 12/3. She has eaten some at urging of family. She has exhibited confusion regarding how to operate a TV remote and her computer. At the time of her visit with me on 12/4, she was speaking slowly in response to questions as if she had a delay processing the question and formulating the answers. She did not have any other significant neurologic findings, and the rest of her exam was benign. I have diagnosed her with encephalopathy.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Slow response to stimuli, Speech disorder, Troponin normal, Unresponsive to stimuli, Urine analysis normal
Clinical narrative: After coming to clinic in stable state on 11/23 and receiving flu vaccine, she went home and prior to making any of the minor adjustments planned to her LANTUS, levothyroxine and Buspirone, she went to bed and reportedly did not get up for 8 days. Family did witness her going to the bathroom, eating, taking medications. Patients recollection of the day symptoms started is fuzzy (doesn't remember coming to my office, thinks she went for an MRI) and she does not recall many details from her week in bed. Family report that she was not unconscious and would respond to them if the spoke to her but resisted their attempts to get her up or to have her eat. She was taken to the ER on 12/1 where she had unremarkable work up but was offered admission which she declined. Since returning home, she continues to be fatigues and desire to spend most of her time in bed. She took her medication on 12/2 but not on 12/3. She has eaten some at urging of family. She has exhibited confusion regarding how to operate a TV remote and her computer. At the time of her visit with me on 12/4, she was speaking slowly in response to questions as if she had a delay processing the question and formulating the answers. She did not have any other significant neurologic findings, and the rest of her exam was benign. I have diagnosed her with encephalopathy.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Urine ketone body present, Varices oesophageal
Clinical narrative: After coming to clinic in stable state on 11/23 and receiving flu vaccine, she went home and prior to making any of the minor adjustments planned to her LANTUS, levothyroxine and Buspirone, she went to bed and reportedly did not get up for 8 days. Family did witness her going to the bathroom, eating, taking medications. Patients recollection of the day symptoms started is fuzzy (doesn't remember coming to my office, thinks she went for an MRI) and she does not recall many details from her week in bed. Family report that she was not unconscious and would respond to them if the spoke to her but resisted their attempts to get her up or to have her eat. She was taken to the ER on 12/1 where she had unremarkable work up but was offered admission which she declined. Since returning home, she continues to be fatigues and desire to spend most of her time in bed. She took her medication on 12/2 but not on 12/3. She has eaten some at urging of family. She has exhibited confusion regarding how to operate a TV remote and her computer. At the time of her visit with me on 12/4, she was speaking slowly in response to questions as if she had a delay processing the question and formulating the answers. She did not have any other significant neurologic findings, and the rest of her exam was benign. I have diagnosed her with encephalopathy.
Age: 1.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Febrile convulsion, Pyrexia, Staring
Clinical narrative: 5 days after PROQUAD developed fever and staring out. Paramedics called and dx "febrile seizure" possibly. They directed her to the ER but because child recovered she did not go.
Age: 3.0
Sex: M
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Gait inability, Heart rate increased, Infection, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report was received from a consumer concerning to her son, an approximately 3-year-old, male patient, with none drug reactions or allergies. The patient's medical history reporter by the mother included seems to pick up infection to easily and quickly (infection susceptibility increased). The concurrent condition was not provided. The concomitant therapies were reported as none. Additionally, the reporter mentioned  that the patient was given with a dose of PREVNAR 13,  "within the last year", on an unspecified date approximately in 2017, and it was reported that a titer test done for pneumococal antibodies  after the patient was given PREVNAR 13 and before the patient was given PNEUMOVAX 23.The patient had also been given an unspecified diphtheria vaccine at an unspecified time, and a titer test  done for diphtheria antibodies after the unspecified diphtheria vaccine was given was also negative. On 16-NOV-2018 the patient was vaccinated with PNEUMOVAX 23 injection, 0.5 milliliter, once, indicated to prevent pneumococcal disease (lot #, expiration date and route of administration were not provided). Other suspect include an unspecified flu vaccine (lot #, expiration date and route of administration were not provided) both administered in the same leg. On the same date, 3 and half hour later, the consumer reported that the patient was unable to walk (gait inability) and his legs hurt too much (pain in extremity). The mother brought the patient to the physician office.  After the visit, the patient was brought to the emergency room because he experienced fever of 104.3 (units not provided) and rapid heartbeat, he was admitted in the hospital, from 17-NOV-2018 to19-NOV-2018. A blood work done at the hospital showed inflammation and it was suspected that the patient had an infection (infection). Also, a x-tray, ultrasound and magnetic resonance imaging (MRI) were performed and the data was not showed. At the time of the result the causality assessment between PNEUMOVAX 23 injection and the adverse events was not reported.
Age: 3.0
Sex: M
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Gait inability, Heart rate increased, Infection, Inflammation, Inflammatory marker increased
Clinical narrative: This spontaneous report was received from a consumer concerning to her son, an approximately 3-year-old, male patient, with none drug reactions or allergies. The patient's medical history reporter by the mother included seems to pick up infection to easily and quickly (infection susceptibility increased). The concurrent condition was not provided. The concomitant therapies were reported as none. Additionally, the reporter mentioned  that the patient was given with a dose of PREVNAR 13,  "within the last year", on an unspecified date approximately in 2017, and it was reported that a titer test done for pneumococal antibodies  after the patient was given PREVNAR 13 and before the patient was given PNEUMOVAX 23.The patient had also been given an unspecified diphtheria vaccine at an unspecified time, and a titer test  done for diphtheria antibodies after the unspecified diphtheria vaccine was given was also negative. On 16-NOV-2018 the patient was vaccinated with PNEUMOVAX 23 injection, 0.5 milliliter, once, indicated to prevent pneumococcal disease (lot #, expiration date and route of administration were not provided). Other suspect include an unspecified flu vaccine (lot #, expiration date and route of administration were not provided) both administered in the same leg. On the same date, 3 and half hour later, the consumer reported that the patient was unable to walk (gait inability) and his legs hurt too much (pain in extremity). The mother brought the patient to the physician office.  After the visit, the patient was brought to the emergency room because he experienced fever of 104.3 (units not provided) and rapid heartbeat, he was admitted in the hospital, from 17-NOV-2018 to19-NOV-2018. A blood work done at the hospital showed inflammation and it was suspected that the patient had an infection (infection). Also, a x-tray, ultrasound and magnetic resonance imaging (MRI) were performed and the data was not showed. At the time of the result the causality assessment between PNEUMOVAX 23 injection and the adverse events was not reported.
Age: 3.0
Sex: M
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Pyrexia, Ultrasound scan, X-ray
Clinical narrative: This spontaneous report was received from a consumer concerning to her son, an approximately 3-year-old, male patient, with none drug reactions or allergies. The patient's medical history reporter by the mother included seems to pick up infection to easily and quickly (infection susceptibility increased). The concurrent condition was not provided. The concomitant therapies were reported as none. Additionally, the reporter mentioned  that the patient was given with a dose of PREVNAR 13,  "within the last year", on an unspecified date approximately in 2017, and it was reported that a titer test done for pneumococal antibodies  after the patient was given PREVNAR 13 and before the patient was given PNEUMOVAX 23.The patient had also been given an unspecified diphtheria vaccine at an unspecified time, and a titer test  done for diphtheria antibodies after the unspecified diphtheria vaccine was given was also negative. On 16-NOV-2018 the patient was vaccinated with PNEUMOVAX 23 injection, 0.5 milliliter, once, indicated to prevent pneumococcal disease (lot #, expiration date and route of administration were not provided). Other suspect include an unspecified flu vaccine (lot #, expiration date and route of administration were not provided) both administered in the same leg. On the same date, 3 and half hour later, the consumer reported that the patient was unable to walk (gait inability) and his legs hurt too much (pain in extremity). The mother brought the patient to the physician office.  After the visit, the patient was brought to the emergency room because he experienced fever of 104.3 (units not provided) and rapid heartbeat, he was admitted in the hospital, from 17-NOV-2018 to19-NOV-2018. A blood work done at the hospital showed inflammation and it was suspected that the patient had an infection (infection). Also, a x-tray, ultrasound and magnetic resonance imaging (MRI) were performed and the data was not showed. At the time of the result the causality assessment between PNEUMOVAX 23 injection and the adverse events was not reported.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Induration, Mass, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain and flu vaccine with an associated reaction of injection site pain (for tolerance refer case US2018GSK228829).  On 4th December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, erythema of extremities, injection site swelling, injection site cellulitis, injection site joint pain and pain in arm. On an unknown date, the patient experienced injection site irritation. The patient was treated with clindamycin. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site warmth, erythema of extremities, injection site irritation, injection site swelling, injection site cellulitis, injection site joint pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, erythema of extremities, injection site irritation, injection site swelling, injection site cellulitis, injection site joint pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient had a dose of SHINGRIX vaccine on her right shoulder. The nurse might have gone too high on her shoulder she said because it was very painful and worse than the first.  It became hot, red, irritated and by the 6th, she took a picture. The patient shoulder was as big as a tennis ball. She went to visit the physician who prescribed clindamycin 300mg four times daily if the site did not calm down. On 7th December 2018, the patient started taking clindamycin on afternoon. The patient suspected she had cellulitis. On the date of reporting the redness was lessened but the redness might spread down her arm a bit. Her bicep on her right arm was swollen and hurts all over at the time of reporting. The reporter gave consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain and flu vaccine with an associated reaction of injection site pain (for tolerance refer case US2018GSK228829).  On 4th December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, erythema of extremities, injection site swelling, injection site cellulitis, injection site joint pain and pain in arm. On an unknown date, the patient experienced injection site irritation. The patient was treated with clindamycin. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site warmth, erythema of extremities, injection site irritation, injection site swelling, injection site cellulitis, injection site joint pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, erythema of extremities, injection site irritation, injection site swelling, injection site cellulitis, injection site joint pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient had a dose of SHINGRIX vaccine on her right shoulder. The nurse might have gone too high on her shoulder she said because it was very painful and worse than the first.  It became hot, red, irritated and by the 6th, she took a picture. The patient shoulder was as big as a tennis ball. She went to visit the physician who prescribed clindamycin 300mg four times daily if the site did not calm down. On 7th December 2018, the patient started taking clindamycin on afternoon. The patient suspected she had cellulitis. On the date of reporting the redness was lessened but the redness might spread down her arm a bit. Her bicep on her right arm was swollen and hurts all over at the time of reporting. The reporter gave consent to follow up.