chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation. It referred to a female patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On an unknown date in 2009, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot/batch # and expiration date were not reported).         Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles (herpes zoster) and was hospitalized due to it (dates not reported). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of herpes zoster was not reported.   The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation. It referred to a patient (pt) of unknown age and gender. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On an unknown date in 2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot/batch # and expiration date were not reported).         Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles (herpes zoster) and was hospitalized due to it (dates not reported). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of herpes zoster was not reported.   The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation. It referred to a female patient (pt) of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On an unknown date in 2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot/batch # and expiration date were not reported).         Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles (herpes zoster) and was hospitalized due to it (dates not reported). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of herpes zoster was not reported.   The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; no adverse effect; This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patient's relevant medical history, concomitant medications, concurrent conditions or drug reactions/allergies were not reported.     On unknown dates, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R035221 expiration date 04-DEC-2020; lo# S005078 expiration date 19-FEB-2021; or lot# S002392 expiration date 23-JAN-2021 for prophylaxis (dose, strength, frequency, and route of administration were not reported).         The patients experienced no adverse events. It was reported that the vaccines had a temperature excursion of 6°F to 14°F (5.7F) during 25 minutes. No previous temperature excursions were reported. Digital data logger was involved.
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; PROQUAD which was administered with expired DILUENT MRK JNJ; This spontaneous report was received from a physician referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 10-OCT-2018, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot# R015742 and expiration date 02-DEC-2019) (dose, frequency and route not reported) for prophylaxis, which was diluted in Merck's sterile diluent (MERCK STERILE DILUENT) (lot# L028663 and expiration date reported as 29-MAR-2018) (Expired product administered). No adverse effect were reported.  This is one of two cases received by the same reporter.; Sender's Comments:  US-009507513-1907USA013306:
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effect; Administration of VAQTA 1.0 ml to an 18 year old patient; This spontaneous report was received from a pharmacist refers to a 18 year old female patient. Information on pertinent medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2010, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 1.0 ml dose, lot # R027987, expiry date: 09-AUG-2019 via unknown route for prophylaxis. Thus the 18-year old patient received 1.0 ml of hepatitis a vaccine, inactivated (VAQTA) (incorrect dose administered). There was no adverse effects (no adverse event) mentioned.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; The patient was vaccinated with improperly stored doses of GARDASIL 9; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies.  On 30-JUL-2019, the patient was vaccinated with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number R029117, with expiration date: 10-JUL-2021 for prophylaxis. No adverse effects were reported.  The doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) underwent temperature excursions of 47.5 degrees Fahrenheit (°F) for a time frame of 2 hours and 45 minutes, which was called by the digital data. There were no previous temperature excursions reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA000459:
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The consumer stated that he received Shingrix and had 3 days of side effects. The reporter did not consent to follow up. The consumer refuses to provide any further details regarding this adverse event at the time of reporting.  The reporter stated that he might call back to update this case after speaking to his health care professional. The reporter stated that he would like his personal information to not be a part of this report. For the tolerances of 2nddose, refer case US2019AMR137275.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Headache, Hypersomnia
Clinical narrative: Joint pain; got sicker than dog; Muscle pain; Headache; Chills; Dizzy; Slept 16 hours straight; This case was reported by a consumer and described the occurrence of joint pain in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included duloxetine hydrochloride (Cymbalta).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced joint pain, sickness, muscle pain, headache, chills, dizziness and sleep excessive. On an unknown date, the outcome of the joint pain, sickness, muscle pain, headache, chills, dizziness and sleep excessive were unknown.   It was unknown if the reporter considered the joint pain, sickness, muscle pain, headache, chills, dizziness and sleep excessive to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient taking blood pressure medication. The patient received 2nd dose of Shingrix and experienced sicker than dog, all joints and muscles  hurt, bad headache,chills, dizzy, slept 16 hours straight The patient asked is this normal after the 2nd shot.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Myalgia
Clinical narrative: Joint pain; got sicker than dog; Muscle pain; Headache; Chills; Dizzy; Slept 16 hours straight; This case was reported by a consumer and described the occurrence of joint pain in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included duloxetine hydrochloride (Cymbalta).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced joint pain, sickness, muscle pain, headache, chills, dizziness and sleep excessive. On an unknown date, the outcome of the joint pain, sickness, muscle pain, headache, chills, dizziness and sleep excessive were unknown.   It was unknown if the reporter considered the joint pain, sickness, muscle pain, headache, chills, dizziness and sleep excessive to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient taking blood pressure medication. The patient received 2nd dose of Shingrix and experienced sicker than dog, all joints and muscles  hurt, bad headache,chills, dizzy, slept 16 hours straight The patient asked is this normal after the 2nd shot.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Axillary mass
Clinical narrative: arm pit lump; Side effects; This case was reported by a consumer via call center representative and described the occurrence of axillary lump in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse reaction (for 1st dose, refer case US2019136512).   On 22nd July 2019, the patient received the 2nd dose of Shingrix. On 22nd July 2019, less than a day after receiving Shingrix, the patient experienced adverse reaction. On 26th July 2019, the patient experienced axillary lump. On an unknown date, the outcome of the axillary lump was not recovered/not resolved and the outcome of the adverse reaction was recovered/resolved.   It was unknown if the reporter considered the axillary lump and adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 4 days before the date of reporting and had 3 days of the side effects, and on the day 4 (day of reporting) had a lump in his arm pit. The reporter did not give consent to follow up. The patient refused to provide any further details regarding this adverse event at the time of reporting. The patient stated he would like his personal information to not be a part of this report.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient asked how long do the side effects last. The reporter was not a health care professional. The reporter did not gave permission to follow up.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant mentioned she had one call back with Bexsero since office implanted a few months ago. The medical assistant stated that the patient called complaining about flu-like symptoms. The reporter did not give permission for follow up contact.
Sex: U
Vaccine: HEPAB
Symptoms: Back pain, Bacterial test negative, Fungal test negative, Headache, Inflammation
Clinical narrative: meningitis; Severe headache; Back pain; Inflammation; This case was reported by a physician via call center representative and described the occurrence of meningitis in a 44-year-old patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix at an unknown dose. On an unknown date, 1 day after receiving Twinrix, the patient experienced meningitis (serious criteria GSK medically significant), headache, back pain and inflammation. On an unknown date, the outcome of the meningitis, headache, back pain and inflammation were unknown.   The reporter considered the meningitis, headache, back pain and inflammation to be possibly related to Twinrix.  Additional details were reported as follows: The healthcare professional reported that he thought a bad batch of Twinrix gave his patient meningitis. The day after vaccination with Twinrix, the patient had severe headache and back pain. On an unknown date, the patient had nuclear magnetic resonance imaging (MRI) and lumbar puncture both showed evidence of inflammation, but all tests for viral, fungal and bacterial meningitis have been negative.      Lab Comments: On an unknown date, the patient had nuclear magnetic resonance imaging (MRI) and lumbar puncture both showed evidence of inflammation, but all tests for viral, fungal and bacterial meningitis have been negative.
Sex: U
Vaccine: HEPAB
Symptoms: Lumbar puncture abnormal, Meningitis, Nuclear magnetic resonance imaging abnormal, Viral test negative
Clinical narrative: meningitis; Severe headache; Back pain; Inflammation; This case was reported by a physician via call center representative and described the occurrence of meningitis in a 44-year-old patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix at an unknown dose. On an unknown date, 1 day after receiving Twinrix, the patient experienced meningitis (serious criteria GSK medically significant), headache, back pain and inflammation. On an unknown date, the outcome of the meningitis, headache, back pain and inflammation were unknown.   The reporter considered the meningitis, headache, back pain and inflammation to be possibly related to Twinrix.  Additional details were reported as follows: The healthcare professional reported that he thought a bad batch of Twinrix gave his patient meningitis. The day after vaccination with Twinrix, the patient had severe headache and back pain. On an unknown date, the patient had nuclear magnetic resonance imaging (MRI) and lumbar puncture both showed evidence of inflammation, but all tests for viral, fungal and bacterial meningitis have been negative.      Lab Comments: On an unknown date, the patient had nuclear magnetic resonance imaging (MRI) and lumbar puncture both showed evidence of inflammation, but all tests for viral, fungal and bacterial meningitis have been negative.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: Wrong route of administration; This case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in a 23-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA087A, expiry date February 2020) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Menveo (subcutaneous) .5 ml. On 31st July 2019, unknown after receiving Menveo, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were received as follows: The age at vaccination was not reported.  The patient received menveo subcutaneously in right arm, which led to intramuscular formulation administered by other route. The medical science liaison is following up with provider.
Sex: U
Vaccine: RAB
Symptoms: Injury associated with device, Product complaint
Clinical narrative: needle stick; the needles that come with the product do not contain safety caps; This case was reported by a pharmacist via call center representative and described the occurrence of needle stick/puncture in a patient who received Rabies NVS (RabAvert) for prophylaxis. This case was associated with product complaint.  On an unknown date, the patient received RabAvert at an unknown dose. On an unknown date, immediately after receiving RabAvert, the patient experienced needle stick/puncture and pharmaceutical product complaint. On an unknown date, the outcome of the needle stick/puncture and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the needle stick/puncture to be related to RabAvert.  Additional information received were as follows: The age at vaccination was not reported. The lot number and expiry date was unknown. It was unknown, whether the patient received RabAvert for pre exposure or post exposure prophylaxis. The pharmacist on the line reported because the needles that came with the product did not contain safety caps, there was a safety event. The reporter clarified further as a needle stick. The reporter consented to follow up. The caller had no information on the person involved in the event and assumed it occurred at the primary address, but did not know for sure.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: erythematous rash from the mid shoulder to the elbow; This case was reported by a physician via call center representative and described the occurrence of red rash in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. In July 2019, 2 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was recovering/resolving.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The patient had his first injection at a pharmacy and 2 to 3 days after developed a erythematous rash from the mid shoulder to the elbow.  No other issues. No hives, and after 6 days, it was fading. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: arm pain; possible Vaccine administered at inappropriate site; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   In July 2019, the patient received Bexsero. In July 2019, less than a week after receiving Bexsero, the patient experienced pain in arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Bexsero possibly too high above the deltoid three days before the date of reporting, which led to vaccine administered at inappropriate site. The patient was experiencing arm pain. The reporter gave consent to follow up. Lot number and the patient date of birth were not available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: tinnitus; This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number LL552, expiry date 8th June 2021) for prophylaxis.   The patient's past medical history included tinnitus (had brief periods of tinnitus before but this was constant).   On 20th June 2019, the patient received the 1st dose of Shingrix. On 20th June 2019, immediately after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was recovering/resolving.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The caller stated that she received Shingrix on left arm and shortly after that she stated she has experienced tinnitus. She noted it started within a day.  She had already notified her physician of the issue.  She was concerned and wonders if she should get the 2nd dose at the time of reporting.  The caller was referred to have that discussion with physician to look at risks and benefits.  The reporter did not consent to follow up. The health care professional declined to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Lip swelling; This case was reported by a pharmacist via call center representative and described the occurrence of lip swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced lip swelling. On an unknown date, the outcome of the lip swelling was unknown.   It was unknown if the reporter considered the lip swelling to be related to Shingrix.  Additional case details were reported as follows: The patient did not have any known allergies. The patient experienced lip swelling after receiving first Shingrix vaccination. The reporter gave permission to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Shingles; Blister; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 74A7L, expiry date 22nd October 2021) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th July 2019, 9 days after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional information received were as follows: The reporter reported that the patient came to the pharmacy to report that she was diagnosed by her physician with Shingles on the reporting date. The patient had one shingles blister on her back. The reporter was unable to provide any additional details.  The call was transferred to medical information.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Sore arm at injection site; Can not raise arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain and mobility decreased. On an unknown date, the outcome of the injection site pain and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm Intramuscularly. The patient received first dose of Shingrix 2 weeks ago. The patient experienced sore arm at injection site that got better with time but 4 days ago the arm felt sore again and got works to the point now cannot raise the arm. The reporter declined physician follow up. The reporter did not gave permission to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Myalgia; fever; chills; This case was reported by a physician via call center representative and described the occurrence of myalgia in an unknown number of adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia, fever and chills. On an unknown date, the outcome of the myalgia, fever and chills were unknown.   It was unknown if the reporter considered the myalgia, fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The physician reported that he had multiple patients that had received the Shingrix and had experienced common local reactions such as myalgia, fever and chills.  The physician asked if the patients received ibuprofin or tylenol afterwards? If these medications decrease the effectiveness of the vaccine?  No additional information provided. The reporter did not consent to follow-up. The physician would not provide patient identifiers.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Rash papular
Clinical narrative: bruising at injection site; redness at injection site; bumpy rash above left elbow and below shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 17th October 2021) for prophylaxis.   On 22nd July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site bruising, injection site erythema and papular rash. On an unknown date, the outcome of the injection site bruising, injection site erythema and papular rash were unknown.   It was unknown if the reporter considered the injection site bruising, injection site erythema and papular rash to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that the patient experienced bruising and redness at the Shingrix injection site. The pharmacist reported that the patient also experienced bumpy rash on left arm above elbow and below shoulder. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Swelling
Clinical narrative: injection site bleeding; Injection site bump; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a adult patient who received Herpes zoster (Shingrix) (batch number 7A799, expiry date unknown) for prophylaxis.   On 26th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 26th July 2019, immediately after receiving Shingrix, the patient experienced injection site hemorrhage and local swelling. On an unknown date, the outcome of the injection site hemorrhage and local swelling were unknown.   It was unknown if the reporter considered the injection site hemorrhage and local swelling to be related to Shingrix.  Additional information was provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix on left deltoid and right after that experienced bleeding and bump in the skin. The batch number 7A799 belongs to Shingrix adjuvant. The reporter consented for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Off label use, Product administered to patient of inappropriate age
Clinical narrative: Off label use; Inappropriate Age at Vaccine Administration; Circumstance or information capable of leading to medication error; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 43-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use, inappropriate age at vaccine administration and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the off label use, inappropriate age at vaccine administration and circumstance or information capable of leading to medication error were unknown.  Additional information received were as follows: The age at vaccination was not applicable for this report. The lot number and expiry date was not available. The pharmacist on the line with a patient who was under 50 years old and had a prescription for Shingrix, which may lead to circumstance or information capable of leading to medication error, inappropriate age at vaccine administration and off label use. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Knee pain; arm pain; flu-like symptoms; dizziness; achiness all over; This case was reported by a consumer via call center representative and described the occurrence of knee pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th July 2019, 1 days after receiving Shingrix, the patient experienced knee pain, pain in arm, influenza-like symptoms, dizziness and general body pain. On 26th July 2019, the outcome of the knee pain, pain in arm, influenza-like symptoms, dizziness and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the knee pain, pain in arm, influenza-like symptoms, dizziness and general body pain to be related to Shingrix.  Additional information received were as follows: The lot number and expiry date was unavailable per patient. The day before the reporting date, the patient received Shingrix on unknown arm. On the reporting date, the patient experienced arm pain, knee pain, flu-like symptoms, achiness all over and dizziness. The reporter offered to send her personal information and advised her to follow up with her healthcare professional. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Infection, Mobility decreased, Muscular weakness, Pyrexia
Clinical narrative: Infection; fever; weakness in legs; fell down; could not get up; This case was reported by a consumer via call center representative and described the occurrence of infection in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2019, the patient received the 1st dose of Shingrix. On 5th July 2019, 12 hrs after receiving Shingrix, the patient experienced infection (serious criteria hospitalization), fever (serious criteria hospitalization), lower extremities weakness of (serious criteria hospitalization), fall (serious criteria hospitalization) and mobility decreased (serious criteria hospitalization). The patient was treated with antibiotics nos. On an unknown date, the outcome of the infection, fever, lower extremities weakness of, fall and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the infection, fever, lower extremities weakness of, fall and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. It was reported that about 12 hours after receiving Shingrix the patient had to use the bathroom and fell down due to weakness in his legs.  He could not get up and paramedics were contacted.  The patient was taken to the hospital and was diagnosed with fever and possibly an infection. The patient was placed on antibiotics and admitted to the hospital and patient had spent four nights in the hospital. An infectious disease specialist was consulted during his visit.  The patient informed the specialist that he had received a dose of Shingrix. The specialist then told the patient that, it would be the reason for the fever and then he was discharged from the hospital.  The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a elderly male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced Guillain-Barre after receiving a flu vaccine years before the date of reporting. The pharmacist was unsure whether the vaccine was a GSK product. He attempted to locate further information in the pharmacy system, but reported that the patient had not received a flu vaccine since he lived in the state, so the pharmacist was unable to provide additional details during the call. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The physician's assistant reported that the patient contracted a case of Shingles after receiving Shingrix. The reporter consented to follow up. The healthcare professional declined to provide data but may do so via letter in the mail.
Sex: F
Vaccine: HEP
Symptoms: Angioedema
Clinical narrative: angio edema; This case was reported by a other health professional via call center representative and described the occurrence of angioedema in a adult female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, less than a year after receiving Engerix B, the patient experienced angioedema (serious criteria GSK medically significant and other: ER visit required). On an unknown date, the outcome of the angioedema was recovered/resolved.   It was unknown if the reporter considered the angioedema to be related to Engerix B.  Additional details were reported as follows: The age at vaccination was not reported, however the patient could be 36 or 37 years old. On an unknown date in 1992, the patient had a severe reaction after receiving dose 2 of Engerix-B vaccine, the patient developed angioedema and required visit to emergent care. It was reported that this was part of the patient history. The patient reported this event and all the follow up was reported to the Center for disease control (CDC) in 1992 after it occurred.  The reporter did not consent to follow-up. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: Product supply issue; This case was reported by a other health professional via call center representative and described the occurrence of product supply issue in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The age group was not provided, but was selected adult as per the vaccine indication. The health care professional (HCP) called to report regarding the group of patients of unknown age and gender that have not received their second Shingrix vaccine due to vaccine supply issue. HCP did not have the exact number of patients or which patients they were at the time of call. The reporter consented to follow up. The VAERS details were reported for 1st dose.
Age: 82.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient claims she woke up one day after receiving the injection in her left deltoid muscle and had an enlarged red area of skin approximately 4 inches below (and 2 inches interiorly) the original injection site (on top of the bicep muscle). Patient claims her deltoid muscle was sore at injection site, but denies pain/itching/swelling at enlarged site of redness. Patient states redness has decreased with application of ice.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Syncope
Clinical narrative: Fainted about 20 min after injection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Abdominal pain upper, Flatulence
Clinical narrative: Stomach cramping and ? gassy type? abdominal pains
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: large swollen and red area ( from where the shot was given in the upper arm down to my elbow approximately half way around the arm) that became warm to the touch a day later. My arm is still red to a lesser extent but still itches occasionally.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Patient called to report being nauseous the first night after receiving Shingrix. Has since developed a rash described to be itchy and very warm to the touch. Due to rash being red and warm, patient will be following up with doctor in case of cellulitis
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Biopsy vocal cord abnormal, Laryngeal cancer, Radiotherapy
Clinical narrative: development of HPV18-positive glottic larynx cancer in a 31-year-old without sexual exposure
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Neck pain
Clinical narrative: Fever 100.5 and shivers Joint and neck pain Headache (mostly back of the head) Muscle aches
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 100.5 and shivers Joint and neck pain Headache (mostly back of the head) Muscle aches
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Hyperaesthesia, Pruritus, Skin warm
Clinical narrative: Itching  Warm to touch (not swollen) Redness SENSITIVE TO PRESSURE
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: She was given vaccine & came back to the office 2 days later with Redness (9cm) swelling, & Soreness. Was advised to use ice pack, Benadryl with IBU as needed.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain in extremity, Pyrexia
Clinical narrative: FROM ABOUT 4-9 PM ON 6/27/19 SHE EXPERIENCED FEVER + CHILLS ARM WAS ALSO RED + PAINFUL
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site pruritus, Respiratory disorder
Clinical narrative: Injection site pruritus/injection site itching; Immediate post-injection reaction; Respiratory disorder; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 793727) concerning a 13-year-old male patient. Information on the patient's medical history, concurrent illness, other medication, lab data and prior vaccinations was not reported. On 27-DEC-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose number 2, dose unknown (lot # R021634 and expiration date: 08-MAY-2021), via intramuscular route in the right arm for prophylaxis. On the same day, the patient experienced immediate post-injection reaction, respiratory disorder and injection site pruritus. It was reported that seconds within administration, patient complained of itching at the inject site which was examined by the physician and told to give diphenhydramine hydrochloride (BENADRYL). It was reported that if any respiratory issues developed, the patient must be brought to Emergency Room. The outcome of the events was unknown. The reporter's causality assessment was not provided.  Follow up information was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act via the Agency (VAERS # 793727) on 03-JUL-2019. On 27-DEC-2018 at 14:00 (reported as 2:00 pm), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose number 2 in the left arm (previously reported as right arm) at private doctor's office/ hospital. The vaccine was purchased with private fund. On 27-DEC-2018 at 14:05 (reported as 2:05 pm), the patient experienced immediate post-injection reaction, respiratory disorder and injection site pruritus.  Follow up information was received from a physician on 31-JUL-2019. The reporter's information updated. The suspect therapy hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# also reported as M16133 (not valid)) was the first dose for the patient. The patient experienced injection site itchingy. The event of injection site itchingy was considered to be medically significant by the physician.
Age: 78.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Computerised tomogram head normal, Skin laceration, Suture insertion, Syncope
Clinical narrative: patient states she "fainted" while standing in her kitchen. was seen by MD, total of 3 stitches on the back of her head and CT scan of the head done. Vaccine received on May 2nd around 2:20. Episode occurred on May 3rd after she woke up at 2:45am.
Age: 78.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Computerised tomogram head normal, Head injury, Suture insertion, Syncope
Clinical narrative: patient states she "fainted" while standing in her kitchen. was seen by MD, total of 3 stitches on the back of her head and CT scan of the head done. Vaccine received on May 2nd around 2:20. Episode occurred on May 3rd after she woke up at 2:45am.