chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2011, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a physician, for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On 02-APR-2016, the patient was treated at an urgent care and primary care facility, for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster. During 2016, the patient was treated at physician office for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Allergy test negative, Autism spectrum disorder, Blood test normal, Cytogenetic analysis normal
Clinical narrative: Patient contracted Autism Spectrum Disorder.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at injection site. Difficulty lift arm 5 days after injection was administered.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Headache
Clinical narrative: Headache persisting longer than 2 weeks that started on the same day of vaccination.
Age: 40.0
Sex: M
Vaccine: ANTH, MMR, MNQ, TYP
Symptoms: Chest discomfort, Electrocardiogram ST-T change, Fatigue, Myalgia
Clinical narrative: Fatigue, myalgias, chest tightness (early repol on ECG, possible mild ST-T changes).
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: PER MOM: THE SITE IS RED, HOT, AND HARD. PER MD: MOM WAS INSTRUCTED TO APPLY WARM COMPRESSES AND GIVE MOTRIN FOR DISCOMFORT. FOLLOW UP IF DEVELOPS FEVER OR STREAKING.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: C/O pain in middle of arm well below the injection site. C/O pain in arm continuous since administration. No other symptoms. No treatment given. Patient did not seek treatment and did not report until today 3-13-18.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: C/O pain in middle left arm since getting the vaccine back in October, no other symptoms. No treatment, did not report until today 3-13-18.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Asthenia, Fatigue, Myalgia
Clinical narrative: The patient stated on Thursday 3/8/18, that she had bad muscle pain, weakness, and fatigue that lasted about 2 to 3 weeks after her flu shot. She specifically kept referring to the flu shot and not the other shots for some reason. She has fully recovered. I do not know if there was medical treatment for this.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness unilateral, Double stranded DNA antibody positive, Eye pain, HLA-B*27 positive, Impaired work ability
Clinical narrative: Lost vision in left eye for 1 month. I had extreme pain of which I had to take pain medication, several eye drops and oral prednisone. Missed 1 month of work as a registered nurse and filed for state disability at that time. Saw several doctors. After extensive testing, they concluded I am HLAB-27 Positive. This test result coincides with paneuveitis which is what I had. The doctors dismissed that this reaction was related to a flu vaccine.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Uveitis
Clinical narrative: Lost vision in left eye for 1 month. I had extreme pain of which I had to take pain medication, several eye drops and oral prednisone. Missed 1 month of work as a registered nurse and filed for state disability at that time. Saw several doctors. After extensive testing, they concluded I am HLAB-27 Positive. This test result coincides with paneuveitis which is what I had. The doctors dismissed that this reaction was related to a flu vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle aches, fever, shivering, dizziness, fatigue worst within the first 24 hours. Persisted through 3 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Headache, muscle aches, fever, shivering, dizziness, fatigue worst within the first 24 hours. Persisted through 3 days.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site mass, Injection site warmth
Clinical narrative: Patient called pharmacy 3/12/18 to report a hard red lump at injection site that felt warm to the touch. She treated with ice. She sought medical attention on 3/13/2018 where she was diagnosed with injection site infection and sinus infection and received two antibiotics: AUGMENTIN 875 with a booster of amoxicillin 875mg.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Sinusitis
Clinical narrative: Patient called pharmacy 3/12/18 to report a hard red lump at injection site that felt warm to the touch. She treated with ice. She sought medical attention on 3/13/2018 where she was diagnosed with injection site infection and sinus infection and received two antibiotics: AUGMENTIN 875 with a booster of amoxicillin 875mg.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Pain of skin
Clinical narrative: Patient states 5 days after receiving vaccine, she experienced tenderness to her scalp and temple on left side of head. Felt like "zaps" to the areas. She denies any formation of lesions or redness. No changes in vision. Also felt numbness over the eyebrows with mild, burning pain. Symptoms progressively improved after reaction occurred. Shingles patient had a month ago were located on T3-4 on right side.
Age: 13.0
Sex: M
Vaccine: TYP
Symptoms: Flushing, Swelling face
Clinical narrative: Patient developed unilateral facial swelling of his L cheek and L eyelid, he has some flushing of bilateral cheeks as well. Treating with BENADRYL. He has no other symptoms and is otherwise well appearing.
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Vaccination site induration, Vaccination site nodule, Vaccination site pain, Vaccination site warmth
Clinical narrative: Developing a knot around vaccine site. Hard and Warm and Pain. 2.5 to 3 inches. It passed 7 days now. The knot is getting smaller to around one inch now, but still feel hard and pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Administration site erythema, Administration site swelling, Local reaction
Clinical narrative: Local reaction - mild erythema and swelling isolated to the upper arm where injection was administered.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site pruritus, Injection site warmth, Pruritus, Skin warm
Clinical narrative: Patient had injection site reaction - site was hot and itchy. Patient also said it was hot and itchy also up that side of her neck as well. Pt said she would also take some BENADRYL to help with the allergic reaction. Started about 6 hours after initial injection.
Age: 37.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Asthenia, Fatigue, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: I had pain for 6 days counting the day it was given where I could not touch or even lay on either side (right and left). I slept on my back for these days. I had a fever the first night into the next day. Then it went away I did take Ibuprofen for it. I had a large rash on my right arm that lasted for 5 days. My rash on my left arm lasted two days. I still have pain in my right upper arm that has not gone away but I can't see the rash. I had low energy and hard time doing much of anything for the first 4 days.
Age: 37.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Sleep disorder
Clinical narrative: I had pain for 6 days counting the day it was given where I could not touch or even lay on either side (right and left). I slept on my back for these days. I had a fever the first night into the next day. Then it went away I did take Ibuprofen for it. I had a large rash on my right arm that lasted for 5 days. My rash on my left arm lasted two days. I still have pain in my right upper arm that has not gone away but I can't see the rash. I had low energy and hard time doing much of anything for the first 4 days.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This serious spontaneous case, initially received on 28-Feb-2018, reported by other non-health professional and concerns a 68-year-old, elderly, male patient. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacture and trade name: not reported). On an unspecified date, after the administration of vaccine, the patient had flu (reported as: three times this year) [considered as vaccination failure]. At the time of this report, the outcome of the event- flu was not reported.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis - from hospital today 3/13/18 rec'vd 2 antibiotics cephalexin and SMZ-TMP DS.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Cellulitis, Chills, Fatigue
Clinical narrative: Cellulitis - from hospital today 3/13/18 rec'vd 2 antibiotics cephalexin and SMZ-TMP DS.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Injection site erythema, Injection site pain, Injection site swelling, Rash pruritic
Clinical narrative: After receiving SHINGRIX vaccine, pt reported serious swelling, redness and pain at the injection site that later developed an itchy rash. She also reported memory loss/difficulty recalling information.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site urticaria, Muscular weakness, Pain, Pyrexia
Clinical narrative: Reaction to a pneumonia vaccine-fever, chills, muscle weakness and pain, hives at site of injection (one week after injection).
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Areflexia, Electromyogram abnormal, Gait inability, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Went to see a neurology on 11/21/17, 84 yr old female w/subacute onset of weakness in lower extremities, sensory loss, and absent reflexes. This is c/w GBS. Her NCS/EMG LE today confirmed this. Patient will be a direct admit to Hosp. If Cr is ok, start IVIG 4 gm/kg IV qd x 5 days. After vaccine given on 9/29/17, I left the hospital unable to walk. After going straight to rehab for 2 1/2 wks. still no better went to see a neurologist, where I was given a nerve test and from her office sent to hospital. She states this c/w GBS.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve conduction studies abnormal, Sensory loss
Clinical narrative: Went to see a neurology on 11/21/17, 84 yr old female w/subacute onset of weakness in lower extremities, sensory loss, and absent reflexes. This is c/w GBS. Her NCS/EMG LE today confirmed this. Patient will be a direct admit to Hosp. If Cr is ok, start IVIG 4 gm/kg IV qd x 5 days. After vaccine given on 9/29/17, I left the hospital unable to walk. After going straight to rehab for 2 1/2 wks. still no better went to see a neurologist, where I was given a nerve test and from her office sent to hospital. She states this c/w GBS.
Age: 48.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Immediate post-injection reaction, Injection site swelling, Nausea, Neck pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 48-year-old female patient who received BEXSERO (batch number 16A301, expiry date January 2019). On 8th March 2018 12:45, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 8th March 2018, several hours after receiving BEXSERO, the patient experienced injection site swelling (serious criteria other: As per reporter), neck pain (serious criteria other: As per reporter) and headache (serious criteria other: As per reporter). On 8th March 2018 12:45, the patient experienced faint (serious criteria other: As per reporter) and nausea (serious criteria other: As per reporter). On an unknown date, the outcome of the injection site swelling, neck pain, headache and nausea were unchanged and the outcome of the faint was recovered/resolved. The reporter considered the injection site swelling, faint, neck pain, headache and nausea to be probably related to BEXSERO. Additional details were provided as follows: The healthcare professional stated that the patient received her 1st dose of BEXSERO in left arm and immediately felt nauseous and faint. The healthcare professional stated that later on 8th March 2018, the patient reported developing a severe headache that involved her head and neck, continued nausea, left arm swollen at injection site that persisted on 9th March 2018 and was described as worse than a day before. The healthcare professional stated patient treated swelling at injection site with a hot compress.
Age: 48.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 48-year-old female patient who received BEXSERO (batch number 16A301, expiry date January 2019). On 8th March 2018 12:45, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 8th March 2018, several hours after receiving BEXSERO, the patient experienced injection site swelling (serious criteria other: As per reporter), neck pain (serious criteria other: As per reporter) and headache (serious criteria other: As per reporter). On 8th March 2018 12:45, the patient experienced faint (serious criteria other: As per reporter) and nausea (serious criteria other: As per reporter). On an unknown date, the outcome of the injection site swelling, neck pain, headache and nausea were unchanged and the outcome of the faint was recovered/resolved. The reporter considered the injection site swelling, faint, neck pain, headache and nausea to be probably related to BEXSERO. Additional details were provided as follows: The healthcare professional stated that the patient received her 1st dose of BEXSERO in left arm and immediately felt nauseous and faint. The healthcare professional stated that later on 8th March 2018, the patient reported developing a severe headache that involved her head and neck, continued nausea, left arm swollen at injection site that persisted on 9th March 2018 and was described as worse than a day before. The healthcare professional stated patient treated swelling at injection site with a hot compress.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Contusion, Decreased appetite, Dizziness, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 86-year-old male patient who received SHINGRIX. Concurrent medical conditions included non-Hodgkin's lymphoma (had not changed in 6 years, asymptomatic). Concomitant products included amlodipine, Aspirin, fenofibrate, Losartan, omeprazole and Vitamins. On 23rd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd February 2018, less than a day after receiving SHINGRIX, the patient experienced bruising of arm. On 27th February 2018, the patient experienced fatigue, appetite lost, weakness and felt faint. On 4th March 2018, the outcome of the fatigue, appetite lost, weakness and felt faint were recovered/resolved. On an unknown date, the outcome of the bruising of arm was unknown. The reporter considered the fatigue, appetite lost and weakness to be probably related to SHINGRIX. It was unknown if the reporter considered the bruising of arm and felt faint to be related to SHINGRIX. Additional details were provided as follows: On 23rd February 2018, at 16:00 hours the patient received SHINGRIX on left arm. The patient had a large bruise on his arm. On 27th February 2018, 4 days after receiving SHINGRIX, the patient was feeling fatigued in the morning, and by evening he was very fatigued and had to go to bed early, he also felt weak, such that he would feel faint when standing, and had no appetite. The patient spent most of the next 2 days in bed.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Arthralgia, Asthenia, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of high temperature in a 16-year-old male patient who received BEXSERO. Concomitant products included MENACTRA. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown receiving BEXSERO, the patient experienced high temperature, weakness generalized and joint pain. On an unknown date, the outcome of the high temperature, weakness generalized and joint pain were recovered/resolved. It was unknown if the reporter considered the high temperature, weakness generalized and joint pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced higher temperature than normal, pain in joints and general weakness. The patient went to emergency room (ER) but the reporter did not know if patient stayed overnight.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dizziness, Fatigue, Flushing, Heart rate increased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of back pain in a 60-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2020). Concomitant products included Levothyroxine and NEXIUM. On 3rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd March 2018, immediately after receiving SHINGRIX, the patient experienced back pain, light headedness, fatigue, heartbeats increased, abnormal breathing, fever, flushing and panic attack. On 4th March 2018, the patient experienced sleep excessive. On 4th March 2018, the outcome of the fever was recovered/resolved. In March 2018, the outcome of the back pain, light headedness, fatigue, heartbeats increased, abnormal breathing and flushing were recovered/resolved. On an unknown date, the outcome of the panic attack and sleep excessive were unknown. It was unknown if the reporter considered the back pain, light headedness, fatigue, heartbeats increased, abnormal breathing, fever, flushing, panic attack and sleep excessive to be related to SHINGRIX. Additional information was reported as follows: On 3rd March 2018 at 18:30, the patient received SHINGRIX, in right arm. Immediately after vaccination with SHINGRIX, the patient experienced intense pain which was extended behind her back and toward neck. The patient also experienced fatigued, dizziness, light-headed immediately after vaccination and she became flushed. After a couple of minutes patient's color returned to normal and heartbeat was rapid and breathing didn't seem right. The reporter asked the patient if she was having difficulty breathing and the patient responded that she didn't know, just that her breathing felt off. The patient stayed seated for 15 min. after the vaccination, then stood up for about 1 min., then sat for an additional 10 minutes. The patient commented that it felt like she was having panic attack. As the time was gone, the patient was feeling better and she went home after about 30 min. On next day the patient came and developed a low fever, about 100 F in the night, but it had resolved by the next day. The pain also continued through the night, but did resolve. The patient slept most of the next day (4th March 2018) and was trying to decide if she was going to get the next shot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Immediate post-injection reaction, Panic attack, Pyrexia, Respiration abnormal
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of back pain in a 60-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2020). Concomitant products included Levothyroxine and NEXIUM. On 3rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd March 2018, immediately after receiving SHINGRIX, the patient experienced back pain, light headedness, fatigue, heartbeats increased, abnormal breathing, fever, flushing and panic attack. On 4th March 2018, the patient experienced sleep excessive. On 4th March 2018, the outcome of the fever was recovered/resolved. In March 2018, the outcome of the back pain, light headedness, fatigue, heartbeats increased, abnormal breathing and flushing were recovered/resolved. On an unknown date, the outcome of the panic attack and sleep excessive were unknown. It was unknown if the reporter considered the back pain, light headedness, fatigue, heartbeats increased, abnormal breathing, fever, flushing, panic attack and sleep excessive to be related to SHINGRIX. Additional information was reported as follows: On 3rd March 2018 at 18:30, the patient received SHINGRIX, in right arm. Immediately after vaccination with SHINGRIX, the patient experienced intense pain which was extended behind her back and toward neck. The patient also experienced fatigued, dizziness, light-headed immediately after vaccination and she became flushed. After a couple of minutes patient's color returned to normal and heartbeat was rapid and breathing didn't seem right. The reporter asked the patient if she was having difficulty breathing and the patient responded that she didn't know, just that her breathing felt off. The patient stayed seated for 15 min. after the vaccination, then stood up for about 1 min., then sat for an additional 10 minutes. The patient commented that it felt like she was having panic attack. As the time was gone, the patient was feeling better and she went home after about 30 min. On next day the patient came and developed a low fever, about 100 F in the night, but it had resolved by the next day. The pain also continued through the night, but did resolve. The patient slept most of the next day (4th March 2018) and was trying to decide if she was going to get the next shot.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Muscular weakness, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vomiting in a 17-year-old female patient who received MENVEO. Concomitant products included TRUMENBA. On an unknown date, the patient received MENVEO at an unknown dose. On an unknown date, unknown after receiving MENVEO, the patient experienced vomiting, fever and muscle weakness. On an unknown date, the outcome of the vomiting, fever and muscle weakness were unknown. It was unknown if the reporter considered the vomiting, fever and muscle weakness to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The patient went to the emergency room, but it was unknown if the patient was hospitalized.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 10-year-old female patient who received BOOSTRIX. On 7th March 2018, the patient received BOOSTRIX (subcutaneous). In March 2018, less than a week after receiving BOOSTRIX, the patient experienced injection site reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site reaction was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site reaction to be related to BOOSTRIX. Additional details were provided as follows: The patient was the healthcare professional's child. The healthcare professional did not have the product information available but the patient was given Tdap vaccine after cutting her leg on a fence. The patient received a dose of Tdap inadvertently which was given subcutaneously, which led to inappropriate route of vaccine administration. The healthcare professional additionally reported that the patient was experiencing tightness in her arm where the vaccine was administered.
Age: 69.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 69-year-old female patient who received TWINRIX adult. Co-suspect products included TWINRIX adult and TWINRIX adult. Concomitant products included prednisone and Cholesterol Medication (NOS). In July 2017, the patient received the 1st dose of TWINRIX adult 1 ml. On an unknown date, the patient received the 2nd dose of TWINRIX adult 1 ml and the 3rd dose of TWINRIX adult 1 ml. On an unknown date, less than a year after receiving TWINRIX adult, TWINRIX adult and TWINRIX adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknwon. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX adult, TWINRIX adult and TWINRIX adult. Additiononal information was reported as follows: The patient received Reflux medication concomitantly. The age at vaccination was not reported. The caller center representative reported that the patient completed his 3 series vaccine schedule of TWINRIX adult. The patient's last blood work was done in February 2018 and result showed that the vaccine increased anti-bodies for HAV and HBV. Lack of drug against vaccine was reported. The reporter stated patient's health care professional might had to take the series again (potential off label). The patient received first dose of the vaccine in July 2017 and it was administered in pharmacy. The patient's HCP was ware of the blood test.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tingling sensation in a 75-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 2nd March 2018 14:30, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2018, 1 days after receiving SHINGRIX, the patient experienced tingling sensation and pain. On an unknown date, the outcome of the tingling sensation was not recovered/not resolved and the outcome of the pain was recovered/resolved. The reporter considered the tingling sensation and pain to be possibly related to SHINGRIX. Additional details were provided as follows: The patient reported tingling sensation in arm, leg, and torso after receiving SHINGRIX. At the time of reporting, tingling did not resolved and the patient was concerned about tingling.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blepharospasm, Chills, Headache, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received SHINGRIX. On 24th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, 8 hrs after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site induration, chills, blepharospasm, tingling, slight temperature and headache. On an unknown date, the patient experienced scab. In February 2018, the outcome of the extensive swelling of vaccinated limb, injection site induration, chills, blepharospasm, tingling, slight temperature and headache were recovered/resolved. In March 2018, the outcome of the scab was recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site induration, chills, scab, blepharospasm, tingling, slight temperature and headache to be related to SHINGRIX. Additional details were provided as follows: The reporter declined to provide concomitant medications. The patient was administered SHINGRIX vaccine in the right deltoid (lot number, expiration date, or dosage was not provided). The patient experienced low grade temperature and bosy temperature was recorded as 101.2. The patient experienced right arm swelling as her arm swelling from mid deltoid to right abouve the elbow; swelling felt hard (extensive swelling of vaccinated limb). Reporter noted that there was no medical doctor who prescribed SHINGRIX for her, but noted it was a standing order for pharmacists. All events, aside from scabs, completely resolved 4 days after the injection was received, no exact date provided. Four to 5 days after received vaccination, scabs appeared on Wednesday or Thursday, no exact dates were provided. Scabs completely resolved Saturday or Sunday after receiving the injection, no exact dates provided.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received SHINGRIX. On 24th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, 8 hrs after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site induration, chills, blepharospasm, tingling, slight temperature and headache. On an unknown date, the patient experienced scab. In February 2018, the outcome of the extensive swelling of vaccinated limb, injection site induration, chills, blepharospasm, tingling, slight temperature and headache were recovered/resolved. In March 2018, the outcome of the scab was recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site induration, chills, scab, blepharospasm, tingling, slight temperature and headache to be related to SHINGRIX. Additional details were provided as follows: The reporter declined to provide concomitant medications. The patient was administered SHINGRIX vaccine in the right deltoid (lot number, expiration date, or dosage was not provided). The patient experienced low grade temperature and bosy temperature was recorded as 101.2. The patient experienced right arm swelling as her arm swelling from mid deltoid to right abouve the elbow; swelling felt hard (extensive swelling of vaccinated limb). Reporter noted that there was no medical doctor who prescribed SHINGRIX for her, but noted it was a standing order for pharmacists. All events, aside from scabs, completely resolved 4 days after the injection was received, no exact date provided. Four to 5 days after received vaccination, scabs appeared on Wednesday or Thursday, no exact dates were provided. Scabs completely resolved Saturday or Sunday after receiving the injection, no exact dates provided.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blepharospasm, Chills, Extensive swelling of vaccinated limb, Headache, Injection site induration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received SHINGRIX. On 24th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, 8 hrs after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site induration, chills, blepharospasm, tingling, slight temperature and headache. On an unknown date, the patient experienced scab. In February 2018, the outcome of the extensive swelling of vaccinated limb, injection site induration, chills, blepharospasm, tingling, slight temperature and headache were recovered/resolved. In March 2018, the outcome of the scab was recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site induration, chills, scab, blepharospasm, tingling, slight temperature and headache to be related to SHINGRIX. Additional details were provided as follows: The reporter declined to provide concomitant medications. The patient was administered SHINGRIX vaccine in the right deltoid (lot number, expiration date, or dosage was not provided). The patient experienced low grade temperature and bosy temperature was recorded as 101.2. The patient experienced right arm swelling as her arm swelling from mid deltoid to right abouve the elbow; swelling felt hard (extensive swelling of vaccinated limb). Reporter noted that there was no medical doctor who prescribed SHINGRIX for her, but noted it was a standing order for pharmacists. All events, aside from scabs, completely resolved 4 days after the injection was received, no exact date provided. Four to 5 days after received vaccination, scabs appeared on Wednesday or Thursday, no exact dates were provided. Scabs completely resolved Saturday or Sunday after receiving the injection, no exact dates provided.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Paraesthesia, Pyrexia, Scab
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received SHINGRIX. On 24th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, 8 hrs after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site induration, chills, blepharospasm, tingling, slight temperature and headache. On an unknown date, the patient experienced scab. In February 2018, the outcome of the extensive swelling of vaccinated limb, injection site induration, chills, blepharospasm, tingling, slight temperature and headache were recovered/resolved. In March 2018, the outcome of the scab was recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site induration, chills, scab, blepharospasm, tingling, slight temperature and headache to be related to SHINGRIX. Additional details were provided as follows: The reporter declined to provide concomitant medications. The patient was administered SHINGRIX vaccine in the right deltoid (lot number, expiration date, or dosage was not provided). The patient experienced low grade temperature and bosy temperature was recorded as 101.2. The patient experienced right arm swelling as her arm swelling from mid deltoid to right abouve the elbow; swelling felt hard (extensive swelling of vaccinated limb). Reporter noted that there was no medical doctor who prescribed SHINGRIX for her, but noted it was a standing order for pharmacists. All events, aside from scabs, completely resolved 4 days after the injection was received, no exact date provided. Four to 5 days after received vaccination, scabs appeared on Wednesday or Thursday, no exact dates were provided. Scabs completely resolved Saturday or Sunday after receiving the injection, no exact dates provided.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2-27-18 Pneumonia vac. pain and swelling, 2-28-18 swelling and pain, rash (later in the evening), 3-1-18 rash and swelling - marking also looked like an m. Dark red. 3-7-18 still having a mark that looks like an m. A little lighter now. Started with pain and swelling. Pain for about 2-3 days and nights. 2-28-18 went to Dr. Showed her swelling and told about pain. Says I didn't get a rash at least like 4 of her other patients. Says to use TYNELOL and ice. Says I had allergic reaction. Told her I had swelling and rash on arm 5 years ago from the Pneumonia vac. That evening after I saw Dr. on 2-28-18 I started getting rash and still having swelling. 3-1-18 went to Dr and she wanted to check rash. Says it was better. I told her I still had a marking of an m.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Hypersensitivity, Pain, Rash, Swelling
Clinical narrative: 2-27-18 Pneumonia vac. pain and swelling, 2-28-18 swelling and pain, rash (later in the evening), 3-1-18 rash and swelling - marking also looked like an m. Dark red. 3-7-18 still having a mark that looks like an m. A little lighter now. Started with pain and swelling. Pain for about 2-3 days and nights. 2-28-18 went to Dr. Showed her swelling and told about pain. Says I didn't get a rash at least like 4 of her other patients. Says to use TYNELOL and ice. Says I had allergic reaction. Told her I had swelling and rash on arm 5 years ago from the Pneumonia vac. That evening after I saw Dr. on 2-28-18 I started getting rash and still having swelling. 3-1-18 went to Dr and she wanted to check rash. Says it was better. I told her I still had a marking of an m.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Hyperhidrosis, Injected limb mobility decreased, Injection site joint movement impairment, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: 3/12 @ 10pm: area of approx. 4.5? radius from injection site became extremely tender to touch,  stiffness in entire bicep & tricep areas of arm that received injection. 3/13 @ 1:00 Am: woke up drenched in sweat, tingling sensation across entire face, continued to sweat profusely for about an hour. 3/13 @ 2:30AM: began violently vomiting. Absurd amounts of bile, vomiting lasted until 6Am. 3/13 @ 12PM: awoke to intense pain in left bicep. Upon waking realized the muscle was so tender and tight could not extend arm at the elbow, nor lift arm up to even dress self. Pain did not get better with ice or ADVIL. Fever around 100 F from 12pm on 3/13 till 3/14. Fever did not improve or break with ADVIL or ALEVE. 3/13 @ 4PM: intense  nausea returned, did not begin vomitting again though. Fever continued
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Musculoskeletal stiffness, Nausea, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: 3/12 @ 10pm: area of approx. 4.5? radius from injection site became extremely tender to touch,  stiffness in entire bicep & tricep areas of arm that received injection. 3/13 @ 1:00 Am: woke up drenched in sweat, tingling sensation across entire face, continued to sweat profusely for about an hour. 3/13 @ 2:30AM: began violently vomiting. Absurd amounts of bile, vomiting lasted until 6Am. 3/13 @ 12PM: awoke to intense pain in left bicep. Upon waking realized the muscle was so tender and tight could not extend arm at the elbow, nor lift arm up to even dress self. Pain did not get better with ice or ADVIL. Fever around 100 F from 12pm on 3/13 till 3/14. Fever did not improve or break with ADVIL or ALEVE. 3/13 @ 4PM: intense  nausea returned, did not begin vomitting again though. Fever continued
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Confusional state, Depression, Dermatitis, Face injury, Fall
Clinical narrative: After 1st dose child had sore throat and flu like symptoms didn't think anything of it. The 2nd dose is when her life changed, she face planted from standing position on to a cement floor having what was observed as a seizure, came to was confused and very tired. She had several episodes following that one which several of those times resulted in her busting up her face and hitting head, being treated for seizures, depression, gastro issues, fainting issues. Stretch marks all over her body which become inflamed and irritated... The list goes on....
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Gastric disorder, Head injury, Influenza like illness, Laboratory test
Clinical narrative: After 1st dose child had sore throat and flu like symptoms didn't think anything of it. The 2nd dose is when her life changed, she face planted from standing position on to a cement floor having what was observed as a seizure, came to was confused and very tired. She had several episodes following that one which several of those times resulted in her busting up her face and hitting head, being treated for seizures, depression, gastro issues, fainting issues. Stretch marks all over her body which become inflamed and irritated... The list goes on....
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Oropharyngeal pain, Seizure, Skin irritation, Skin striae, Syncope
Clinical narrative: After 1st dose child had sore throat and flu like symptoms didn't think anything of it. The 2nd dose is when her life changed, she face planted from standing position on to a cement floor having what was observed as a seizure, came to was confused and very tired. She had several episodes following that one which several of those times resulted in her busting up her face and hitting head, being treated for seizures, depression, gastro issues, fainting issues. Stretch marks all over her body which become inflamed and irritated... The list goes on....
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site reaction, Rash macular
Clinical narrative: "Had QUADRACEL in L thigh and MMRV in R thigh. Developed mild pink rash around injection sites within 24 hrs. Yesterday developed deeper red area around injection on R thigh which mother marked. The deeper redness has decreased in size but milder redness has spread. Pt acting and feeling fine, no fever". "Area of deep erythema and induration circled, if this spreads, mom should call back. Expect blotchy erythema around injection site of varicella vaccine and then maculopapular rash more widespread due to measles".
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash maculo-papular
Clinical narrative: "Had QUADRACEL in L thigh and MMRV in R thigh. Developed mild pink rash around injection sites within 24 hrs. Yesterday developed deeper red area around injection on R thigh which mother marked. The deeper redness has decreased in size but milder redness has spread. Pt acting and feeling fine, no fever". "Area of deep erythema and induration circled, if this spreads, mom should call back. Expect blotchy erythema around injection site of varicella vaccine and then maculopapular rash more widespread due to measles".