chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Illness, Pneumonia, Vaccination failure
Clinical narrative: sick; has been diagnosed with 52 pneumonia cases; in 2008 she was given the pneumovax but she just kept getting pneumonia no matter what/her system rejects all vaccine; This spontaneous report has been received from an approximately 58-year-old female patient via Pfizer referring to herself. The patient's concurrent condition included born with immune deficiency and pneumonia. Her medical history included a girl ran over her foot with a "b ke" and crushed every ligament, tendon and muscle in her foot. Historical vaccine included tetanus vaccine. Her family history included her grandson and her daughter had immune problems as well. Concomitant medication was not reported.  The patient stated that her pneumonia started in 2007. On an unknown date in 2008, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route, lot#, and expiration date were not reported), but she just kept getting pneumonia no matter what (vaccination failure, pneumonia). The patient stated that her body rejects all vaccines.  On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) again (strength, dose, route, lot#, and expiration date were not reported), which made her really sick (illness). The outcome of vaccination failure, pneumonia, and illness was unknown.  The causality between vaccination failure and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was determined to be related. The causality between the remaining events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not reported. The reporter stated that it was part of her immune deficiency.  Upon internal review, pneumonia was determined to be medically significant.; Sender's Comments:  US-009507513-2202USA001407:
Age: 0.17
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event reported; Administration of GARDASIL 9 to a 2 month old patient; This spontaneous report was received from a nurse, referring a 2-month-old patient of unknown gender.  The patient's medical history, concurrent conditions an concomitant therapies were not reported.  On 02-FEB-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #T036812, expiration date: 28-APR-2023 (strength, dose and, route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever; Age reported as 0.66 years; Literature report:   This literature marketed report was received from the authors in a published literature article titled as stated above, regarding an infant female patient, which age was reported as "0.66 years", from an initial group of 204 patients (84 female and 120 male patients; enrolled in a study, which aim  was to evaluate the safety of live virus vaccines and the characteristics of the recipient population that are associated with successful live virus vaccination (LVV) post liver transplant (LT).  On an unknown date, the patient received a LT, along with an immunosuppressive regimen of tacrolimus and Mycophenolate mofetil (MMF) (doses, routes and frequencies were not reported). It was reported that, pre-transplant, the patient was Negative for the IgG of the corresponding vaccine  On an unknown date, "3 years" after the LT (discrepant information),  the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) along with varicella virus vaccine live (oka/merck)(manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis.    On an unknown date, the patient experienced fever that was considered a side effect from the 2 received vaccines.  At the reporting time, the outcome of fever was not reported. The authors considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck)(manufacturer unknown)   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports obtained from the same literature article.; Sender's Comments:  US-009507513-2201MEX008251: US-009507513-2202USA001022: US-009507513-2202USA001023:
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This literature marketed report was received from the authors in a published literature article titled as stated above, regarding an infant male patient, which age was reported as "0.48 years", from an initial group of 204 patients (84 female and 120 male patients; enrolled in a study, which aim  was to evaluate the safety of live virus vaccines and the characteristics of the recipient population that are associated with successful live virus vaccination (LVV) post liver transplant (LT).  On an unknown date, the patient received a LT, along with an immunosuppressive regimen of sirolimus (dose, route and frequency were not reported). It was reported that, pre-transplant, the patient's IgG of the corresponding vaccine was not available.  On unknown dates, 4.9 years after the LT (discrepant information),  the patient was vaccinated with 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis, along with varicella virus vaccine live (oka/merck)(manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis.    On an unknown date, the patient experienced an injection site reactions with erythema and swelling following co-administration of both vaccines; that was considered a side effect from the 2 vaccines.  At the reporting time, the outcome of vaccination site reaction, vaccination site swelling and vaccination site erythema was not reported. The authors considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck)(manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports obtained from the same literature article.; Sender's Comments:  US-009507513-2201MEX008251: US-009507513-2202USA001021: US-009507513-2202USA001023:
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: This literature marketed report was received from the authors in a published literature article titled as stated above, regarding a child  male patient, which age was reported as 1.11 years; from an initial group of 204 patients (84 female and 120 male patients; enrolled in a study, which aim  was to evaluate the safety of live virus vaccines and the characteristics of the recipient population that are associated with successful live virus vaccination (LVV) post liver transplant (LT). The patient's concurrent conditions included biliary atresia. On an unknown date, the patient received a LT, along with an immunosuppressive regimen of sirolimus (dose, route and frequency were not reported). It was reported that,  pre-transplant, the patient was Negative for the IgG of the corresponding vaccine  On an unknown date, before the LT,  the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis, along with varicella virus vaccine live (oka/merck)(manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis.    On an unknown date, the patient underwent a LT, due to her biliary atresia. On an unknown date, the patient experienced fever that was considered a side effect from the received vaccinations.  At the reporting time, the outcome of fever was not reported. The authors considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis, along with varicella virus vaccine live (oka/merck)(manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports obtained from the same literature article.; Sender's Comments:  US-009507513-2201MEX008251: US-009507513-2202USA001021: US-009507513-2202USA001022:
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral
Clinical narrative: became blind in his left eye; This spontaneous report was received from the patient's wife referring to her husband, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.     On an unknown date in 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for shingles (strength, dose, anatomical location, route of administration, lot #, and expiration date were not reported).         On an unknown date in 2008, the patient became blind of his left eye. The patient's wife was inquired of the vaccine could have caused the blindness.   The outcome of blindness unilateral was unknown.  The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was not reported.       Upon internal review, blindness unilateral was considered a medically significant event.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional ae reported; undergone temperature excursion; This spontaneous report was received from a registered nurse referring to a 15 year old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.  On 02-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (lot# U008180 with an expiration date on 12-MAR-2023)(strength, dose, anatomical location, and route of administration were not reported) that had undergone temperature excursion (product storage error).         No additional adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: she was given the shingles vaccine but then got shingles and so that obviously didn't work; she was given the shingles vaccine but then got shingles and so that obviously didn't work; This spontaneous report has been received from a currently 71-year-old female patient referring to herself. The patient's concurrent condition included born with immune deficiency and pneumonia. Her medical history included a girl ran over her foot with a "b ke" and crushed every ligament, tendon and muscle in her foot. Historical vaccine included tetanus vaccine. Her family history included her grandson and her daughter had immune problems as well. Concomitant medication was not reported.  On an unknown date, the patient was vaccinated with Zoster Vaccine Live (manufacturer unknown) for prophylaxis (strength, dose, route, lot#, and expiration date were not reported).   On an unknown date, the patient experience shingles (herpes zoster), so that the vaccine obviously didn't work (vaccination failure). The patient stated that her body rejects all vaccines. The outcome of vaccination failure and shingles was unknown.  The causality between vaccination failure and Zoster Vaccine Live (manufacturer unknown) was determined to be related. The causality shingles and Zoster Vaccine Live (manufacturer unknown) was not reported. The reporter stated that it was part of her immune deficiency.; Sender's Comments:  US-009507513-2202USA000779:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Ill-defined disorder, Product storage error
Clinical narrative: adverse experience; Temperature excursion involving GARDASIL 9; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 11-year-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 13-DEC-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiration date: 20-MAY-2023, which have been verified to be valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) administered in left deltoid(strength, exact dose and route of administration were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parent agrred to revaccination. The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582:
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Ill-defined disorder, Product storage error
Clinical narrative: adverse experience; Temperature excursion involving GARDASIL 9; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 16-year-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 17-DEC-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiration date: 20-MAY-2023, which have been verified to be valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) administered in left deltoid (strength, exact dose and route of administration was not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination. The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582:
Age: 0.33
Sex: F
Vaccine: HIBV, RV5
Symptoms: Ill-defined disorder, Inappropriate schedule of product administration, Product storage error
Clinical narrative: adverse experience; revaccinated; Temperature excursion involving, PEDVAX HIB, RECOMBIVAX HB, VAQTA, GARDASIL 9, and ROTATEQ; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 4-month-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 20-DEC-2021, the patient was vaccinated with an improperly stored doses haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # U003873, expiration date: 15-APR-2023, which have been verified to be valid lot numbers for haemophilus b conjugate vaccine (meningococcal protein conjugate) administered in left thigh and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (lot # 1821803, expiration date: 26-JUL-2022 (also reported as 25-JUL-2022), which have been verified to be valid lot numbers for rotavirus vaccine, live, oral, pentavalent (strengths, doses # and exact doses were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination (inappropriate schedule of vaccine administered). The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2201USA000582:
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Ill-defined disorder, Product storage error
Clinical narrative: adverse experience; Temperature excursion involving GARDASIL 9; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 16-year-old of male patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 20-DEC-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiration date: 20-MAY-2023, which have been verified to be valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) administered in right deltoid (strength, exact dose and route of administration were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination. The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582:
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Ill-defined disorder, Inappropriate schedule of product administration, Product storage error
Clinical narrative: adverse experience; revaccinated; Temperature excursion involving, PEDVAX HIB; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 2-month-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 27-DEC-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # U003873, expiration date: 15-APR-2023, which have been verified to be valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) in left thigh (strength, exact dose, dose # and route of administration were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination (inappropriate schedule of vaccine administered). The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2201USA000582:
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Ill-defined disorder, Inappropriate schedule of product administration, Product storage error
Clinical narrative: adverse experience; revaccinated; Temperature excursion involving VAQTA; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 18-month-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 27-DEC-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # U024504, expiration date: 15-OCT-2022, which have been verified to be valid lot numbers for hepatitis a vaccine, inactivated (strength, exact dose and route of administration were not provided) in left thigh for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination (inappropriate schedule of vaccine administered). The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582:
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Ill-defined disorder, Product storage error
Clinical narrative: adverse experience; Temperature excursion involving GARDASIL 9; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 12-year-old of male patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 16-DEC-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiration date: 20-MAY-2023, which have been verified to be valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) administered in left deltoid (strength, exact dose and route of administration was not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination. The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582:
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Ill-defined disorder, Product storage error
Clinical narrative: adverse experience; Temperature excursion involving GARDASIL 9; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 14-year-old of male patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 27-DEC-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiration date: 20-MAY-2023, which have been verified to be valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) administered in left deltoid (strength, exact dose and route of administration was not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination. The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Ill-defined disorder, Product storage error
Clinical narrative: adverse experience; Temperature excursion involving GARDASIL 9; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 11-year-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 30-DEC-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiration date: 20-MAY-2023, which have been verified to be valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) administered in right deltoid (strength, exact dose and route of administration was not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination. The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582 :
Sex: U
Vaccine: VARZOS
Symptoms: Blindness unilateral
Clinical narrative: loss of vision of right eye; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the vaccine, the pt suffered loss of vision of right eye. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental cost of suit, attorneys' fees, and all such other relief as the Court deems just and proper as well as: a. Compensatory damages to the pt for past, present, and future damages, including, but not limited to, pain and suffering for severe and permanent personal injuries sustained by the pt, health and medical care costs, together with interest and costs as provided by law; b. Restitution and disgorgement of profits; c. Reasonable pts' fees; d. The costs of these proceedings; e. All ascertainable economic damages; f. Punitive damages; and g. Such other and further relief as this Court deems just and proper. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the event loss of vision of right eye to be disabling. Upon internal review, loss of vision of right eye was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Cardiac monitoring normal, Chest X-ray normal, Chest pain, Dyspnoea
Clinical narrative: Severe muscle pain; Occasional chest pain, ER thinking a possible heart attack; Shortness of breath, ER thinking a possible heart attack; severe muscle pain in my left shoulder blade and arm down to; This case was reported by a consumer and described the occurrence of muscle pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included medication unknown (Blood Pressure Medication) and hmg coa reductase inhibitors (nos) (Statin (Unknown)).   On 5th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than 3 weeks after receiving Shingrix, the patient experienced muscle pain, chest pain, shortness of breath and pain in arm. On an unknown date, the outcome of the muscle pain, chest pain, shortness of breath and pain in arm were recovered/resolved.   It was unknown if the reporter considered the muscle pain, chest pain, shortness of breath and pain in arm to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was unknown. The patient received a dose of Shingrix and experienced severe muscle pain in left shoulder blade and arm down to elbow and occasional chest pain and shortness of breath which lasted for more than 3 days after injection. The patient visited emergency room on 25th January 2022 for fear of experiencing possible heart attack symptoms. The patient underwent EKG (Electrocardiogram), chest X-rays and 2 rounds of blood work and several hours of heart monitoring. The patient was released as all tests showed normal activity and no signs of heart issues. The patient later read some comments on the website of the same symptoms by others months later. The patient was taking BP (Blood pressure),  medications and statin and not had any heart issues in past. The patient stated that the side effects on the information sheet should include these possible symptoms too which lasted for more than 3 days after injection. The patient expected to get paid the emergency room bill as a result of taking the vaccine. Consent to follow up was requested. This case has been linked to US2022AMR016128, reported by the same reporter, case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR016128:Same reporter. case.
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram normal, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Severe muscle pain; Occasional chest pain, ER thinking a possible heart attack; Shortness of breath, ER thinking a possible heart attack; severe muscle pain in my left shoulder blade and arm down to; This case was reported by a consumer and described the occurrence of muscle pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included medication unknown (Blood Pressure Medication) and hmg coa reductase inhibitors (nos) (Statin (Unknown)).   On 5th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than 3 weeks after receiving Shingrix, the patient experienced muscle pain, chest pain, shortness of breath and pain in arm. On an unknown date, the outcome of the muscle pain, chest pain, shortness of breath and pain in arm were recovered/resolved.   It was unknown if the reporter considered the muscle pain, chest pain, shortness of breath and pain in arm to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was unknown. The patient received a dose of Shingrix and experienced severe muscle pain in left shoulder blade and arm down to elbow and occasional chest pain and shortness of breath which lasted for more than 3 days after injection. The patient visited emergency room on 25th January 2022 for fear of experiencing possible heart attack symptoms. The patient underwent EKG (Electrocardiogram), chest X-rays and 2 rounds of blood work and several hours of heart monitoring. The patient was released as all tests showed normal activity and no signs of heart issues. The patient later read some comments on the website of the same symptoms by others months later. The patient was taking BP (Blood pressure),  medications and statin and not had any heart issues in past. The patient stated that the side effects on the information sheet should include these possible symptoms too which lasted for more than 3 days after injection. The patient expected to get paid the emergency room bill as a result of taking the vaccine. Consent to follow up was requested. This case has been linked to US2022AMR016128, reported by the same reporter, case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR016128:Same reporter. case.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: rash above waist; itching above waist; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On 26th January 2021, between 4 and 6 months after receiving Shingrix, the patient experienced rash and pruritus. On 26th January 2022, the outcome of the rash and pruritus were recovered/resolved.   It was unknown if the reporter considered the rash and pruritus to be related to Shingrix.     Linked case(s) involving the same patient:  US2022016246  Additional details were reported as follows: The age at vaccination was not reported. The patient received a 2 doses of Shingrix on August 2020 and experienced  rash and itching above waist from 26th January 2021 to 26th January 2022. The patient received 2nd dose on February 2021. The doctor suggested her to get an additional shot. The reporter confirmed with HCP that patient had not yet been administered a 3rd dose of Shingrix, till the time of reporting.  The reporter consent to follow up was denied.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: arm redness; arms swollen; Arms sore; Incredibly itchy; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, pain in arm and pruritus. On an unknown date, the outcome of the erythema of extremities, swelling arm, pain in arm and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, pain in arm and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received second dose of Shingles vaccine and patient's arms red swollen and sore. The patient stated that he/she know that takes time but it was incredibly itchy. The patient asked if it was normal and how much longer would it that last?  Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported the case. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced worst arm pain, which patient thought was better than getting shingles. Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: cold sore; This case was reported by a consumer via interactive digital media and described the occurrence of cold sores in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient had cold sores in the past. The patient received a dose of Shingrix and got another cold sores. The patient asked that it could had been a side effect. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 26th January 2022, the patient received Shingles vaccine. In January 2022, less than a week after receiving Shingles vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the dizziness 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 received a shingle shot on Wednesday (from the date of reporting) and now (on the day of reporting) experienced dizziness. The patient asked that if this was a side effect to the shot. The follow-up could not possible as no contact details were available.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Infanrix was administered; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 9BC23, expiry date 30th January 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2022, the patient received Infanrix .5 ml and Infanrix Pre-Filled Syringe Device. On 31st January 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK 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 an expired dose of Infanrix, which led to expired vaccine used. The reporter (reporting nurse) was not the person administering the vaccine. The reporter was notified of the event and called GlaxoSmithKline to ask about the dose validity and timing to repeat the dose, if needed. The reporter did not have any patient details at the time of the call. The reporter stated that there was no reaction following the administration of expired vaccine. The reporter consented to follow-up.
Age: 76.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Deafness unilateral, Herpes zoster, Illness, Pain, Vaccination failure
Clinical narrative: Lost hearing in right ear; pain; Sick; shingles; Suspected vaccination failure; This case was reported by a consumer and described the occurrence of vaccination failure in a 80-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2018, the patient received the 2nd dose of Shingrix. On 25th January 2018, the patient received the 1st dose of Shingrix. On 8th December 2021, 1348 days after receiving Shingrix and 1413 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria other: serious as per reporter). On an unknown date, the patient experienced deafness unilateral (serious criteria GSK medically significant), pain and sickness. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure, deafness unilateral, shingles, pain and sickness were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, deafness unilateral, shingles, pain and sickness to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient stated he/she was reporting a serious bout of shingles, even though he/she was vaccinated with Shingrix (2 doses). The patient had been in a lot of pain with shingles and had lost the hearing in his/her right ear. The patient stated he/she was very sick and in a lot of pain, which he/she did not expect because he/she was fully vaccinated with Shingrix. On 8th December 2021, the patient was diagnosed with shingles. The patient provided contact details of doctor. The patient further asked if there should be a Shingrix booster. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (the patient's 25 year old son had it and felt so bad for him).   In January 2022, the patient received the 1st dose of Shingles vaccine. In January 2022, less than 2 weeks 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's 25 year old son had shingles, he/she felt so bad for him. The patient received a dose of Shingles vaccine last week and hurt very bad. The patient stated as soon as he/she turned 50, he/she was at getting it. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Minor fatigue side effect; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR017694  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced minor fatigue side effect. The follow-up would not possible, as no contact details were available. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR017694:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Only felt bad; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included stress (break out from stress and wearing himself/herself down).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad 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 was break out from stress and wearing himself/herself down. The patient had learned to manage stress better and listen to his/her body when it's tired. The patient had received a shot of Shingles vaccine and 3 days after vaccination, the patient only felt bad for one day. The patient really hope this helps because he/she was so tired of Shingles. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: terrible pain you all had; This case was reported by a consumer via interactive digital media and described the occurrence of pain in an unspecified number of patients 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 age at vaccination was not applicable for this report. The reporter commented that, after reading comments for the terrible pain the all other consumers had, he/she was just going to shut the mouth and push on. The reporter stated the pain other consumers had was much greater. The reporter hoped all other get well and was going to pass this information on to get shingles shots. The follow-up would not possible as no contact details were available. This case has been linked to US2022AMR017842, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR017842:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm was sore for about 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm 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 stated, no the shingles shot did not hurt, had no side effects and the patient's arm was sore for about 2 days. The follow-up would not be possible as no contact details were available.