chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Muscle twitching, Pain, Pain in extremity, Pyrexia
Clinical narrative: Within 3 hours, felt extreme pain in both arms just resting, especially the shingles, moving arms was very painful. About 4 1/2 hours after I was shivering, chills and aches in my entire body, could not stop shaking and twitching. Massive headache. Entire night was awake, every hour taking temperature, was 100.3-100.5 till 9 am. then went down to 99. (My body temp is usually low, 97.) Aches and chills eventually calmed down, headache still awful, went back to bed by 10:30 a.m. slept till 3:30 pm. Spent the rest of the evening exhausted. Now on day two I'm still having a low temp fever of 99, but body aches, chills, headache etc gone. Able to get back to my work although feeling weak and a bit foggy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Decreased appetite, Discomfort
Clinical narrative: Intestinal and stomach pain, bloating, loss of appetite, nausea, no vomiting, but some acid reflux, chills. Started Monday, November 26 late afternoon, worked Tuesday with a lot of discomfort, did not feel like working on Wednesday, Thursday not much better, Friday pain is easing some and a little less bloating, still no appetite. Took nothing for symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastrooesophageal reflux disease, Intestinal perforation, Nausea
Clinical narrative: Intestinal and stomach pain, bloating, loss of appetite, nausea, no vomiting, but some acid reflux, chills. Started Monday, November 26 late afternoon, worked Tuesday with a lot of discomfort, did not feel like working on Wednesday, Thursday not much better, Friday pain is easing some and a little less bloating, still no appetite. Took nothing for symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient came in complaining of localized reaction, red, swollen, limited to site, warm to touch. Patient denied fever. Advised patient that these can be normal reactions based on VIS, advised local minor first aid.
Age: 54.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Peripheral swelling
Clinical narrative: The patient describes moderate to severe pain at the site of injection starting one day after the immunization. Patient describes worsening as well as redness and swelling of the arm starting another day after that. I informed him to try BENADRYL, ibuprofen, and icing to try to manage symptoms. I informed the patient to call his  primary care provider if symptoms worsened or did not improve.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: Rash, achy, injection site tenderness and redness, fever, malaise.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash, achy, injection site tenderness and redness, fever, malaise.
Age: 38.0
Sex: F
Vaccine: FLUR4
Symptoms: Lip swelling, Nausea, Vomiting
Clinical narrative: Lip swelling within 2 hours of injection. Nausea and vomiting the following morning. BENADRYL taken on day of infection. Unsure of outcome or if additional medications/treatments needed.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Low grade fever, myalgia, joint pain, fatigue.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Blood in stool.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Low grade temp 99.9 F, myalgia and joint pain, especially hands and knees, fatigue.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Heart rate increased
Clinical narrative: About 15 minutes after the vaccination, I noticed a fast heartbeat and some dizziness. The dizziness was very brief but the fast heartbeat continued off and one for about 1-2 hours.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site pain, Nervousness
Clinical narrative: Around 6:00 pm on the day of vaccination the patient reported pain at the site of injection, feeling shaky, and loose stools.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: Pt. reported extreme pain upon injection and immediate swelling occurred at the site.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: Patient called pharmacy stating that left arm was swollen to twice the size of right arm.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.25 ml instead of 0.5 ml.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old patient of unknown gender. Patient's medical history, concomitant therapies and concurrent conditions were not provided. On 08-NOV-2018, the patient inadvertently received a dose of PROQUAD recombinant Human albumin (rHA), lot# R017626, expiry date 18-DEC-2019 (dose, route and site of administration were not reported) for prophylaxis. The vaccine was diluted with sterile diluent (lot # and expiry date were not provided). No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 16-SEP-2015, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 14-NOV-2016 and 18-NOV-2016, the patient was treated by a physician and a healthcare provider at a physician's office and an eye institute for shingles and shingles around the eyes respectively. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Upon internal review, shingles around the eyes was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-FEB-2009, the healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-MAR-2014, the patient was treated by her healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 08-OCT-2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-AUG-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 27-MAR-2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 08-DEC-2014, the patient was treated by a physician's assistant at a dermatology physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 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 concurrent conditions, medical history, or concomitant medications. In or about 2013, a healthcare provider at a medical branch administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided).  In or about 2014, the patient was treated by a healthcare professional at the same medical branch for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 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 concurrent conditions, medical history, or concomitant medications. On or about 27-JAN-2007, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 06-NOV-2015, the patient was treated by a physician at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reports continued soreness in left arm and difficulty in raising arm 10 days after vaccination.
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: Breast swelling, Hypoaesthesia, Muscular weakness, Pain in extremity, Thinking abnormal
Clinical narrative: 3 hours after shot, patient was doing yard work. Sudden onset of muscle weakness in arms and legs. Very unusual because she does a lot of work outside and has never happened before. About 10 days later, sharp pain in left leg above ankle. 2 days later, left foot and right foot was numb along with left and right hands. Her thinking was "foggy and different".  Also had minor breast swelling. The breast swelling went away in about 4 to 5 days. Then all symptoms seemed to cycle through body, but not as severe as first time. Took about 30 days to feel completely normal again.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Dizziness, Headache, Heart rate increased
Clinical narrative: Patient reported feeling sick with flu-like symptoms (shivering, nausea, headache, dizziness), increased blood pressure and heart rate, severe swollen and warm to the site of the injection after a few hours of getting the SHINGRIX vaccine. Patient got nervous so she went to the hospital. She said she stayed at the ER for half a day until her blood pressure got normal.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling, Injection site warmth, Malaise, Nausea
Clinical narrative: Patient reported feeling sick with flu-like symptoms (shivering, nausea, headache, dizziness), increased blood pressure and heart rate, severe swollen and warm to the site of the injection after a few hours of getting the SHINGRIX vaccine. Patient got nervous so she went to the hospital. She said she stayed at the ER for half a day until her blood pressure got normal.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Nervousness
Clinical narrative: Patient reported feeling sick with flu-like symptoms (shivering, nausea, headache, dizziness), increased blood pressure and heart rate, severe swollen and warm to the site of the injection after a few hours of getting the SHINGRIX vaccine. Patient got nervous so she went to the hospital. She said she stayed at the ER for half a day until her blood pressure got normal.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Blood potassium decreased, Blood test normal, Fatigue, Gait disturbance, Headache
Clinical narrative: Mother reports within 2.5 hours of vaccination patient experienced sudden and severe onset of headache, muscle aches, and fatigue. She also reported having trouble moving her legs but was able to walk independently. Symptoms reportedly resolved by 11/23/18 however patient was in bed for several days following onset of event. Mother reports fever of 100.3 during course of event.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Myalgia, Pyrexia, Urine analysis normal
Clinical narrative: Mother reports within 2.5 hours of vaccination patient experienced sudden and severe onset of headache, muscle aches, and fatigue. She also reported having trouble moving her legs but was able to walk independently. Symptoms reportedly resolved by 11/23/18 however patient was in bed for several days following onset of event. Mother reports fever of 100.3 during course of event.
Age: 1.17
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Client received immunizations on 11-26-18. Mother called on 11-30-18 and reported that on 11-28-18 client broke out with a rash to his whole body, but it is more pronounced on client's legs. Mother denied the rash bothering the client. Mother reported a mild fever off and on that started on 11-30-18 at 1 am. No other symptoms reported.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: I completed the 2nd round of the shingles vaccination on Tuesday, 27 November. I experienced some pain and tenderness at the injection site an hour or two after receiving the vaccination --that seemed normal and I also experienced it after first round. On the night of 27 November, about 12 hours after the injection, I became chilled and a fever came on sometime during the night. I experienced moderate tachycardia that night as well. I took my pulse and it was 100-110 bpm. I woke on Wednesday 28 November with the mild fever (I didn't measure it) and a bad headache; the tachycardia was gone and ibuprofen relieved the headache and took down the fever. I missed two days of work but after sleeping for two days I'm close to 100% again.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: I completed the 2nd round of the shingles vaccination on Tuesday, 27 November. I experienced some pain and tenderness at the injection site an hour or two after receiving the vaccination --that seemed normal and I also experienced it after first round. On the night of 27 November, about 12 hours after the injection, I became chilled and a fever came on sometime during the night. I experienced moderate tachycardia that night as well. I took my pulse and it was 100-110 bpm. I woke on Wednesday 28 November with the mild fever (I didn't measure it) and a bad headache; the tachycardia was gone and ibuprofen relieved the headache and took down the fever. I missed two days of work but after sleeping for two days I'm close to 100% again.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Haemorrhage, Headache, Injection site discomfort, Injection site erythema
Clinical narrative: Redness and discomfort at the site of the vaccination. Wheezing, headache, bleeding, cloudy mind.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Redness and discomfort at the site of the vaccination. Wheezing, headache, bleeding, cloudy mind.
Age: 24.0
Sex: F
Vaccine: PPV, RAB, TD, TYP
Symptoms: Blood culture negative, Blood lactic acid normal, Chills, Erythema, Human chorionic gonadotropin normal
Clinical narrative: Right arm redness, pain started several hours after injections, progressed proximally with marked redness, and distally with streaking, accompanied by fevers, rigors. She called clinic and received nurse advice. Symptoms progressed and she presented to ED 1 day after vaccination, discharged for conservative treatment. Later that day 11/27/18, she eturned to ED with further progression and was admitted. Treated with IV ceftriaxone 1-2 doses, ibuprofen, slowly improved and discharged on 11/28/18.
Age: 24.0
Sex: F
Vaccine: PPV, RAB, TD, TYP
Symptoms: Influenza virus test negative, Metabolic function test normal, Pain in extremity, Pyrexia, White blood cell count increased
Clinical narrative: Right arm redness, pain started several hours after injections, progressed proximally with marked redness, and distally with streaking, accompanied by fevers, rigors. She called clinic and received nurse advice. Symptoms progressed and she presented to ED 1 day after vaccination, discharged for conservative treatment. Later that day 11/27/18, she eturned to ED with further progression and was admitted. Treated with IV ceftriaxone 1-2 doses, ibuprofen, slowly improved and discharged on 11/28/18.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: High fever, Febrile seizure less than 10 min. 1 dose of Amox prior to seizure after vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: FLU4, PER
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. Co-suspect products included WHOOPING COUGH VACCINE for prophylaxis. On 6th November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season and WHOOPING COUGH VACCINE. On 6th November 2018, less than a day after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: This case was posted by patient on social media. The age at vaccination was not reported. On the day of reporting, the patient received a flu shot and whooping cough shot and experienced sore arm. The patient reported that these shots were very much worth it for the baby patients. It was unknown if the reporter considered the sore arm to be related to whooping cough shot as well.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of injection site irritation in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site irritation. On an unknown date, the outcome of the injection site irritation was unknown. It was unknown if the reporter considered the injection site irritation to be related to SHINGRIX. Additional details were provided as follows: This case was received from the consumer via the vaccine patient assistance program. The age at vaccination was not reported. The patient reported that she had irritation at injection site. The patient's healthcare professional (HCP) told her to call her to report. The patient was incorrectly advised that GSK needed her HCP to call and report. The patient did not provide personal information for claim. The reporter had not been informed that they had reported an experience with a GlaxoSmithKline (GSK) product that needs to be shared with GSK. The reporter had not agreed to have GSK's safety team follow up with them via postal mail. This event did not include a product complaint.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a 57-year-old female patient who received SHINGRIX (batch number P45M9, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (injection site pain, nausea, headache and chills after receiving 1st dose on 14th May 2018, refer case US2018GSK203655). On 2nd November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever, headache, nausea, chills and injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, headache, nausea, chills and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, headache, nausea, chills and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient experienced fever of 104 degree F, slight soreness at injection site, headache, nausea and chills which lasted for 3 days. The nurse did not agree to follow up.
Sex: F
Vaccine: MEN
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a female patient who received Meningococcal B vaccine for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to Meningococcal B vaccine. Additional information received as follows: The case was reported by the patient's mother. The age at vaccination was not reported. The patient had not been the same since she got the vaccine. She had been chronically ill. Side effects of the vaccine were not worth the risks. The reporter asked to look at how many people actually died from meningitis each year and then look at how many had became ill from this vaccine.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 68-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. In October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, 2 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the patient experienced tiredness. Rechallenge with SHINGRIX was positive. In October 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the tiredness was unknown. It was unknown if the reporter considered the tiredness and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. On 30th July 2018, the patient received 1st dose of SHINGRIX and felt slightly tired. The patient received 2nd dose of SHINGRIX about 2 weeks before the date of reporting. Less than a month after receiving SHINGRIX, the patient experienced tiredness but that worse than 1st dose and he had to go to bed for a day. He had a little fever on the 2nd day after administration. This case had been linked with case US2018201340, reported by same reporter for same patient.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 15th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th October 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced injection site itching and injection site irritation. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site itching and injection site irritation were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site itching and injection site irritation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient experienced pain at the injection site during the injection. The injection site became sore and then when the soreness resolved, less than a month after receiving SHINGRIX, the injection site started to itch and was irritated. The patient had been scratching the injection site and the site had become sore again. He was using topical BENADRYL at the injection site to deal with the symptoms. He already had a physical scheduled with his physician this upcoming Thursday, so he would have the physician to look at his arm then. Consent to follow up was given.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Feeling abnormal, Headache, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX (in July 2018, received 1st dose, took TYLENOL as a safety precaution and did not experience side effects). Concomitant products included Levothyroxine. On 6th November 2018, the patient received the 2nd dose of SHINGRIX. On 6th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain, injection site swelling, injection site erythema, upset stomach and headache. On 7th November 2018, the patient experienced feeling abnormal, pallor and tiredness. On an unknown date, the outcome of the injection site muscle pain and tiredness were not recovered/not resolved and the outcome of the injection site swelling, injection site erythema, upset stomach, headache, feeling abnormal and pallor were recovered/resolved. It was unknown if the reporter considered the injection site muscle pain, injection site swelling, injection site erythema, upset stomach, headache, feeling abnormal, pallor and tiredness to be related to SHINGRIX. Additional details were provided as follows: On that same day after receiving SHINGRIX, the patient experienced side effects at the injection site of muscle pain, swollen, redness. In addition the patient also experienced an upset stomach and a headache. The second night, 1 day after receiving SHINGRIX, on 7th November 2018, Wednesday, she felt like falling over when she went to the bathroom that night. She was pale and tired. On Saturday, 10th November 2018, she finally started to feel better and the only side effects that she still has were tenderness at the injection site and she still felt tired. The patient had the pharmacy and second dose at her physician's office. Consent to follow up was given. During the call patient initially said that at her physician's office she was told that several people called about the second shot - she did not complete her sentence. When asking about this statement, patient took it back and said that she just meant that she talked to moms at her church about children having shingles nowadays and she did not want to get about any details. Unable to clarify if there was an actual event.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pallor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX (in July 2018, received 1st dose, took TYLENOL as a safety precaution and did not experience side effects). Concomitant products included Levothyroxine. On 6th November 2018, the patient received the 2nd dose of SHINGRIX. On 6th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain, injection site swelling, injection site erythema, upset stomach and headache. On 7th November 2018, the patient experienced feeling abnormal, pallor and tiredness. On an unknown date, the outcome of the injection site muscle pain and tiredness were not recovered/not resolved and the outcome of the injection site swelling, injection site erythema, upset stomach, headache, feeling abnormal and pallor were recovered/resolved. It was unknown if the reporter considered the injection site muscle pain, injection site swelling, injection site erythema, upset stomach, headache, feeling abnormal, pallor and tiredness to be related to SHINGRIX. Additional details were provided as follows: On that same day after receiving SHINGRIX, the patient experienced side effects at the injection site of muscle pain, swollen, redness. In addition the patient also experienced an upset stomach and a headache. The second night, 1 day after receiving SHINGRIX, on 7th November 2018, Wednesday, she felt like falling over when she went to the bathroom that night. She was pale and tired. On Saturday, 10th November 2018, she finally started to feel better and the only side effects that she still has were tenderness at the injection site and she still felt tired. The patient had the pharmacy and second dose at her physician's office. Consent to follow up was given. During the call patient initially said that at her physician's office she was told that several people called about the second shot - she did not complete her sentence. When asking about this statement, patient took it back and said that she just meant that she talked to moms at her church about children having shingles nowadays and she did not want to get about any details. Unable to clarify if there was an actual event.
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: White blood cell count decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of white blood cell count low in a 69-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. On 30th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On 12th November 2018, 13 days after receiving SHINGRIX and unknown after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced white blood cell count low. On an unknown date, the outcome of the white blood cell count low was unknown. It was unknown if the reporter considered the white blood cell count low to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional information was reported as follows: The patient was vaccinated with the dose of SHINGRIX on the left deltoid. On Monday, 12th November 2018, the patient carried out a blood work that showed that her white blood cell count was low (2.0). The patient had a follow-up appointment with her physician. Consent to follow-up was provided. The contact details of physician was provided. The vaccination date was unclear, it could be 16th October 2018 or 30th October 2018. Clarification was requested for the same.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Headache, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 13th November 2018, 1 days after receiving SHINGRIX, the patient experienced headache, stomach pain, fatigue, loss of energy and feeling unwell. On an unknown date, the outcome of the headache, fatigue, loss of energy and feeling unwell were not recovered/not resolved and the outcome of the stomach pain was recovering/resolving. It was unknown if the reporter considered the headache, stomach pain, fatigue, loss of energy and feeling unwell to be related to SHINGRIX. Additional details were reported as follows: Late on 13th November 2018, the patient started experiencing headache, stomach pain, fatigue and no energy. The stomach pain was bad initially, but it had abated. It was tolerable, but she was still felt ill at the reporting time. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On 31st October 2018, the patient received the 1st dose of SHINGRIX. On 31st October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 1st November 2018, the patient experienced injection site erythema. In November 2018, the patient experienced injection site swelling and injection site itching. The patient was treated with TYLENOL, BENADRYL and BENADRYL Cream. On 31st October 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were reported as follow: The age at vaccination was not reported. The same day of vaccination, the patient experienced pain at the injection site and she treated it with TYLENOL. The next day after vaccination, the patient had the injection site started turning red. Over the next few days, the patient experienced really red, itchy and swollen. The patient was uncomfortable and the patient treated with oral BENADRYL, but it did not really help. About to a day 5, the patient used BENADRYL cream and that was really helped to the patient. It was mostly went away in 7 days. The patient had concerned because she interpreted the literature to expect only 2 to 3 days of discomfort. The patient felt GlaxoSmithKline should do a better job of informing people about these effects and how to treat them. The reporter declined to provide further information and requested to remain anonymous. The reporter declined to provide the physician information. The reporter had not given consent for follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shivering in a 66-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received 6 to 8 weeks before the time of reporting, refer case US2018GSK216201). On 14th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 14th November 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. In November 2018, the patient experienced shivering, back pain and fever. On an unknown date, the outcome of the shivering, back pain, fever and drug dose administration interval too short were unknown. It was unknown if the reporter considered the shivering, back pain and fever to be related to SHINGRIX. Additional details were reported as follow: The patient was a physician. The patient received 2nd dose of SHINGRIX 6 to 8 weeks after the 1st dose of SHINGRIX, which might led to possible shortening of the vaccination schedule. After vaccination, the patient experienced severe shivering, back pain and a mild fever during the night.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 7th October 2018, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved. It was unknown if the reporter considered the tingling of extremity to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on unknown arm. The batch number was not reported. The patient was experiencing tingling in the unspecified arm that the injection was given. The tingling was from the wrist up to the injection site area. The tingling was intermittent throughout the day. The only relief the patient experiences from the tingling was when she places her arm over her head. The onset of symptoms was not known. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, Injection site pain, Insomnia
Clinical narrative: This spontaneous report was received from 59 year old female patient with diabetes, who was reporting on herself. She had no known drug reactions or allergies and no information regarding the her concomitant medications was provided. On 31-OCT-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, intramuscularly, (exact dose, lot number and expiration date were not reported). On the same date, she experienced normal shot pain and had a hard time sleeping. She that she spoke with her doctor who told her to came back to get re-vaccinated". And at the reporting time, she was considering re-vaccination. No lab diagnostics or studies were performed and no treatment was given for the events. The patient mentioned that an unspecified flu shot also gave her normal shot pain (timeframe unspecified). At the time of the report, the patient did not recover from the events. The causality assessment was not provided.