chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Posterior capsule opacification, Rash pruritic, Tinnitus, Vitreous detachment
Clinical narrative: right ear hearing loss; serous otitis media; tinnitus.; posterior capsule opacification; posterior vitreous detachment; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 04-AUG-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Defendants' zoster vaccine live (ZOSTAVAX) vaccine, patient suffered right ear hearing loss, serous otitis media and tinnitus. Additionally, patient suffered vision loss and was diagnosed with posterior capsule opacification and posterior vitreous detachment. Later, patient began to experience an itching and burning rash on the back of her left shoulder and was diagnosed with herpes zoster.   As a direct and proximate result of zoster vaccine live (ZOSTAVAX)  vaccine, patient symptoms have resulted in physical limitations not present prior to using this product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries, further, as a tragic consequence of this wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, deafness, vitreous detachment and posterior capsule opacification were determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Cystitis, Eye pain, Eye swelling, Haematuria
Clinical narrative: acute cystitis with hematuria; hematuria; neuralgic pain; periorbital cellulitis; 6th nerve palsy of the left eye; high suspicion of shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 12-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a painful burning sensation to the right lateral mid and right mid anterior torso. The patient was diagnosed with acute cystitis with hematuria and neuralgic pain, with high suspicion of shingles. Shortly thereafter, the patient's left eye started to have pain and swelling and she was diagnosed with periorbital cellulitis and 6th nerve palsy of the left eye.   As a direct and proximate result of zoster vaccine live (ZOSTAVAX)  vaccine, patient symptoms have resulted in physical limitations not present prior to using this product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries, further, as a tragic consequence of this wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, 6th nerve paralysis and periorbital cellulitis were determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Periorbital cellulitis, VIth nerve paralysis
Clinical narrative: acute cystitis with hematuria; hematuria; neuralgic pain; periorbital cellulitis; 6th nerve palsy of the left eye; high suspicion of shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 12-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a painful burning sensation to the right lateral mid and right mid anterior torso. The patient was diagnosed with acute cystitis with hematuria and neuralgic pain, with high suspicion of shingles. Shortly thereafter, the patient's left eye started to have pain and swelling and she was diagnosed with periorbital cellulitis and 6th nerve palsy of the left eye.   As a direct and proximate result of zoster vaccine live (ZOSTAVAX)  vaccine, patient symptoms have resulted in physical limitations not present prior to using this product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries, further, as a tragic consequence of this wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, 6th nerve paralysis and periorbital cellulitis were determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: The patient was inadvertently administered an expired dose of M-M-R II; This spontaneous report was received from an office manager, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (DILUENT MRK). The patient's medical history, historical drugs, concurrent conditions or drug reactions or allergies were not provided.   On 28-DEC-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(recombinant human albumin)(M-M-R II) lot # N032749, with expiration date 20-NOV-2019 for prophylaxis (strength, frequency, route, vaccination scheme and anatomical location were not provided. No temperature excursion were reported).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient is not experiencing any symptoms; A 5 week old patient was administered a dose of ROTATEQ earlier than 6 to 12 weeks of age as indicated; This spontaneous report was received from a clinic coordinator referring to a 5 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 03-JAN-2020, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength, dose number, route, frequency, lot number and expiration date were unknown) for prophylaxis (product administered to patient of inappropriate age).  The primary reporter stated that the patient was not experiencing any symptoms.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: The patient was inadvertently administered an expired dose of M-M-R II; This spontaneous report was received from an office manager, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (DILUENT MRK). The patient's medical history, historical drugs, concurrent conditions or drug reactions/allergies were not provided.   On 28-DEC-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(recombinant human albumin)(M-M-R II) lot # N032749, with expiration date 20-NOV-2019 for prophylaxis (strength, frequency, route, vaccination scheme and anatomical location were not provided).No temperature excursion was reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effect; Inappropriate schedule of vaccine administered; This spontaneous report was received from a pharmacist referring to a 24-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and drug reactions/ allergies were not reported.  On an unknown date in December 2018, June 2019 and September 2019, the patient was vaccinated with doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, anatomical location, route, lot # and expiry date not reported) (inappropriate schedule of product administration) for prophylaxis. The patient did not experience any adverse event. No product quality complaint was involved in this report.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose administered; no adverse effect; This spontaneous report was received from a licensed practical nurse (LRN) referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions/ allergies were not reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) with lot # R030115 and expiry date 29-DEC-2019 for prophylaxis (strength, dose, route and anatomical location not reported). On an unknown date, the patient received an expired dose of hepatitis a vaccine, inactivated (VAQTA) (expired product administered). The patient had no adverse events. No product quality complaint involved in this report.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: HEPLISAV-B Administered 2 Weeks Earlier; Initial Report Received on 05-Dec-2019  A nurse reported that her friend received the HEPLISAV-B series.  The first dose was administered in Nov-2019 (date not specified) and the second dose was administered 2 weeks later instead of a month later.    The nurse refused to provide any information about the patient, did not know the lot number, expiration date, or if the doses were administered from a pre-filled syringe.    No additional information was provided.   Company comment: The company assessed the event of inappropriate schedule of product administration as non-serious. The event of inappropriate schedule of product administration is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of inappropriate schedule of product administration as non-serious. The event of inappropriate schedule of product administration is unlisted per HEPLISAV-B USPI and IB.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: 2 Doses Given; Product Dispensing Error; Initial Report Received on 11-Dec-2019  A pharmacist reported that a female patient was administered 2 doses of HEPLISAV-B in the clinic visit.    No medical history, concomitant medications, or concurrent vaccine administration information was provided.  On 11-Dec-2019, a female patient was administered 2 doses of HEPLISAV-B in the same clinic visit.  The pharmacist stated that the clinic's procedure states to "give 2 lower doses to make a larger dose of hepatitis B vaccine."  The patient received 2 doses of HEPLISAV-B instead of Engerix-B.  The pharmacist was not aware if the patient experienced any adverse events following the vaccination, did not have the lot number, or expiration date available.  Information regarding the prescribing doctor was not provided.  Information regarding the patient's initials and date of birth were refused to be provided.  No other information was provided.   Company comment: The company assessed the events of product dispensing error and extra dose administered as non-serious. The events of product dispensing error and extra dose administered are unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the events of product dispensing error and extra dose administered as non-serious. The events of product dispensing error and extra dose administered are unlisted per HEPLISAV-B USPI and IB.
Sex: U
Vaccine: HEP
Symptoms: Blood glucose increased
Clinical narrative: Increased Fasting Glucose Levels; Initial Report Received on 12-Dec-2019  A Nurse Practitioner called and reported that a female patient who received Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) and HEPLISAV-B had elevated fasting glucose after having received HEPLISAV-B.  No medical history or concomitant medications were reported.   On 02-Dec-2019, the patient received Ixiaro.    On 04-Dec-2019, the patient received a dose of HEPLISAV-B (Lot # 933839, expiration 28-Feb-2021).    On 11-Dec-2019, 8 days after having received HEPLISAV-B, the patient called the Nurse Practitioner and reported that her fasting glucose levels went up after the HEPLISAV-B dose.  No additional information was provided.    Company comment: The company assessed the event of increased fasting glucose levels as non-serious. The event of increased fasting glucose levels is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of increased fasting glucose levels as non-serious. The event of increased fasting glucose levels is unlisted per HEPLISAV-B USPI and IB.
Sex: U
Vaccine: HEP
Symptoms: Blood glucose increased
Clinical narrative: Increased Fasting Glucose Levels; Initial Report Received on 12-Dec-2019  A Nurse Practitioner called and reported that a male patient who received Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) and HEPLISAV-B had elevated fasting glucose after having received HEPLISAV-B.  Medical history included liver transplant and diabetes.    Concomitant medication information was not specified.   On 02-Dec-2019, the patient received Ixiaro.    On 04-Dec-2019, the patient received a dose of HEPLISAV-B (Lot # 93383917210228, expiration 28-Feb-2021) from a pre-filled syringe.    On 11-Dec-2019, 8 days after having received HEPLISAV-B, the patient called the Nurse Practitioner and reported that he noticed that his fasting glucose levels went up to 141 from 90-96 (units, dates not specified).  The patient reported that he thinks his fasting glucose levels are up due to the HEPLISAV-B but the health care provider thinks that the other factors can cause it as well.  No additional information was provided.    Company comment: The company assessed the event of increased fasting glucose levels as non-serious. The event of increased fasting glucose levels is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of increased fasting glucose levels as non-serious. The event of increased fasting glucose levels is unlisted per HEPLISAV-B USPI and IB.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Medication Stored Outside of Recommended Temperature Excursion Ranges Was Administered to Patient; Initial Report Received on 20-Dec-2019  A Nurse called and reported that a male patient received HEPLISAV-B that was stored outside of the recommended temperature range.  The patient has had a blood pressure of 131/78 at the time of vaccination with HEPLISAV-B.    Medical history reported included hypertension that had not been diagnosed and for which he does not take medication.    The patient had no medication history.   On 19-Dec-2019, the patient was vaccinated with his first dose of HEPLISAV-B (Lot # 933842, expiration 30 May 2021, Box Serial # 277427890985) that was determined to have been stored outside of the recommended range (maximum 16 degrees Celsius for 65 hours) for a temperature excursion.     On 19-Dec-2019, at the time of vaccination, the patient's blood pressure was taken and was noted to be 131/78.   At the time of the report, the patient had not been informed and there were no adverse reactions reported.   No additional information was provided.    Company comment: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI and IB.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Medication Stored Outside of Recommended Temperature Excursion Ranges Was Administered to Patient (; Initial Report Received on 20-Dec-2019  A Nurse called and reported that a 48-year-old female patient received HEPLISAV-B that was stored outside of the recommended temperature range.  The patient has had a blood pressure of 131/78 at the time of vaccination with HEPLISAV-B.    The patient had no medical history and medication history was unknown.  On 19-Dec-2019, the patient was vaccinated with her second dose of HEPLISAV-B (Lot # 933842, expiration 30 May 2021, Box Serial # 277427890985) that was determined to have been stored outside of the recommended range (maximum 16 degrees Celsius for 65 hours) for a temperature excursion.     At the time of the report, the patient had not been informed and there were no adverse reactions reported.   No additional information was provided.    Company comment: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI and IB.
Age: 89.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood urine present, Chest X-ray abnormal, Cough, Dysstasia, Fall
Clinical narrative: blood in urine; needed assistance getting up; fell down; cough; gurgling sound in throat; pneumonia; felt ill; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th December 2019, 4 hrs after receiving Shingrix, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant) and feeling unwell (serious criteria hospitalization). On 28th December 2019, the patient experienced fall (serious criteria hospitalization), cough (serious criteria hospitalization), throat discomfort (serious criteria hospitalization) and difficulty in standing (serious criteria hospitalization). On 31st December 2019, the patient experienced blood in urine (serious criteria hospitalization). The patient was treated with antibiotics nos (Unspecified Antibiotic). On an unknown date, the outcome of the pneumonia, feeling unwell, fall, cough, throat discomfort, blood in urine and difficulty in standing were unknown.   It was unknown if the reporter considered the pneumonia, feeling unwell, fall, cough, throat discomfort, blood in urine and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The patient received dose of Shingrix in the right arm in reported pharmacy. Several hours, perhaps 4 hours after vaccination, the patient had pneumonia, blood urine and felt ill and went to bed to lie down. 1 day after vaccination, the patient had fall, cough, throat discomfort and difficulty in standing. The patient got up to use the bathroom  and fell down, and needed assistance getting up. The patient experienced cough and a gurgling sound coming from the throat. The patient went to urgent care and had X ray test which showed pneumonia in both lungs. The patient was given an unspecified antibiotic as a treatment medication and sent home. On 29th December 2019, the patient fall again and 911 was called. The patient was admitted to the hospital on Sunday, 29th December 2019 and discharged on 2nd January 2020. The patient was diagnosed with pneumonia. The reporter stated that emergency visit required. The reporter consented to follow up.      Lab Comments: Lab test performed on an unknown date
Age: 89.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Oropharyngeal discomfort, Pneumonia
Clinical narrative: blood in urine; needed assistance getting up; fell down; cough; gurgling sound in throat; pneumonia; felt ill; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th December 2019, 4 hrs after receiving Shingrix, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant) and feeling unwell (serious criteria hospitalization). On 28th December 2019, the patient experienced fall (serious criteria hospitalization), cough (serious criteria hospitalization), throat discomfort (serious criteria hospitalization) and difficulty in standing (serious criteria hospitalization). On 31st December 2019, the patient experienced blood in urine (serious criteria hospitalization). The patient was treated with antibiotics nos (Unspecified Antibiotic). On an unknown date, the outcome of the pneumonia, feeling unwell, fall, cough, throat discomfort, blood in urine and difficulty in standing were unknown.   It was unknown if the reporter considered the pneumonia, feeling unwell, fall, cough, throat discomfort, blood in urine and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The patient received dose of Shingrix in the right arm in reported pharmacy. Several hours, perhaps 4 hours after vaccination, the patient had pneumonia, blood urine and felt ill and went to bed to lie down. 1 day after vaccination, the patient had fall, cough, throat discomfort and difficulty in standing. The patient got up to use the bathroom  and fell down, and needed assistance getting up. The patient experienced cough and a gurgling sound coming from the throat. The patient went to urgent care and had X ray test which showed pneumonia in both lungs. The patient was given an unspecified antibiotic as a treatment medication and sent home. On 29th December 2019, the patient fall again and 911 was called. The patient was admitted to the hospital on Sunday, 29th December 2019 and discharged on 2nd January 2020. The patient was diagnosed with pneumonia. The reporter stated that emergency visit required. The reporter consented to follow up.      Lab Comments: Lab test performed on an unknown date
Age: 89.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: blood in urine; needed assistance getting up; fell down; cough; gurgling sound in throat; pneumonia; felt ill; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th December 2019, 4 hrs after receiving Shingrix, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant) and feeling unwell (serious criteria hospitalization). On 28th December 2019, the patient experienced fall (serious criteria hospitalization), cough (serious criteria hospitalization), throat discomfort (serious criteria hospitalization) and difficulty in standing (serious criteria hospitalization). On 31st December 2019, the patient experienced blood in urine (serious criteria hospitalization). The patient was treated with antibiotics nos (Unspecified Antibiotic). On an unknown date, the outcome of the pneumonia, feeling unwell, fall, cough, throat discomfort, blood in urine and difficulty in standing were unknown.   It was unknown if the reporter considered the pneumonia, feeling unwell, fall, cough, throat discomfort, blood in urine and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The patient received dose of Shingrix in the right arm in reported pharmacy. Several hours, perhaps 4 hours after vaccination, the patient had pneumonia, blood urine and felt ill and went to bed to lie down. 1 day after vaccination, the patient had fall, cough, throat discomfort and difficulty in standing. The patient got up to use the bathroom  and fell down, and needed assistance getting up. The patient experienced cough and a gurgling sound coming from the throat. The patient went to urgent care and had X ray test which showed pneumonia in both lungs. The patient was given an unspecified antibiotic as a treatment medication and sent home. On 29th December 2019, the patient fall again and 911 was called. The patient was admitted to the hospital on Sunday, 29th December 2019 and discharged on 2nd January 2020. The patient was diagnosed with pneumonia. The reporter stated that emergency visit required. The reporter consented to follow up.      Lab Comments: Lab test performed on an unknown date
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Headache, Insomnia, Muscle twitching
Clinical narrative: Neck Twitches; Difficulty Sleeping; Fever; Aches; Chills; Nausea; Dull headache; Elevated Blood Pressure; Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of herpes zoster.   On 2nd January 2020 10:30, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd January 2020, less than a day after receiving Shingrix, the patient experienced fever, pain, chills, nausea, headache dull, increased blood pressure, pain in arm and difficulty sleeping. On 2nd January 2020 20:00, the patient experienced twitching. On an unknown date, the outcome of the fever, pain, chills, nausea, headache dull, increased blood pressure, pain in arm, twitching and difficulty sleeping were recovering/resolving.   It was unknown if the reporter considered the fever, pain, chills, nausea, headache dull, increased blood pressure, pain in arm, twitching and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patients wife reported that  he received 2nd dose of Shingrix in left arm on 2nd January 2020 at approximately 10.30 am, and that night he developed fever, aches, chills, nausea, dull headache, elevated blood pressure, sore arm, and neck twitches. The patient had a low-grade fever and the sore arm, aches, chills and nausea have gotten better but not resolved.  Headache was reported as not being sharp and still dull, and blood pressure was decreased to 138/88 but is still higher than normal. The patient experienced neck twitches approximately 8 to 9 pm at the back of his neck on the bottom of skull that caused difficulty sleeping at night. Consent to follow up was provided.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Neck Twitches; Difficulty Sleeping; Fever; Aches; Chills; Nausea; Dull headache; Elevated Blood Pressure; Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of herpes zoster.   On 2nd January 2020 10:30, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd January 2020, less than a day after receiving Shingrix, the patient experienced fever, pain, chills, nausea, headache dull, increased blood pressure, pain in arm and difficulty sleeping. On 2nd January 2020 20:00, the patient experienced twitching. On an unknown date, the outcome of the fever, pain, chills, nausea, headache dull, increased blood pressure, pain in arm, twitching and difficulty sleeping were recovering/resolving.   It was unknown if the reporter considered the fever, pain, chills, nausea, headache dull, increased blood pressure, pain in arm, twitching and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patients wife reported that  he received 2nd dose of Shingrix in left arm on 2nd January 2020 at approximately 10.30 am, and that night he developed fever, aches, chills, nausea, dull headache, elevated blood pressure, sore arm, and neck twitches. The patient had a low-grade fever and the sore arm, aches, chills and nausea have gotten better but not resolved.  Headache was reported as not being sharp and still dull, and blood pressure was decreased to 138/88 but is still higher than normal. The patient experienced neck twitches approximately 8 to 9 pm at the back of his neck on the bottom of skull that caused difficulty sleeping at night. Consent to follow up was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb discomfort, Pain
Clinical narrative: soreness; redness; discomfort; This case was reported by a consumer via call center representative and described the occurrence of pain in a female 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 pain, erythema and arm discomfort. On an unknown date, the outcome of the pain, erythema and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the pain, erythema and arm discomfort to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced redness, soreness and arm discomfort with the 1st dose. This case has been linked to US2020002546, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male 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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the husband of a friend received shingrix and had soreness at the site of injection.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Serve Chills and body aches and pains. Lasting 24 hours. I took tylenol with minimal effect. Complete recovery after 48 hours after shot
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Headache, Paraesthesia
Clinical narrative: Slight tingling sensation; Slight light headenest; Entire body ( head to toes ) became bright red; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 79-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received the 2nd dose of Shingrix. In November 2019, 2 weeks after receiving Shingrix, the patient experienced tingling, headache and erythema. On an unknown date, the outcome of the tingling, headache and erythema were unknown.   It was unknown if the reporter considered the tingling, headache and erythema to be related to Shingrix.  Additional details were received as follows: The patient about 2 week later after vaccination felt a slight tingling sensation and had a slight light headenest and entire body became bright red. The patient stated that had occurred 5 times. The 3rd time it occurred the patient went to a walk in clinic. The physician said there have been many reactions to the shot but he had not seen or heard of reaction. The patient concern was that after 2 months now still getting a reaction. The patient would like to know the thought regarding the events.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Headache; Sinus inflammed; Chills; Fatigue; Fever; Body ache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (received 1st dose on an unknown date and experienced soreness and arm discomfort, refer case id US2020002547).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, sinusitis, chills, fatigue, fever, general body pain and nausea. On an unknown date, the outcome of the headache, sinusitis, chills, fatigue, fever, general body pain and nausea were recovered/resolved.   It was unknown if the reporter considered the headache, sinusitis, chills, fatigue, fever, general body pain and nausea to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced headache, sinus inflammed, chills, fatigue, fever, body aches and nausea with the 2nd dose. This case has been linked to cases US2020002546, reported by the same reporter (reported for different patient).
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sinusitis
Clinical narrative: Headache; Sinus inflammed; Chills; Fatigue; Fever; Body ache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (received 1st dose on an unknown date and experienced soreness and arm discomfort, refer case id US2020002547).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, sinusitis, chills, fatigue, fever, general body pain and nausea. On an unknown date, the outcome of the headache, sinusitis, chills, fatigue, fever, general body pain and nausea were recovered/resolved.   It was unknown if the reporter considered the headache, sinusitis, chills, fatigue, fever, general body pain and nausea to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced headache, sinus inflammed, chills, fatigue, fever, body aches and nausea with the 2nd dose. This case has been linked to cases US2020002546, reported by the same reporter (reported for different patient).
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Headache; Sinus inflammation; Chills; Fatigue; Fever; Body ache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (received 1st dose on an unknown date and experienced soreness and arm discomfort, refer case id US2020002548).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, sinusitis, chills, fatigue, fever, general body pain and nausea. On an unknown date, the outcome of the headache, sinusitis, chills, fatigue, fever, general body pain and nausea were recovered/resolved.   It was unknown if the reporter considered the headache, sinusitis, chills, fatigue, fever, general body pain and nausea to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experiencedheadache, sinus inflammed, chills, fatigue, fever, body aches and nausea with the 2nd dose. This case has been linked to cases US2020002546 and US2020002548, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sinusitis
Clinical narrative: Headache; Sinus inflammation; Chills; Fatigue; Fever; Body ache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (received 1st dose on an unknown date and experienced soreness and arm discomfort, refer case id US2020002548).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, sinusitis, chills, fatigue, fever, general body pain and nausea. On an unknown date, the outcome of the headache, sinusitis, chills, fatigue, fever, general body pain and nausea were recovered/resolved.   It was unknown if the reporter considered the headache, sinusitis, chills, fatigue, fever, general body pain and nausea to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experiencedheadache, sinus inflammed, chills, fatigue, fever, body aches and nausea with the 2nd dose. This case has been linked to cases US2020002546 and US2020002548, reported by the same reporter.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal, Immediate post-injection reaction, Seizure, Syncope
Clinical narrative: Immediately after vaccine patient said he felt funny and then fainted. It lasted about 30 seconds. As he was recovering the patient started to have a seizure. Seizure lasted 30 to 45 seconds. Pharmacy called 911. Paramedics checked vitals and child was released to go home. (Patient caregiver answered NO on the form regarding fainting & seizures, however while waiting for paramedics the caregiver told pharmacist that he does have a history of fainting & seizures, but she was not aware of the extent)
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Injection site pain, Retching
Clinical narrative: extreme pain at injection site, severe diarrhea for 12 hours, upset stomach, dry heaves, tiredness Lot number is unknown
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt had lost consciousness and fainted after getting up from exam table about 10 minutes later, no injury occurred. Pt had not eaten that morning.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Joint range of motion decreased, Pain
Clinical narrative: Hardened area, limited range of motion, soreness
Age: 8.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Culture throat, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Pt. developed fever (Tmax 103.4) 12 hours post administration, fever persits approx. 48 hours later. (L) upper arm developed localized erythema tenderness & warmth to touch, area increased to 3 1/2 x 2 1/2". Recommended warm compress, Benedryl topical hydrocortisone, ibuprofen/Tylenol as directed
Age: 8.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Streptococcus test, Streptococcus test negative
Clinical narrative: Pt. developed fever (Tmax 103.4) 12 hours post administration, fever persits approx. 48 hours later. (L) upper arm developed localized erythema tenderness & warmth to touch, area increased to 3 1/2 x 2 1/2". Recommended warm compress, Benedryl topical hydrocortisone, ibuprofen/Tylenol as directed
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot
Clinical narrative: Employee's right side of face became warm.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Bedridden, Feeling abnormal, Gait disturbance
Clinical narrative: Joints aching; Could barely walk; Felt very weak; Felt very bad; Back to bed and slept; Arm was very sore; Muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of arthralgia (received 1st dose on 25th July 2019 and experienced events, refer case US2020000352) and Flu vaccine with an associated reaction of pain in extremity (received flu vaccine on an unknown date in 1970 and experienced pain in arm).   On 27th September 2019, the patient received the 2nd dose of Shingrix .5 ml. In September 2019, less than a day after receiving Shingrix, the patient experienced joint pain, walking difficulty, pain in arm and muscle weakness. On 28th September 2019, the patient experienced weakness, feeling bad and bedridden. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the joint pain, walking difficulty, weakness, feeling bad, bedridden, pain in arm and muscle weakness were recovered/resolved.   It was unknown if the reporter considered the joint pain, walking difficulty, weakness, feeling bad, bedridden, pain in arm and muscle weakness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination awoke in the middle of night with every joint aching. The patient could barely walk, in the morning it was still hard to walk. The patient felt very weak and bad, she went back to bed and slept till 2pm. The patient also had arm pain and muscle weakness. The patient stated had not discussed the events with her physician but her mother did and the doctor said he was not aware of the events. This is 1 of the 3 cases reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Joints aching; Could barely walk; Felt very weak; Felt very bad; Back to bed and slept; Arm was very sore; Muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of arthralgia (received 1st dose on 25th July 2019 and experienced events, refer case US2020000352) and Flu vaccine with an associated reaction of pain in extremity (received flu vaccine on an unknown date in 1970 and experienced pain in arm).   On 27th September 2019, the patient received the 2nd dose of Shingrix .5 ml. In September 2019, less than a day after receiving Shingrix, the patient experienced joint pain, walking difficulty, pain in arm and muscle weakness. On 28th September 2019, the patient experienced weakness, feeling bad and bedridden. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the joint pain, walking difficulty, weakness, feeling bad, bedridden, pain in arm and muscle weakness were recovered/resolved.   It was unknown if the reporter considered the joint pain, walking difficulty, weakness, feeling bad, bedridden, pain in arm and muscle weakness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination awoke in the middle of night with every joint aching. The patient could barely walk, in the morning it was still hard to walk. The patient felt very weak and bad, she went back to bed and slept till 2pm. The patient also had arm pain and muscle weakness. The patient stated had not discussed the events with her physician but her mother did and the doctor said he was not aware of the events. This is 1 of the 3 cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Product Availability; This case was reported by a nurse via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 details were reported as follows: The age at vaccination was not reported. 2 people on patients wait list had ironically gotten Shingles.  Both had suggested that If the patient would have given them the shot this was not have happened. The patient would not give out patient's information.  But, general questions were fine. The reporter consented to follow up. This case has been linked with US2019220446 and US2019GSK238613, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Product Availability; This case was reported by a nurse via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 details were reported as follows: The age at vaccination was not reported. 2 people on patients wait list had ironically gotten Shingles.  Both had suggested that If the patient would have given them the shot this was not have happened. The patient would not give out patient's information.  But, general questions were fine. The reporter consented to follow up. This case has been linked with US2019220446 and US2019GSK238612, reported by same reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were received as follows: The reporter stated the patient received the first dose of Shingrix and experienced rash in the face. The reporter consented to follow up. This case has been linked to US2020000394, reported by the same reporter.