chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Rash
Clinical narrative: Patient complains of a painful and burning rash on her upper, center back. The rash is comprised of six small, round, red bumps. Her skin appears irritated around the bumps. Patient reports pain from touch and clothing at the site of rash. Patient denies pruritis. Her primary care physician's office was closed for the day when she presented to the pharmacy. We were able to get ahold of Dr. on his personal number. He prescribed Valacyclovir 1g 3 times per day for 7 days. She is to be examined at his office tomorrow (8/10/18). I also recommended, and she purchased, OTC Lidocaine 4% cream. Patient reports that she has been immunized with ZOSTAVAX in the past, but I do not have the date recorded at the pharmacy. She told me that she was planning to babysit her four-month-old grandchild this week, and I advised against it.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Left arm pain starting that evening.  Radiating from the injection site all the way down arm and also to the left shoulder.  Very painful to move arm or raise shoulder.  Anti-inflammatories, rest and ice/heat.  Just started treating this.  Outcome yet to be determined.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Constant itching on arms and head for 2 months.
Age: 0.08
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a physician assistant and refers to 1-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was accidentally vaccinated with a dose of VAQTA lot # N030286 and expiration date: 10-NOV-2018 (dose and route of administration were not reported) instead of getting a pediatric dose of hepatitis b vaccine (recombinant) (manufacturer unknown), possibly due to product confusion. There were not adverse reactions reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as a severe herpetic rash. As a direct and proximate result of 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Muscle spasms, Nuclear magnetic resonance imaging, Pain management
Clinical narrative: This spontaneous report was received from the patient's mother, concerning a female patient of currently 30 years old. The patient's historical condition, concurrent condition or allergies were not reported. The reporter states that her daughter, received doses of GARDASIL 9  (laterality, strength, dose, route, frequency, lot# and expiration date were not reported) all (as vaccination for prophylaxis) on 23-AUG-2008, 10-NOV-2008 and 16-MAR-2009. On an unknown date in May 2009, also reported as two months after finishing the series, the patient began having muscle spasms in her neck; which she experienced even under sedation (unspecified), and it had resulted in trouble breathing on numerous occasions, on unknown dates in 2009, the patient was approximately 21 years old at the time. It was reported that she has seen three neurologists, had magnetic resonance imaging's (MRI's) (dates an results were not provided) and been to pain care management. The patient also has been on an unspecified anti-seizure medication, massage therapy, physical therapy and had "spinal injections" (unspecified). It was reported that the patient's condition was currently not resolved. The causality assessment between GARDASIL 9 and the aforementioned events was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a female patient of unknown age who was reporting on herself. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route of administration, lot# and expiry date was not reported) for prophylaxis. On an unknown date, the patient had several cold sores on her lips that have broken out. Outcome of the event was unknown. The reporter's causality assessment was not provided.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 07-AUG-2018, the patient was inadvertently vaccinated with an expired dose of ROTATEQ via oral (strength and dose were not reported) lot # M043836 and expiration date: 17-JUN-2018, indicated for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-NOV-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In or around approximately August 2016, the patient was treated by a physician for herpes zoster or shingles. The outcome of the events is unknown. The patient suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, 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: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. Upon information and belief, a physician recommended the ZOSTAVAX to the patient for the intended purpose of the long-term prevention of shingles and zoster-related injuries. On or about 17-SEP-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or approximately 24-JUL-2016, the patient was treated for his zoster-related symptoms. In or around July 2016 and August 2016, the patient was treated by two physicians for shingles and zoster-related injuries. The outcome of the events is unknown. The patient suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, 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: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 06-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N020352 and expiration 10-APR-2020 (dose, frequency and route were not provided) for prophylaxis. The vaccine was stored at a temperature below 32 Fahrenheit degrees (30.7) Fahrenheit degrees, time frame of 1 day, 12 hours and 30 minutes with no previous temperature excursion. Digital Data logger was involved.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Injection site pain
Clinical narrative: Received a spontaneous report on 23JAN2018 and 25JAN2018 from a MEDCOM personnel. The physician reported that on 23JAN2018, a member received 3ml of BIOTRHAX vaccine injected into the right deltoid rather than the prescribed 0.5ml amount. The subject experienced soreness at the site, and then developed mild headaches approximately 8 hours after the injection. No other complications were reported after 24 hours observation. The subject was restricted from caffeine and working out for the first 72 hours. It was also noted that he received a flu shot on 19DEC2017 and was on doxycycline for malaria prophylaxis. FOLLOW UP Information was received on 16FEB2018 from the physician. The physician reported that the patient was evaluated by medics and no evidence of lingering side effects was found. It was also noted that the patient felt excellent, had no signs of complications at the sight, and no signs or symptoms that would lead one to believe he is not in perfect/usual health. No additional information is expected.
Sex: U
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 03-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (age and gender not reported) who had expired imovax dose that was inadvertently administered for a pre-exposure immunization, while he/she received vaccine IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 ml once dose of suspect RABIES (HDC) VACCINE lot M13911M, expiration date- 24-Jul-2018 via unknown route. It was a case of actual medication error due to expired vaccine used. It was unknown if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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: 16.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from nurse on 03-AUG-2018. This case was linked to 2018SA216267 (same reporter). This case involves a 16 years old male patient who was vaccinated with fifth dose of IPOL (Batch number: N1K921M, expiration date: 14-Nov-2019, dose, route and site of administration was not reported) on 01-AUG-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was unknown if patient had adverse event. 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 and Module VI of the 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. List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 03-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA216254 (same reporter). This case involves a five years old male patient who was vaccinated with fourth dose of IPOL (Batch number: N1K921M, expiration date: 14-Nov-2019, dose was not reported) via intramuscular route in left arm on 01-AUG-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as vaccines were stored out of temperature range. The discovered that Ipol that was stored outside of range was given to the patient. It was unknown if patient had adverse event. 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. List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from an other healthcare professional on 03-Aug-2018. This case involves a six-month old male patient who was inadvertently vaccinated with an expired dose of 0.5 ml PENTACEL lot number: C5386AB expiry date: 17-Jul-2018 (frequency once) via unknown route in the left thigh on 03 Aug 2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and ROTATEQ for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Initial information received on 03-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (Office staff). This case involves unknown demographic patient (age and gender not reported) who was vaccinated with a dose of PENTACEL lot number: C5463AA via unknown route in unknown administration site on an unspecified date (reported suspected incorrect dose dates as May 17-July 17th) without the diluent. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate reconstitution technique. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Induration, swelling and redness over the lateral left arm up to before the left elbow.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test abnormal, Injection site vesicles, Rash vesicular, Secondary transmission, Varicella
Clinical narrative: After getting the vaccine I started getting red blisters close to the injection site. After this my entire right arm got them, I went to the doctor for a physical and showed her. She was not sure what it was.  After awhile it spread to the other arm. I went back to the dr and blood was taken to test for chickenpox. Blood work confirmed chickenpox.  However now is well over the 2 weeks they are suppose to last and I am still getting new ones. My 6 year old daughter also has gotten them. I also took her to the dr. Dr prescribed us an antiviral. Now yesterday my 1 year old has got 1 on her arm. This has been going on for many weeks and the antiviral medication is not working. Dr now wants to refer us to a infection control specialist doctor. My 6 year old and I took the antiviral for 5-7 days before, now dr is having us take it for 10 days. Today is day 6 and still getting new ones. What kind of chickenpox virus is this? It seems to be very contagious, as I have passed in onto my 2 children. And why is it so antiviral resistant? We now have spots one our entire body.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: After getting the vaccine I started getting red blisters close to the injection site. After this my entire right arm got them, I went to the doctor for a physical and showed her. She was not sure what it was.  After awhile it spread to the other arm. I went back to the dr and blood was taken to test for chickenpox. Blood work confirmed chickenpox.  However now is well over the 2 weeks they are suppose to last and I am still getting new ones. My 6 year old daughter also has gotten them. I also took her to the dr. Dr prescribed us an antiviral. Now yesterday my 1 year old has got 1 on her arm. This has been going on for many weeks and the antiviral medication is not working. Dr now wants to refer us to a infection control specialist doctor. My 6 year old and I took the antiviral for 5-7 days before, now dr is having us take it for 10 days. Today is day 6 and still getting new ones. What kind of chickenpox virus is this? It seems to be very contagious, as I have passed in onto my 2 children. And why is it so antiviral resistant? We now have spots one our entire body.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Gaze palsy, Loss of consciousness, Pallor
Clinical narrative: Patient's eyes rolled upwards, and he fell backwards and was briefly unconscious (1-3 seconds). He was pale, recovered over 5-10 minutes, and ambulated out of the clinic with his mother. He had eaten no breakfast this morning.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Pt received DTaP but should have received Tdap. Per Health Department, it is okay that the patient received DTaP and will still count towards Tdap.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pruritus generalised
Clinical narrative: Patient reports itching and aches all over the body for 1 day. Reports feeling tired all week.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Tues., the day after the vaccine, I was up early for golf, very tired, lack of energy; couldn't wait to finish. Took husband to his Dr. appt. had to wait quite a while. So tired when we returned home that I could barely fix lunch. Afterwards I laid down and slept soundly for 4 hours. No energy. Had dinner and went to bed. Wed. feeling better except vaccination site very red and quite swollen 4" x 4". Called pharmacy and they said "not unusual".  Upper arm still hurting. Today, Thurs 8/9/2018 redness & swelling down, still painful to the touch. Back to normal energy level.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient experienced a very sore, red, and warm area around the injection site. The radius around the injection point was around 1 inch. Patient is fine and just wanted to let us know about her reaction. It appeared when she woke up the next morning after receiving the vaccination.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia, Palpitations
Clinical narrative: Myalgia, chills, fatigue, anorexia, palpitations.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dizziness, Headache, Mobility decreased, Nausea
Clinical narrative: Nausea, vomiting, lightheaded, headaches, pain in neck, back, arms, legs. Swelling, unable to get out of bed. Dizziness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Swelling, Vomiting
Clinical narrative: Nausea, vomiting, lightheaded, headaches, pain in neck, back, arms, legs. Swelling, unable to get out of bed. Dizziness.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, C-reactive protein increased, Headache, Myalgia, Pain
Clinical narrative: Hives, myalgias, headache, joint pain, pain to walk, severe pruritus, Sx started day after vaccine.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus, Red blood cell sedimentation rate increased, Urticaria
Clinical narrative: Hives, myalgias, headache, joint pain, pain to walk, severe pruritus, Sx started day after vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 25-FEB-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In 2016, the patient was treated by a physician for herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 12-MAY-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In 2015, the patient was treated by a physician for shingles. The patient was later treated by a physician for shingles in her eye and other zoster related injuries. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, 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. The outcome of the events was unknown. Causality assessment was related. Upon internal review, shingles in her eye was determined to be medical significant. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) via company representative regarding a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reaction/ allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL or GARDASIL 9 third dose (strength, anatomical location, frequency, lot # and expiration date were not reported) for prophylaxis. On an unknown date, it was reported that the medical assistant's daughter developed itching and redness at the injection site after receipt of her 3rd dose of GARDASIL or GARDASIL 9 (vaccination site erythema) (vaccination site pruritus). The outcome of the events itching and redness at the injection site was recovered (reported as could not confirm if doses administered were GARDASIL or GARDASIL 9. The causality of the events was not reported. This report was not associated with a product quality complaint.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date 31st July 2019) for prophylaxis. The patient's past medical history included respiratory disorder (had a history of respiratory issues). Concurrent medical conditions included immunocompromised. Concomitant products included SHINGRIX. On 9th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 22nd July 2018, 13 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received the first dose of SHINGRIX on 2nd May 2018 and the 2nd dose of SHINGRIX on 9th July 2018 at 1:30 PM and she went to an urgent care on 22nd July 2018 and was diagnosed with shingles. The patient indicated that she was immunocompromised and had a history of respiratory issues.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (26 years before the date of reporting). Concomitant products included SHINGRIX. On 21st July 2018, the patient received the 2nd dose of SHINGRIX. On 26th July 2018, 5 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir and prednisone. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was reported as follows: This case was previously reported to the physician. On 14th May 2018, the patient received the 1st dose of SHINGRIX as an concomitant product. The reporter stated that she was diagnosed with shingles on 26th July 2018. The reporter stated that, she felt that the shingles that had come up might had started before she received her 2nd dose, but she further stated that at that time she assumed it was something else, since she had already received the 1st dose of SHINGRIX. The reporter further stated that, the patient experienced shingles on her back, left side and surrounded to the left breast area. The patient further stated that the events experienced by her after the vaccination, were more milder as compared to the shingles acquired by her 26 years ago before the date of reporting.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 84-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included penicillin shot with an associated reaction of chills (years before the date of reporting). On 22nd May 2018, the patient received the 1st dose of SHINGRIX. On 22nd May 2018, less than a day after receiving SHINGRIX, the patient experienced allergic reaction, shivering, feeling cold, injection site pain, injection site itching and injection site erythema. On 23rd May 2018, the outcome of the shivering and feeling cold were recovered/resolved. On an unknown date, the outcome of the allergic reaction, injection site pain, injection site itching and injection site erythema were recovered/resolved. It was unknown if the reporter considered the allergic reaction, shivering, feeling cold, injection site pain, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient was vaccinated in the afternoon and that night he was physically shivering and felt cold and the symptoms resolved by the morning. The patient also experienced redness, a dull pain, soreness and itching at the injection site on the same day and that lasted a couple of weeks. At the time, the patient was told he had an allergic reaction to that vaccine.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 84-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included penicillin shot with an associated reaction of chills (years before the date of reporting). On 22nd May 2018, the patient received the 1st dose of SHINGRIX. On 22nd May 2018, less than a day after receiving SHINGRIX, the patient experienced allergic reaction, shivering, feeling cold, injection site pain, injection site itching and injection site erythema. On 23rd May 2018, the outcome of the shivering and feeling cold were recovered/resolved. On an unknown date, the outcome of the allergic reaction, injection site pain, injection site itching and injection site erythema were recovered/resolved. It was unknown if the reporter considered the allergic reaction, shivering, feeling cold, injection site pain, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient was vaccinated in the afternoon and that night he was physically shivering and felt cold and the symptoms resolved by the morning. The patient also experienced redness, a dull pain, soreness and itching at the injection site on the same day and that lasted a couple of weeks. At the time, the patient was told he had an allergic reaction to that vaccine.
Age: 20.0
Sex: F
Vaccine: HPVX, MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 20-year-old female patient received TRUMENBA;(lot number and expiration date not reported) via an unspecified route of administration, on an unspecified date, 0.5 ml single; and HPV vaccine via an unspecified route of administration, on an unspecified date, at unspecified dose and frequency both given for immunization. Relevant medical history and concomitant medications were not reported. On an unknown date, the patient complained of burning and pain at the injection site after receiving meningococcal group b rlp2086. Patient also received HPV vaccine in the same arm during visit. Patient may have received other vaccines in the opposite arm during the visit as well. Outcome of the event was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from other non-health care professional. This case involves a 7 months old female patient who was administered 0.5 ml dose of expired vaccine PENTACEL lot C5386AB, expiry date 17 Jul 2018 via intramuscular route in the right thigh on 06 Aug 2018. The patients past medical history and family history were not provided. Concomitant medications included ROTAVIRUS, HEPATITIS B and PREVNAR vaccine (Lot number, expiry date, dose, route and site of administration not reported) on an unknown date. It was an actual medication error due to expired vaccine used. It was reported that patient received Pentacel vaccine on 06 Aug 2018 that was expired on 17 July 2018. The patient did not experience any side effects. 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. List of documents held by sender- none.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Fatigue, Injection site discomfort
Clinical narrative: Cold sweats began 1 d. after vaccination. Slight arm discomfort at site of injection. Fatigue. All Sx subsided in 24 hrs.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Patient states the next day approximately 5 inch circular area appeared at vaccination site which was sore to touch with no movement issues reported. One month later a 2 inch light pinkish circular area remains with no soreness or movement issues reported.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Pain in extremity
Clinical narrative: Patient felt a bit numb in his arm the first day and sore but that seemed ok the next day. His main complaint was that his arm was red but not at the site of injection. Redness was located from below injection site down to elbow.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Mobility decreased, Neck pain, Nodule
Clinical narrative: The day after vaccine patient reported she was so sick she couldn't get out of bed. The arm was so sore that she could not lift it initially. 2 days post vaccination she can lift her arm but there are 2 distinct circular red hot areas on the arm. She also reports having an enlarged, sore knot closer to the neck that she said might be a lymph node.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: The day after vaccine patient reported she was so sick she couldn't get out of bed. The arm was so sore that she could not lift it initially. 2 days post vaccination she can lift her arm but there are 2 distinct circular red hot areas on the arm. She also reports having an enlarged, sore knot closer to the neck that she said might be a lymph node.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea muscle aches.
Age: 56.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Fall, Headache, Incorrect dose administered, Malaise
Clinical narrative: The client completed pre exposure vaccine series in the past.  Was bitten by a bat on Thursday, August 2nd.  Went to a different facility and states she received Imovax 2.5cc which I questioned because that was not the appropriate dose.  Client swears she saw the 3cc syringe herself with the "pink vaccine" in it.  She said she had a headache later that day and felt generally unwell after the shot.  She said it is documented that she Imovax 2.5ml on her discharge papers from the other facility and that she told them that they were not to give her immune globulin so they didn't.  She had her second post exposure rabies vaccine from us on Sunday, August 5th per protocol and later that afternoon felt nauseous, dizzy, fell in her kitchen, vomited several times and had HA.  She took a nausea pill which she thinks was Zofran.  All symptoms spontaneously resolved by Monday, August 6th.  She insisted that I file this report as a vaccine reaction.  There is no injection site reaction.
Age: 56.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Vomiting
Clinical narrative: The client completed pre exposure vaccine series in the past.  Was bitten by a bat on Thursday, August 2nd.  Went to a different facility and states she received Imovax 2.5cc which I questioned because that was not the appropriate dose.  Client swears she saw the 3cc syringe herself with the "pink vaccine" in it.  She said she had a headache later that day and felt generally unwell after the shot.  She said it is documented that she Imovax 2.5ml on her discharge papers from the other facility and that she told them that they were not to give her immune globulin so they didn't.  She had her second post exposure rabies vaccine from us on Sunday, August 5th per protocol and later that afternoon felt nauseous, dizzy, fell in her kitchen, vomited several times and had HA.  She took a nausea pill which she thinks was Zofran.  All symptoms spontaneously resolved by Monday, August 6th.  She insisted that I file this report as a vaccine reaction.  There is no injection site reaction.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site mass, Injection site rash, Pyrexia
Clinical narrative: Patient experienced fever, chills, a large rash around injection site and a hard lump that lasted for 3 weeks.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Aches, chills, hot bumpy and sore injection site, and headache started on Wednesday 8/7 and continued to today (8/8).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Aches, chills, hot bumpy and sore injection site, and headache started on Wednesday 8/7 and continued to today (8/8).
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Burning sensation, Lip blister
Clinical narrative: Patient reports day following the vaccination that a sore on inner low lip developed. She said the sore spread to outer lip and "feels like lower lip has sunburn". Patient denies food allergies. Patient denies: new lipstick, new chapstick, acidic foods, drinking or eating hot food, history of HSV, prolonged sun exposure, or being in environment with high winds. Patient reports lesion on lip is still present. Patient denied throat swelling or itching. Patient denied rash.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chest discomfort, Erythema, Headache, Induration, Malaise
Clinical narrative: Localized induration with tenderness to palpation, erythema and warmth. Patient has generalized malaise. Headache and chest pressure.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Skin warm, Tenderness
Clinical narrative: Localized induration with tenderness to palpation, erythema and warmth. Patient has generalized malaise. Headache and chest pressure.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Painful to touch or move, Swelling and Redness 3 3/4 x 4 in in arm MENACTRA vaccine was given.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site pain
Clinical narrative: Pain in injection site, large bruise and redness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Rash, Urticaria
Clinical narrative: 06/01/2018 - injection site swelling and redness. 06/02/2018 - rash/hives.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Hypoaesthesia, Incorrect route of drug administration, Pain in extremity
Clinical narrative: Given SQ instead of IM leading to: hospital visit due to elevated blood pressure, hand numbness, extreme soreness of vaccinated arm.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness postural, Dyskinesia, Fall
Clinical narrative: Pt. became dizzy when standing, fell over slowly and had one minor jerking movement. No known loss of consciousness. Pt. recovered quickly after the event and was given a snack and rested as he had not eaten at all that day. Pt. doing very well following the event.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Muscular weakness
Clinical narrative: Flu like symptoms starting the day after immunization and lasted for a day and a half. Weakness of arm. Injection site red and swollen. Redness and swelling still present today, 8/9/18. Patient tried cold packs, seemed to make pain worse. Patient saw PCP today, 8/9/18, and was given prednisone 4 day course.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In 2016, the patient was treated by a physician for herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In approximately 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 09-NOV-2016, the patient was treated by a physician for a rash, which was diagnosed as shingles, and post herpetic neuritis. The patient was prescribed VALTREX and gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-JAN-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 11-SEP-2015, the patient was treated by a physician assistant for symptoms of a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In 2018, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. 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. The patient was the caller's husband, he developed flu like symptoms after his first SHINGRIX dose. This case has been linked with case US2018136199, US2018136201 and US2018136205.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received). On 22nd July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. 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. The patient was the caller's husband, he developed flu like symptoms after his second SHINGRIX dose. This case has been linked with case US2018136199, US2018136201 and US2018136203.