chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st July 2018, several hours after receiving SHINGRIX, the patient experienced general body pain and shivering. On 1st August 2018, the patient experienced weakness. On an unknown date, the outcome of the general body pain, weakness and shivering were recovered/resolved. It was unknown if the reporter considered the general body pain, weakness and shivering to be related to SHINGRIX. Additional information was received as follows: At 14:00, the patient received SHINGRIX on the right arm. The patient stated that the night of vaccination she experienced body ache, and shivering. Next day, the patient experienced weakness. The patient had denied permission to contact their physician. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Injection site pain, Pain, Rash
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 2nd August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, raised rash, vesicular rash and painful rash. On an unknown date, the outcome of the injection site pain, raised rash, vesicular rash and painful rash were unknown. It was unknown if the reporter considered the injection site pain, raised rash, vesicular rash and painful rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced soreness at the injection site, but below that area she had raised areas of redness that were sore to the touch. The reporter thought that it looks like a mild case of shingles. After hours voicemail, the caller only provided the patient's name, but did not spell it.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Swelling
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 2nd August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, raised rash, vesicular rash and painful rash. On an unknown date, the outcome of the injection site pain, raised rash, vesicular rash and painful rash were unknown. It was unknown if the reporter considered the injection site pain, raised rash, vesicular rash and painful rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced soreness at the injection site, but below that area she had raised areas of redness that were sore to the touch. The reporter thought that it looks like a mild case of shingles. After hours voicemail, the caller only provided the patient's name, but did not spell it.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site vesicles, Scar
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 20th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site blisters and bullae. On an unknown date, the patient experienced scar. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site blisters and bullae were recovered/resolved and the outcome of the scar was unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site blisters, bullae and scar to be related to SHINGRIX. Additional details were provided as follows: The patient recently reported swelling, redness and blisters at the injection site within 24 hours after receiving vaccine. It was also reported that patient developed a 3 cm superficial bullae. At the time of reporting, the patient's symptoms had resolved however the patient had scaring on arm (latency was less than a year after receiving vaccination) where blisters were. The healthcare professional reported that, the patient received vaccine at another facility, possibly local pharmacy, however was unsure of the exact location.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of axillary lymph nodes enlarged in a 66-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Concomitant products included PNEUMOVAX 23. On 27th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th July 2018, several hours after receiving SHINGRIX, the patient experienced axillary lymph nodes enlarged. On 29th July 2018, the outcome of the axillary lymph nodes enlarged was recovered/resolved. It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to SHINGRIX. Additional details were provided as follows: On 27th July 2018, the patient received PNEUMOVAX 23. The patient received SHINGRIX in the left arm. The patient developed an enlarged axillary lymph node on the same arm as the vaccine was given within 24 hours that lasted for 2 day and currently resolved.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose 6 months ago). On 6th August 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 6th August 2018, unknown after receiving SHINGRIX the patient experienced intramuscular formulation administered by other route. On 7th August 2018, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The caller reported that he got his 2nd dose of SHINGRIX yesterday on 6th August 2018, and was told by the pharmacist that she was administering it into the fatty part of his arm. She did administer it in the back of his arm and not into the muscle, which led to intramuscular formulation administered by other route. Today on 7th August 2018 it was very red and swollen around the injection site, the area was about the size of a baseball and raised up a good 1/2 inch from his arm. The patient got his 1st dose of SHINGRIX about 6 months ago. The patient did not know if that was also administered subcutaneously or not, but thought the reaction was the same then.
Age: 71.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 71-year-old male patient who received BOOSTRIX (batch number 54B74, expiry date 14th September 2020) for prophylaxis. Co-suspect products included SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. Concomitant products included PREVNAR. On 18th May 2018, the patient received BOOSTRIX (intramuscular) and the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving BOOSTRIX and SHINGRIX, the patient experienced pain and tingling. On an unknown date, the outcome of the pain and tingling were not recovered/not resolved. It was unknown if the reporter considered the pain and tingling to be related to BOOSTRIX and SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient received SHINGRIX, BOOSTRIX, and PREVNAR, all on 18th May 2018. The patient stated it was not severe. The healthcare professional was not sure when the patient 1st started experiencing these adverse events.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Rash erythematous
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, itchy rash, headache, fatigue, muscle pain, erythematous rash and raised rash. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the injection site pain, itchy rash, headache, fatigue, muscle pain, erythematous rash and raised rash were unknown. It was unknown if the reporter considered the injection site pain, itchy rash, headache, fatigue, muscle pain, erythematous rash and raised rash to be related to SHINGRIX. Additional details reported as follows: The patient experienced local injection site soreness. The caller reported that 2 days after the injection the patient developed red raised itchy rash in spots all over back, up to base of neck around shoulders and down the front trunk. The caller stated that patient used TYLENOL for pain and BENADRYL for itchy rash.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, itchy rash, headache, fatigue, muscle pain, erythematous rash and raised rash. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the injection site pain, itchy rash, headache, fatigue, muscle pain, erythematous rash and raised rash were unknown. It was unknown if the reporter considered the injection site pain, itchy rash, headache, fatigue, muscle pain, erythematous rash and raised rash to be related to SHINGRIX. Additional details reported as follows: The patient experienced local injection site soreness. The caller reported that 2 days after the injection the patient developed red raised itchy rash in spots all over back, up to base of neck around shoulders and down the front trunk. The caller stated that patient used TYLENOL for pain and BENADRYL for itchy rash.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 84-year-old female patient who received SHINGRIX (batch number JC92P ? the reported lot number dose not match with any GSK lot number, expiry date November 2020) for prophylaxis. On 5th August 2018, the patient received the 1st dose of SHINGRIX. On 6th August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash. The patient was treated with hydrocortisone. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The pharmacist reported that a patient experienced a rash on their left deltoid. The patient was counseled by the pharmacist to apply hydrocortisone.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 4 days after receiving SHINGRIX, the patient experienced shingles, sickness and fever. In April 2018, the outcome of the sickness and fever were recovered/resolved. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles, sickness and fever to be related to SHINGRIX. Additional details were reported as follows: The patient was sick with fever for 3 days, then on the 4th day after vaccination, the patient broke out with shingles. The patient requested to help and asked what was happening to her. The patient stated that she had no insurance and paid over 300 dollars out of pocket and she was a senior citizen. The patient asked, if it would not going to help, and obviously made things worse, then she would like to get refund. The patient had send the receipts from the vaccines given by the pharmacy. For tolerance to next dose, refer case US2018GSK143781.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient had all of the side effects, and had question that how long would these last.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown. It was unknown if the reporter considered the joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller called in reporting that she experienced joints ache and overnight her joints ache was bad.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Feeling hot, Flushing, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown. It was unknown if the reporter considered the joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller called in reporting that she experienced joints ache and overnight her joints ache was bad.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown. It was unknown if the reporter considered the joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller called in reporting that she experienced joints ache and overnight her joints ache was bad.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included sickness. Previously administered products included SHINGRIX (fever and shingles after receiving 1st dose on 2nd April 2018, refer case US2018GSK142353)). On 3rd July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 3 days after receiving SHINGRIX, the patient experienced shingles, fever and sickness. In July 2018, the outcome of the fever and sickness were recovered/resolved. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles, fever and sickness to be related to SHINGRIX. Additional details were reported as follows: The patient waited for the allotted time before receiving 2nd dose of SHINGRIX vaccine after the 1st dose. The patient was sick with fever for 2 days before she broke out with shingles on the 3rd day after vaccination. The patient consistently had shingles outbreaks every 2 to 2 ½ weeks since then. One outbreak was starting to clear up when the next outbreak was beginning. The patient requested to help and asked what was happening to her. The patient stated that she had no insurance and paid over 300 dollars out of pocket and she was a senior citizen. The patient asked, if it would not going to help, and obviously made things worse, then she would like to get refund. The patient had send the receipts from the vaccines given by the pharmacy.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Twenty-four hours after receiving SHINGRIX, the patient experienced flu like symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a elderly patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for SHINGRIX, time to onset for event shingles were not provided. The age at vaccination was not reported. The patient was over the age of 70 years of age at the time of reporting. The patient received a SHINGRIX vaccine and broke out with shingles. This was all the information that the patient has provided. The healthcare professional explained that she needed to report the adverse event and said that she would not release any information without speaking to the patient first. The healthcare professional also instructed the patient to contact GlaxoSmithKline to report the adverse event.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 19 years old male patient who received a 0.5 mL third dose of MENACTRA (lot number: U5917AA, expiry date: 30-Jun-2019) intramuscularly in left deltoid instead of BEXSERO (lot number and expiry date not reported) on 07-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Myalgia
Clinical narrative: Headache, muscle soreness, redness at injection site.
Age: 72.0
Sex: M
Vaccine: VARZOS, YF
Symptoms: Gingival discomfort, Herpes zoster
Clinical narrative: On 08/05/2018, I noticed that my gum on the upper left side of my mouth had become irritated from what I thought was a piece of food caught under my gum. This persisted for several days so I made an appointment with my dentist. On 08/09/2018 I went to my dentist. Upon inspecting my mouth, he said that it was a virus and then noted it was a mild case of shingles. He said to contact my doctor and the place I had the shot to note my reaction to the shingles shot I received a few days earlier. He said that no treatment was needed because it appeared the condition was going away on its own.
Age: 72.0
Sex: M
Vaccine: VARZOS, YF
Symptoms: Oral mucosal blistering, Oral mucosal erythema, Stomatitis
Clinical narrative: On 08/05/2018, I noticed that my gum on the upper left side of my mouth had become irritated from what I thought was a piece of food caught under my gum. This persisted for several days so I made an appointment with my dentist. On 08/09/2018 I went to my dentist. Upon inspecting my mouth, he said that it was a virus and then noted it was a mild case of shingles. He said to contact my doctor and the place I had the shot to note my reaction to the shingles shot I received a few days earlier. He said that no treatment was needed because it appeared the condition was going away on its own.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash papular, Rash pruritic
Clinical narrative: Patient wife reports that he experienced small blistering, itchy bumps/rash on knuckles of both hands and inner wrists starting about 3 days after injection. Started small and spread to a larger area on hands. Stopped spreading now but the rash is not going away after 10 days. Will be seeing doctor in the next day or two.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dental examination normal, Pain in jaw
Clinical narrative: One week after injection I began having intermittent jaw pain on right side. My dentist after a thorough exam ruled out any tooth or root problem. Pain episodes last a few minutes to several hours, are moderate to severe, and are not relieved by ibuprofen. They are unpredictable and are not correlated with heat, cold, or any specific foods.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red and hot 4 inch spot at the site of injection of the vaccination.
Age: 19.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Dyspnoea
Clinical narrative: Per medical assistant: Pt came in for college vaccines. I administered two vaccines Varicella and MC4 at 11:15AM. Pt was very anxious at first I suggested her to relax and had her relax her arm as I administered the first vaccine which was MCV4; I asked if she was ok her response was "Yes". After I said "Okay this is the last one" then I administered Varicella, after I was done she stated "Oh I felt that one". She then began to have trouble breathing. I immediately called Dr. and she came in, and so did the charge nurse, and MA. I began to get vitals as MA held her legs elevated upward. First set of vitals were BP: 136/76 HR: 41 min after went up to 50 T: 98.9 P: 97 min after went up to 100. We also administered 2 liters of 02 (Nasal). We stayed in the exam room with the pt. until she was able to respond to us, and until she was okay. Before she left clinic we asked if she was okay to walk pt. stated yes, pt. stated she does not feel dizzy or nauseous. Last vital sets were T: 98.1 P: 65 R: 16 BP: 114 74 O2: 99 at 11:45am.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Insomnia, Mobility decreased, Pain in extremity, Palpitations
Clinical narrative: 30 minutes after vaccine, experienced coughing, tightness in throat, itchy throat. I was advised to take an antihistamine which seemed to help the itchiness. 8 hours later, my arm was not mobile and in extreme pain. The shot was administered in my left upper arm, but the pain radiated down my arm into my hand and up across my clavicle. I have a dilated cardiomyopathy and had palpitations. My arm hurt so bad that I could not sleep that night.  My arm is much better after 24 hours. Also, I'm allergic to soy.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Throat irritation, Throat tightness
Clinical narrative: 30 minutes after vaccine, experienced coughing, tightness in throat, itchy throat. I was advised to take an antihistamine which seemed to help the itchiness. 8 hours later, my arm was not mobile and in extreme pain. The shot was administered in my left upper arm, but the pain radiated down my arm into my hand and up across my clavicle. I have a dilated cardiomyopathy and had palpitations. My arm hurt so bad that I could not sleep that night.  My arm is much better after 24 hours. Also, I'm allergic to soy.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever 100 degrees. Continued soreness at injection site. Slight chill, Fatigue, Infrequent head pain. All within 24 hours after vaccine injection. I am currently experiencing above symptoms .
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF immunoglobulin increased, CSF oligoclonal band absent, CSF protein increased, CSF white blood cell count increased, Gait disturbance
Clinical narrative: A few weeks after the first SHINGRIX vaccine patient developed a sensory level from bra line down to feet which led to gait instability and numbness. This was similar to the 2000 episode of transverse myelitis in that it was the exact same sensory level, but symptoms were more severe this time, and recovery this time has been prolonged and is still ongoing. My best impression as the treating neurologist is that she has multiple sclerosis based on the 2000 episode of tranverse myelitis, a 2015 episode of electric shocks down left leg, and the MRI appearance of multiple short segment cord lesions with brainstem and one periventricular lesion. None of the lesions were enhancing. She received steroids the end of May with some relief, but otherwise is still improving in regard to sensory loss and gait instability.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Pleocytosis, Sensory disturbance
Clinical narrative: A few weeks after the first SHINGRIX vaccine patient developed a sensory level from bra line down to feet which led to gait instability and numbness. This was similar to the 2000 episode of transverse myelitis in that it was the exact same sensory level, but symptoms were more severe this time, and recovery this time has been prolonged and is still ongoing. My best impression as the treating neurologist is that she has multiple sclerosis based on the 2000 episode of tranverse myelitis, a 2015 episode of electric shocks down left leg, and the MRI appearance of multiple short segment cord lesions with brainstem and one periventricular lesion. None of the lesions were enhancing. She received steroids the end of May with some relief, but otherwise is still improving in regard to sensory loss and gait instability.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received on 13-AUG-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 26-APR-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a hospital health center as recommended for routine adult health maintenance and for the long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. On or about 16-APR-2016, the patient was treated at an urgent care for the onset of a rash, which was diagnosed as shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX), ondansetron hydrochloride (ZOFRAN) and ibuprofen for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving the ZOSTAVAX for the long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of ZOSTAVAX 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, Pain, Scab, Skin lesion
Clinical narrative: Information has been received on 13-AUG-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. A physician recommended and/or administered the ZOSTAVAX to the patient for the long-term prevention of shingles and zoster-related injuries. On or about 18-JUL-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. On or about 04-OCT-2016, the patient was treated by a physician for multiple crusted lesions and was diagnosed with herpes zoster. The patient was prescribed valacyclovir hydrochloride (VALTREX) and lidocaine (LIDODERM) for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving the ZOSTAVAX for the long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of ZOSTAVAX the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with an expired dose of VARIVAX for prophylaxis, lot # L034369 and expiration date reported as 11-SEP-2017 (dose, strength, frequency, and route of administration were unknown). No adverse effects were reported.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Erythema, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of pain in a 55-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 14th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th February 2018, 1 days after receiving SHINGRIX, the patient experienced pain, erythema, fever and chills. The patient was treated with Antibiotics (Brand Names Not Known)). On 24th February 2018, the outcome of the pain, erythema, fever and chills were recovered/resolved. The reporter considered the pain, erythema, fever and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the licensed nurse. The physician had ordered antibiotics for cellulitis.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who received 0.5 mL dose DAPTACEL (lot number: C5216AA, expiry date: 17-May-2019) intramuscularly in right deltoid instead of ADACEL (lot number and expiry date not reported) on 07-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, Vision blurred
Clinical narrative: Double and blurred vision, PCP doubts from vaccine, patient was unsure if symptoms started after vaccine but thinks they did, patient was advised to see eye doctor. Vaccine was not given at clinic, patient said she got it at Pharmacy.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt received vaccine in right deltoid on 8/10/18. Pt returned to the pharmacy on 8/14/18 and reported that he still had significant pain in his arm near the site and up to shoulder that was impeding his arm/shoulder mobility. Pt has not taken any NSAIDS or pain relievers. Pt said symptoms have improved, but are still significant. We advised pt to call his physician if pain does not subside. At this point, the pt says he will monitor his pain and call his physician if it does not continue to improve.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Impaired driving ability, Vision blurred
Clinical narrative: After the vaccination the patient became dizzy and had blurred vision. We had her to sit down and gave her water and a wet cloth to put on her neck. She sat for several minutes and I asked if she felt bad enough for us to call 911. She said she thought she would be ok but she said she wasn't stable enough to drive home. She sat for around 30 min and then called her dad to come pick her up. We escorted her to his car and they left. She said if she didn't start feeling better she was going to go to the ER and get checked.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt came in for a HC I printed WIR and it stated she need HepA and I gave her the injection when I look again pt had already received vaccination last year.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Gait disturbance, Headache, Laboratory test normal, Lip swelling
Clinical narrative: 1h later, patient had chills/fever, lip swelling, difficulty walking, poor memory, headache.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Memory impairment, Pyrexia
Clinical narrative: 1h later, patient had chills/fever, lip swelling, difficulty walking, poor memory, headache.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Erythema, Tinnitus
Clinical narrative: Two days later face turned red and ringing in ears. Checked blood pressure and it had skyrocketed to 202/85. This has never happened before. There was no difference in exercise or eating habits.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Severe popular rash all over lower legs, tops of feet and trunk. Unable to stop itching.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness 4x6 inch area of left Deltoid 24hrs after shot.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Rash vesicular, Vision blurred
Clinical narrative: Patient reported dry skin on arms, hand, and face. Patient said it looked like shingles but only had some pain. He reported blurry vision that continued for 2 days. Patient went to the Dr. and was treated with prednisone and his symptoms cleared up after a couple weeks.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Pain in extremity, Skin warm
Clinical narrative: Redness and excessive swelling in injected arm from shoulder to elbow, hot and painful to touch, last 3-4 days before resolution.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Immediate post-injection reaction, Muscle twitching, Mydriasis, Pallor, Seizure like phenomena
Clinical narrative: FIRST GAVE MENACTRA IN RIGHT ARM AND PATIENT HAD NO REACTION.  THEN, GAVE TDAP IN LEFT ARM AND IMMEDIATELY AFTER, WHILE PATIENT WAS SEATED ON EXAM TABLE, SHE TURNED PALE, HER PUPILS DILATED, AND SHE STARTED TO LEAN BACK.  SHE AND HER MOTHER LOWERED HER ON THE EXAM TABLE UNTIL SHE WAS LAYING DOWN.  SHE WAS LAYING DOWN FOR ABOUT 2-3 MINUTES, SAID SHE FELT A LITTLE BETTER AND TRIED TO SIT UP.  HER PUPILS DILATED AGAIN AND SHE STARTED TO HAVE VERY MILD SEIZURE-LIKE ACTIVITY IN WHICH HER UPPER AND LOWER LIMBS CONVULSED FOR ABOUT 2-3 SECONDS BEFORE SHE WAS LAYED BACK ON THE EXAM TABLE.  SHE LAID ON EXAM TABLE FOR ABOUT 10 MORE MINUTES.  I SUGGESTED SHE GO TO ED.  WE OBTAINED WHEELCHAIR AND MOM AND I HELPED PATIENT TO CHAIR.  DAD PULLED TO FRONT OF STORE TO PICK UP.  MOM SAID THEY WOULD TAKE HER TO ER.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Patient reported nausea vomiting dizziness and headache. She said these symptoms started about 5 and half hours after the vaccine administration. I spoke to her physician's office listed above and the nurse recommended fluids and rest. We are still waiting to follow up. Instructed pt that if symptoms get worse or do not improve in 24 hours to seek medical attention.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Balance disorder, Blister, Erythema, Headache, Pyrexia
Clinical narrative: Patient woke up this morning with fever up to 101, headache, felt wobbly for one hour and had a 6X6 cm area of redness with a 2cm area of vesicle cluster in the center of the redness.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: After giving the vaccination, the  injection site bled. I applied light pressure with gauze and the bleeding stopped immediately. There was an immediate bump on the area at the injection site approximately the size of a marble. The patient did not complain of pain. The customer remained seated in our waiting room for approximately 15 minutes while I called Sanofi to report the incidence. At no time did the patient report any dizziness, shortness of breath, or distress. Patient was advised to apply ice if needed and to follow up with doctor if the injection site became more swollen or painful. Patient was advised to call 911 if signs of anaphylaxis.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site haemorrhage, Injection site mass
Clinical narrative: After giving the vaccination, the  injection site bled. I applied light pressure with gauze and the bleeding stopped immediately. There was an immediate bump on the area at the injection site approximately the size of a marble. The patient did not complain of pain. The customer remained seated in our waiting room for approximately 15 minutes while I called Sanofi to report the incidence. At no time did the patient report any dizziness, shortness of breath, or distress. Patient was advised to apply ice if needed and to follow up with doctor if the injection site became more swollen or painful. Patient was advised to call 911 if signs of anaphylaxis.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Injection site pruritus, Injection site swelling, Oropharyngeal pain
Clinical narrative: Patient experienced chills, aches and unable to get out of bed for 2 days post injection. She also had a sore throat, and large swollen area around injection site with itching. This all started the day after the injection and the itching is still occuring a week later (although much more tolerable). Patient is in a long term care facility.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient experienced chills, aches and unable to get out of bed for 2 days post injection. She also had a sore throat, and large swollen area around injection site with itching. This all started the day after the injection and the itching is still occuring a week later (although much more tolerable). Patient is in a long term care facility.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Loss of consciousness, Skin discolouration
Clinical narrative: Patient was instructed to wait 15 minutes in the room sitting in chair provided. After 3 minutes felt lightheaded and laid her head against Dad's shoulder and proceeded to pass out. Dad picked up patient and laid her on the floor and called for help. With Dad, doctor, and medical assistant present, patient quickly came to on her own, but was very green in color and feeling very weak. After letting her lay for 5 minutes, she was helped to a sitting position against the wall with pillow behind her back and given water and some saltines. After 1 hour and evaluation patient was able to ambulate from the clinic with her father and felt fine. Father was given instructions to keep her hydrated and healthy foods tonight. If she is still feeling poorly tomorrow, to call and have her come in for appointment.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Mental status changes, Peripheral swelling, Skin irritation
Clinical narrative: Patient wife called stating his arm was red, swollen, and irritated at reaction site. Also states patient was hospitalized. She states changes in his mental state.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: PATIENT CALLED TO SAY HE HAD A SWOLLEN TONGUE AFTER THE VACCINATION.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: Fever, chills, fatigue, fogginess, diarrhea.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, excessive swelling from shoulder to elbow in injected arm, hot and painful to touch, resolved after 3-4 days, monitored, used TYLENOL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Somnolence, Vomiting
Clinical narrative: PT HAS REDDISH ON FACE, THROWING UP, SLEEPINESS.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PT has not complained about any adverse events as of 08/14/2018.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient came to pharmacy with bumps on left arm and he said had some also on his chest. The red bumps also itched. He said this started shortly after receiving the immunization.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Dysgeusia, Fatigue
Clinical narrative: Muscle pain, tired, weak, achy throughout body, shivering hot and cold, upset stomach, taste of medicine twice, gas.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Flatulence, Myalgia, Pain
Clinical narrative: Muscle pain, tired, weak, achy throughout body, shivering hot and cold, upset stomach, taste of medicine twice, gas.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Burning sensation, Injection site pain
Clinical narrative: Soon after receiving flu shot Left arm began burning. I figured it was just part of getting an IM. It burned like fire going down my arm for several months every day. The pain also went into my back. The pain slowly subsided over the past 9 months but it still hurts in the exact spot of the injection and I have to rub topical pain medication over the area every night.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: SHINGRIX administration site became red, warm to touch, area is about 5 inches across. Pt self admin ibuprofen to control symptoms. Pt reported that she had similar reactions for the first dose of her SHINGRIX on May 2, 2018. Pt also remembers having similar reactions when she had her Dtap shot many years ago.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Aldolase normal, Antinuclear antibody negative, Arthralgia, Blood creatine phosphokinase normal, Blood creatinine normal
Clinical narrative: A plethora of irritating symptoms: Aching feet, hands, toes, fingers; muscle aches and soreness in various areas, not necessarily all at the same time; stiff and painful right middle finger when waking  in AM, which is painful to straighten out; burning sensations in various areas, again not necessarily all at the same time; skin sensitive, as when putting on pants; fasciculations in various areas, especially left hand where thumb and index finger meet; tingling sensations in arms and legs; transitory sensations of weakness in legs and arms, like when an arm or leg partially "falls asleep" or as if pressure is being applied to a "soft spot" in the armpit.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Borrelia test negative, Burning sensation, C-reactive protein normal, Discomfort
Clinical narrative: A plethora of irritating symptoms: Aching feet, hands, toes, fingers; muscle aches and soreness in various areas, not necessarily all at the same time; stiff and painful right middle finger when waking  in AM, which is painful to straighten out; burning sensations in various areas, again not necessarily all at the same time; skin sensitive, as when putting on pants; fasciculations in various areas, especially left hand where thumb and index finger meet; tingling sensations in arms and legs; transitory sensations of weakness in legs and arms, like when an arm or leg partially "falls asleep" or as if pressure is being applied to a "soft spot" in the armpit.