chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. On or about 16-SEP-2014, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (strength, lot # expiration date, dosage, injection anatomical location and route of administration were not provided) at a clinic 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 or shingles. On or about 31-DEC-2015, he was treated by a physician at a clinic, for a severe vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed famciclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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, he had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Therefore, the outcome for herpes zoster was not recovered, and for vaccination failure was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. On or about 13-JUN-2012, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (strength, lot # expiration date, dosage, injection anatomical location and route of administration were not provided) 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 or shingles. On or about 09-MAY-2013, she was treated at a hospital, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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, she had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Therefore, the outcome for herpes zoster was not recovered, and for vaccination failure was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: persistent strain of herpes zoster or shingles; The vaccine did not prevent shingles as intended; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. On or about 19-FEB-2010, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (strength, lot # expiration date, dosage, injection anatomical location and route of administration were not provided) at an urgent care clinic 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 or shingles. On or about 25-MAR-2015, she was treated by a certified physician assistant at the urgent care clinic, for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management for her painful symptoms and chronic pain. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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, she had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Therefore, the outcome for herpes zoster was not recovered, and for vaccination failure was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; subsequently contracted a persistent strain of herpes zoster or shingles; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 13-OCT-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended (Vaccination failure), and the pt subsequently contracted a persistent strain of herpes zoster or shingles. On or about 16-OCT-2015, the pt was treated by the physician who vaccinated her, for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving the vaccine for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was mot reported. The events were reported to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: vesicular outbreak accompanied by weakened immune symptoms; The vaccine did not prevent shingles as intended; vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In an unspecified date in 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended (Vaccination failure), and the pt subsequently contracted a persistent strain of herpes zoster or shingles. On or about 30-MAY-2015, the pt was treated for a vesicular outbreak accompanied by weakened immune symptoms (Immune system disorder), which was diagnosed as herpes zoster, or shingles. The pt was prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving the vaccine for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not reported. The events were reported to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In an unspecified date in 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended (Vaccination failure), and the pt subsequently contracted a persistent strain condition of herpes zoster or shingles. Later that year, the pt was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving the vaccine for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not reported. The events were reported to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; vesicular outbreak, which was diagnosed as herpes zoster or shingles; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In an unspecified date in 2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended (Vaccination failure), and the pt subsequently contracted a persistent strain of herpes zoster or shingles. In an unspecified date in 2015, the pt was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving the vaccine for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not reported. The events were reported to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Rash vesicular, Vaccination failure
Clinical narrative: vesicular outbreak and decreased immune symptoms; The vaccine did not prevent shingles as intended; vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles; Information was received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In an unspecified date in 2009, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended (Vaccination failure), and the pt subsequently contracted a persistent strain of herpes zoster or shingles. In an unspecified date in 2011, the pt was treated for a severe vesicular outbreak and decreased immune symptoms (Decreased immune responsiveness), which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving the vaccine for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not reported. The events were reported to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Death, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Pt had suffered significant medical expenses, and pain and suffering, and damages until her death; Chronic pain; Pt was treated for blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles; The vaccine did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-DEC-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) in a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 10-FEB-2014, pt was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. Patient was prescribed with valacyclovir (VALTREX), lidocaine, gabapentin and hydrocodone (+) acetaminophen (VICODIN) for management of her painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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, patient had suffered significant medical expenses, and pain and suffering, and other damages until her death. The cause of death and if an autopsy was performed was unknown. The outcome of herpes zoster and chronic pain was unknown. The reporter assessed that the events were related to zoster vaccine live (ZOSTAVAX).; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The patient received one improperly stored dose of VARIVAX; This spontaneous report was received from a nurse prescriber concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On 11-MAR-2020, the patient received one improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # S028920 and expiration date 16-SEP-2021 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (lot number and expiration date were not reported).  The administered dose of the vaccine experienced a temperature excursion of 6°F to 14°F (5.69F) degrees Fahrenheit for 1 second, as recorded by a data logger. There was a previous temperature excursion of 6°F to 14°F (5.81F) for 28 minutes. No additional adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; the patient received one improperly stored dose of PROQUAD; This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender. The patient's past drug and pertinent medical history, as well as their concomitant medications and drug reaction or allergies, were not provided.  On 25-FEB-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) (PROQUAD) for prophylaxis (product storage error) (lot number S012532 has been verified to be a valid lot number, expiration date reported and validated as 20-OCT-2020) (concentration, dose, frequency of vaccination scheme and anatomical location of vaccination were not reported; route of administration was unknown to the reporter).  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (rHA) (PROQUAD) underwent a temperature excursion between 6 to 14 degrees Fahrenheit (5.69 degrees Fahrenheit) for 1 second as recorded by the data logger. A previous temperature excursion from 6 to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes was also recorded by the data logger.    The diluent used was properly stored. No additional adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 16-MAR-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; lot number S028920 and expiration date 16-SEP-2021). The sterile diluent (manufacturer unknown) used to reconstitute the vaccine was stored properly.    According to the reporter, the temperature excursion was not reported and was for a time frame of 1 minute on an unspecified date (product storage error), with previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for a time frame of 28 minutes; which was detected by a digital data logger.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; 5 year old patient received unspecified dose in PROQUAD innnunization series that was improperly stored; This spontaneous report was received from a licensed practical nurse, concerning a 5-year-old patient of unknown gender. The patient's past drug and pertinent medical history, as well as the concomitant medications and drug reaction or allergies, were not provided.  On 13-MAR-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) (PROQUAD) for prophylaxis (product storage error) (lot number S003866  has been verified to be a valid lot number, expiration date reported as 08-AUG-2020, but upon internal validation, it was established 08-AUG-2024) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) (PROQUAD) underwent a temperature excursion at 38.1 degrees Fahrenheit for a time frame of 20.7 hours as recorded by the data logger. There were no other temperature excursions previously.  The diluent used was properly stored.   No symptoms were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; received one improperly stored dose of VARIVAX; This spontaneous report as received from a nurse prescriber refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported.   On 13-MAR-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S028920, expiry date : 16-SEP-2021) for prophylaxis. The sterile diluent(MERCK STERILE DILUENT) used to reconstitute the varicella virus vaccine live (oka/merck)(VARIVAX) was stored properly.     It was reported that the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees F (5.69F) for a duration of 1 second (product storage error). There was previous temperature excursion of 6 degrees F to 14 degrees F (5.81 F) for a duration of 28 minutes. It was reported that this call was due to a digital data logger. The patient had no adverse event and there was no product quality complaint involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX; Information has been received from a nurse prescriber referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On 17-MAR-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S028920 with expiration date 16-SEP-2021 for prophylaxis (dose number, exact dose and route of administration were not provided) (product storage error). The sterile diluent (STERILE DILUENT) ( (lot number and expiration date were not reported) used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly.  The temperature excursion was not reported and was for a time frame of 1 second. There was previous temperature excursion reported: the temperature excursions were from 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes. The digital data logger was involved. No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX on 3/3/2020; Information has been received from a nurse prescriber, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 03-MAR-2020, the patient received one improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S028920, expiration date 16-SEP-2021; dose detail, strength and route were unknown) for prophylaxis. The vaccine was exposed to temperature excursion between 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.69 degrees Fahrenheit) for 1 second (incorrect product storage). There was previous temperature excursion between 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes. The sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. The call was due to digital data logger. No additional adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect; the patient received one improperly strored dose of Varivax; This spontaneous report was received from a nurse prescriber refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 26-FEB-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) of lot # S028920 with an expiry date of 16-SEP-2021 for prophylaxis (strength, dose, anatomical location and route were not reported) (Product storage error). The concomitant medication included sterile diluent (MERCK STERILE DILUENT) which was reported to be stored properly. No additional adverse effects were reported. The outcome of product storage error was unknown. It was reported that the vaccine was exposed to a temperature of 6 degree Fahrenheit (F) to 14 degree Fahrenheit (5.69 F) for a time frame of 1 second. The previous temperature excursion reported as 6 degree Fahrenheit (F) to 14 degree Fahrenheit (5.81 F) for 28 minutes. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: DIARRHEA; STOMACH PAIN; This spontaneous case (PVX2019-1336) report was received from a nurse on 24-May-2019. It describes a 39-year-old female consumer who had diarrhea and stomach pain, after the administration of Vivotif for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 23-May-2019 at 10 pm. On 24-may-2019, she had diarrhea and stomach pain at 6 am. She reported that, at 11 am both the events were continued. She had diarrhea and vomiting in every 10 minute. The nurse reported that there was no treatment medication reported for the events and she did not report any concomitant medications. She had no medical history related to the vaccine. She did not take any unhygienic food or water. Furthermore, she did not want to take other doses of Vivotif.   Action taken with Vivotif was unknown.  The consumer had not recovered from the events.  Company's Comment: In this case, it was reported that the consumer had diarrhea and stomach pain after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhoea and stomach pain are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had diarrhea and stomach pain after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhoea and stomach pain are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed shingles in month four; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 months 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 reported as follows: The age at vaccination was not reported. The patient experienced shingles 4 months after receiving Shingrix vaccine.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site mass, Injection site warmth, Pain in extremity
Clinical narrative: 37 years old patient received the first dose of Shingrix; redness in the injection site /Redness in the injection site after second dose; injection site, warm to touch / Warm to touch after second dose; huge lump in the injection site / Huge Lump in the injection site after second dose; pain that extended from the arm to the collarbone after second dose; severe chilling / Severe chilling after second dose; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 37-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received on unown date, refer case US2020030286). Concurrent medical conditions included leukemia (when patient was younger).   On 17th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site lump, pain in arm and chills. On 17th February 2020, the patient experienced inappropriate age at vaccine administration. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site warmth, pain in arm, chills and inappropriate age at vaccine administration were unknown and the outcome of the injection site lump was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site lump, pain in arm and chills to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. On 17th February 2020, the patient received 2nd dose of vaccine which led to inappropriate age at vaccine administration. The patient experienced severe chilling, pain that extended from the arm to the collarbone, redness in the injection site, warm to touch and a huge lump in the injection site. The reported stated that patient was feeling better now but she still had the lump. This was medication error with harm. The reporter consented to follow up. This case had been linked to the case US2020030286, reported for same patient.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 37 years old patient received the first dose of Shingrix; redness in the injection site /Redness in the injection site after second dose; injection site, warm to touch / Warm to touch after second dose; huge lump in the injection site / Huge Lump in the injection site after second dose; pain that extended from the arm to the collarbone after second dose; severe chilling / Severe chilling after second dose; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 37-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received on unown date, refer case US2020030286). Concurrent medical conditions included leukemia (when patient was younger).   On 17th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site lump, pain in arm and chills. On 17th February 2020, the patient experienced inappropriate age at vaccine administration. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site warmth, pain in arm, chills and inappropriate age at vaccine administration were unknown and the outcome of the injection site lump was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site lump, pain in arm and chills to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. On 17th February 2020, the patient received 2nd dose of vaccine which led to inappropriate age at vaccine administration. The patient experienced severe chilling, pain that extended from the arm to the collarbone, redness in the injection site, warm to touch and a huge lump in the injection site. The reported stated that patient was feeling better now but she still had the lump. This was medication error with harm. The reporter consented to follow up. This case had been linked to the case US2020030286, reported for same patient.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site muscle pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was unknown.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced no side effects except for muscle pain at the injection site. The reporter consented to follow up. The pharmacist was retired and the patient. For tolerance of 2nd dose of Shingrix, refer linked case US2020030233.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: shingles rash appeared bi-laterally on the patients face; This case was reported by a other health professional via call center representative and described the occurrence of vesicular rash in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In February 2020, 7 days after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The shingles rash appeared bi-laterally on the patients face a week after receiving the vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix a year ago and have not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received the second dose yet, which led to incomplete course of vaccination.  Pharmacist did not provide date of birth of the patients nor lot number or expiration date of the vaccines administered. The reporter consented to follow up. This case was linked with case US2020037873, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: muscle cramps at night on both legs; This case was reported by a consumer via call center representative and described the occurrence of nocturnal leg muscle cramps in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix (injection). In February 2020, 1 day after receiving Shingrix, the patient experienced nocturnal leg muscle cramps. On an unknown date, the outcome of the nocturnal leg muscle cramps was not recovered/not resolved.   It was unknown if the reporter considered the nocturnal leg muscle cramps to be related to Shingrix.  Additional case details were reported as follows: The patient reported the case for herself. The patient received the Shingrix vaccine a week ago and after the second night, she experienced muscle cramps at night on both legs.  The muscle cramps were more severe last night and were unresolved at the time of reporting. The permission to follow up was denied.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye pain, Headache, Neuralgia, Pain, Sensitive skin
Clinical narrative: Sensitive nerve endings; Sensitive Skin; Sore eyes; Headache; Body ache; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 24th February 2020, the dose was an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced nerve pain, sensitive skin, sore eye, headache and general body pain. On an unknown date, the outcome of the nerve pain, sensitive skin, sore eye, headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the nerve pain, sensitive skin, sore eye, headache and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A day after receiving the 1st dose of Shingrix experienced sensitive nerve endings, sensitive skin, sore eyes, headache and body ache. This side effects lasted for one day. For tolerance of 2nd dose refer case US2020AMR039693 The reporter consented to follow up. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. Shingrix was discontinued. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The physician reported that she had patients refusing to get the second dose of Shingrix because of the side effects. She mentioned flu like symptoms. Probed for additional information but HCP did not have specific information to provide.  The reporter consented to follow up.
Sex: F
Vaccine: HPV9
Symptoms: Accident, Inappropriate schedule of product administration, Meniscus injury, Meniscus operation
Clinical narrative: meniscus torn in a skiing accident; patient did not receive the 3rd dose of vaccine yet (over 6 months since the initial dose)/she will have to delay the vaccine further due to surgery after accident; patient did not receive the 3rd dose of vaccine yet (over 6 months since the initial dose)/she will have to delay the vaccine further due to surgery after accident; This spontaneous report was received from a patient's mother and refers to a 15-year-old female patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant medications was provided.  On an unknown dates (reported as on time), the patient received two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact doses, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. At the time of the report (reported as over 6 months since the initial dose), the patient did not receive the third dose. It was also reported that the patient torn her meniscus on an unknown date in a skiing accident and she would have to delay the vaccine further. The patient would have surgery due to torn meniscus.  The outcome of the events was unknown.  The causality assessment between torn meniscus and of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: diagnosis of post-herpetic neuralgia; persistent strain of herpes zoster or shingles; The vaccine did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On or about 29-OCT-2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 16-DEC-2015, patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. Patient was prescribed acetaminophen (+) hydrocodone bitartrate (VICODIN) for management of his painful symptoms and chronic pain. On or about 22-JAN-2016, patient was treated by the physician for the diagnosis of post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. He was prescribed gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, 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. The reporter considered all events to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 13-MAR-2020, the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number: S028920, expiration date: 16-SEP-2021 (strength and frequency were not provided) subcutaneously for prophylaxis. Sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. The suspect vaccine was exposed to temperature from 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.69 degrees Fahrenheit) for a time frame of 1 second. There was a previous temperature excursion reported, at a temperature from 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes. Data logger was involved. No additional adverse effect was reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles; She had two shingles episodes; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (1st Shingles episode at age of 32 years). Previously administered products included Zostavax (received on an unknown date years before date of reporting).   In April 2019, the patient received the 1st dose of Shingrix. In September 2019, the patient received the 2nd dose of Shingrix. In November 2019, between 6 and 8 months after receiving Shingrix, between 1 and 3 months after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported, but it could be 56 years old. The patient had she first shingles episode at the age of 32 years and it presented on her back under her bra strap. The patient  had a history of shingles 2-4 times a year since the first time.   Since it had presented sporadically over the years on her right hip only. The patient received both the doses on the left arm. 1st dose of Shingrix in April 2019.   She had 2nd dose of Shingrix in September 2019.   She had two shingles episodes.   One in November 2019 and the other in December 2019.   Both times it presented on the right hip and the entire area was the size of a half dollar.   The patient received acyclovir and it resolves within 7 days.   In February 2020, last month she felt it coming on and took acyclovir immediately and it did not present.   She also went 6 years without an outbreak years ago. The reporter consented to follow up.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Neuralgia, Pain, X-ray
Clinical narrative: pt contacted our office March 2020, stating she had nerve pain from flu vaccination. Pt stated injection was administered 2 finger breaths below acromion process almost level to armpit. Pt stated no pain during injection, then 1-2 days later started feeling sharp pain, stated having difficulty with mobility. Pt first sought medical attention from urgent care Feb 6, 2020, then went to primary care provider Dec 27th 2019, was prescribed medication for nerve pain.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site reaction, Myalgia, Pyrexia
Clinical narrative: Patient is an 81-year-old veteran who received his second dose of Shingrix (recombinant zoster shingles vaccine) intramuscularly in his left deltoid on 9/25/19 complaining of fever, myalgia, weakness, and injection site reactions on his left arm. He noted that he took ibuprofen for symptomatic relief.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Patient vomited 2x after vaccine was given. Within 1 hrs of vaccine.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Injection site erythema
Clinical narrative: Rapid hearth beat for 3 hours (120-130) the morning after the injection after a morning walk Pain and redness at injection site 4 days Muscle pain 3 days Tiredness 4 days Headache 3 days Shivering 2 days Fever 4 days
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Rapid hearth beat for 3 hours (120-130) the morning after the injection after a morning walk Pain and redness at injection site 4 days Muscle pain 3 days Tiredness 4 days Headache 3 days Shivering 2 days Fever 4 days