chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored temperature excursion - 08/05/2020; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 05-AUG-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot# S020160, expiration date 30-JUN-2021 ,for prophylaxis (strength, dose, route and frequency were not reported) and varicella virus vaccine live (Oka/Merck)(VARIVAX) lot# S038175, expiration date 26-NOV-2021, for prophylaxis (strength, dose, route and frequency were not reported).    The temperature excursion was of -50 Fahrenheit degrees (°F), time frame -6°F (10°F) for 1 hour and 15 minutes; 15°C to 46°F (44.8°F) for 1 hour and 30 minutes; 47°F to 77°F (50°F) for 2 hours and 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: the improperly stored temperature excursion; 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 therapies were not reported.  Approximately in August 2020, the patient was vaccinated with doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S038175, expiration date 26-NOV-2021 (dose, route and vaccination site were not provided), for prophylaxis and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot# S020160, expiration date 30-JUN-2021 (dose, route and vaccination site were not provided), for prophylaxis which were improperly stored on 06-AUG-2020.   Temperature- 50F Time frame - 6°F to 14°F (l0F) for 1 hour and 15 minutes; 15°F to 46°F (44.8F) for 1 hour and 30 minutes; 47°F to 77°F (50F) for 2 hours and 30 minutes Previous temperature excursion? N Was call because of a "data logger"? Y
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored temperature excursion; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 07-AUG-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot# S020160, expiration date 30-JUN-2021 ,for prophylaxis (strength, dose, route and frequency were not reported) and varicella virus vaccine live (Oka/Merck)(VARIVAX) lot# S038175, expiration date 26-NOV-2021, for prophylaxis (strength, dose, route and frequency were not reported).    The temperature excursion was of -50 Fahrenheit degrees (°F), time frame -6°F to 14 °F (10°F) for 1 hour and 15 minutes; 15°C to 46°F (44.8°F) for 1 hour and 30 minutes; 47°F to 77°F (50°F) for 2 hours and 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: patient passed away; This case was reported by a consumer via patient support programs and described the occurrence of unknown cause of death in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On 26th July 2020, less than 9 months after receiving Shingrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 26th July 2020. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be unrelated to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination with Shingrix 1st dose on December 2019, the patient passed away on 26th July 2020. The reporter stated that, cause of death was undisclosed. There was no product complaint. The reporter consented to follow up; Reported Cause(s) of Death: Death NOS
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Ended up in the hospital with a fever of 105-106 degrees; This case was reported by a consumer via call center representative and described the occurrence of fever in a 80-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included asthma, penicillin allergy, latex allergy, food allergy, drug allergy, allergy to chemicals, drug allergy and shellfish allergy.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced fever (serious criteria hospitalization). On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient stated that many years ago after receiving a flu shot she ended up in the hospital with a fever of 105 to 106 degrees F. Since then she refused to get any flu shots. The patient received a pneumonia shot since then however. The patient did not provide the specific name of the flu shot but stated that it was many years ago back when the flu shot was made with eggs and chicken embryos. The reporter consented to follow up. This is 1 of the 3 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153376:same reporter US-GLAXOSMITHKLINE-US2020153378:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Mild allergic response; This case was reported by a physician via call center representative and described the occurrence of allergic reaction 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported but was taken as an adult as per vaccine indication. The patient received 1 dose of Shingrix without the second dose and experienced a mild allergic response and wanted to have an informed discussion regarding risks and benefits of having a second dose. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis around the site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 53L2Z, expiry date 15th May 2022) for prophylaxis.   On 12th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th June 2020, 5 days after receiving Shingrix, the patient experienced injection site cellulitis. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site cellulitis was unknown.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in left deltoid. The reporter stated that, after vaccination with dose of Shingrix, the patient had cellulitis around the site of injection. The patient started on antibiotics as a treatment medication. No additional information was provided. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Fatigue, Impaired work ability, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Fever of 100, abdominal cramping/pain. Very tired (in bed from 9am  on 8/11/2020 until 3:00pm - unable to work or perform daily house routines.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: States the left injection site developed redness and swelling approx. size of a 50 cent piece. There is also a quarter sized whelp on the back of his left arm close to the axilla. There was a third red, raised whelp on his left side that is approx. 6 inches long and 1.5 inches wide. Has itching with these areas. Has taken Benadryl which helped with the itching, but whelps remained at the time. Provider had recommended to continue Benadryl q6h and apply cool compresses and follow up in office if no improvement by 8/12/2020.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: States the left injection site developed redness and swelling approx. size of a 50 cent piece. There is also a quarter sized whelp on the back of his left arm close to the axilla. There was a third red, raised whelp on his left side that is approx. 6 inches long and 1.5 inches wide. Has itching with these areas. Has taken Benadryl which helped with the itching, but whelps remained at the time. Provider had recommended to continue Benadryl q6h and apply cool compresses and follow up in office if no improvement by 8/12/2020.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Pt was given a Tdap and a PPD she has denied any history of issues with vaccines the immunization was given per protocol. the Pt walked to the front desk where she got dizzy she was evaluated by her PCP given smelling salts and her BP was taken after 10 min she was feeling better and left the office.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Computerised tomogram, Magnetic resonance imaging, Oligodendroglioma, Seizure
Clinical narrative: I had a severe seizure 3 weeks after getting this vaccine and was hospitalized for 2.5 days.  I assume the two things are unrelated, as the seizure was diagnosed as related to an oligodendroglioma that was found following the seizure.  However, I found a note on the Vaccine Information Sheet from the CDC that mentions to let your vaccine provider know about seizures occurring within 7 days of getting the vaccine.  While this seizure happened 21 days after the vaccine was administered instead of 7 and seems attributable to the brain tumor instead of the vaccine, I'm reporting it in case it is of interest.  This glioma likely developed over years, so I'm curious if the vaccine may have in some way triggered the seizure at this point in time, which if it did, may have helped identify this  medical issue for treatment.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Pedvaxhib was improperly stored and administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-JUL-2020, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S03150, expiration date 21-APR-2022 for prophylaxis (dose and route of administration were not reported). Administered doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion of 50 Fahrenheit degrees (F) for 1 hour and 46 minutes. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion.o additional adverse event was reported.; Sender's Comments:  US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2008USA000307: US-009507513-2008USA000372:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a dose of VARIVAX after a temperature excursion; No other adverse effects were reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.      On an unknown date, the patient was vaccinated with an improperly stored dose varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038177, expiration date 26-NOV-2021 (exact dose and route of administration were not reported) for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) 0.5 ml (frequency, route of administration, indication, lot# and expiration date were not reported).     Digital Data logger was involved. The vaccine was stored at the temperature that was reported as in the range of 15 degrees of F to 46 degrees of F (-9 degrees of C to 8 degrees of C) (-3 degrees of C) for 44 minutes. There was a previous temperature excursion reported as: in the range of 6 degrees of F to 14 degrees of F (-14 degrees of C to -10 degrees of C) (-10.4 degrees of C) for 29 minutes; in the range of 6 degrees of F to 14 degrees of F (-14 degrees of C to -10 degrees of C) (-13 degrees of C) for 24 minutes and in the range of 15 degrees of F to 46 degrees of F (-9 degrees of C to 8 degrees of C) (-5.6 degrees of C) for 39 minutes. No adverse effect reported.
Age: 88.0
Sex: F
Vaccine: PPV, FLUA4, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Joint swelling, Peripheral swelling
Clinical narrative: Patient reported redness and swelling in upper left arm 1 day after immunization. She applied ice to soothe injection site. Day 2 redness and swelling spread below her elbow. Primary care physician ordered doxycycline, famotidine and diphenhydramine. Day 3 patient reported swelling and redness on entire left arm to the wrist.
Age: 88.0
Sex: F
Vaccine: PPV, FLUA4, PPV
Symptoms: Injection site swelling
Clinical narrative: Patient reported redness and swelling in upper left arm 1 day after immunization. She applied ice to soothe injection site. Day 2 redness and swelling spread below her elbow. Primary care physician ordered doxycycline, famotidine and diphenhydramine. Day 3 patient reported swelling and redness on entire left arm to the wrist.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Chills, body aches, took naproxin every 12 hours
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: flulike symptoms,pain/redness/heat in bicep and below vaccination site,needle mark had red ring around it,worsening symptoms
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Fever, chills, injection site soreness ,tired
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Red rash extending from injection site to elbow--width of upper arm to elbow, swelling, pain
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient states her injection site raised, red , warm and tender.  Patient is instructed to use warm moist compress, tylenol, Hydrocortisone cream. Call back if needs to be seen.  Patient denies any SOB or swollen lips or additional sx.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Malaise, Mobility decreased
Clinical narrative: fever, chills, widespread acute pain in entire body, nausea , stomach pain .  Pain so debilitating that I couldn't move around. The symptoms are continuing into second day. It's as if I was given a virus. Because I have autoimmune diseases, I am usually cautious about live vaccines. However, because I was told this wasn't live, I thought it would be similar to a flu or pneumonia vaccine. It is not. I am incredibly ill
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: fever, chills, widespread acute pain in entire body, nausea , stomach pain .  Pain so debilitating that I couldn't move around. The symptoms are continuing into second day. It's as if I was given a virus. Because I have autoimmune diseases, I am usually cautious about live vaccines. However, because I was told this wasn't live, I thought it would be similar to a flu or pneumonia vaccine. It is not. I am incredibly ill
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Appetite disorder, Pyrexia
Clinical narrative: FEVER:HIGHEST 102 degrees F(parent reported) APETITE CHANGE ACTIVITY CHANGE
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Injection site pain, Pain, Pyrexia
Clinical narrative: Soreness at injection site on arm immediately and increasing for next 2 days.  Body aches, shivering and fever began about 24 hours after vaccination with fever up to 100.3. Fever lowered within 3 hours to normal range with NSAIDs. Continued use of NSAIDs for 24 hours. By next morning, no fever, but continued NSAIDs to manage body aches. Body aches resolved by morning of 3rd day. Still soreness on arm (less than previously.)
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster oticus
Clinical narrative: zoster related hearing loss; zoster related hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On or about 01-OCT-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions.At the time of the pt's vaccination, the pt relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX), and the information relayed through the pt's healthcare providers that the zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the pt to be vaccinated. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for zoster related hearing loss. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and 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 outcomes of the events were considered as not recovered. The reporter assessed that the events were related to the zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of zoster related hearing loss was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Ear congestion
Clinical narrative: sensorineural hearing loss, unilateral of the right ear; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 21-AUG-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route 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 right ear fullness with no hearing. The patient was diagnosed with sensorineural hearing loss, unilateral, of the right ear. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The 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), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event to be disability. Upon internal review, the event of sensorineural hearing loss was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: varicella type rash, consistent with shingles, on his left upper quadrant; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 28-AUG-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route 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 varicella type rash, consistent with shingles, on his left upper quadrant. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event to be disability.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash erythematous
Clinical narrative: shingles/red rash on her abdomen; painful and red rash on her abdomen/ postherpetic nervous system involvement; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 06-FEB-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route 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 painful and red rash on her abdomen and was diagnosed with shingles and postherpetic nervous system involvement. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The 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), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of both events was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered both events to be disability.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: administered MMR II that was improperly stored in the freezer; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 24-JUL-2020, the patient was vaccinated with an improperly stored one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) Recombinant human albumin (rHA), lot # S020161, expiration date 30-JUL-2021 (exact dose and route of administration were not reported) for prophylaxis.        Digital Data logger was involved. The vaccine was stored at the temperature that was reported as -10 degrees of F, the time frame was not reported. There was a previous temperature excursion reported as below 36 degrees of F (10 degrees of F) for 50 minutes.; Sender's Comments:  US-009507513-2008USA001787: US-009507513-2008USA002399: US-009507513-2008USA001689:
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Vaccination complication
Clinical narrative: zoster related Guillain-Barre syndrome; zoster related Guillain-Barre syndrome; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On or about 18-SEP-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a healthcare provider at a public clinic, for the long-term prevention of shingles and/or zoster-related conditions.At the time of the pt's vaccination, the pt relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX), and the information relayed through the pt's healthcare providers that the zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the pt to be vaccinated. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for zoster related Guillain-Barre syndrome. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and 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 outcomes of the events were considered as not recovered. The reporter assessed that the events were related to the zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of zoster related Guillain-Barre syndrome was considered to be medically significant.
Sex: F
Vaccine: MEN, MEN
Symptoms: Chills, Confusional state, Crying, Decreased appetite, Extra dose administered
Clinical narrative: Body aches / Crying in so much pain/body pain,; Chills; Fever; Vomiting; Confusion; Nausea; Little to no food intake; Eyes were swollen; crying in so much pain; Got 2 shots same day; Bad headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   Co-suspect products included Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 31st July 2020, the patient received the 1st dose of Meningococcal B vaccine and Meningococcal B vaccine. On 31st July 2020, less than a day after receiving Meningococcal B vaccine and Meningococcal B vaccine, the patient experienced headache and overdose. On 1st August 2020, the patient experienced general body pain, chills, fever, vomiting, confusion, nausea, decreased appetite, eye swelling and crying. On an unknown date, the outcome of the headache, general body pain, chills, fever, vomiting, confusion, nausea, decreased appetite, eye swelling and crying were not recovered/not resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the headache, general body pain, chills, fever, vomiting, confusion, nausea, decreased appetite, eye swelling and crying to be related to Meningococcal B vaccine and Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by the parent of the patient. The age at vaccination was not reported. The patient received Meningococcal B vaccine and had bad reaction to the vaccine.  Severe headaches, vomiting, nausea, body pain, confusion and eyes were swollen.  The doctor said just a reaction and should resolve in 3 days and had been in tears. The patient had body aches, chills, fever, vomiting, confusion.  The patient got 2 shots same day, which led to overdose.  The reporter took her to emergency room because she was crying in so much pain.  The reporter just gave her something for nausea and sent her home.  The patient was on day 3 of same symptoms and little to no food intake.
Sex: F
Vaccine: MEN, MEN
Symptoms: Eye swelling, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Body aches / Crying in so much pain/body pain,; Chills; Fever; Vomiting; Confusion; Nausea; Little to no food intake; Eyes were swollen; crying in so much pain; Got 2 shots same day; Bad headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   Co-suspect products included Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 31st July 2020, the patient received the 1st dose of Meningococcal B vaccine and Meningococcal B vaccine. On 31st July 2020, less than a day after receiving Meningococcal B vaccine and Meningococcal B vaccine, the patient experienced headache and overdose. On 1st August 2020, the patient experienced general body pain, chills, fever, vomiting, confusion, nausea, decreased appetite, eye swelling and crying. On an unknown date, the outcome of the headache, general body pain, chills, fever, vomiting, confusion, nausea, decreased appetite, eye swelling and crying were not recovered/not resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the headache, general body pain, chills, fever, vomiting, confusion, nausea, decreased appetite, eye swelling and crying to be related to Meningococcal B vaccine and Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by the parent of the patient. The age at vaccination was not reported. The patient received Meningococcal B vaccine and had bad reaction to the vaccine.  Severe headaches, vomiting, nausea, body pain, confusion and eyes were swollen.  The doctor said just a reaction and should resolve in 3 days and had been in tears. The patient had body aches, chills, fever, vomiting, confusion.  The patient got 2 shots same day, which led to overdose.  The reporter took her to emergency room because she was crying in so much pain.  The reporter just gave her something for nausea and sent her home.  The patient was on day 3 of same symptoms and little to no food intake.
Sex: F
Vaccine: MEN, MEN
Symptoms: Vomiting
Clinical narrative: Body aches / Crying in so much pain/body pain,; Chills; Fever; Vomiting; Confusion; Nausea; Little to no food intake; Eyes were swollen; crying in so much pain; Got 2 shots same day; Bad headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   Co-suspect products included Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 31st July 2020, the patient received the 1st dose of Meningococcal B vaccine and Meningococcal B vaccine. On 31st July 2020, less than a day after receiving Meningococcal B vaccine and Meningococcal B vaccine, the patient experienced headache and overdose. On 1st August 2020, the patient experienced general body pain, chills, fever, vomiting, confusion, nausea, decreased appetite, eye swelling and crying. On an unknown date, the outcome of the headache, general body pain, chills, fever, vomiting, confusion, nausea, decreased appetite, eye swelling and crying were not recovered/not resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the headache, general body pain, chills, fever, vomiting, confusion, nausea, decreased appetite, eye swelling and crying to be related to Meningococcal B vaccine and Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by the parent of the patient. The age at vaccination was not reported. The patient received Meningococcal B vaccine and had bad reaction to the vaccine.  Severe headaches, vomiting, nausea, body pain, confusion and eyes were swollen.  The doctor said just a reaction and should resolve in 3 days and had been in tears. The patient had body aches, chills, fever, vomiting, confusion.  The patient got 2 shots same day, which led to overdose.  The reporter took her to emergency room because she was crying in so much pain.  The reporter just gave her something for nausea and sent her home.  The patient was on day 3 of same symptoms and little to no food intake.
Sex: U
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased
Clinical narrative: elevated liver enzymes; This case was reported by a consumer and described the occurrence of elevated liver enzymes in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown.   It was unknown if the reporter considered the elevated liver enzymes to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that her physician informed her that the patient had also experienced elevated liver enzymes after receiving the Shingrix vaccine. This is 2 of 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153365:same reporter US-GLAXOSMITHKLINE-US2020AMR153873:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased
Clinical narrative: elevated liver enzymes; This case was reported by a consumer and described the occurrence of elevated liver enzymes in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown.   It was unknown if the reporter considered the elevated liver enzymes to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that her physician informed her that the patient had also experienced elevated liver enzymes after receiving the Shingrix vaccine. This is 2 of 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153365:same reporter US-GLAXOSMITHKLINE-US2020AMR153870:sae reporter US-GLAXOSMITHKLINE-US2020153365:same reporter
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Adverse reaction
Clinical narrative: AE was experienced; This case was reported by a nurse and described the occurrence of adverse reaction in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Menveo and Tdap Vaccine. On an unknown date, unknown after receiving Menveo and Tdap Vaccine, 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 Menveo and Tdap Vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced adverse event after receiving the vaccine. The reporter did not have much information about the event. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: how long before the side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had side effects. The reporter asked how long before the side effects disappear.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: who had a allergic reaction; rash spreading to her chest; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction 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 allergic reaction and rash. Shingrix was discontinued. On an unknown date, the outcome of the allergic reaction and rash were unknown.   It was unknown if the reporter considered the allergic reaction and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had allergic reaction. The rash spreading to her chest. The reporter stated that they likely not pursuing a second shot because of this.
Sex: U
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Increased heart rate; This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was not recovered/not resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had heart rate increased. The reporter asked as a side effect of the shingrix injection how long did the increased heart rate last.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Grade 3 reaction with swelling and redness that covered the left arm from the elbow to the shoulder; Grade 3 reaction with swelling and redness that covered the left arm from the elbow to the shoulder; This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 54A2T, expiry date 11th December 2021) for prophylaxis.   On 14th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had Grade 3 reaction with swelling and redness that covered the left arm from the elbow to the shoulder. No other vaccines administered that visit. The reporter agrees to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Paraesthesia
Clinical narrative: along with tingling./Tingling happened; patient had shivers; This case was reported by a other health professional via sales rep and described the occurrence of shivers in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2020, the patient received Shingrix. On 4th August 2020, less than a day after receiving Shingrix, the patient experienced shivers and tingling. On an unknown date, the outcome of the shivers was recovered/resolved and the outcome of the tingling was unknown.   It was unknown if the reporter considered the shivers and tingling to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had Shivers for approximately 6 hours along with tingling. The patient was monitoring their health till the time of reporting. The reporter agreed to follow up with GlaxoSmithKline.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site warmth
Clinical narrative: Red spot underneath injection site; Warm spot underneath injection site; This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2020, the patient received Shingrix. On 5th August 2020, 2 days after receiving Shingrix, the patient experienced localized erythema and feeling of warmth. On an unknown date, the outcome of the localized erythema and feeling of warmth were unknown.   It was unknown if the reporter considered the localized erythema and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The reporter was the caller. The patient received Shingrix and experienced a red, warm spot underneath the area where they got the shot.  The spot was about 1/2 inch underneath the injection site.  The reporter stated that the reaction was not at the injection site, but deeper in the tissues. The reporter did not consent to follow up. Not all information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Mild case of shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix shot(s) and developed a mild case of shingles.  This case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation was not provided. The case was linked with the cases US2020153380 and US2020153376 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153376:same reporter US-GLAXOSMITHKLINE-US2020153380:same reporter
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia, Weight decreased
Clinical narrative: Tiredness; Headache in the back of his head; Fever with Chills; Weight loss; chills; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had a very severe case of chickenpox as a child). Concurrent medical conditions included tooth abscess.   In July 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced tiredness, headache, fever chills, weight loss and chills. On an unknown date, the outcome of the tiredness and weight loss were recovering/resolving and the outcome of the headache, fever chills and chills were recovered/resolved.   It was unknown if the reporter considered the tiredness, headache, fever chills, weight loss and chills to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix approximately 3 weeks ago and had fever with chills, a headache in the back of his head, tiredness, weight loss, and other symptoms that he could not remember.  The patient was just beginning to feel better and headache, fever and chills had fully recovered.  The reporter was unclear if all symptoms were related to Shingrix as he also had 2 teeth abscess that he had to receive care for. No Lot or Expiry was provided. The reporter did not consent to follow up.