chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: Period length has increased by 4 additional days every month since receiving vaccine.  I spot / bleed for two additional days before and two additional days after my period than I did before having the vaccine.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Pain, Pyrexia
Clinical narrative: really sick; a feeling "like 2 trucks hit her," and her body hurt all over; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), PAIN (a feeling "like 2 trucks hit her," and her body hurt all over), HEADACHE (headache) and PYREXIA (fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick), PAIN (a feeling "like 2 trucks hit her," and her body hurt all over), HEADACHE (headache) and PYREXIA (fever). At the time of the report, ILLNESS (really sick), PAIN (a feeling "like 2 trucks hit her," and her body hurt all over), HEADACHE (headache) and PYREXIA (fever) had resolved.            Patient reported no significant past medical history and no previous diagnosis of covid-19.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-475933 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Induration, Pain, Pyrexia, Rash
Clinical narrative: High fever of 101-102 F resulted in less than 12 hours. After 24 hours, fever reduced to 99 F. By 2/10/22, fever gone, but in its place a rash on both ears, particularly the area behind the ears. By 2/11/22, rash persists and ear lobes now experiencing swelling. On left ear, swelling slightly worse and extends down to the jaw joint, is hard and painful to the touch. Both ears are hot to the touch.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: High fever of 101-102 F resulted in less than 12 hours. After 24 hours, fever reduced to 99 F. By 2/10/22, fever gone, but in its place a rash on both ears, particularly the area behind the ears. By 2/11/22, rash persists and ear lobes now experiencing swelling. On left ear, swelling slightly worse and extends down to the jaw joint, is hard and painful to the touch. Both ears are hot to the touch.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph node; pain in left arm; tiredness; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 11:30 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Apr2021 13:00, outcome "unknown", described as "Swollen lymph node"; PAIN IN EXTREMITY (non-serious) with onset 01Apr2021 13:00, outcome "unknown", described as "pain in left arm"; FATIGUE (non-serious) with onset 01Apr2021 13:00, outcome "unknown", described as "tiredness"; CHILLS (non-serious) with onset 01Apr2021 13:00, outcome "unknown", described as "chills". Therapeutic measures were not taken as a result of lymphadenopathy, pain in extremity, fatigue, chills.  Additional Information: No other vaccine in four weeks. No covid prior vaccination. Covid was not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion for VAQTA; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. No information regarding patient's medical history, concurrent conditions or concomitant therapies was provided.  On 03-JAN-2022, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) lot # U024505, expiration date 15-OCT-2022 (dose, dose number and site of administration were not provided) for prophylaxis (Product storage error) . No details regarding time and conditions were provided for the temperature excursion. No adverse events were reported (No adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA006297: US-009507513-2201USA005595: US-009507513-2201USA005673: US-009507513-2201USA005751: US-009507513-2201USA005901: US-009507513-2201USA006305: US-009507513-2201USA006322: US-009507513-2201USA006342: US-009507513-2201USA006419: US-009507513-2201USA006445: US-009507513-2201USA006536:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On 20-JAN-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U022321 was confirmed to be valid, expiration date: 15-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided).  The temperature excursion was - 14.1 Celsius degrees (C) (C) for 12 Minutes (Product storage error). There were no previous excursions reported. No adverse effects were reported.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion occurred; This spontaneous report was received from a nurse referring to a 36 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-JAN-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, (lot U010398, expiration date 01-APR-2023) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously, (lot T034389, expiration date 08-OCT-2022)  (strength, dose and anatomical location were not provided for any vaccine).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion occurred on 11/22/21; This spontaneous report was received from a nurse referring to a 24 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 17-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion occurred on 11/22/21; This spontaneous report was received from a nurse referring to a 40 years old, male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 10-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously in the right arm (lot T027914, expiration date 18-AUG-2022) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion occurred 11/22/21; This spontaneous report was received from a nurse referring to a 20 years old, male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  The vaccine was improperly stored on 22-NOV-2021 and on 29-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, in the left arm (lot number U010398, expiration date 01-APR-2023); (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Temp excursion occurred on 11/22/21; no further ae reported; This spontaneous report was received from a nurse referring to a 33 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  The vaccine was improperly stored on 22-NOV-2021 and on 02-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, in the right arm (lot number U020244, expiration date 28-JUN-2023); and with influenza vaccine inact split 3v (FLULAVAL) intramuscularly in the left arm (lot number 3P3TX, expiration date 30-JUN-2023) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; product storage error temperature too high; This spontaneous report was received from a nurse referring to a 66 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  The vaccine was improperly stored on 22-NOV-2021 and on 24-NOV-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, in the left arm (lot U020244, expiration date 28-JUN-2023) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously, in the right arm (lot number T027914, expiration date 18-AUG-2022) (strength and dose were not provided for any vaccine).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion occurred; This spontaneous report was received from a nurse referring to a 24 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, in the left arm (lot U020244, expiration date 28-JUN-2023) (strength and dose were not provided for any vaccine).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: M
Vaccine: FLUR3, MMR, TDAP, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; product storage error temperature too high; This spontaneous report was received from a nurse referring to a 34 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  The vaccine was improperly stored on 23-NOV-2021 and on 07-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, in the left arm; measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously, in the right arm; diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) intramuscularly, in the right arm (lot number QFAA21, expiration date 30-JUN-2021), influenza vaccine rha 3v (baculovirus) (FLUBLOK) in the left arm (lot number C5787AA, expiration date 01-OCT-2022) (strength and dose were not provided for any vaccine).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: F
Vaccine: VARZOS
Symptoms: Myelitis transverse, Polyneuropathy idiopathic progressive
Clinical narrative: myelitis transverse; idiopathic polyneuropathy; Information has been received from a lawyer, regarding a case in litigation, concerning a female patient (pt) of unknown age. There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. In or around May 2017, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location, and route of administration were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving the zoster vaccine live (ZOSTAVAX), the pt suffered transverse myelitis and idiopathic polyneuropathy. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of company wrongful conduct, the pt suffered serious, progressive, permanent and incurable injures, as well as significant conscious pain suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The reporter considered the events to be disabling. Upon internal review the events were considered to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; 5 day old infant was inadvertently administered ROTATEQ; This spontaneous report was received from a medical assistant referring to a 5-day-old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 02-FEB-2022, the 5-day-old patient was inadvertently administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product administered to patient of inappropriate age) 2 milliliter (lot number U006175, expiration date 02-SEP-2022; vaccination scheme, route of administration, and anatomical location of vaccination were not reported), for prophylaxis.  No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No addtional AE; Inadvertently concomitantly administered PROQUAD and VARIVAX; This spontaneous report was received from a medical assistant referring to a 1-year-old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.   On 03-FEB-2022 the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) 0.5 (lot number U015481, expiration date 13-NOV-2022 ; vaccination scheme, route of administration, and anatomical location of vaccination were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 (lot number T028305, expiration date 20-AUG-2022) for prophylaxis. On same day, medical assistant reported that measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) were inadvertently concomitantly administered to a one-year-old patient (inappropriate schedule of product administration).  No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: The patient is now 18 years old and never received the 3 rd dose; No other AE; This spontaneous report has been received from a physician, concerning a currently 18-year-old patient of unknown gender.       The patient's concurrent conditions, medical history and concomitant medication were not reported.  On an unknown date (reported as "at age of 15 years and 4 months"), the patient was vaccinated with first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (anatomical location, lot number and expiration date were not reported) as prophylaxis.  Then, on unknown date (reported as "two months later") the patient received the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (anatomical location, lot number and expiration date were not reported) as prophylaxis. At the reporting time, the patient had never received the 3rd dose (inappropriate schedule of vaccine administration). No adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; Inadvertently administered an expired dose of MMR II to a patient; This spontaneous report was received from a physician referring to a patient of unreported age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 04-FEB-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (expiration date 28-JAN-2022, lot number, dose, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis.  It was reported that they inadvertently administered an expired dose of MMR II to a patient (expired product administered). the product did not experience any temperature excursions prior to administration.  No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered as not recovered/not resolved. The reporter considered the events were related to zoster vaccine live (ZOSTAVAX).  The lawyer considered the events to be disability.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain, Pain
Clinical narrative: Abdominal cramping and pain; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of abdominal cramp in a 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 abdominal cramp and pain. On an unknown date, the outcome of the abdominal cramp and pain were unknown.   It was unknown if the reporter considered the abdominal cramp and pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR019700  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received his/her 1st dose of Shingrix and experienced abdominal cramping and pain which were most notable side effects. The follow up would not possible as no contact details were available. For tolerance to 2nd dose, refer case US2022AMR019700.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR019700:same report, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 2 years ago, can still have second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of shingrix 2 years ago).   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 reported as follows: Age at vaccination was not applicable for this report. The patient asked if they could receive second dose now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: so painful when injected; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The reporter asked why was the Shingrix vaccine so painful when injected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the vaccine, shingles anyway/suspected vaccination failure; shingles; stabbing pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient got the Shingrix vaccine and had shingles anyway. Stabbing pain was unbearable . The patient asked futher guidance on this. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not available. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles immediately after their booster shots; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were reported as follows: The patient was reporter's friend. The age at vaccination was not reported. The patient developed shingles immediately after the booster shot. The reporter stated that the doctor already explained this to the reporter. The follow-up would not possible as no contact details were available. This case has been linked to US2022AMR021503, from the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR021503:Same Reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and he got the worst case/ Suspected vaccination failure; got the worst case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's brother. The age at vaccination was not reported. The reporter stated that, the Shingles shot did not work as the patient got Shingle shot and got worst case of shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles for 3rd time, even after vaccine/Suspected Vaccination Failure; Shingles for 3rd time; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case.                                        The age at vaccination was not reported. The patient had shingles for the 3rd time, even after getting Shingle vaccine.    This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pain in extremity, Vaccination failure
Clinical narrative: I got them and I got the shot; I got them; awful painful; got pain in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles (had shingles).   On an unknown date, the patient received Shingles vaccine. In July 2019, less than 2 years after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles and the patient got the shot. The shot did not help the patient, one bit somehow there awful painful and still got pain in arm since July 19. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. Follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Immune system disorder
Clinical narrative: Pronounced immune response; Beat me up, Kicked my ass, Felt horrible; This case was reported by a consumer via interactive digital media and described the occurrence of immune system disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced immune system disorder and feels awful. On an unknown date, the outcome of the immune system disorder was unknown and the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the immune system disorder and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The patient self- reported this report. The age at vaccination was not reported. The patient got 1st shingles vaccine 3 months ago and get a pronounced immune response and felt horrible for a few days.  The patient stated that Antibiotics did not work on shingles as it was a virus.  However, the patient would get the 2nd vaccine as getting full blown shingles was much worse than the side effects of the vaccine. The patient stated that the 1st one beat him/her up, but he/she guess it's better than getting shingles. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nerve injury, Vaccination failure
Clinical narrative: had it twice, took the 2 in a series vac/suspected vaccination failure; had it twice; Left me with nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles and nerve damage were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the nerve damage to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient had shingles twice and got once from the Shingle vaccine which was faulty some years ago from reporting date.  The patient took both Shingle vaccine in a series, 4 years ago from reporting date.  The patient was left with nerve damage. The patient reported that he/she would not wish this on his/her worst enemy. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: fever; chills; Headache; nausea; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th February 2022, the patient received Shingles vaccine. In February 2022, less than a week after receiving Shingles vaccine, the patient experienced fever, chills, headache and nausea. On 6th February 2022, the outcome of the fever, chills, headache and nausea were recovered/resolved.   It was unknown if the reporter considered the fever, chills, headache and nausea to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shot on Friday and the weekend was horrible from the side effects.  The patient experienced fever,chills,headache,nausea. It was Sunday afternoon (at the time of reporting) before the patient felt better.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the vaccine, got shingles/Suspected vaccination failure; shingles breakthrough; pain; still have the pain (3 weeks now and it's awful); This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a 73-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included death of son (Family History) (patient's 52 year old son died in patient's arms in December 2021). Concurrent medical conditions included stress (had stress of that trauma of son's death).   On an unknown date, the patient received Shingles vaccine. In January 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and feels awful. On an unknown date, the outcome of the vaccination failure, shingles and feels awful were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got Shingles vaccine years ago from reporting date and got shingles. The patient still had pain 3 weeks now and it was awful, and he still recommend the shot. The patient was sure that the stress of that trauma of son's death caused the breakthrough. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: most painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and it was one of his/her most painful shot. The follow-up would not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis acneiform, Pruritus, Urticaria
Clinical narrative: Itching; pimple-like hives; pimple like rash; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included biopsy (had biopsies done which had not revealed any information). Previously administered products included Shingrix with an associated reaction of pruritus (1st dose received in March 2021, refer case US2022021678).   In May 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pruritus, hives and pimple-like rash. The patient was treated with prednisone and dupilumab (Dupixent). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pruritus, hives and pimple-like rash were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, hives and pimple-like rash to be related to Shingrix.     Linked case(s) involving the same patient:  US2022021678  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in her left arm and experienced hives, rash and itching. Since receiving Shingrix, she had continued with the pimple-like hives, rash and itching the areas of her body that are currently affected by the itching, rash and pimple like hives include both legs, under both arms, and down both her sides of her torso. The patient had been to an allergist, her primary care physician, and a dermatologist.  The patient had been treated with prednisone which helps clear it up, but the hives and itching subsequently comes back, she had recently started on Dupixant by her dermatologist to treat her itching and hives. Spoke per package insert (PI). Gave Medical Information phone number for her to provide to HCP to call on her behalf.  The patient was given medical advice disclaimer and was referred to HCP.  The reporter consented to follow-up with HCP (Pharmacy).; Sender's Comments:  US-GLAXOSMITHKLINE-US2022021678:Same patient, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles twice, diagnosed with a 3rd bout; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient stated that the patient's shingles came back worse after the vaccine Shingrix.  The patient had shingrix vaccine and had shingles twice and was diagnosed with a 3rd bout on 8th February 2022. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Consent to follow up was not possible as no contact details were available.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Dose 2 a month late; This case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received TWINRIX for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device TWINRIX Pre-Filled Syringe Device injection syringe for prophylaxis. Concomitant products included TWINRIX. On 12th January 2022, the patient received the 2nd dose of TWINRIX 1 ml and TWINRIX Pre-Filled Syringe Device. On 12th January 2022, unknown after receiving TWINRIX and TWINRIX Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Twinrix, later than the recommended schedule, which led to lengthening of vaccination schedule. No adverse event was reported but the patient did not return on recommended schedule for dose 2:
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Syringe issue
Clinical narrative: Product Complaint; not full dose was given; part fell off from arm of patient; part fell off from arm of patient; syringe issue; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 49R79, expiry date 2nd April 2022) for prophylaxis. This case was associated with a product complaint.   On 1st February 2022, the patient received Boostrix. On 1st February 2022, unknown after receiving Boostrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine, exposure via skin contact and syringe issue. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine, exposure via skin contact, syringe issue and pharmaceutical product complaint were unknown.  Additional details were provided as follows: Registered nurse reported that Boostrix's little white attachment had a malfunction during administration so not full dose was given, white part fell off and needle came out from the arm of the patient, which led to incomplete dose administered, inadvertent exposure to vaccine, exposure via skin contact, syringe issue and pharmaceutical product complaint. No further information reported. The reporter consented to follow-up.
Age: 7.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7yo patient received Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   Previously administered products included Infanrix (received their first 4 doses when they were younger).   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The registered nurse reported that 7 year old patient received Boostrix a couple months prior to the reporting as their 5th dose which led to inappropriate age at vaccine administration.   No patient details or date of administration was available for Infanrix doses.  The reporter consented to follow up.