chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Guillain-Barre syndrome
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A 17-years-old male patient of an unspecified ethnicity received TRUMENBA, (lot 90621), via an unspecified route of administration on 07Jan2017 at single dose for immunisation. The patient medical history and concomitant medications were not reported. After use of product the patient experienced Guillain Barre syndrome on an unspecified date with outcome of unknown. The patient was hospitalized for the event. No follow up attempts are possible. No further information is expected. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 79.0
Sex: M
Vaccine: FLUC4
Symptoms: Eye pain, Headache, Injection site pain
Clinical narrative: Pt. complained of extreme pain around site of injection. Later, he said the pain moved into his shoulder, then eye. He complained of mild headaches.
Age: 61.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and urticaria pruritus. Diphenhydramine, hydrocortisone.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Pruritus, Rash, Skin test positive, Urticaria
Clinical narrative: Rash and urticaria pruritus. Prednisone 60 mg every day, hydroxyzine 25 mg TID.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Asthenia, Diarrhoea, Emotional distress, Fatigue, Insomnia
Clinical narrative: Diarrhea - 01/04/18 - 01/07/18, Fever - 01/04/18 - 01/05/18, Upset - 01/04/18 - 01/05/18, Not sleeping - 01/04/18 - 01/05/18, Fatigue/no energy - 01/06/18
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Diarrhea - 01/04/18 - 01/07/18, Fever - 01/04/18 - 01/05/18, Upset - 01/04/18 - 01/05/18, Not sleeping - 01/04/18 - 01/05/18, Fatigue/no energy - 01/06/18
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: Decreased eye contact, Pyrexia, Screaming, Staring, Unresponsive to stimuli
Clinical narrative: Patient at 3 months was given vaccinations by Dr. Less than 24 hours, patient screamed in his sleep a high pitch sound, which he never screamed prior in his young life. He also had fevers to which I gave him TYLENOL every 4-6 hours for 24 hours as advised by his Pediatrician at the time. When patient awoke in the morning, he made no eye contact and did not respond to me calling his name and stared into space for about 15 minutes. I immediately knew something was wrong and yelled to my mother for help who was visiting. I told her I was taking him to the ER and she persuaded me to stay home and monitor him. He finally just snapped out of what seemed like a trance and suddenly made eye contact and became engaging. I was just so grateful that he was okay and cried tears of joy, but I knew the vaccinations and his seizure episode was related, even though I did not know it was a seizure at the time in 2013. I decided it was in his best interest in order to save his life, and to prevent this from ever happening again, with the possibility of something worse, to terminate him receiving vaccinations. Given vaccines in 2013 at 3 months old. That night had fevers given TYLENOL every 4-6 hours around the clock for 24 hours as advised by his pediatrician Dr. Screamed in his sleep a high pitch sound never heard before. That morning no eye contact. That morning no response to my engagement with him. That morning I rushed to my mother to make her aware and ask for help. Told her I was taking him to the ER. She said to relax, breathe, give him time and he would be okay. He was in a non-responsive/non engaging/no eye contact state for about 15 minutes. When he "snapped" out of it I thought he was okay and had no idea that it was a seizure. I learned when he was in preschool in casual conversation that he had an absence (staring) seizure. My instincts and intuition knew that the vaccinations were related and I never took him back to be to receive additional shots.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Crying, Emotional distress, Screaming
Clinical narrative: 4 hours after the vaccines, patient started screaming crying - a cry I've never heard before. It was piercing and she was inconsolable for over two hours. Until she finally fell asleep from crying so hard. She's never carried like that and has yet to cry like that again. All clear signs of encephalitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Injection site pain, Irritability, Musculoskeletal disorder, Vomiting
Clinical narrative: Mother called PCP office 1/5/2018 indicating child had immunizations at his WCC on 1/4. Later that evening about 4 hours after receiving he started with a temp by 7:30 pm his temp was 102.3- Gave ADVIL and it did come down but at 3:30 am temp back at 102.3. She said he did c/o left leg shot really hurt but no redness or swelling. He c/o that his hands don't want to work when he tries to pull up his pants, he did throw up a bit in the morning of 1/5 but mom attributed to ADVIL. She indicated he is not happy, cranky. No resp sx, was in good general health prior to shots. Mother called today 1/8/2018 to report all symptoms completely resolved in 24 hour period. The highest his temp reached was 103 during that 24 hour period.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PATIENT WAS INADVERTENTLY GIVEN INTRADERMAL FLU VACCINE AND IT IS ONLY APPROVED FOR USE IN ADULTS AGED 18 THROUGH 64 YEARS OLD. PATIENT IS 14 YEARS OLD.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Rash
Clinical narrative: Pt states that the day of vaccine she got a rash on her arm and redness at injection site. She states that rash spread and has since resolved some. When she came in today, she showed me the arm where she has some slight redness. She states it did not itch, burn, or swell and it wasn't uncomfortable. She did not seek medical attention and did not apply any creams or treatment to area.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PATIENT WAS INADVERTENTLY GIVEN INTRADERMAL FLU VACCINE AND IT IS ONLY APPROVED FOR USE IN ADULTS AGED 18 THROUGH 64 YEARS OLD. PATIENT IS 11 YEARS OLD.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PATIENT WAS INADVERTENTLY GIVEN INTRADERMAL FLU VACCINE AND IT IS ONLY APPROVED FOR USE IN ADULTS AGED 18 THROUGH 64 YEARS OLD. PATIENT IS 16 YEARS OLD.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Four hours after vaccination, I developed arm pain at site of injection and below toward the insertion point of the deltoid and was unable to abduct or extend my shoulder -- I think this was actually an inability to abduct the arm, but the severe pain was certainly a limiting factor. I applied ice, which gave temporary relief of pain, but did not affect pain with attempted motion. I also had pain radiating to the back of my hand, in the "webbing" between my thumb and first finger. About 16 hours after vaccination, I noticed mild redness and tenderness lateral to injection site, but that disappeared after a few hours. I never had redness at the injection site or induration or swelling. I was unable to use my left arm for 3 1/2 days. On day four I had full range of motion of that arm, pain remained, although much diminished. (The pain on days 4-7 was similar to what I've experienced in the first 24 hours after other vaccinations in the past.) From week two through today, I have had full range of motion and no pain EXCEPT for vague nerve pain a couple of times a day that lasts less than a minute, perhaps precipitated by certain movements of that arm.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-APR-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster. On or about 05-NOV-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. The patient was prescribed VALTREX and BACTRIM in attempts to curb her painful symptoms. 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. On or about 09-JUL-2016, the patient was vaccinated 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 ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. About two weeks after being vaccinated, the patient broke out in severe blistering lesions. The patient was treated by a physician for the vesicular outbreak that was 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: 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. On or about 01-JAN-2013, the patient was vaccinated at a Medical Center 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 ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. During 2014, the patient was treated at the same center for blistering vesicular outbreaks that were 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, Pain, 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. On or about 07-AUG-2015, the patient was vaccinated 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 ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 03-JUN-2016, the patient was treated for a blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. The patient was prescribed  acyclovir and tramadol for management of her painful and persistent symptoms. 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, Ear pain, 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 22-DEC-2014, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JUN-2016, she was treated by a physician at the office for a blistering outbreak and stabbing pain in her ears which was then diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir (VALTREX) and acetaminophen-codeine in attempts to curb her painful symptoms. As a direct and proximate result of these malfunctions, she suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-MAY-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 24-APR-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The patient was prescribed acyclovir for management of her painful symptoms and outbreaks. 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, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 23-SEP-2013, the patient was inoculated with ZOSTAVAX at community health center for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-AUG-2016, the patient was treated at the Emergency Room for a blistering outbreak that was diagnosed as severe herpes zoster, or shingles. The patient was prescribed famciclovir and Calamine lotion for management of his painful symptoms and outbreaks. 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, pain and suffering, and other damages.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Migraine, Nerve injury, Nervous system disorder
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 16-APR-2010, the patient was inoculated with ZOSTAVAX at a Medical Center 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, also known as shingles, and permanent nerve damage and residual pain. On or about 23-MAY-2015, the patient was treated by a physician at the office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. On or about 03-JUL-2015, he received subsequent treatment from a physician at a hospital for worsening symptoms of shingles, which had broken out continuously since his initial diagnosis of shingles. At this encounter, the patient reported issues of neurological interference, persistent burning sensation on his head, and migraine headaches, which were collectively diagnosed as post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to zoster infections. He was prescribed NORCO, oxycodone-acetaminophen, "famicyclovir", hydrocodone-acetaminophen, and increasing doses of gabapentin for management of his painful persistent symptoms and outbreaks. 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, he has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The lawyer considered post-herpetic neuralgia to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 16-APR-2010, the patient was inoculated with ZOSTAVAX at a Medical Center 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, also known as shingles, and permanent nerve damage and residual pain. On or about 23-MAY-2015, the patient was treated by a physician at the office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. On or about 03-JUL-2015, he received subsequent treatment from a physician at a hospital for worsening symptoms of shingles, which had broken out continuously since his initial diagnosis of shingles. At this encounter, the patient reported issues of neurological interference, persistent burning sensation on his head, and migraine headaches, which were collectively diagnosed as post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to zoster infections. He was prescribed NORCO, oxycodone-acetaminophen, "famicyclovir", hydrocodone-acetaminophen, and increasing doses of gabapentin for management of his painful persistent symptoms and outbreaks. 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, he has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The lawyer considered post-herpetic neuralgia to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, 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. On or about 03-MAR-2009, the patient was vaccinated by a physician 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 ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 29-NOV-2016, the patient was treated by a physician for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. She has also been diagnosed with post-herpetic neuralgia, a chronic condition of residual pain and damage secondary to shingles infections. The patient has been prescribed valacylovir, hydrocodone nortriptyline HCl, gabapentin, and lidocaine for management of her painful and persistent symptoms. 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: the vaccine did not prevent shingles as intended; severe herpes zoster; weakened immune symptoms; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On or about 10-JAN-2011, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-FEB-2015, she was treated by a physician at the a clinic for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. She was prescribed valacyclovir for management of her painful condition. 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.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Enema administration, Haematochezia, Intussusception
Clinical narrative: One hour after administration of vaccine, patient had a massive bloody stool. He was directed to the ER where he was found to have intussusception that was reduced with air contrast enema. He was kept overnight for observation and released the next day without complication.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Extra dose administered, Rash macular, Vaccination complication
Clinical narrative: Patient is getting spots on hands and feet that come and go and is having soreness in her joints.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Chest discomfort, Discomfort, Dizziness, Exposure during pregnancy
Clinical narrative: Client is 31 weeks pregnant. EDC is 3/08/18. She has been treated for preterm labor signs. Quit taking PROCARDIA but is taking Progesterone vaginally daily to help stop contractions. Only having occasional Braxton Hicks contractions recently. About 25 minutes after Tdap was given, client complained of tasting plastic & then having a "hot, burning throat", & pressure to her throat & chest like someone was sitting on her. After drinking a glass of water, she became dizzy & said she saw spots. She then was laid on the floor with her feet up in a chair. 50 mg of BENADRYL was administered IM which helped relieve the chest pressure she was experiencing. She continued to have other symptoms for close to an hour & after she was given BENADRYL, complained of her lips being numb. She then felt OK enough to sit in a chair but her symptoms persisted. She then agreed to have her sister drive her to the ER/walk in clinic.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Premature labour, Throat irritation, Uterine contractions during pregnancy, Visual impairment
Clinical narrative: Client is 31 weeks pregnant. EDC is 3/08/18. She has been treated for preterm labor signs. Quit taking PROCARDIA but is taking Progesterone vaginally daily to help stop contractions. Only having occasional Braxton Hicks contractions recently. About 25 minutes after Tdap was given, client complained of tasting plastic & then having a "hot, burning throat", & pressure to her throat & chest like someone was sitting on her. After drinking a glass of water, she became dizzy & said she saw spots. She then was laid on the floor with her feet up in a chair. 50 mg of BENADRYL was administered IM which helped relieve the chest pressure she was experiencing. She continued to have other symptoms for close to an hour & after she was given BENADRYL, complained of her lips being numb. She then felt OK enough to sit in a chair but her symptoms persisted. She then agreed to have her sister drive her to the ER/walk in clinic.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Induration, Local reaction, Skin warm, Swelling, Tenderness
Clinical narrative: Localized reaction - swelling, hot, hard, tender to touch.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PT STATED THAT AROUND THE INJECTION SITE WAS RED AND SWOLLEN.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abdominal pain, Autism spectrum disorder, Emotional distress, Irritability, Learning disorder
Clinical narrative: Patient received 3 vaccinations. She had a fever for three days. The first night home she was very cranky. I was changing her diaper and she appeared to maybe have a seizure. It lasted for about 15 seconds, maybe less. My mom and I, didn't know what to do. Patient calmed down and we gave her some more TYLENOL according to instructions. Patient was very colicky for each evening and it was difficult to soothe her and to calm her down. Easter Sunday Evening and she was cranky but not as bad as days since April 3, 2007. Patient was cranky every night up thru April 8, 2007.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Patient received 3 vaccinations. She had a fever for three days. The first night home she was very cranky. I was changing her diaper and she appeared to maybe have a seizure. It lasted for about 15 seconds, maybe less. My mom and I, didn't know what to do. Patient calmed down and we gave her some more TYLENOL according to instructions. Patient was very colicky for each evening and it was difficult to soothe her and to calm her down. Easter Sunday Evening and she was cranky but not as bad as days since April 3, 2007. Patient was cranky every night up thru April 8, 2007.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Dizziness, Fatigue
Clinical narrative: 1000 on 1/5 states she developed a headache and neck and back pain. Later that evening was fuzzy thinking. When walking got lightheaded and dizzy. Friday middle of the night had pain in stomach and nauseated. Saturday and Sunday, was nauseated and fatigued and dizzy. States she stayed in bed all weekend. Today states she feels nauseated and stomach hurt. On Monday right arm started hurting from the lateral antecubital down to wrist. States she didn't take anything for it until last night 2 regular TYLENOL and yesterday took 2 ADVIL. Today took two Ibuprofen in the afternoon. States the medication helps some.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Nausea, Neck pain, Pain in extremity, Thinking abnormal
Clinical narrative: 1000 on 1/5 states she developed a headache and neck and back pain. Later that evening was fuzzy thinking. When walking got lightheaded and dizzy. Friday middle of the night had pain in stomach and nauseated. Saturday and Sunday, was nauseated and fatigued and dizzy. States she stayed in bed all weekend. Today states she feels nauseated and stomach hurt. On Monday right arm started hurting from the lateral antecubital down to wrist. States she didn't take anything for it until last night 2 regular TYLENOL and yesterday took 2 ADVIL. Today took two Ibuprofen in the afternoon. States the medication helps some.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Eye swelling, Injection site erythema
Clinical narrative: Swelling of both eyes. Red area on left arm down from the injection site.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, X-ray normal
Clinical narrative: 7 days after he received the vaccine, he has been experiencing severe pain in the upper right arm.  He has been taking ADVIL and TYLENOL and had to go see his doctor because there was no relief with OTC meds.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Hypoaesthesia
Clinical narrative: On 1/8/18 Patient reported to pharmacy. She states on morning after flu vaccine, she awoke with entire left side of body numb. She called her physician who sent her to ER to rule out stroke.   Symptoms began to resolve later that night. She reports mild symptoms still in left fingers as of 1/8/18, but her doctor tells her that will eventually go away.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia
Clinical narrative: Woke up at 1:30am with swollen & numb lips and left ring finger & pinkie finger tingling.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient says her shoulder and arm have been sore since the immunization (about three months ago).  Patient says the pain also sometimes radiates down her arm. She mentioned that the pain is most painful at night. Patient has not gone to see the doctor.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented with redness and swelling at the injection site.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dyspnoea
Clinical narrative: On 11/27/2017, patient received two vaccinations, PNEUMOVAX 23 and FLUZONE HD. Patient states that shortly after receiving the vaccinations he started to feel shortness of breath. Patient did not come back to pharmacy due to concern about groceries he had purchased. Patient left home and was taken to the hospital an hour later by ambulance where he had a hospital stay of two days. Patient believes it was an allergic reaction to PNEUMOVAX 23 as he has had the Flu vaccination in the past.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site nodule, Swelling
Clinical narrative: Patient reported redness and some swelling starting a few hours after receiving ZOSTAVAX. Said she feels like there is a hard knot at the injection site. She has just been taking TYLENOL to relieve the swelling, and I counseled her around 6 pm on 1-8-18 and she showed me the redness on her arm. It is about the size of 1/2 of a dollar bill and wraps partway around her arm. I suggested she take 50 mg of BENADRYL every 4-6 hours for a couple days to see if that will help relieve the redness and also reduce the swelling some more. I also suggested she ice the area 3-4 times a day to see if that helps decrease the size of the knot and to call her dr and follow up with us again in a few days, or sooner if it gets worse.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Influenza B virus test positive, Malaise
Clinical narrative: This serious spontaneous case, initially received on 26-Dec-2017, from a consumer, concerns an adult (reported as under age 65) female patient of unspecified age. The patient's current illness Included asthma and concomitant medications were not reported. The patient's vaccination history included annual influenza vaccine. On an unspecified date in 2014, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date (same year), after vaccination, the patient became very sick and was diagnosed with Influenza B (confirmed through unspecified lab tests). It was reported that, the patient was less than 65-year old, at that time and did not receive a strong vaccine that year. The outcome of the event was not reported. The reporter assessed this case as non-serious and causality of the events as related to the suspect vaccine. Case  Comment: Although the event influenza and vaccination failure occurred with a plausible temporal relationship, the causality for the event influenza and vaccination failure cannot be assessed with respect to the suspect vaccine as the case lacks the information regarding the strain of influenza with which the patient was diagnosed with influenza, clinical presentation, detailed investigations (swab and blood culture, immunological tests), immune status of the patient prior to vaccination, concurrent medications and relevant medical history. The company assessed the case as serious (medically significant).
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Nausea, vomiting, headache, 4 inch circular rash with warmth, erythema and swelling at site. Pt was given ice pack, EMETROL and Fexofenadine.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, vomiting, headache, 4 inch circular rash with warmth, erythema and swelling at site. Pt was given ice pack, EMETROL and Fexofenadine.
Age: 71.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Asthma, Condition aggravated, Cough, Pyrexia
Clinical narrative: Asthma attack within 1 hour, then fever x 3 days and a cough.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13, RV1, TTOX
Symptoms: Full blood count, Metabolic function test, Seizure, Urine analysis
Clinical narrative: Per mother, Patient had a "seizure" because of vaccinations. ER Physician did not agree with that assessment.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 12-19-17 FLUZONE administered ->redness, swelling. 12-20-17 Increasing redness, pain, swelling, warm to touch, hard skin, swelling from inguinal area to knee, "cranky" due to pain. 12-21-17 Pain improved; swelling, warmth, heat, induration persisted. Previous reaction only with Influenza vaccine-but each reaction is progressively getting worse.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth, Irritability, Swelling
Clinical narrative: 12-19-17 FLUZONE administered ->redness, swelling. 12-20-17 Increasing redness, pain, swelling, warm to touch, hard skin, swelling from inguinal area to knee, "cranky" due to pain. 12-21-17 Pain improved; swelling, warmth, heat, induration persisted. Previous reaction only with Influenza vaccine-but each reaction is progressively getting worse.
Age: 14.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Pruritus
Clinical narrative: Mother noticed redness right thigh next day...DTaP and MMR placed right thigh, diphenhydramine 12.5/5ml 2.5 ml TID PRN itching. KEFLEX 250mg/5ml 5ml QID x 7 days.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Erythema, Headache, Nausea
Clinical narrative: Bad headache, low fever, chills, body aches, nausea, diarrhea, progressing from onset then improving just shy of 2 days. Redness 12 cm x 6cm (L) arm. 2 days of symptoms.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Bad headache, low fever, chills, body aches, nausea, diarrhea, progressing from onset then improving just shy of 2 days. Redness 12 cm x 6cm (L) arm. 2 days of symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 09-OCT-2012, 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 severe herpes zoster. On or about 15-DEC-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed VALTREX for management of his painful and persistent symptoms. On or about 16-JAN-2015, the patient had additional treatment for ongoing and worsening symptoms, which was then diagnosed ad intercostal post-herpetic neuralgia, a chronic condition or nerve pain and damage secondary to shingles. The patient has been prescribed gabapentin, LYRICA, lidocaine, in addition to CELESTONE injections for management of his persistent and painful symptoms. 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 suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Chronic fatigue syndrome, Fibromyalgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Severe pain in entire arm that received vaccines. Lasted 7 days. Extreme difficulty moving/using left arm. Development of fibromyalgia and chronic fatigue sydrome within one month of recieving vaccines.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Seroconversion test negative
Clinical narrative: This spontaneous report was received from a nurse and refers to a 19 year old female patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. The nurse reported that on multiple unspecified dates, the patient received a full 3 dose series of RECOMBIVAX HB (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis at unspecified ages. After the series were complete, on an unspecified date, the patient had "titers" drawn which showed that the patient did not seroconvert. The reporter stated also that on an unknown date, the patient was inadvertently vaccinated with one adult dose of RECOMBIVAX HB 10/1.0 microgram/ ml (lot #, expiration date, dose and route of administration were not provided). No other adverse events were reported. The outcome of the events and the relatedness between the event and RECOMBIVAX HB were not reported.
Age: 0.25
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 3-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-DEC-2017, the patient was vaccinated with one dose of GARDASIL 9 injection, intramuscularly, lot # N020352 (also reported as n020352), expiration date 10-APR-2020, for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 29-DEC-2017 the patient was vaccinated with one improperly stored dose of VARIVAX (dose, frequency and route of administration were not reported) lot # N014632 and expiration date: 11-MAY-2019). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was stored in between -14 degrees Celsius (C) to -10 C for 1 hour and 15 minutes and between -9 C to 8 C for 4 hours and 25 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA002606.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Decreased immune responsiveness, Herpes zoster, Herpes zoster oticus, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 14-AUG-2013 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 or about 11-SEP-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster accompanied by Ramsay Hunt Syndrome (a condition brought on by a shingles outbreak that interferes with facial nerves and causes facial paralysis and hearing loss, secondary to zoster infections.) On or about 30-SEP-2014, the patient sought subsequent treatment from the physician for ongoing symptoms of Herpes Zoster Oticus and Unilateral high frequency sensorineural hearing loss. The patient sought ongoing treatment for these conditions, but will experience hearing loss that is likely permanent and irreversible due to the interferences she has experienced from zoster complications with her ears. The patient has been prescribed VALTREX and prednisone for management of her painful and bothersome symptoms. 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. Unilateral high frequency sensorineural hearing loss was reported to be disabling. Upon internal review Ramsay-Hunt Syndrome and unilateral high frequency sensorineural hearing loss were considered medically significant events. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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. On or about 14-AUG-2013 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 or about 11-SEP-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster accompanied by Ramsay Hunt Syndrome (a condition brought on by a shingles outbreak that interferes with facial nerves and causes facial paralysis and hearing loss, secondary to zoster infections.) On or about 30-SEP-2014, the patient sought subsequent treatment from the physician for ongoing symptoms of Herpes Zoster Oticus and Unilateral high frequency sensorineural hearing loss. The patient sought ongoing treatment for these conditions, but will experience hearing loss that is likely permanent and irreversible due to the interferences she has experienced from zoster complications with her ears. The patient has been prescribed VALTREX and prednisone for management of her painful and bothersome symptoms. 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. Unilateral high frequency sensorineural hearing loss was reported to be disabling. Upon internal review Ramsay-Hunt Syndrome and unilateral high frequency sensorineural hearing loss were considered medically significant events. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 25-JUN-2014 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 or about 11-JAN-2016, the patient was treated at a health facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The patient has been prescribed famciclovir (FAMVIR) for management of her painful and bothersome symptoms. 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.