chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain
Clinical narrative: Client states evening of 4/13/18 extreme pain/tenderness began in upper arm area where vaccine give. By the next morning (4/14/18) client was unable to move/use arm and noticed red blotches around injection site, swelling of arm from shoulder to elbow, and red streaks from shoulder moving down to elbow. Client states that on 4/16/18 she had continued pain and tenderness of arm as well as red "blotches" and swelling, and some mobility had returned to arm. On 4/16/18 client states that swelling has improved and she now has full use of arm. Slight redness in area, but much improved.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Breath sounds abnormal, Chills, Condition aggravated, Cough
Clinical narrative: I gradually became exhausted some hours after injection and by about 8 hours later, was completely wiped out so I went to bed early but had generally sleepless night -- woke continuously with chills, severe shivering, headache, stomach gas, shoulder muscle pain, coughing, respiratory weirdness (audible noise when breathing in), and extreme thirst.  The next day (day 1 after injection) continued to feel exhausted, with intermittent chills and continued shoulder muscle pain, low energy to do anything, plus my stomach was off, little appetite, nothing tasted right. Was able to get good night's sleep the second night after the injection. Day 2: symptoms better but still very tired, with muscle soreness, some coughing, some chills, and stomach/appetite still off. Day 3: prior symptoms better but still coughing and notice some throat soreness -- but lots of wind here and pollen yesterday and today so maybe those symptoms are related to seasonal allergies rather than the shot. I think I'm hopefully pretty much past the vaccination reaction, unless the respiratory symptoms are related -- unknown to me at this point.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dysgeusia, Fatigue, Flatulence, Gastric disorder
Clinical narrative: I gradually became exhausted some hours after injection and by about 8 hours later, was completely wiped out so I went to bed early but had generally sleepless night -- woke continuously with chills, severe shivering, headache, stomach gas, shoulder muscle pain, coughing, respiratory weirdness (audible noise when breathing in), and extreme thirst.  The next day (day 1 after injection) continued to feel exhausted, with intermittent chills and continued shoulder muscle pain, low energy to do anything, plus my stomach was off, little appetite, nothing tasted right. Was able to get good night's sleep the second night after the injection. Day 2: symptoms better but still very tired, with muscle soreness, some coughing, some chills, and stomach/appetite still off. Day 3: prior symptoms better but still coughing and notice some throat soreness -- but lots of wind here and pollen yesterday and today so maybe those symptoms are related to seasonal allergies rather than the shot. I think I'm hopefully pretty much past the vaccination reaction, unless the respiratory symptoms are related -- unknown to me at this point.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Middle insomnia, Musculoskeletal pain, Myalgia
Clinical narrative: I gradually became exhausted some hours after injection and by about 8 hours later, was completely wiped out so I went to bed early but had generally sleepless night -- woke continuously with chills, severe shivering, headache, stomach gas, shoulder muscle pain, coughing, respiratory weirdness (audible noise when breathing in), and extreme thirst.  The next day (day 1 after injection) continued to feel exhausted, with intermittent chills and continued shoulder muscle pain, low energy to do anything, plus my stomach was off, little appetite, nothing tasted right. Was able to get good night's sleep the second night after the injection. Day 2: symptoms better but still very tired, with muscle soreness, some coughing, some chills, and stomach/appetite still off. Day 3: prior symptoms better but still coughing and notice some throat soreness -- but lots of wind here and pollen yesterday and today so maybe those symptoms are related to seasonal allergies rather than the shot. I think I'm hopefully pretty much past the vaccination reaction, unless the respiratory symptoms are related -- unknown to me at this point.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Seasonal allergy, Thirst
Clinical narrative: I gradually became exhausted some hours after injection and by about 8 hours later, was completely wiped out so I went to bed early but had generally sleepless night -- woke continuously with chills, severe shivering, headache, stomach gas, shoulder muscle pain, coughing, respiratory weirdness (audible noise when breathing in), and extreme thirst.  The next day (day 1 after injection) continued to feel exhausted, with intermittent chills and continued shoulder muscle pain, low energy to do anything, plus my stomach was off, little appetite, nothing tasted right. Was able to get good night's sleep the second night after the injection. Day 2: symptoms better but still very tired, with muscle soreness, some coughing, some chills, and stomach/appetite still off. Day 3: prior symptoms better but still coughing and notice some throat soreness -- but lots of wind here and pollen yesterday and today so maybe those symptoms are related to seasonal allergies rather than the shot. I think I'm hopefully pretty much past the vaccination reaction, unless the respiratory symptoms are related -- unknown to me at this point.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, fatigue, achiness, stomach upset.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Decreased appetite, Dizziness, Feeling cold
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 68-year-old female patient who received SHINGRIX (batch number 3S354, expiry date 7th July 2020) and (batch number X3M27, expiry date 29th August 2020). Concomitant products included SHINGRIX. On 28th March 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, the dose was an unknown dose. On 28th March 2018, less than an hour after receiving SHINGRIX, the patient experienced dizziness, shivering, feeling cold and body temperature increased. On an unknown date, the patient experienced nausea, appetite lost and headache. On an unknown date, the outcome of the dizziness, nausea, appetite lost, shivering, headache, feeling cold and body temperature increased were recovered/resolved. It was unknown if the reporter considered the dizziness, appetite lost, shivering, headache, feeling cold and body temperature increased to be related to SHINGRIX. The reporter considered the nausea to be related to SHINGRIX. Additional details were provided as follows: The patient did not have any other concomitant medications. The patient received the 2nd dose of SHINGRIX, 60 days after the 1st dose in SHINGRIX series. The patient did not receive any other vaccines on date of SHINGRIX vaccination. The lot number (X3M27) and expiration date (29th August 2020) were provided for the solution. The patient was dizzy within 30 to 50 minutes after receiving SHINGRIX. Less than a day (within 5 hours) after receiving SHINGRIX, the patient experienced shivering, described as shivering uncontrollably, feeling cold, and temperature of 99 degree F (body temperature increased). In 2018, less than a month after receiving SHINGRIX, the patient experienced nausea, appetite lost and headache. These events continued intermittently and completely resolved as of 5th April 2018. The reporter denied the events jeopardized or required intervention to prevent life threatening outcomes such as death, hospitalization, or disability. The patient advised the reporter that she was open to contact from GlaxoSmithKline should any additional details be required. The reporter could not confirm or deny the patient provided permission to contact healthcare professional.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 68-year-old female patient who received SHINGRIX (batch number 3S354, expiry date 7th July 2020) and (batch number X3M27, expiry date 29th August 2020). Concomitant products included SHINGRIX. On 28th March 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, the dose was an unknown dose. On 28th March 2018, less than an hour after receiving SHINGRIX, the patient experienced dizziness, shivering, feeling cold and body temperature increased. On an unknown date, the patient experienced nausea, appetite lost and headache. On an unknown date, the outcome of the dizziness, nausea, appetite lost, shivering, headache, feeling cold and body temperature increased were recovered/resolved. It was unknown if the reporter considered the dizziness, appetite lost, shivering, headache, feeling cold and body temperature increased to be related to SHINGRIX. The reporter considered the nausea to be related to SHINGRIX. Additional details were provided as follows: The patient did not have any other concomitant medications. The patient received the 2nd dose of SHINGRIX, 60 days after the 1st dose in SHINGRIX series. The patient did not receive any other vaccines on date of SHINGRIX vaccination. The lot number (X3M27) and expiration date (29th August 2020) were provided for the solution. The patient was dizzy within 30 to 50 minutes after receiving SHINGRIX. Less than a day (within 5 hours) after receiving SHINGRIX, the patient experienced shivering, described as shivering uncontrollably, feeling cold, and temperature of 99 degree F (body temperature increased). In 2018, less than a month after receiving SHINGRIX, the patient experienced nausea, appetite lost and headache. These events continued intermittently and completely resolved as of 5th April 2018. The reporter denied the events jeopardized or required intervention to prevent life threatening outcomes such as death, hospitalization, or disability. The patient advised the reporter that she was open to contact from GlaxoSmithKline should any additional details be required. The reporter could not confirm or deny the patient provided permission to contact healthcare professional.
Sex: U
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Foetal hypokinesia, Ultrasound antenatal screen, Wrong drug administered
Clinical narrative: This spontaneous report was received from the patient's grandmother and refers to an unborn patient. The patient's mother was 20 year of age with no drug reactions or allergies. Her concurrent conditions included high cholesterol and fatigue and she was also a mononucleosis carrier. At the time of the report on 25-FEB-2016, the patient's mother was 30 weeks pregnant with LMP (last menstrual period) of 30-JUL-2015, EDD (estimated date of delivery) of 05-MAY-2016 and date of conception of 13-AUG-2015. The pregnancy outcome was pending. On 11-FEB-2016 (reported as "2 weeks ago"), the patient's mother had visited her physician for her 28-week examination. The physician advised, that she should take a "whooping cough vaccine". On an unknown date in February 2016, the patient's mother was erroneously vaccinated with a dose of GARDASIL (lot # was not provided) first injection, 0.5 ml, intramuscularly for prophylaxis instead of receiving a "whooping cough vaccine". Concomitant therapies included prenatal vitamins. The patient's mother sought medical attention and was given an ultrasound to check progress of the baby (patient) in uterus (results were not provided). Since an unknown date in February 2016 (reported as "since that time"), the patient's mother noted that the baby (patient) had "flipped" and felt less active. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. This is one of two reports received from the same source. Additional information has been requested. This is an amended report. The suspect therapy was corrected to GARDASIL. Sender's Comments: US-009507513-1602USA012213: MERCK 1603USA001784: Mfr number.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: This spontaneous report was received from a physician, it refers to a 12 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications. On 20-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9 (lot N021732, expiration date 01-FEB-2020), for prophylaxis (dose and route of administration were not reported). On 20-MAR-2018, after receiving 1st dose of GARDASIL 9, the patient, who was seated in a chair at the time of vaccination,  passed out (syncope), it was also reported that the patient fall back in chair and looked pale in color. The physician further reported that her heart rate, respiratory rate were within normal limits and after 20 minutes of observation was discharge to come. At the reporting time the outcome of the events was reported as recovered on 20-MAR-2018. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the events.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Cervix carcinoma, Papilloma viral infection, Vaccination failure
Clinical narrative: This initial spontaneous report was received from the mother of a currently 26 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. In 2003 or 2004, at the age of 12, the patient was vaccinated with GARDASIL 9 (dose, route, lot and number in series not provided). However, the mother also could not confirm whether the product was GARDASIL 9 or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine GARDASIL (note that GARDASIL was approved for marketing in June 2006 and GARDASIL 9 was approved for marketing in December 2014). The mother reported that GARDASIL 9 did not work the way it claimed. On an unspecified date (but reported as "recently"), the patient was diagnosed with cervical cancer and high grade HPV types 18 and 16.  Due to the diagnosis, the patient "has to have some, if not all, of her cervix removed." The patient has many medical bills due to the issues that resulted in the vaccination failure and the mother was trying to get her daughter's past, current, and possibly future medical bills covered by Merck. The mother stated if she needs to, she will get a lawyer. It was not specified whether the vaccination series was completed. The outcome of the events was unknown. Causality assessment was not provided. Upon internal review, cervical cancer was considered medically significant. The reporter did not provide consent to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 27-AUG-2012, 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, the patient subsequently contracted a persistent strain of herpes zoster. On or about 29-JUL-2013, the patient was treated by a physician for severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient has been prescribed Valacyclovir and Ibuprofen for management of her painful symptoms. As a direct a proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster infection neurological, Pain, Rash vesicular
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 11-MAY-2016, 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, and the patient subsequently contracted a persistent strain of herpes zoster with complications. On or about 25-MAY-2016, the patient was treated by a physician for a persistent and severe vesicular rash accompanied by nerve pain which was diagnosed as severe herpes neuropathy. The patient has been prescribed KENALOG and tramadol for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and 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: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye pruritus, Eye swelling, Mouth swelling, Oral pruritus
Clinical narrative: Severe aching, fever, chills, swelling around eyes and mouth with itching, treated at home with TYLENOL and BENADRYL. Took a week for swelling, redness and itching to decrease around eyes and mouth. Fever, aching, and chills gone in 48 hours. No other medical intervention needed. Administered by Pharmacist.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Severe aching, fever, chills, swelling around eyes and mouth with itching, treated at home with TYLENOL and BENADRYL. Took a week for swelling, redness and itching to decrease around eyes and mouth. Fever, aching, and chills gone in 48 hours. No other medical intervention needed. Administered by Pharmacist.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Very painful and sore at injection site lasting past usual 2-3 days.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site exfoliation
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site exfoliation in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site exfoliation. On an unknown date, the outcome of the injection site exfoliation was unknown. The reporter considered the injection site exfoliation to be possibly related to SHINGRIX. Additional details were provided as follows: The doctor said that the patient received the SHINGRIX injection at a pharmacy about 5 weeks before the date of reporting. The physician treated the patient about 3 weeks before the date of reporting (2 weeks after the injection because her skin was peeling like bad sunburn at the injection site. The physician thought the skin peeling was most likely related to the SHINGRIX injection. This was much as he could remember but he would research for additional information and would like to be contacted for additional information. This case was linked with A0916427A and A0653798A, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Rash, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in an unspecified number of patients who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema, swelling and rash. On an unknown date, the outcome of the erythema, swelling and rash were unknown. It was unknown if the reporter considered the erythema, swelling and rash to be related to Influenza vaccine quadrivalent unspecified season. Additional information was received as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that the patient had experienced similar localized reactions such as redness, rash and swelling which were to the reactions experienced after being vaccinated with SHINGRIX vaccine (refer case US2018059343) as observed by the pharmacist. This case was linked with case US2018046768, reported by the same reporter.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Nausea, Presyncope
Clinical narrative: Pt had severe vasovagal response within 2-3 minutes of administration, BP dropped 77/46 HR 41, to 84/64 HR 51 for more than 15 minutes, nausea. Patient remained conscious and responsive. EMS was activated, they monitored for 15 minutes, BP stabilized. Patient declined to go to ER.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration
Clinical narrative: At time of appointment, patient was noted to have 1 HPV vaccine given 8/28/06. Then when rest of records were received and obtained after patient left, patient was noted to have HPV vaccine on 8/7/08, 8/6/07, 8/5/08 and 11/6/06. Therefore, she would have gotten a 6th dose of the vaccine today.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Insomnia, Irritability, Pyrexia, Rash
Clinical narrative: Fever, rash, trouble sleeping, extreme fussiness.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Impaired driving ability, Mobility decreased, Skin warm, Tenderness
Clinical narrative: For the first few days it was not too bad but now it is tender, warm. Cannot tell if it is swollen or red. Cannot use it to drive. Cannot lift it.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Neck pain, Rash, Rash vesicular
Clinical narrative: Patient reported no adverse events with the 1st dose. With the 2nd dose on 4/14/18, she said she experienced back/neck pain and a rash resembling herpes on her lower leg. This occurred in the afternoon following administration of the vaccine. Patient reports feeling better within 24 hrs of the vaccine.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain
Clinical narrative: Extreme pain in the deltoid muscle that has lasted months. Unable to raise arm without extreme pain. Pain is finally tolerable (but not fully resolved) 7 months after receiving the vaccination.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Sleep disorder
Clinical narrative: Sleep Disturbance.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Blood pressure increased, Chest X-ray abnormal, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Patient reported pain and redness at injection site as well as increased blood pressure. Patient notes he felt really sick afterwards and proceeded to the ER where he was diagnosed with Community acquired pneumonia.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia, X-ray
Clinical narrative: Patient reported pain and redness at injection site as well as increased blood pressure. Patient notes he felt really sick afterwards and proceeded to the ER where he was diagnosed with Community acquired pneumonia.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Neuralgia
Clinical narrative: Patient got a rash around the site the injection was given two days later and also had nerve pain. She went to Urgent Care at this time and states she was treated for Shingles.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin burning sensation, Skin warm
Clinical narrative: Pt stated that on 4/15/18 they noticed redness that burns warm on right buttocks that appeared separately from vaccination.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Head injury, Laboratory test normal, Loss of consciousness, Syncope
Clinical narrative: Patient had a syncopal event with LOC, fall and blunt trauma to the left forehead above the eye. He was admitted to an outside hospital for workup of CV etiologies which was negative.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient noticed fluid/swelling in arm with redness and warmth around site beginning the day after vaccine. 6 days later experiencing pain, swelling in lower arm/tricep area to armpit with redness and itching. Patient reports fever during the past week. Swelling and pain moved from area of immunization to back of arm. Patient to being methylprednisolone treatment.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient noticed fluid/swelling in arm with redness and warmth around site beginning the day after vaccine. 6 days later experiencing pain, swelling in lower arm/tricep area to armpit with redness and itching. Patient reports fever during the past week. Swelling and pain moved from area of immunization to back of arm. Patient to being methylprednisolone treatment.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient reported pain at first then swelling later in the evening of her arm where the vaccine was given.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: Extreme itching at site. Red and swollen from shoulder to elbow for 10 days.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Cold sweat, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Immediately after the injection (less than a minute), she was lightheaded & dizzy, very pale/grey, had ringing in the ears. She said she didn't feel good, then fainted/passed out. She began twitching. She was very clammy to the touch and she was shivering cold. The doctor was notified right away and I (her mother) was able to wake her, by then the doctor was in the room. The doctor had my daughter lay on her back with her knees to her chest for a few minutes. After a few minutes, her well child visit was able to be completed. After the exam, my daughter moved from the exam table to a chair to begin putting her clothing back on. She was able to get her pants on before she just sat there feeling nauseous along with lightheaded, dizzy, pale/grey, ringing in the ears for a second time. I was able to get her back to the exam table to lay down just before she again fainted. She again felt cold and clammy, she was shivering. The nurse happened to pop her head back in and quickly spoke to the doctor who advised my daughter to have a Popsicle. That was actually very helpful. My daughter had eaten breakfast, but that was about four hours prior to the vaccine. After all of this, she is mentally and physically exhausted. She is moving very slowly and deliberately. Every time she stands, it takes effort because of the dizziness/lightheaded feeling. It will be a few days before I can fully say that she's okay. As a parent, this is very traumatic. I made the choice to give her this vaccine, but will not be finishing the dosing.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling cold, Immediate post-injection reaction, Incomplete course of vaccination, Loss of consciousness, Muscle twitching
Clinical narrative: Immediately after the injection (less than a minute), she was lightheaded & dizzy, very pale/grey, had ringing in the ears. She said she didn't feel good, then fainted/passed out. She began twitching. She was very clammy to the touch and she was shivering cold. The doctor was notified right away and I (her mother) was able to wake her, by then the doctor was in the room. The doctor had my daughter lay on her back with her knees to her chest for a few minutes. After a few minutes, her well child visit was able to be completed. After the exam, my daughter moved from the exam table to a chair to begin putting her clothing back on. She was able to get her pants on before she just sat there feeling nauseous along with lightheaded, dizzy, pale/grey, ringing in the ears for a second time. I was able to get her back to the exam table to lay down just before she again fainted. She again felt cold and clammy, she was shivering. The nurse happened to pop her head back in and quickly spoke to the doctor who advised my daughter to have a Popsicle. That was actually very helpful. My daughter had eaten breakfast, but that was about four hours prior to the vaccine. After all of this, she is mentally and physically exhausted. She is moving very slowly and deliberately. Every time she stands, it takes effort because of the dizziness/lightheaded feeling. It will be a few days before I can fully say that she's okay. As a parent, this is very traumatic. I made the choice to give her this vaccine, but will not be finishing the dosing.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Pallor, Syncope, Tinnitus
Clinical narrative: Immediately after the injection (less than a minute), she was lightheaded & dizzy, very pale/grey, had ringing in the ears. She said she didn't feel good, then fainted/passed out. She began twitching. She was very clammy to the touch and she was shivering cold. The doctor was notified right away and I (her mother) was able to wake her, by then the doctor was in the room. The doctor had my daughter lay on her back with her knees to her chest for a few minutes. After a few minutes, her well child visit was able to be completed. After the exam, my daughter moved from the exam table to a chair to begin putting her clothing back on. She was able to get her pants on before she just sat there feeling nauseous along with lightheaded, dizzy, pale/grey, ringing in the ears for a second time. I was able to get her back to the exam table to lay down just before she again fainted. She again felt cold and clammy, she was shivering. The nurse happened to pop her head back in and quickly spoke to the doctor who advised my daughter to have a Popsicle. That was actually very helpful. My daughter had eaten breakfast, but that was about four hours prior to the vaccine. After all of this, she is mentally and physically exhausted. She is moving very slowly and deliberately. Every time she stands, it takes effort because of the dizziness/lightheaded feeling. It will be a few days before I can fully say that she's okay. As a parent, this is very traumatic. I made the choice to give her this vaccine, but will not be finishing the dosing.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Lip swelling, Pruritus, Rash
Clinical narrative: Patient called today to report on reaction. Per patient, has a high pain tolerance level. Pt noticed on Wed/Thurs. (04/11/18) a slight itch on neck, swelling and a pink color at injection site, pt also noticed itch and rash around lymph nodes area of neck, and groin area. Rash/itch persisted on Saturday and patient took a BENADRYL, got better but once BENADRYL wears off, pt feels itchy again. On Sunday (04/15/18) pt noticed lips a bit swollen, pt took a chlorpheniramine and got better. As of today, 4/16/18, still is still present, all over, but getting better. Lips no longer swollen as of today. I encouraged patient to notify PCP of reaction and call 911 if symptoms ever get worse (lips swelling or difficulty breathing, etc.).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reported developing shingle 3 days after the administration of the vaccine---diagnosis was confirmed by her physician.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Patient developed headache, low-grade fever, and chills half hour after receiving the shot. The fever continued for 24 hours, headache for 2 days.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Nausea
Clinical narrative: This spontaneous report was received from a consumer referring to her aunt a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU Injection by unspecified route; in gluteus muscle (dose, frequency, lot # and expiration date were unknown) for prophylaxis, the patient had no known adverse effects after receiving the vaccine. Subsequently, on 02-APR-2018, the patient received the first dose in the two dose series of SHINGRIX, and on an unspecified date after receiving the vaccine, the patient had been having redness and pain at the injection site, and nausea. At the time of the report, the outcome of vaccination site pain, nausea and vaccination site erythema was reported as not recovered. The patient did not mention the causality assessment between the events, and ZOSTAVAX and SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 13-APR-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 27-FEB-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-DEC-2015, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed with herpes zoster, or shingles. The patient has been prescribed ZOVIRAX for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 13-APR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 28-FEB-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-NOV-2014, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed with herpes zoster, or shingles. The patient has been prescribed gabapentin for management of his 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: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-DEC-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, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-JAN-2016, the patient was treated by a physician, for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed Acyclovir for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further 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 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 01-NOV-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, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-SEP-2016, the patient was treated at a hospital for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Nerve injury, Pain, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 16-SEP-2010, 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, and he subsequently contracted a persistent strain condition of herpes zoster. On or about 21-JUL-2014, the patient was treated at a medical Center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 22-JUL-2014, the patient sought further treatment at physician office, for continued and worsening shingles-related symptoms, which was diagnosed as post-herpetic trigeminal neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient has been prescribed FAMVIR, PERCOCET, ELAVIL, gabapentin, and lidocaine for management of his painful and persistent symptoms. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 16-SEP-2010, 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, and he subsequently contracted a persistent strain condition of herpes zoster. On or about 21-JUL-2014, the patient was treated at a medical Center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 22-JUL-2014, the patient sought further treatment at physician office, for continued and worsening shingles-related symptoms, which was diagnosed as post-herpetic trigeminal neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient has been prescribed FAMVIR, PERCOCET, ELAVIL, gabapentin, and lidocaine for management of his painful and persistent symptoms. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, 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 an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 24-APR-2013, the patient was inoculated at a physician office 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, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-AUG-2016, the patient was treated at a physician office for blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient has been prescribed acyclovir and LYRICA for management of her painful symptoms. As a direct an proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain lower, Chills, Headache, Herpes zoster, Myalgia
Clinical narrative: Patient first developed severe headache, chills, myalgia; on 4/2/2018. By 4/11/2018 he had right lower abdominal pain and rash around the same area to his lower right back. Was diagnosed and treated for shingles.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Patient first developed severe headache, chills, myalgia; on 4/2/2018. By 4/11/2018 he had right lower abdominal pain and rash around the same area to his lower right back. Was diagnosed and treated for shingles.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient first developed severe headache, chills, myalgia; on 4/2/2018. By 4/11/2018 he had right lower abdominal pain and rash around the same area to his lower right back. Was diagnosed and treated for shingles.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Redness and swelling at site of injection, muscle aches and headache, fever starting the night after and for about two days; took ADVIL; no additional treatment sought.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Abnormal behaviour, Dyspnoea, Erythema, Pain, Paraesthesia
Clinical narrative: After administration, patient was advised to wait 20-30 minutes for any adverse reactions. Mother and patient failed to wait, then received call at 10:53 AM by mother informing a medical assistant that her daughter was starting swell in bilateral arms and face with tingly/itchy sensation and throbbing sensation in face. Mother also mentioned patient was having unusual behavior. Pt arrived at 10:55 AM. Brought into an exam room with redness in face and hands/arms. Then began to C/O swelling in throat and SOB. Another medical assistant examined patient, physician was brought in for examination with approval to administer EPI 0.3 mg. Patient agreed and administered, during injection dispatch was contact to send EMS for pt to be taken to ER for evaluation. Physician then order Diphenhydramine 50 mg IM, administered in left deltoid. EMS arrived and taken to ER.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Peripheral swelling, Pharyngeal oedema, Pruritus, Swelling face
Clinical narrative: After administration, patient was advised to wait 20-30 minutes for any adverse reactions. Mother and patient failed to wait, then received call at 10:53 AM by mother informing a medical assistant that her daughter was starting swell in bilateral arms and face with tingly/itchy sensation and throbbing sensation in face. Mother also mentioned patient was having unusual behavior. Pt arrived at 10:55 AM. Brought into an exam room with redness in face and hands/arms. Then began to C/O swelling in throat and SOB. Another medical assistant examined patient, physician was brought in for examination with approval to administer EPI 0.3 mg. Patient agreed and administered, during injection dispatch was contact to send EMS for pt to be taken to ER for evaluation. Physician then order Diphenhydramine 50 mg IM, administered in left deltoid. EMS arrived and taken to ER.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Flank pain, Impaired work ability, Injection site reaction, Migraine
Clinical narrative: Dizziness, migraine headache for 30 hours, body aches, sore neck and arms, sore sides, unable to work for 27+ hours, red rash on arm (injection site) for 4 days.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Rash erythematous
Clinical narrative: Dizziness, migraine headache for 30 hours, body aches, sore neck and arms, sore sides, unable to work for 27+ hours, red rash on arm (injection site) for 4 days.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Disturbance in attention, Dizziness, Impaired work ability, Injection site erythema
Clinical narrative: Dizziness, migraine headache for 30 hours, body aches, sore neck and arms, sore sides, unable to work for 27+ hours, red rash on arm (injection site) for 4 days.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Loss of personal independence in daily activities, Migraine, Neck pain, Pain
Clinical narrative: Dizziness, migraine headache for 30 hours, body aches, sore neck and arms, sore sides, unable to work for 27+ hours, red rash on arm (injection site) for 4 days.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Dizziness, migraine headache for 30 hours, body aches, sore neck and arms, sore sides, unable to work for 27+ hours, red rash on arm (injection site) for 4 days.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Flank pain, Impaired work ability, Injection site reaction, Migraine
Clinical narrative: Dizziness, migraine headache for 30 hours. Body ache, sore neck and arms, sore sides. Unable to work for 27+ hours. Rash on arm 4 days. Unable to concentrate, dizziness. Severe migraine for over 30 hours. Aching in neck, back, sides (both). Whole body was aching. Red rash about 4 inches in diameter around injection site (on arm) (4 days). Unable to work for 27 hours. Unable to keep any commitments for this length of time or leave my home.