chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 05-FEB-2019, the patient was vaccinated with improperly stored GARDASIL 9 (1 injection, via intramuscular, lot #: N025428, expiration date: 19-JUN-2020; strength and anatomical location were not reported)for prophylaxis (Incorrect product storage)(product storage error). No adverse effect was reported. The GARDASIL 9 was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter.  Sender's Comments: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies were not provided. On 14-JAN-2019, the patient was administered GARDASIL 9 (strength, one dosage form, intramuscular, lot # and expiration date were not reported) for prophylaxis. On 26-FEB-2019, the patient was administered another dose GARDASIL 9 (one dosage form, intramuscular; lot # and expiration date were not reported) for prophylaxis. (inappropriate schedule of product administration) No adverse effects were reported in the patient.
Age: 0.75
Sex: F
Vaccine: HPV9
Symptoms: Constipation, Diarrhoea, Wrong patient received product
Clinical narrative: This spontaneous report has been received from the mother of a 9 month old female patient with anaemia as concurrent condition. The patient's medical history included difficulties during her birth, including being stuck, having a hard time keeping her body temperature up, had difficulty with unspecified thyroid levels, and low hemoglobin levels. The patient had not drug reaction/allergy or concomitant medications to be reported. It was reported that the administrators of the vaccine confused the patient room numbers on 28-FEB-2019, and the patient was vaccinated by mistake with GARDASIL 9, Lot # reported as R073111 with expiration date 29-APR-2021 (strength and route of administration were not provided) for prophylaxis. The reported stated on an unspecified date in 2019 (reported as shortly after being vaccinated), the patient began to experience constipation, which was treated with MIRALAX and then the patient on an unspecified date in 2019 developed diarrhea. The outcome of constipation and diarrhoea was reported as resolved as the patient had not had a more recent diaper change. At the reporting time, the causality between the events and GARDASIL 9 was not provided. Lot Number R073111 is NOT valid for GARDASIL 9.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patient was inadvertently administered a dose of PROQUAD, lot # R024015, expiration date 19-FEB-2020 for prophylaxis (dose and route of administration were not reported) that had been improperly stored (product storage error ). The lot of PROQUAD  was reconstituted with properly stored DILUENT MRK (lot # and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion 20.1 F for 4 hours and 10 minutes, as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported. The outcome of the event product storage error was not provided.
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a health care professional regarding a patient of unknown gender and age (reported as 1-year old child). The patient's relevant medical history, concurrent conditions, concomitant medication and drug/allergies were not reported. On 08-MAR-2019, the patient (reported as 1-year old child ) was vaccinated with 1 dose of GARDASIL 9 (strength, route not reported) lot # N035955 and expiry date: 09-OCT-2020, for prophylaxis (product administered to patient of inappropriate age and product use issue). No adverse effects were reported. The outcome of product administered to patient of inappropriate age, no adverse event and product use issue was unknown.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature decreased, Lethargy, Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Information has been received from the patient's mother referring to a currently 7 years old female patient. There were no drug reactions/allergies, concomitant medication or pertinent medical history with respect to the patient. In approximately September 2015, when the patient was four and a half years old, she got M-M-R II (lot#, expiration date, dose and frequency were unknown) subcutaneously vaccinated to prevent disease. The patient experienced a measles-like rash from head to toe and extreme lethargy exactly one week after the vaccination. Then, the patient was taken to physician and diagnosed with reaction to M-M-R II. After returning home that night, the patient's mother noticed that the patient had a high fever of 106 (units not provided) and began convulsing. The patient was admitted for one night. After being discharged from the hospital, the patient's mother reported that the patient was experiencing low body temperature for several days and did not start to really improve until a week after being in the hospital (Body temperature decreased). No treatment was given for the events. Some unspecified tests were performed to rule out other viruses, the result of tests was not provided. The patient was recovered at the time of reporting. The causality between the events of "measles-like rash" and lethargy and the suspect therapies was related. The causality between the other events and the suspect therapies was not reported.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Seizure, Vaccination complication, Viral test
Clinical narrative: Information has been received from the patient's mother referring to a currently 7 years old female patient. There were no drug reactions/allergies, concomitant medication or pertinent medical history with respect to the patient. In approximately September 2015, when the patient was four and a half years old, she got M-M-R II (lot#, expiration date, dose and frequency were unknown) subcutaneously vaccinated to prevent disease. The patient experienced a measles-like rash from head to toe and extreme lethargy exactly one week after the vaccination. Then, the patient was taken to physician and diagnosed with reaction to M-M-R II. After returning home that night, the patient's mother noticed that the patient had a high fever of 106 (units not provided) and began convulsing. The patient was admitted for one night. After being discharged from the hospital, the patient's mother reported that the patient was experiencing low body temperature for several days and did not start to really improve until a week after being in the hospital (Body temperature decreased). No treatment was given for the events. Some unspecified tests were performed to rule out other viruses, the result of tests was not provided. The patient was recovered at the time of reporting. The causality between the events of "measles-like rash" and lethargy and the suspect therapies was related. The causality between the other events and the suspect therapies was not reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse via Pfizer refers to a patient of unknown demographics. The patient's relevant medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, single dose vial (strength, lot number, expiry date was not provided) for prophylaxis (incorrect product storage).
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 71-year-old female patient. The patient's pertinent medical history and concomitant therapies were unknown by reporter. Concurrent condition was allergy to codeine sulfate. On 01-MAR-2019 the patient was vaccinated with a dose PNEUMOVAX 23 lot # R007721, expiration date 01-MAR-2020 (strength, dose, route and frequency were not reported), for prophylaxis. After the vaccination the patient experienced "cellulitis in her left deltoid" and went to emergency room for an evaluation but was not admitted to the hospital on the same day. The outcome of "cellulitis in her left deltoid" was unknown. Causality was not provided. Upon internal review, cellulitis in her left deltoid was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Superinfection
Clinical narrative: This spontaneous report was received from a physician via Pfizer (#2019103793) refers to a patient of unknown age and gender. Patient's medical history, concurrent disease and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, lot number, expiry date was not provided) for prophylaxis. On an unknown date, the patient experienced superinfection (super infection). The outcome of event was unknown. The reporter considered that event superinfection to be related to therapy with ZOSTAVAX. This is 1 of 3 reports received from the same source. Sender's Comments: US-009507513-1903USA006919.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an approximately 74 year old male. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26-FEB-2009, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an approximately 54 year old female. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 12-APR-2017, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an approximately 68 year old male. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-JUN-2011, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site pain, Pruritus
Clinical narrative: This spontaneous report was received from a health care professional and refers to a currently 91 year old patient of unknown gender. No information regarding patient's medical history, current conditions and drug reactions or allergies were provided. On an unspecified date in 2013, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, dose number, administration route, lot number and expiration date were not provided) for prophylaxis. And in this occasion the patient experienced some allergy signs such as pain on the injection site, and itching. (Hypersensitivity), (pruritus) and (injection site pain). The outcome of the events was unknown and the events were considered to be related to PNEUMOVAX 23. Sender's Comments: US-PFIZERINC-US19012730.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 27-NOV-2013, at age 65, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a nurse practitioner at a hospital for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2014, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a county health department. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-JUN-2012, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a physician's office. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine, Rash
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, dose number, unit, route, anatomical location, lot # and expiration date was not reported) for prophylaxis. On an unknown date, the patient experienced drug allergies to pneumococcal vaccines (also reported as rash) (drug hypersensitivity). The outcome of drug hypersensitivity was unknown. The reporter considered drug hypersensitivity to be related to PNEUMOVAX 23. Sender's Comments: US-PFIZER INC-2019024236: WWID #.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a medical assistant regarding to a 19-year-old patient of unknown gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 26-JUL-2018 the patient was vaccinated with VAQTA 25/0.5 (lot # R006209; expiry date: 16-MAR-2019), at a dose of 0.5 milliliter for prophylaxis (incorrect dose administered). No adverse effects (no adverse event) reported. No additional information provided.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning to a 5 years old male patient. Information regarding the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medication was not reported. On 13-MAR-2019, the patient was vaccinated with a dose of PROQUAD intramuscularly in the right leg instead of subcutaneously (Incorrect route of product administration), lot # R020816, expiration date 16-JAN-2020 for prophylaxis. The vaccine did not experienced any temperature excursion and was reconstituted with properly stored diluent (lot # and expiration date were not provided). No adverse events were reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypotension, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of syncopal attack in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 8th February 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 8th February 2019, less than a day after receiving SHINGRIX, the patient experienced fever, general body pain, headache, injection site warmth, injection site swelling, injection site erythema and injection site induration. On 9th February 2019, the patient experienced syncopal attack (serious criteria GSK medically significant) and low blood pressure. On an unknown date, the outcome of the syncopal attack, fever, general body pain, headache, injection site warmth, injection site swelling,  site erythema, injection site induration and low blood pressure were unknown. It was unknown if the reporter considered the syncopal attack, fever, general body pain, headache, injection site warmth, injection site swelling, injection site erythema, injection site induration and low blood pressure to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on in the left deltoid within 24 hours of receipt of vaccine had a fever of 100 degree F, body aches and a severe headache. The injection site was warm and patient had red swelling induration. The patient went to work the following day after vaccine administration and had a syncopal episode due to blood pressure being 90/56. The patient was sent home from work and stayed in the bed all weekend. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia, Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of syncopal attack in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 8th February 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 8th February 2019, less than a day after receiving SHINGRIX, the patient experienced fever, general body pain, headache, injection site warmth, injection site swelling, injection site erythema and injection site induration. On 9th February 2019, the patient experienced syncopal attack (serious criteria GSK medically significant) and low blood pressure. On an unknown date, the outcome of the syncopal attack, fever, general body pain, headache, injection site warmth, injection site swelling,  site erythema, injection site induration and low blood pressure were unknown. It was unknown if the reporter considered the syncopal attack, fever, general body pain, headache, injection site warmth, injection site swelling, injection site erythema, injection site induration and low blood pressure to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on in the left deltoid within 24 hours of receipt of vaccine had a fever of 100 degree F, body aches and a severe headache. The injection site was warm and patient had red swelling induration. The patient went to work the following day after vaccine administration and had a syncopal episode due to blood pressure being 90/56. The patient was sent home from work and stayed in the bed all weekend. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Hunger
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old female patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. In March 2019, less than a week after receiving SHINGRIX, the patient experienced tiredness, feeling hungry and loss of energy. In March 2019, the outcome of the feeling hungry was recovered/resolved. On an unknown date, the outcome of the tiredness and loss of energy were not recovered/not resolved. It was unknown if the reporter considered the tiredness, feeling hungry and loss of energy to be related to SHINGRIX. Additional details were provided as follows: The SHINGRIX was administered by a pharmacy in a grocery store in the right deltoid. The reporter was a patient herself, who was vaccinated a couple of days before reporting and the only symptom she had was no energy. The patient asked whether she was correctly vaccinated or not. The patient stated that she was tired/no energy/fatigue and was hungry after receiving a dose of SHINGRIX. Every source the patient googled stressed how painful it was and she had found virtually nothing. The patient did notify her physician, however, she did not mention the side effects. The reporter stated that the tiredness had not resolved completely but she thought she was probably just operating at a slower pace today due to lack of exercise. The patient was asking will the second dose have the same side effects she experienced, or, will it be double painful. The patient expected to be fully functional again by 9th March 2019. The patient was unable to locate a lot number.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Lethargy, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date 7th February 2021) for prophylaxis. On 4th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever, chills, lethargy and pain in arm. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, chills, lethargy and pain in arm were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, chills, lethargy and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The registered pharmacist reported having a pretty healthy immune system and describes experiencing a sore arm about 8 hours after receiving SHINGRIX and then for about 24 hours she experienced flu like symptoms including body aches, fever, chills, and lethargy. The symptoms were worse with dose 1 when compared to dose 2. The lot number and expiration date not available. The reporter consented to follow up. For tolerance after 2nd dose, refer case US2019042944.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date 7th February 2021) for prophylaxis. On 4th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever, chills, lethargy and pain in arm. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, chills, lethargy and pain in arm were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, chills, lethargy and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The registered pharmacist reported having a pretty healthy immune system and describes experiencing a sore arm about 8 hours after receiving SHINGRIX and then for about 24 hours she experienced flu like symptoms including body aches, fever, chills, and lethargy. The symptoms were worse with dose 1 when compared to dose 2. The lot number and expiration date not available. The reporter consented to follow up. For tolerance after 2nd dose, refer case US2019042944.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Lethargy, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose, refer case US2019042943). On 11th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th September 2018, 8 hrs after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, general body pain, fever, chills and lethargy. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, general body pain, fever, chills and lethargy were recovered/resolved.  It was unknown if the reporter considered the pain in arm, influenza-like symptoms, general body pain, fever, chills and lethargy to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The registered pharmacist reported having a pretty healthy immune system and describes experiencing a sore arm about 8 hours after receiving SHINGRIX and then for about 24 hours she experienced flu like symptoms including body aches, fever, chills, and lethargy. The symptoms were worse with dose 1 when compared to dose 2. The lot number and expiration date not available. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose, refer case US2019042943). On 11th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th September 2018, 8 hrs after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, general body pain, fever, chills and lethargy. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, general body pain, fever, chills and lethargy were recovered/resolved.  It was unknown if the reporter considered the pain in arm, influenza-like symptoms, general body pain, fever, chills and lethargy to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The registered pharmacist reported having a pretty healthy immune system and describes experiencing a sore arm about 8 hours after receiving SHINGRIX and then for about 24 hours she experienced flu like symptoms including body aches, fever, chills, and lethargy. The symptoms were worse with dose 1 when compared to dose 2. The lot number and expiration date not available. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Injection site pruritus, Injection site swelling, Lip pain, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult male patient who received DTPa (Reduced antigen) for an unknown indication. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included gluten intolerance. In July 2018, the patient received DTPa vaccine. In September 2018, the patient received SHINGRIX (intramuscular). In August 2018, less than a year after receiving DTPa vaccine and not applicable after receiving SHINGRIX, the patient experienced injection site itching and injection site swelling. In October 2018, the patient experienced pruritus, erythema, rash and lip soreness. On an unknown date, the outcome of the injection site itching and injection site swelling were recovered/resolved and the outcome of the pruritus, erythema, rash and lip soreness were recovering/resolving. It was unknown if the reporter considered the injection site itching and injection site swelling to be related to DTPa vaccine. It was unknown if the reporter considered the pruritus, erythema, rash and lip soreness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient's wife. The patient received SHINGRIX vaccine in September 2018 and received DTaP vaccine in July 2018. In August 2018, the patient experienced swelling and itching around injection site after receiving DTaP vaccine. The patient experienced itchiness, redness and spots specific to the back area, lip soreness and facial redness as well as itchiness 1 month after SHINGRIX administration. Itchiness seems worse at night. The reporter did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult male patient who received DTPa (Reduced antigen) for an unknown indication. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included gluten intolerance. In July 2018, the patient received DTPa vaccine. In September 2018, the patient received SHINGRIX (intramuscular). In August 2018, less than a year after receiving DTPa vaccine and not applicable after receiving SHINGRIX, the patient experienced injection site itching and injection site swelling. In October 2018, the patient experienced pruritus, erythema, rash and lip soreness. On an unknown date, the outcome of the injection site itching and injection site swelling were recovered/resolved and the outcome of the pruritus, erythema, rash and lip soreness were recovering/resolving. It was unknown if the reporter considered the injection site itching and injection site swelling to be related to DTPa vaccine. It was unknown if the reporter considered the pruritus, erythema, rash and lip soreness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient's wife. The patient received SHINGRIX vaccine in September 2018 and received DTaP vaccine in July 2018. In August 2018, the patient experienced swelling and itching around injection site after receiving DTaP vaccine. The patient experienced itchiness, redness and spots specific to the back area, lip soreness and facial redness as well as itchiness 1 month after SHINGRIX administration. Itchiness seems worse at night. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 25th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient called in to notify them that she developed a potential (no definitive diagnosis) case of Shingles. The rash was said to be on her face and the patient was going to an ophthalmologist at the time of call. The patient has not completed the series at the time of report. The pharmacist stated that she did not want to do double work by providing GlaxoSmithKline with the data. She also stated that she was waiting for an update from the patient.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a consumer (patient's mother) via call center representative and described the occurrence of fever in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 1st December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st December 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site erythema, injection site pain and injection site swelling. SHINGRIX was continued with no change. On an unknown date, the outcome of the fever, injection site erythema, injection site pain and injection site swelling were recovered/resolved. It was unknown if the reporter considered the fever, injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received both injections (doses). The adverse events experienced after 1st dose of SHINGRIX were more intense compared to 2nd dose. This case has been linked with case US2019GSK048457, reported for same patient by same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Viral infection
Clinical narrative: Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff). This case involves a female patient of unknown age who presented an unspecified viral infection after received vaccine INFLUENZA VACCINE.(unknown manufacturer). The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient presented an unspecified viral infection (viral infection), following the administration of INFLUENZA VACCINE. No lab test was reported. Final diagnosis was viral infection.. It was not reported if the patient received a corrective treatment. The event outcome was not reported.. List of documents held by sender: none.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 16 years old patient (gender unknown) who received MENACTRA instead of the 2nd dose of TRUMENBA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Jul-2018, the patient received a first dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On 05-Feb-2019, the patient received a dose of suspect MENACTRA lot number not reported via unknown route in unknown administration site. It was an actual medication error due to wrong vaccine administered. A patient received MENACTRA instead of the 2nd dose of TRUMENBA. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 111.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 12 years old female patient who received vaccine MENACTRA and reported that MENACTRA on 3/8/2019 that had expired on 3/5/2019/no AE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included BOOSTRIX. On 08-Mar-2019, the patient received a dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U5841AA and expiry date: 05-Mar-2019) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to expired vaccine used. It was not reported if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old male patient who received only the diluent of vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and ROTATEQ. On 11-Mar-2019, the patient received only a diluent (DTAP/IPV liquid) of a suspect PENTACEL Lot # UJ108AA, Expiration Date: 24-Jul-2020, PENTACEL Box Lot # UJ062AAA, Expiration Date: 24-Jul-2020, HIB: Lot # UJ062AA, Expiration Date: 24-Jul-2020) via intramuscular route in left leg. This would have been the first PENTACEL for the patient. It was a case of actual medication error due to inappropriate reconstitution technique. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Injection site ache 24 hours of fever with shivering.
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: THERE HAS BEEN NO ADVERSE EVENT NOTED BY PARENT. NO ER OR URGENT CARE VISITS FOR PATIENT AFTER DATE OF VACCINE.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperhidrosis, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: Severe swelling right arm, erythema. Fever, sweats, unwell x 3 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema
Clinical narrative: Mother reports child had an orange size reddened area on R thigh 24 to 48 hours after receiving vaccines. Mother reports she gave child TYLENOL and the reddened area decreased in size. Child did not see Dr.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Arthralgia, Gait disturbance, Injection site swelling, Joint swelling, Peripheral swelling
Clinical narrative: Arm swelled from top of shoulder to elbow within 5 hours and slowly went down over the next 5 days.  Child complained of joint pain in knees, ankles and wrists. Left knee and top of left foot swelled 6 days after vaccine. Difficult to walk.
Age: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Crying, Decreased appetite, Erythema of eyelid, Swelling of eyelid
Clinical narrative: Loss of appetite, inconsolable crying, swollen eyelids bilaterally with redness.
Sex: U
Vaccine: HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored vaccine administered; No adverse effects; This spontaneous report was received from a nurse referring unspecified patients of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II lot # N013295, expiration date: 28-APR-2019; lot # N025894, expiry date: 19-SEP-2019, therapy type rHA (strength, dose number, dose, unit, route and anatomical location were not reported) for prophylaxis (product storage error). Other suspect therapies which were improperly stored included ROTATEQ lot # N022015, expiry date: 10-MAR-2019, LIQUID PEDVAXHIB lot # M032148, expiry date: unknown for prophylaxis and sterile diluent (was used as reconstitute) (strength, dose number, dose, unit, route and anatomical location were not reported). The administered doses of the vaccines experienced temperature excursion from 47ºF to 9 Degree Celsius (48.2ºF) for 4 hours and there was no previous temperature excursion. The action taken with sterile diluent with respect to all the events was not reported. The call was due to digital data logger. No adverse effects were reported. The outcome of product storage error was unknown. No product quality complaint (PQC) was involved.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 16-JAN-2015, at age 60, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Postherpetic neuralgia. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the postherpetic neuralgia is unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 24-SEP-2014, at age 69, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 31-AUG-2013, at age 72, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.