chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site nodule, Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 62-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 5th March 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site lump, injection site rash, injection site erythema, injection site warmth, pain in arm and swelling arm. On an unknown date, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the injection site lump, injection site rash, injection site erythema, injection site warmth, pain in arm and swelling arm were recovered/resolved and the outcome of the activities of daily living impaired was unknown. The reporter considered the injection site lump, injection site rash, injection site erythema, injection site warmth, pain in arm and swelling arm to be probably related to SHINGRIX. It was unknown if the reporter considered the activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The patient developed a knot the size of an orange at the injection site after a dose of SHINGRIX on left deltoid. The injection site was warm and hot. The patient developed a 3 inch wide rash underneath the injection site, swelling down the arm where the injection was given, and soreness in the arm in which the vaccine was given. The arm soreness interfered with the patient's activities of daily living for 3 weeks. The adverse effects lasted about one month.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 62-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 5th March 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site lump, injection site rash, injection site erythema, injection site warmth, pain in arm and swelling arm. On an unknown date, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the injection site lump, injection site rash, injection site erythema, injection site warmth, pain in arm and swelling arm were recovered/resolved and the outcome of the activities of daily living impaired was unknown. The reporter considered the injection site lump, injection site rash, injection site erythema, injection site warmth, pain in arm and swelling arm to be probably related to SHINGRIX. It was unknown if the reporter considered the activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The patient developed a knot the size of an orange at the injection site after a dose of SHINGRIX on left deltoid. The injection site was warm and hot. The patient developed a 3 inch wide rash underneath the injection site, swelling down the arm where the injection was given, and soreness in the arm in which the vaccine was given. The arm soreness interfered with the patient's activities of daily living for 3 weeks. The adverse effects lasted about one month.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Ataxia, Blood culture negative, Culture urine negative, Full blood count normal, Pyrexia
Clinical narrative: Patient developed febrile illness on 6/2/18. Persisted for 5 days and then resolved. No other symptoms until 6/7/18 when developed ataxia.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Urine analysis normal
Clinical narrative: Patient developed febrile illness on 6/2/18. Persisted for 5 days and then resolved. No other symptoms until 6/7/18 when developed ataxia.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Influenza like illness, Skin warm
Clinical narrative: EXTREMELY SWOLLEN, RED, AND HOT TO THE TOUCH, FATIGUE, FLU LIKE SYMPTOMS, HEADACHE.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: EXTREMELY SWOLLEN, RED, AND HOT TO THE TOUCH, FATIGUE, FLU LIKE SYMPTOMS, HEADACHE.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: She appeared to have a red slightly swollen area around the injection site. She was seen in the clinic and prescribed KEFLEX. The NP in the clinic said it was just an adverse reaction to the vaccine.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Injection site erythema, Injection site swelling, Iritis, Skin warm
Clinical narrative: Crankier today. At the injection site, 1 inch red, raised area. He has red welts around his arms, torso, legs. Raised and red, circular, warm to the touch, no itching or respiratory problems. ZYRTEC has not helped, suggested trying BENADRYL.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Crankier today. At the injection site, 1 inch red, raised area. He has red welts around his arms, torso, legs. Raised and red, circular, warm to the touch, no itching or respiratory problems. ZYRTEC has not helped, suggested trying BENADRYL.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Contusion, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: As soon as vaccination administered patient got a sore arm. On 5/21 arm was swollen, very sore and unbelievable pain at injection site. Patient try rubbing it, put compresses, and started turning bruising -blue down to fingers. Taking TYLENOL eased the pain but did not take it away; bruise kept growing. On 5/24 went to doctor, pain was at more than a 10; patient had ultrasound and blood work. In blood work, INR at 4.09 which is much higher than normal since takes Warfarin.  Patient spoke to doctor on 5/29 but did not receive any recommendations. Patient has continued taking TYLENOL and rubbing arm with astringent--it is not improving. Site of injection is swollen the size of a tennis ball and has a red mark. Area still is very sore. Bruise is fading now. Today pain is at 7, better than before.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: International normalised ratio increased, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: As soon as vaccination administered patient got a sore arm. On 5/21 arm was swollen, very sore and unbelievable pain at injection site. Patient try rubbing it, put compresses, and started turning bruising -blue down to fingers. Taking TYLENOL eased the pain but did not take it away; bruise kept growing. On 5/24 went to doctor, pain was at more than a 10; patient had ultrasound and blood work. In blood work, INR at 4.09 which is much higher than normal since takes Warfarin.  Patient spoke to doctor on 5/29 but did not receive any recommendations. Patient has continued taking TYLENOL and rubbing arm with astringent--it is not improving. Site of injection is swollen the size of a tennis ball and has a red mark. Area still is very sore. Bruise is fading now. Today pain is at 7, better than before.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with swollen, red welt on front of left arm in the bicep region, separate from where the injection was given. Patient stated that the welt was noticed 6-7-18 (vaccine given 6-5-18) and was very swollen, red, and hot to the touch. When presented to pharmacy, she reported the welt and stated that the swelling had gone down since the previous day and it was not as red or hot to the touch. She stated that following the vaccine her arm was sore in general to lift or move and she was more fatigued than usual, which were side effects she was expecting from the vaccine. The welt, however, was very distinctly separated from where the vaccine was administered, but she does not recall any other events that would have caused the welt to occur so wondered if it was related to the vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: Patient presented with swollen, red welt on front of left arm in the bicep region, separate from where the injection was given. Patient stated that the welt was noticed 6-7-18 (vaccine given 6-5-18) and was very swollen, red, and hot to the touch. When presented to pharmacy, she reported the welt and stated that the swelling had gone down since the previous day and it was not as red or hot to the touch. She stated that following the vaccine her arm was sore in general to lift or move and she was more fatigued than usual, which were side effects she was expecting from the vaccine. The welt, however, was very distinctly separated from where the vaccine was administered, but she does not recall any other events that would have caused the welt to occur so wondered if it was related to the vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angiogram cerebral, Computerised tomogram head, Culture, Encephalopathy, Injection site reaction
Clinical narrative: The day following the vaccine, the patient fainted and had encephalopathy and left deltoid myositis. Seen by neurology, neurosurgery and hospitalized for 4 days.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myositis, Nuclear magnetic resonance imaging, Syncope
Clinical narrative: The day following the vaccine, the patient fainted and had encephalopathy and left deltoid myositis. Seen by neurology, neurosurgery and hospitalized for 4 days.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aneurysm, Chills, Computerised tomogram abnormal, Headache, Infection
Clinical narrative: The day following the vaccine, the patient fainted and had encephalopathy and left deltoid myositis. Seen by neurology, neurosurgery and hospitalized for 4 days.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness, Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: The day following the vaccine, the patient fainted and had encephalopathy and left deltoid myositis. Seen by neurology, neurosurgery and hospitalized for 4 days.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Speech disorder, Urinary incontinence
Clinical narrative: The day following the vaccine, the patient fainted and had encephalopathy and left deltoid myositis. Seen by neurology, neurosurgery and hospitalized for 4 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Migraine
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of migraine type headaches in a 65-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced migraine type headaches, feeling unwell and activities of daily living impaired. On an unknown date, the outcome of the migraine type headaches, feeling unwell and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the migraine type headaches, feeling unwell and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX dose at an unknown pharmacy. The patient experienced migraine like headache that lasted for 3 to 4 days. This reportedly affected daily activity to point could not care out normal functions for at least 3 days. The patient reported the headache as debilitating as general feeling of being sick.
Age: 37.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 37-year-old male patient who received SHINGRIX. On 22nd May 2018, the patient received SHINGRIX. On 22nd May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, inappropriate age at vaccine administration and wrong vaccine administered. On 23rd May 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: On 22nd May 2018, the patient went to a pharmacy to receive the Varicella vaccine. On 29th May 2018, the patient received the Hepatitis A vaccine. The paperwork was faxed to the reporter and the reporter discovered that, on 22nd May 2018, the patient was administered a dose of SHINGRIX vaccine instead of the Varicella vaccine which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter stated that, the patient tolerated the vaccine well except that, he had a fever on the same day which resolved the following day after receiving SHINGRIX. The reporter could not see the lot number or expiry date on the paperwork which was faxed to him because, it was hard to read.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX (batch number B9739 ?, expiry date unknown). On 25th May 2018, the patient received the 1st dose of SHINGRIX. On 26th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site warmth and injection site erythema were not recovered/not resolved. The reporter considered the injection site pain, injection site warmth and injection site erythema to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The healthcare professional (HCP) had no expiry date for SHINGRIX. The redness was the size of the bottom of a small bottle of water as per the HCP (4 to 5 cm). The reported lot number (B9739) does not match any GSK lot number and was updated to B9739 ?.
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 20 year old male patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 08-MAY-2018, the patient was vaccinated at the physician's office with a dose of VAQTA injection, 50/1.0 U/ml, dose 50 U, intramuscularly, lot # N032753, expiration date 23-MAR-2019 and at the unspecified pharmacy with a dose of HAVRIX 1440EL U (exact dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from patient of unknown age and gender reporting on itself. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in 2015, (also reported as "about two and a half years ago") the patient was vaccinated with a primary dose of VAQTA, intramuscularly for prophylaxis (dose, lot number and expiration date were not reported) prior to going on a vacation. It was reported that the patient did not return for booster dose of VAQTA. No adverse reaction reported.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a license practical nurse via a company representative referring to an 18 week 2 day old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-MAY-2018, the patient was vaccinated with the first dose of ROTATEQ lot number R003534 for prophylaxis. No adverse effects were reported.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Puncture site infection, Respiration abnormal, Swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 65-year-old female patient. The patient had no pertinent medical history but she had allergies to "sulfas". Historical drug included Pneumococcal Conjugate Vaccine (PCV13). Concomitant therapies included numerous unspecified medications. On 24-MAY-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R000579, expiry date 09-SEP-2019; strength, dose and route of administration were not reported) as "second follow up to PCV13". On 24-MAY-2018, the patient experienced severe reaction, which included "swelling under the arm, up to the shoulder and across the chest" and the reaction "affected her breathing". On 25-MAY-2018, the patient was hospitalized due to these events. Upon the patient's office visit on 31-MAY-2018 for her follow-up hospital visit, the patient stated that she, the patient, was admitted to the hospital due to an "infection at blood draw site", which was performed also on 24-MAY-2018 but prior to vaccination with PNEUMOVAX 23. The infection started the same day as blood was drawn. It was clarified by a nurse that the patient's reaction was located "a foot away from the injection site" for PNEUMOVAX 23. The nurse stated the patient was treated for the infection at a blood draw site, not an allergic reaction to PNEUMOVAX 23. The nurse stated no antihistamines and no breathing treatments were administered to the patient. On 27-MAY-2018, the patient was discharged from the hospital. On an unspecified date, approximately in May 2018, the patient recovered from the events. The reporter did not provide causality assessment between the events and PNEUMOVAX 23. However the patient's opinion that the reaction was not related to PNEUMOVAX 23 was mentioned. Furthermore, in nurse's opinion the reaction was not due to the suspected vaccine.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a male patient of an unknown age. The patient's medical history included splenectomy. Information about the patient's allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not reported). On an unknown date, the patient experienced injection site reaction. The patient did not receive any treatment for reported event. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD albumin status: recombinant human albumin (rHA) (dose, anatomical location and route of administration were not reported) lot # N025926, expiration date: 18-MAR-2019 indicated for prophylaxis which was reconstituted with sterile diluent (MERCK) properly stored. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes on unspecified date called by a data logger. There were previous excursions reported of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 45 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA002899.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 16-MAY-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD albumin status: recombinant human albumin (rHA) (dose, anatomical location and route of administration were not reported) lot # N025926, expiration date: 18-MAR-2019 indicated for prophylaxis which was reconstituted with MERCK STERILE DILUENT properly stored. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes on unspecified date called by a data logger. There were previous excursions reported of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 45 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA002429.
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. In March 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 09-JUL-2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in July 2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The outcome was unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: 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 an unknown date in 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date during 2016, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-MAR-2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUL-2016, the patient was treated by a physician for a 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, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-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. In 2011, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a family practice office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In July 2016, the patient was treated at a primary care office for a vesicular rash, 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, the patient has 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, 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. In October 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In July 2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-AUG-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. The patient has been prescribed NORCO and valacyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and 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 is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In July 2016, the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In July 2016, the patient was treated at a physician's office for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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 an unknown date in 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-JUL-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). On 23rd May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site warmth and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. Beginning on an unknown date, the patient began to experience erythema, swelling, warm to the touch, and pain to the touch at the injection site. Further described as, the size of a softball, worsening, and starting to go around the patient's arm. The patient did not require any hospitalization, emergency room or doctor's visit, and the symptoms were not considered life threatening or disabling.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Pain in extremity, Product preparation error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 6th April 2018, the patient received SHINGRIX .5 ml. On 6th April 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The patient received only adjuvant, and was not mixed with the powder before the injection, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The batch number reported was of the powder, the batch number from the adjuvant was not available. Follow up information received from pharmacists via call center representative on 30th May 2018: The patient received 1st dose of SHINGRIX intramuscularly. The VAERS details were updated. The pharmacists working that day administered the adjuvant vial to the patient without mixing it with the powder, the patient complained of sore arm but nothing else. On an unknown date in less than a year after vaccination, the patient experienced pain in arm. On an unknown date, the outcome of pain was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. The patient came about a month later to get the correct dose of SHINGRIX. It was a medication error without harm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020). On 28th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site swelling and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site tenderness were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX on the left deltoid. The pharmacist has denied permission to contact their pharmacy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dehydration, Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly male patient who received SHINGRIX. Concomitant products included AVODART, CRESTOR and doxazosin. On 22nd May 2018, the patient received SHINGRIX (intramuscular). On 23rd May 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue, dehydration and muscle pain. On an unknown date, the outcome of the fatigue, dehydration and muscle pain were not recovered/not resolved. The reporter considered the fatigue, dehydration and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but could be 67 or 68 years. The reporter stated that it was been more than a week after receiving SHINGRIX, and he still had the fatigue, dehydration and muscle pain at the time of reporting. This case has been linked to US2018096979, reported by the same reporter for his wife.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly male patient who received SHINGRIX. Concomitant products included AVODART, CRESTOR and doxazosin. On 22nd May 2018, the patient received SHINGRIX (intramuscular). On 23rd May 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue, dehydration and muscle pain. On an unknown date, the outcome of the fatigue, dehydration and muscle pain were not recovered/not resolved. The reporter considered the fatigue, dehydration and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but could be 67 or 68 years. The reporter stated that it was been more than a week after receiving SHINGRIX, and he still had the fatigue, dehydration and muscle pain at the time of reporting. This case has been linked to US2018096979, reported by the same reporter for his wife.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dehydration, Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly female patient who received SHINGRIX. Concomitant products included amlodipine, CRESTOR, TOPAMAX and XANAX. On 22nd May 2018, the patient received SHINGRIX (intramuscular). On 23rd May 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue and muscle pain. On an unknown date, the outcome of the fatigue and muscle pain were not recovered/not resolved. The reporter considered the fatigue and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but could be 66 or 67 years. The reporter stated that, it was more than a week after receiving SHINGRIX, and the patient still had the fatigue and muscle pain at the time of reporting. This case has been linked to US2018096978, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly female patient who received SHINGRIX. Concomitant products included amlodipine, CRESTOR, TOPAMAX and XANAX. On 22nd May 2018, the patient received SHINGRIX (intramuscular). On 23rd May 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue and muscle pain. On an unknown date, the outcome of the fatigue and muscle pain were not recovered/not resolved. The reporter considered the fatigue and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but could be 66 or 67 years. The reporter stated that, it was more than a week after receiving SHINGRIX, and the patient still had the fatigue and muscle pain at the time of reporting. This case has been linked to US2018096978, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. After receiving SHINGRIX, the patient had redness localized to around the injection site. The redness was approximately 5-6 inches around and has lasted 2 weeks. The patient stated that redness was improving and she has not sought any interventions or seen her PCP due to this reaction.