chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 63 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 67 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 58 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 73 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 13-JUL-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 77 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date IN 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling
Clinical narrative: swelling in the whole arm that received the dose of GARDASIL 9; This spontaneous report as received from a medical assistant via company representative refers to a 36 year-old-female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.       On 03-JUL-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1614897, expiration date 20-SEP-2021) (dose and route of administration were not provided) to prevent human papillomavirus (HPV).        Then, on an unspecified date in July 2019, the patient developed swelling in the whole arm that she received the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient sought medical attention and went to see a physician assistant. On an unknown date, she started treatment with unspecified steroid therapy for the swelling. On an unspecified date in July 2019, the patient recovered from the event.  The relatedness between the event and the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; The patient was inadvertenly administerted a dose of GARDASIL 9 that had been improperly stored; This spontaneous report has been received from a nurse and referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.  On 01-JUL-2019, the patient was inadvertently administered a dose of improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency and route were not reported) (lot #: R016971, expiration date: 22-MAR-2021) for prophylaxis (product storage error). The temperature excursion was 50.2 degrees Fahrenheit for a total time frame of 48 minutes. There was a previous temperature excursion, above 47 degrees Fahrenheit or 9 degrees Celsius (51.6 degrees Fahrenheit) for a total time frame of 3 hours and 55 minutes. The data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA000398:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; 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.   In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles, which lead to hospitalization. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a 65-year-old female patient (pt). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-AUG-2017, pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. Within one month after receiving zoster vaccine live (ZOSTAVAX), and as a result of her receipt of zoster vaccine live (ZOSTAVAX), pt was caused to suffer shingles, including any and all of its sequelae. A s a result of her receipt of zoster vaccine live (ZOSTAVAX), pt has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 75-year-old female patient (pt). The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 12-DEC-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, lot#, expiration date and route of administration were not provided) by a pharmacist in a pharmacy for the long-term prevention of shingles and zoster-related conditions. The pt was treated by the physician for herpes zoster from an unknown date, which resulted from pt's zoster vaccine live (ZOSTAVAX) use. The outcome of herpes zoster was not reported. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a currently 70-year-old female patient (pt). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In 2015, pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not provided) by the pharmacist for for the long-term prevention of shingles and zoster-related conditions. Pt was treated by a healthcare provider at hospital for the following injuries resulting from pt's zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; the patient was administered VAQTA via the subcutaneous route rather than the intramuscular route.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.   On 09-AUG-2019, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) (lot # S007769, expiration date was 24-JUL-2020) 1 dose via the subcutaneous route rather than the intramuscular route for prophylaxis(Incorrect route of product administration). No adverse effects reported.
Age: 0.17
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered VAQTA at two months of age; administered VAQTA at two months of age; This spontaneous report as received from a patient's mother refers to a 2-month-old female. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.      On 09-AUG-2019, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) injection, 1 dosage form (reported as 1 shot),  lot # S005723, expiration date 10-JUL-2020 (exact dose and route of administration were not provided) for prophylaxis.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: patient fainted 3 times in the office; This spontaneous report was received from a physician via a company representative referring to a 14 year old female patient. The patient's pertinent medical history, drug reactions and allergies were unknown by the reporter. No concomitant medications were reported.    On an unknown date, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, anatomical location, lot #, and expiration date were not reported) indicated for routine vaccination.         On an unknown date after the administration of the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient fainted 3 times in the office (syncope) for which the patient sought medical attention.  It was unknown if a treatment was given for the event and if laboratory diagnostics and studies were performed.   The outcome of syncope was reported as recovered the same day that the event occurred. The causal relationship between syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.       Upon internal review, syncope was considered a medically significant event.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported; patient received GARDASIL 9 on the following dosing schedule: first dose on 7/14/17, and second dose on 7/5/2019; This spontaneous report as received from a nurse refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 14-JUL-2017, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dosage form (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On 05-JUL-2019, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dosage form (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; one patient was administered an improperly stored dose of ROTATEQ; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided.     On 13-AUG-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R033252, expiration date 29-JUN-2020; dose and route were unknown) for prophylaxis.         The storage temperature of the vaccine was reported as 15.5 degrees Celsius for a time frame of 17 hours and 30 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. The call was due to a data logger.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects; a patient received an expired dose of PNEUMOVAX; This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 15-AUG-2019, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (Expired product administered) lot number N019837 with expiration date on 21-FEB-2019 (dose number, frequency, strength and route of administration were not reported) for prophylaxis. No known adverse effects.   The outcome of expired product administered was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: The patient's father reports that in 2019, the physician office did not have records of administration, and a fourth dose was administered; This spontaneous report was received from a consumer referring to his daughter as a 17 years old female patient. The patient had none pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant.  On unknown date in 2016, when the patient was 15 years old, the patient completed the 3 dose series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number and expiration dates were unknown).  On unknown date in July 2019, the physician office didn't have the records of administration, and a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Extra dose administered) as recommended by pediatrician for prophylaxis (route of administration, lot number and expiration date were unknown by the reporter). The consumer reports that the physician office did located her records of prior vaccination. The consumer was considering speaking with Legal Counsel regarding the mishandling of his daughter's medical records and possible side effects of extra dose administration. It was also reported that the patient didn't sought medical attention and none laboratory diagnostics or studies were performed.   The outcome of extra dose administered was unknown.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects reported; a 15 year old patient was inadvertenly administered an adult formulation dose of VAQTA; This spontaneous report was received from an office manager referring to an unknown gender 15 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 22-JUL-2019, the patient was vaccinated with an adult formulation dose of hepatitis a vaccine, inactivated(VAQTA) 50/1.0 U/ml, lot # R027987 and expiration date 09-AUG-2019 (dose, frequency and route were not provided) for prophylaxis (incorrect dose administered). No adverse effects were reported.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The patient was vaccinated with improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a 3 unspecified patients of unknown age and gender. The patients' medical history, concomitant medications, drug reactions or allergies were not reported.  On 07-AUG-2019, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # R031626, expiration date: 01-NOV-2020 (strength, route of administration and anatomical location were not provided) for prophylaxis. Temperature excursion was 11. Fahrenheit (F) during a time frame of 1 hour and 36 minutes which was recorded by a data logger. No previous temperature excursions were involved. No adverse effects were reported.   Follow up information was received form the nurse concerning a 4 years old male patient on 15-AUG-2019.   Patient demographics were updated.   On 07-AUG-2019, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneously, lot number R031626, expiration date: 01-NOV-2020 in the right arm (strength was not reported) for prophylaxis.   The reporter stated that three doses of varicella virus vaccine live (oka/merck)(VARIVAX) were accidentally administered before realized the digital data logger noted an out of range temperature. Upon realized the out of range temperature measures were taken to address it staff was educated on excursion process and ways to prevent this from happening in the future.  This is one of three cases received by the same reporter. ; Sender's Comments:  US-009507513-1908USA004291: US-009507513-1908USA006568:
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The  patient was vaccinated with improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a 3 unspecified patients of unknown age and gender. The patients' medical history, concomitant medications, drug reactions or allergies were not reported.  On 07-AUG-2019, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # R031626, expiration date: 01-NOV-2020 (strength, route of administration and anatomical location were not provided) for prophylaxis. Temperature excursion was 11. Fahrenheit (F) during a time frame of 1 hour and 36 minutes which was recorded by a data logger. No previous temperature excursions were involved. No adverse effects were reported.   Follow up information was received form the nurse concerning a 3 years old female patient on 15-AUG-2019.   Patient demographics were updated.   On 07-AUG-2019, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneously, lot number R031626, expiration date: 01-NOV-2020 in the right arm (strength was not reported) for prophylaxis.   The reporter stated that three doses of varicella virus vaccine live (oka/merck)(VARIVAX) were accidentally administered before realized the digital data logger noted an out of range temperature. Upon realized the out of range temperature measures were taken to address it staff was educated on excursion process and ways to prevent this from happening in the future.  This is one of three cases received by the same reporter. ; Sender's Comments:  US-009507513-1908USA006567: US-009507513-1908USA004291:
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling, Insomnia, Rash
Clinical narrative: Extreme rash on arm / rash on both arms; Could not sleep; Welts under skin; bumps on both arm; itchy rash; Arm was very swollen; redness / arm redness; Painful at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd July 2019, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 4th July 2019, 1 days after receiving Shingrix, the patient experienced injection site swelling, erythema of extremities and injection site pain. On 8th July 2019, the patient experienced rash, sleeplessness, rash urticaria-like, papular rash and itchy rash. The patient was treated with steroids nos (Steroid Shot (Nos)), benadryl (nos) (Benadryl Cream), benadryl (nos) (Benadryl Tablet), gabapentin and non-drug therapy (Ice Pack (No Medication)). On 5th August 2019, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the injection site swelling, erythema of extremities and injection site pain were recovered/resolved and the outcome of the sleeplessness was not recovered/not resolved and the outcome of the rash urticaria-like, papular rash and itchy rash were unknown.   It was unknown if the reporter considered the injection site swelling, erythema of extremities, injection site pain, rash, sleeplessness, rash urticaria-like, papular rash and itchy rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The day after vaccination, the patient's arm was very swollen, red and painful at the injection site. The redness continued to spread all the way down to her wrist. The patient put ice packs on it that day and on 5th July 2019 it seemed to be getting better. 5 days after receiving Shingrix, the patient experienced an extreme rash on her arm with welts under her skin that spread from shoulder to wrist and was extremely itchy. The rash and bumps were on both arms. The rash spread to the back of her legs. The itching became so bad that she could not sleep. She continued to use ice packs to help relieve the symptoms. On 16th July 2019, the patient saw her primary care provider and was given a steroid shot and told to treat the itching with Benadryl cream. The patient used the Benadryl cream and Benadryl tablets as well, but the symptoms did not improve, other than that the rash on the back of her legs went away. The patient still had the very itchy rash on both arms. On 2nd August 2019, the patient saw her PCP again and was prescribed a steroid dose pack and a two week supply of gabapentin. On the reporting date, the rash and itching had improved a little bit. At some point the pain, redness and swelling at the injection site resolved.  The reporter consented to follow up. The case was related to patient.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash papular, Rash pruritic, Urticaria
Clinical narrative: Extreme rash on arm / rash on both arms; Could not sleep; Welts under skin; bumps on both arm; itchy rash; Arm was very swollen; redness / arm redness; Painful at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd July 2019, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 4th July 2019, 1 days after receiving Shingrix, the patient experienced injection site swelling, erythema of extremities and injection site pain. On 8th July 2019, the patient experienced rash, sleeplessness, rash urticaria-like, papular rash and itchy rash. The patient was treated with steroids nos (Steroid Shot (Nos)), benadryl (nos) (Benadryl Cream), benadryl (nos) (Benadryl Tablet), gabapentin and non-drug therapy (Ice Pack (No Medication)). On 5th August 2019, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the injection site swelling, erythema of extremities and injection site pain were recovered/resolved and the outcome of the sleeplessness was not recovered/not resolved and the outcome of the rash urticaria-like, papular rash and itchy rash were unknown.   It was unknown if the reporter considered the injection site swelling, erythema of extremities, injection site pain, rash, sleeplessness, rash urticaria-like, papular rash and itchy rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The day after vaccination, the patient's arm was very swollen, red and painful at the injection site. The redness continued to spread all the way down to her wrist. The patient put ice packs on it that day and on 5th July 2019 it seemed to be getting better. 5 days after receiving Shingrix, the patient experienced an extreme rash on her arm with welts under her skin that spread from shoulder to wrist and was extremely itchy. The rash and bumps were on both arms. The rash spread to the back of her legs. The itching became so bad that she could not sleep. She continued to use ice packs to help relieve the symptoms. On 16th July 2019, the patient saw her primary care provider and was given a steroid shot and told to treat the itching with Benadryl cream. The patient used the Benadryl cream and Benadryl tablets as well, but the symptoms did not improve, other than that the rash on the back of her legs went away. The patient still had the very itchy rash on both arms. On 2nd August 2019, the patient saw her PCP again and was prescribed a steroid dose pack and a two week supply of gabapentin. On the reporting date, the rash and itching had improved a little bit. At some point the pain, redness and swelling at the injection site resolved.  The reporter consented to follow up. The case was related to patient.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Injection site rash, Pruritus, Rash
Clinical narrative: Extreme rash on arm / rash on both arms; Could not sleep; Welts under skin; bumps on both arm; itchy rash; Arm was very swollen; redness / arm redness; Painful at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd July 2019, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 4th July 2019, 1 days after receiving Shingrix, the patient experienced injection site swelling, erythema of extremities and injection site pain. On 8th July 2019, the patient experienced rash, sleeplessness, rash urticaria-like, papular rash and itchy rash. The patient was treated with steroids nos (Steroid Shot (Nos)), benadryl (nos) (Benadryl Cream), benadryl (nos) (Benadryl Tablet), gabapentin and non-drug therapy (Ice Pack (No Medication)). On 5th August 2019, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the injection site swelling, erythema of extremities and injection site pain were recovered/resolved and the outcome of the sleeplessness was not recovered/not resolved and the outcome of the rash urticaria-like, papular rash and itchy rash were unknown.   It was unknown if the reporter considered the injection site swelling, erythema of extremities, injection site pain, rash, sleeplessness, rash urticaria-like, papular rash and itchy rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The day after vaccination, the patient's arm was very swollen, red and painful at the injection site. The redness continued to spread all the way down to her wrist. The patient put ice packs on it that day and on 5th July 2019 it seemed to be getting better. 5 days after receiving Shingrix, the patient experienced an extreme rash on her arm with welts under her skin that spread from shoulder to wrist and was extremely itchy. The rash and bumps were on both arms. The rash spread to the back of her legs. The itching became so bad that she could not sleep. She continued to use ice packs to help relieve the symptoms. On 16th July 2019, the patient saw her primary care provider and was given a steroid shot and told to treat the itching with Benadryl cream. The patient used the Benadryl cream and Benadryl tablets as well, but the symptoms did not improve, other than that the rash on the back of her legs went away. The patient still had the very itchy rash on both arms. On 2nd August 2019, the patient saw her PCP again and was prescribed a steroid dose pack and a two week supply of gabapentin. On the reporting date, the rash and itching had improved a little bit. At some point the pain, redness and swelling at the injection site resolved.  The reporter consented to follow up. The case was related to patient.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Injection site pain, Malaise
Clinical narrative: injection site soreness; diarhea; chills; fever; headache; felt sick; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date 29th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 14th May 2019 and experienced injection site soreness, refer case US2019144922).   On 31st July 2019, the patient received the 2nd dose of Shingrix .5 ml. On 1st August 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, diarrhea, chills, fever, headache and feeling unwell. Rechallenge with Shingrix was positive. On 4th August 2019, the outcome of the injection site pain, diarrhea, chills, fever, headache and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the injection site pain, diarrhea, chills, fever, headache and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The patient experienced injection site soreness, diarrhea, chills, fever, headache, and felt sick. The reporter consented to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: injection site soreness; diarhea; chills; fever; headache; felt sick; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date 29th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 14th May 2019 and experienced injection site soreness, refer case US2019144922).   On 31st July 2019, the patient received the 2nd dose of Shingrix .5 ml. On 1st August 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, diarrhea, chills, fever, headache and feeling unwell. Rechallenge with Shingrix was positive. On 4th August 2019, the outcome of the injection site pain, diarrhea, chills, fever, headache and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the injection site pain, diarrhea, chills, fever, headache and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The patient experienced injection site soreness, diarrhea, chills, fever, headache, and felt sick. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: injection site itching; injection site redness; This case was reported by a other health professional via call center representative and described the occurrence of injection site itching in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix (intramuscular). In February 2019, 1 day after receiving Shingrix, the patient experienced injection site itching and injection site erythema. In February 2019, the outcome of the injection site itching and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient developed injection site itching and redness that resolved in 2 days. The reporter consented to follow up. This case has been linked with case US2019143868, reported by the same reporter.
Sex: M
Vaccine: MENB
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: body ache; chills; muscle pain; fever; This case was reported by a physician via sales rep and described the occurrence of general body pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Bexsero. On an unknown date, less than 3 weeks after receiving Bexsero, the patient experienced general body pain, chills, muscle pain and fever. On an unknown date, the outcome of the general body pain, chills, muscle pain and fever were recovered/resolved.   It was unknown if the reporter considered the general body pain, chills, muscle pain and fever to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient after receiving 1st dose of Bexsero experienced body ache, chills, muscle pain, fever that lasted 2 days. The reporter did not agree to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lethargy, Pyrexia, Swelling, Tenderness
Clinical narrative: redness; swelling; pain to the touch; fever; felt lethargic; This case was reported by a consumer and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced erythema, swelling, tenderness, fever and lethargy. On an unknown date, the outcome of the erythema, swelling, tenderness, fever and lethargy were unknown.   It was unknown if the reporter considered the erythema, swelling, tenderness, fever and lethargy to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. On Tuesday, the patient received Shingrix and experienced redness, swelling and pain to the touch, tenderness, fever and lethargy. This is 1 of the 3 linked cases, reported by the same reporter.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Myalgia, Pyrexia
Clinical narrative: fever; chills; muscle pains; dizziness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th August 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, muscle pain and dizziness. On an unknown date, the outcome of the fever, chills, muscle pain and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, muscle pain and dizziness to be related to Shingrix.  Additional information received were as follows: The caller reported that he received the 1st dose of Shingrix the day before the reporting date. The patient woke up this morning with mild side effects of fever, chills, muscle pains, and dizziness. The reporter consented to follow up.  The case was related to patient.
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Urticaria
Clinical narrative: hives; lesions on neck and chin; This case was reported by a other health professional via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included adalimumab (Humira).   On 28th June 2019, the patient received the 1st dose of Shingrix. On 15th July 2019, 17 days after receiving Shingrix, the patient experienced hives and skin lesion. The patient was treated with valaciclovir hydrochloride (Valtrex), hydrocortisone and triamcinolone. On an unknown date, the outcome of the hives and skin lesion were not recovered/not resolved.   It was unknown if the reporter considered the hives and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy intern stated that the patient was on Humira was given the Shingrix and developed hives and lesions on her neck and chin. These symptoms have not resolved till the time of reporting. The patient was prescribed Valtrex, hydrocortison and triamcinolone. The pharmacy intern was not aware of the patient name, administering pharmacy or doctor's information. The pharmacy provides the patient's Humira. The reporter consent to follow up.  Additional information was not available.
Age: 49.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Product administered to patient of inappropriate age
Clinical narrative: rash; Inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a 49-year-old male patient who received DTPa (Infanrix) (batch number J947T, expiry date 30th May 2021) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, unknown after receiving Infanrix, the patient experienced injection site rash and adult use of a child product. On an unknown date, the outcome of the injection site rash and adult use of a child product were unknown.   It was unknown if the reporter considered the injection site rash to be related to Infanrix.  Additional details were provided as follows: The medical assistant reported that Infanrix was inadvertently administered to the 49 years old patient, which led to adult use of a child product. The Patient developed rash on arm of injection. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine last Sunday and he was still experiencing muscle pain. The patient refused follow up and did not want to answer any questions. The reporter denied permission to follow up.  In the XML document outcome of events was reported as recovering, but in database its mentioned as not recovered, so kept as reported in database
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Influenza like illness, Lethargy
Clinical narrative: Fatigue; Not Hungry; Lethargic; Flu-like; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and breast cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 hrs after receiving Shingrix, the patient experienced fatigue, appetite absent, lethargy and influenza like illness. On an unknown date, the outcome of the fatigue, appetite absent, lethargy and influenza like illness were recovered/resolved.   It was unknown if the reporter considered the fatigue, appetite absent, lethargy and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose approximately 3 months ago and within 2 hours after the patient felt fatigues like she was ready to take a nap.  The patient experienced not hungry and was similar to flu but not as serious. Lastly the patient felt a little lethargic and that she only wanted to watch TV. The next morning caller's mother felt better and by the afternoon back to normal. The reporter did not consent to follow up. The reporter declined to provide demographics including last name and address.  The patient would receive 2nd dose from a pharmacy in the town. and if her mother experiences side effects that she would call back and possibly provide follow up contact information.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Injection site reaction, Somnolence
Clinical narrative: Injection site reactions; Fatigue; feel like they need a nap; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site reaction, fatigue and sleepiness. On an unknown date, the outcome of the injection site reaction, fatigue and sleepiness were unknown.   It was unknown if the reporter considered the injection site reaction, fatigue and sleepiness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the most commonly seen adverse events from Shingrix that they have noted at the pharmacy are local injection site reactions. The reporter stated that about 50% of patients also experience severe fatigue, they get very tired, feel like they need a nap and end up sleeping for 16 hours. The reporter consented to follow up. The reporter granted permission for follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: arm swelling; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   On 17th March 2019, the patient received the 1st dose of Shingrix. On 19th March 2019, 2 days after receiving Shingrix, the patient experienced swelling arm. On 21st March 2019, the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were provided as follows: Arm swelling was resolved after about 4 days post injection. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site rash, Rash, Rash erythematous, Skin warm
Clinical narrative: rash that consist of "little tiny bumps"; little tiny bumps; Rash is Warm to Touch; Became a litle redder; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 3HX44, expiry date 15th November 2021) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th August 2019, 5 days after receiving Shingrix, the patient experienced rash, swelling, skin warm and erythema. On an unknown date, the outcome of the rash, skin warm and erythema were not recovered/not resolved and the outcome of the swelling was unknown.   It was unknown if the reporter considered the rash, swelling, skin warm and erythema to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on right deltoid. a day before the reporting date, the patient presented to the pharmacist with a rash that consisted of little tiny bumps surrounding the injection site.  The reporting pharmacist reported that the patient's rash was warm to touch and had mostly remained the same but became a little redder. The onset of rash was eporting pharmacist reports the patient's rash is warm to touch and has mostly remained the same but became a little redder.  The onset of rash was unknown.