chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP
Symptoms: Febrile convulsion
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of febrile seizure in a 8-week-old female patient who received PEDIARIX (batch number MP9H4, expiry date 5th December 2020) for prophylaxis. On 21st January 2019, the patient received the 1st dose of PEDIARIX (intramuscular) .5 ml. On 21st January 2019, less than a day after receiving PEDIARIX, the patient experienced febrile seizure (serious criteria hospitalization and GSK medically significant). PEDIARIX was discontinued. On an unknown date, the outcome of the febrile seizure was unknown. The reporter considered the febrile seizure to be related to PEDIARIX. Additional details were provided as follows: The patient was given the dose of PEDIARIX in the left thigh and experienced a febrile seizure. The patient went to the emergency room and was admitted to the hospital. The patient was observed and then discharged on 22nd January 2019. The patient did not require treatment. The patient was seen by a neurologist who stated the febrile seizure was due to the pertussis component of the vaccine. The neurologist recommended that the patient should not receive any more pertussis. The reporter consented to follow up via fax.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Fever (101), mild chills, moderate soreness at injection site. TYLENOL, 2-days.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Abnormal behaviour, Aggression, Diet refusal, Eczema, Gastrooesophageal reflux disease
Clinical narrative: Shrieked until he fell asleep then would wake up shrieking. He wouldn't eat, just shriek and very high pitched. This continued for hours until I took him to the ER. They immediately brushed off the vaccination but I knew. At first, he broke out from head to toe in eczema right after. Then the reflux started and milk allergy. He now hand claps, PICA and sucks on his shirt until it's drenched, aggressive behavior, must hold and rub a tag, is particular about certain foods and textures, colors and sounds.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: High-pitched crying, Milk allergy, Pica
Clinical narrative: Shrieked until he fell asleep then would wake up shrieking. He wouldn't eat, just shriek and very high pitched. This continued for hours until I took him to the ER. They immediately brushed off the vaccination but I knew. At first, he broke out from head to toe in eczema right after. Then the reflux started and milk allergy. He now hand claps, PICA and sucks on his shirt until it's drenched, aggressive behavior, must hold and rub a tag, is particular about certain foods and textures, colors and sounds.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Hyperhidrosis, Injection site pain, Pain
Clinical narrative: Sweating, body aches; soreness at injection site, stomach pain.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist of unknown age and gender reporting on themselves. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II injection, in an unspecified arm (exact dose, lot# and expiration date were not reported). The administrating nurse pulled the patient's arm fat down and administered vaccine. The reporter believed that the route of administration was incorrect, however could not confirm if it was subcutaneous or not. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1901USA011995.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 12 month old male patient. The patient had no pertinent medical history and no drug reactions/allergies. On 15-JAN-2019 the patient was vaccinated with M-M-R II, 1 injection, lot # unknown, via unspecified route. Concomitant therapies were not reported. The mother said that on 20-JAN-2019, reported as 'on Sunday' the patient developed an unspecified fever that resolved on Monday (21-JAN-2019). On 29-JAN-2019 (reported as yesterday), a rash that did not itch developed on the patient's torso. The mother said the rash did not seem to bother the patient. However the mother said she noticed on 30-JAN-2019, the rash was spreading to the patient's face and near his eyes. She had not treated the rash and was waiting for a physician's consult. No lab diagnostics were done at the moment of report. The outcome of rash was reported as not recovered/not resolved. The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: 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 and concurrent conditions were not reported. On 31-JAN-2019, the patient was vaccinated with an improperly stored dose of VARIVAX one dose, subcutaneous, lot# R020651 and expiration date 18-JUL-2020, for prophylaxis (strength and frequency were not reported) reconstituted with a properly stored sterile diluent. The temperature excursion was of -9 Centigrade degrees (°C) to 8°C (-9°C), during 3 hours. A previous temperature excursion was not reported. A digital data logger was not involved. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blepharitis, Retinal detachment, Vision blurred, Visual impairment, Vitreous detachment
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. In or around 12-SEP-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately 2013 [reported as "shortly after" receiving the ZOSTAVAX], the patient suffered vision issues including but not limited to blurry vision, floaters and black swirls in his vision. The patient was diagnosed with posterior vitreous detachment of the left eye and partial retinal detachment of the right eye. He was additionally diagnosed with blepharitis in both eyes. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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 consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical expenses and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, posterior vitreous detachment of the left eye and partial retinal detachment of the right eye were determined to be medically significant. Posterior vitreous detachment of the left eye, partial retinal detachment of the right eye, and blepharitis in both eyes were considered to be disabling.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Vitreous floaters
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. In or around 12-SEP-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately 2013 [reported as "shortly after" receiving the ZOSTAVAX], the patient suffered vision issues including but not limited to blurry vision, floaters and black swirls in his vision. The patient was diagnosed with posterior vitreous detachment of the left eye and partial retinal detachment of the right eye. He was additionally diagnosed with blepharitis in both eyes. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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 consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical expenses and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, posterior vitreous detachment of the left eye and partial retinal detachment of the right eye were determined to be medically significant. Posterior vitreous detachment of the left eye, partial retinal detachment of the right eye, and blepharitis in both eyes were considered to be disabling.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a medical assistant concerning a currently 24-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with a pediatric dose of VAQTA (strength, dose, route, frequency, lot number and expiration date were not reported) for prophylaxis. No adverse symptoms were reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 12 month old patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-JAN-2019, the patient was vaccinated with 1 dose of VARIVAX lot # R018143, expiring on 25-JUN-2020 for prophylaxis (dose, dose number, route of administration and site of injection were not reported). On the same day, the patient received a dose of PROQUAD lot # R018779, expiring on 29-DEC-2019 for prophylaxis (dose, dose number, route of administration and site of injection were not reported). The patient experienced no adverse event. The outcome of inappropriate schedule of product administration was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The primary reporter was the caller who said that she heard from a physician that the patient who get SHINGRIX did not feel well the next day of vaccination. No further adverse event information was provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of chills in a 62-year-old female patient who received 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 chills, fever and nausea. On an unknown date, the outcome of the chills, fever and nausea were recovered/resolved. The reporter considered the chills, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced episodes of chills, fever and nausea. This lasted for definitely for 1 month and then the episodes tapered over the next month. The patient thought it was related to the vaccine. The reporter did not agree for follow up contact.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced sickness, injection site swelling, injection site erythema, injection site pain, headache, nausea, fever, lethargy, influenza like illness and product supply issue. SHINGRIX was discontinued. On an unknown date, the outcome of the sickness, injection site swelling, injection site erythema, injection site pain, headache, nausea, fever, lethargy and product supply issue were unknown and the outcome of the influenza like illness was recovered/resolved. It was unknown if the reporter considered the sickness, injection site swelling, injection site erythema, injection site pain, headache, nausea, fever, lethargy and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient could be 54 or 55 years old. The patient was trying to locate the vaccine for her booster and was worried on how to get the booster in time. The patient had called at her physician's location. The locator showed it was available but there was no availability at any of the locations.  The patient kept calling but was hoping for an updated list. The reporter had no specific information as to which locations currently the vaccine would be available. The locator only listed the locations that offered the vaccine. The shipment had just released the week from the date of reporting and had one scheduled for the next week. The patient got really sick and did not want to start over. The patient experienced bad side effects such as swelling, red and painful at site, plus headache, nausea, fever, felt lethargic and flu like for 3 day. It was reported that as per FDA dosing schedule for SHINGRIX, the vaccine must be received as the 1st dose at month zero, followed by 2nd dose 2 to 6 months after the 1st dose. It had been 6 months since the patient had received the 1st dose and was advised to receive the 2nd dose as soon as possible and need not to restart the vaccine series.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Malaise, Nausea, Product supply issue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced sickness, injection site swelling, injection site erythema, injection site pain, headache, nausea, fever, lethargy, influenza like illness and product supply issue. SHINGRIX was discontinued. On an unknown date, the outcome of the sickness, injection site swelling, injection site erythema, injection site pain, headache, nausea, fever, lethargy and product supply issue were unknown and the outcome of the influenza like illness was recovered/resolved. It was unknown if the reporter considered the sickness, injection site swelling, injection site erythema, injection site pain, headache, nausea, fever, lethargy and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient could be 54 or 55 years old. The patient was trying to locate the vaccine for her booster and was worried on how to get the booster in time. The patient had called at her physician's location. The locator showed it was available but there was no availability at any of the locations.  The patient kept calling but was hoping for an updated list. The reporter had no specific information as to which locations currently the vaccine would be available. The locator only listed the locations that offered the vaccine. The shipment had just released the week from the date of reporting and had one scheduled for the next week. The patient got really sick and did not want to start over. The patient experienced bad side effects such as swelling, red and painful at site, plus headache, nausea, fever, felt lethargic and flu like for 3 day. It was reported that as per FDA dosing schedule for SHINGRIX, the vaccine must be received as the 1st dose at month zero, followed by 2nd dose 2 to 6 months after the 1st dose. It had been 6 months since the patient had received the 1st dose and was advised to receive the 2nd dose as soon as possible and need not to restart the vaccine series.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Dizziness, Face oedema, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of face edema in a 11-year-old male patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced face edema, cough, rash and dizziness. The patient was treated with BENADRYL. On an unknown date, the outcome of the face edema, cough, rash and dizziness were recovered/resolved. The reporter considered the face edema, cough, rash and dizziness to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT in left arm on 8th time. The patient experienced coughing, rash on face, mild edema on cheeks, dizzy, lasted after 8 min. The patient given BENADRYL, same day he was fine within hour. The reporter thinks reaction was related to product. The reporter was agree to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza like illness, Insomnia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, muscle pain, influenza like illness, headache, exhaustion and feeling abnormal. On an unknown date, the outcome of the pain in arm, influenza like illness, headache, exhaustion and feeling abnormal were recovering/resolving and the outcome of the muscle pain was unknown. It was unknown if the reporter considered the pain in arm, muscle pain, influenza like illness, headache, exhaustion and feeling abnormal to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Friday afternoon, the patient received a dose of SHINGRIX correctly in the deltoid. Within a few hours after vaccination, the patient experienced arm soreness in the vaccinated arm. At that night, the patient's arms ached and she had difficulty in sleeping due to not being able to get comfortable. On Saturday, the patient had muscle aches, headache, felt like flu-without the fever, exhausted and just felt eh. On Sunday the patient felt better and was pretty much back to normal on Monday. The reporter agreed to follow up from the GlaxoSmithKline. This case has been linked with case US2019GSK017834 (wife's case), reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, muscle pain, influenza like illness, headache, exhaustion and feeling abnormal. On an unknown date, the outcome of the pain in arm, influenza like illness, headache, exhaustion and feeling abnormal were recovering/resolving and the outcome of the muscle pain was unknown. It was unknown if the reporter considered the pain in arm, muscle pain, influenza like illness, headache, exhaustion and feeling abnormal to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Friday afternoon, the patient received a dose of SHINGRIX correctly in the deltoid. Within a few hours after vaccination, the patient experienced arm soreness in the vaccinated arm. At that night, the patient's arms ached and she had difficulty in sleeping due to not being able to get comfortable. On Saturday, the patient had muscle aches, headache, felt like flu-without the fever, exhausted and just felt eh. On Sunday the patient felt better and was pretty much back to normal on Monday. The reporter agreed to follow up from the GlaxoSmithKline. This case has been linked with case US2019GSK017834 (wife's case), reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose in September 2018). On 22nd January 2019, the patient received the 2nd dose of SHINGRIX. On 24th January 2019, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient complained to pharmacist at pharmacy where she got immunized that she has redness swelling and pain at the injection site. The pharmacist informed her that if her symptoms worsened then contact her doctor.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 41-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Benlysta (refer case, US2019GSK017189 and US2019001652). On an unknown date, the patient received SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site burning and drug administration error. On an unknown date, the outcome of the injection site burning and drug administration error were unknown. It was unknown if the reporter considered the injection site burning to be related to SHINGRIX. Additional details were reported as follows: The reporter stated that when she gave herself her SHINGRIX injection in October or November 2018, that it burned. The reporter stated that she didn't report this because the pharmacist told her that it would be painful and burn.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 1st November 2018, the patient received the 1st dose of SHINGRIX. On 2nd November 2018, 1 days after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The patient had no side effects except for might be a little bit of soreness the next day. The patient stated when they gave her the shot there was no burning there was nothing. The patient declined permission to contact her doctor. The patient consented to follow up. For tolerance to the 2nd dose of SHINGRIX, refer case US2019011766.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 28-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (shingles back in 2017). Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received in November 2018, refer case US2019GSK015292). In January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced fatigue, fever and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fatigue, fever and general body pain were recovered/resolved. It was unknown if the reporter considered the fatigue, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, could be 27 or 28yrs. The patient 28 year old who was now in healthy condition. The patient received a dose of SHINGRIX and experienced mild fever, body aches and fatigue. The patient wanted to know how long would SHINGRIX be effective for the patient to prevent a shingles flare up. All side effects subsided within 24-48 hours. This case was 1 of the 2 cases, reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Insomnia, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, muscle pain, influenza like illness, exhaustion and feeling abnormal. On an unknown date, the outcome of the pain in arm, influenza like illness, exhaustion and feeling abnormal were recovering/resolving and the outcome of the muscle pain was unknown. It was unknown if the reporter considered the pain in arm, muscle pain, influenza like illness, exhaustion and feeling abnormal to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Friday, the patient received a dose of SHINGRIX correctly in the deltoid. Within a few hours after vaccination, the patient experienced arm soreness in the vaccinated arm. At that night, the patient's arms ached and she had difficulty in sleeping due to not being able to get comfortable. On Saturday (the day following vaccination), the patient had muscle aches, felt like flu-without the fever, exhausted and just felt eh. On Sunday the patient felt better and was pretty much back to normal on Monday. The reporter agreed to follow up from the GlaxoSmithKline. This case has been linked with case US2019GSK014100 (husband's case), reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, muscle pain, influenza like illness, exhaustion and feeling abnormal. On an unknown date, the outcome of the pain in arm, influenza like illness, exhaustion and feeling abnormal were recovering/resolving and the outcome of the muscle pain was unknown. It was unknown if the reporter considered the pain in arm, muscle pain, influenza like illness, exhaustion and feeling abnormal to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Friday, the patient received a dose of SHINGRIX correctly in the deltoid. Within a few hours after vaccination, the patient experienced arm soreness in the vaccinated arm. At that night, the patient's arms ached and she had difficulty in sleeping due to not being able to get comfortable. On Saturday (the day following vaccination), the patient had muscle aches, felt like flu-without the fever, exhausted and just felt eh. On Sunday the patient felt better and was pretty much back to normal on Monday. The reporter agreed to follow up from the GlaxoSmithKline. This case has been linked with case US2019GSK014100 (husband's case), reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Swelling face, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of fatigue (received 1st dose refer case US2019013592). On 5th January 2019, the patient received the 2nd dose of SHINGRIX. On 7th January 2019, 2 days after receiving SHINGRIX, the patient experienced facial puffiness. In January 2019, the patient experienced tiredness and injection site pain. The patient was treated with HYALURONIC ACID (JUVEDERM). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the tiredness, injection site pain and facial puffiness were unknown. It was unknown if the reporter considered the tiredness, injection site pain and facial puffiness to be related to SHINGRIX. Additional details were provided as follows: The batch number was not reported. The patient received SHINGRIX in the left arm. Less than a month after receiving vaccination, the patient reported that she had her second injection and experienced feeling tired and soreness at her injection site.  The patient planned to continue follow up with her physician on an unknown date. Consented to follow up was provided. The patient reported that her dermatologist reported this to Allergan regarding the Juvederm. This case linked with US2019013592, reported by same reporter for the same patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Product preparation error
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 60-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 29th November 2018, the patient received the 2nd dose of SHINGRIX. On 29th November 2018, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were received as follows: The patient received SHINGRIX was inadvertently reconstituted with sterile saline and administered to a patient, which led to drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. Follow up information received from Nurse on 23rd January 2019: The reporter details were updated. On 29th November 2018, instead of using provided SHINGRIX diluent, nurse used sterile water & also gave injection with subcutaneous route instead of intramuscular route, which led to inappropriate route of vaccine administration. On 2nd December 2018, after 3 days, the patient's arm was streaked red. On 3rd December 2018, the patient contacted and redness was much better but at the time of reporting present. The patient never had a doctor visit and redness resolved. On 10th January 2019, the patient came to receive shot repeated with no problems vaccine series complete previous injection on 27th Sep 2018. At the time of this report, the outcome of the erythema of extremities was resolved and the outcome of the inappropriate route of vaccination and were unknown. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. The VAERS details were updated.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Lethargy, Lymph node pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old male patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) and (batch number unknown, expiry date 22nd January 2019) for prophylaxis. On 19th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In January 2019, 18 hrs after receiving SHINGRIX, the patient experienced fever, fatigue, feeling bad, headache, axillary lymph nodes enlarged, lymph node tenderness and lethargy. On an unknown date, the outcome of the fever, fatigue, feeling bad, headache, axillary lymph nodes enlarged and lymph node tenderness were not recovered/not resolved and the outcome of the lethargy was unknown. It was unknown if the reporter considered the fever, fatigue, feeling bad, headache, axillary lymph nodes enlarged, lymph node tenderness and lethargy to be related to SHINGRIX. Additional details were provided as follows: The patient's wife who administered the vaccine reported this case. At 5:00 PM, the patient received SHINGRIX in the right deltoid. On Sunday, at approximately 11:00 AM, the patient started feeling bad. The patient had a fever of 102 degree F and felt lethargic. At 12:00 PM on Sunday, 19 hours after vaccination, the patient started experiencing an excruciating headache. At 6:00 PM on Sunday, 1 day and 1 hour after vaccination, the patient noted that the lymph nodes in the armpit of the arm where he received the vaccination are swollen and tender. The reporter did not consent to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old male patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) and (batch number unknown, expiry date 22nd January 2019) for prophylaxis. On 19th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In January 2019, 18 hrs after receiving SHINGRIX, the patient experienced fever, fatigue, feeling bad, headache, axillary lymph nodes enlarged, lymph node tenderness and lethargy. On an unknown date, the outcome of the fever, fatigue, feeling bad, headache, axillary lymph nodes enlarged and lymph node tenderness were not recovered/not resolved and the outcome of the lethargy was unknown. It was unknown if the reporter considered the fever, fatigue, feeling bad, headache, axillary lymph nodes enlarged, lymph node tenderness and lethargy to be related to SHINGRIX. Additional details were provided as follows: The patient's wife who administered the vaccine reported this case. At 5:00 PM, the patient received SHINGRIX in the right deltoid. On Sunday, at approximately 11:00 AM, the patient started feeling bad. The patient had a fever of 102 degree F and felt lethargic. At 12:00 PM on Sunday, 19 hours after vaccination, the patient started experiencing an excruciating headache. At 6:00 PM on Sunday, 1 day and 1 hour after vaccination, the patient noted that the lymph nodes in the armpit of the arm where he received the vaccination are swollen and tender. The reporter did not consent to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site pain, Injection site rash, Rash, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 19th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 21st January 2019, the patient experienced rash, tenderness and touch sensitivity increased. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the rash, tenderness and touch sensitivity increased were unknown. It was unknown if the reporter considered the injection site pain, rash, tenderness and touch sensitivity increased to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The patient received the dose of SHINGRIX in the left arm. The patient experienced soreness at injection site which lasted for a day. A day before the date of reporting, 2 days after receiving SHINGRIX, the patient developed a rash around the area of injection site, along with being tender and increased sensitivity to touch. This covered an area of 5 inches top to bottom and 3 inches left to right around the injection site. The reporter consented to follow-up. No further details were provided. This case was linked with US2019011825, reported by the same reporter.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 19th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX in the left arm. The patient developed soreness at the injection site which lasted for about day and half. The patient did not consent to follow-up. No further details were provided. This case was linked with US2019011816, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. On 7th January 2019, immediately after receiving SHINGRIX, the patient experienced burning sensation. In January 2019, the patient experienced injection site rash, injection site itching, swelling arm, pain in arm and scratch. The patient was treated with dermatologicals NOS (Anti-Itch Cream (Medication Unknown)). On an unknown date, the outcome of the burning sensation was recovered/resolved and the outcome of the injection site rash, injection site itching, swelling arm, pain in arm and scratch were unknown. It was unknown if the reporter considered the burning sensation, injection site rash, injection site itching, swelling arm, pain in arm and scratch to be related to SHINGRIX. Additional details were provided as follows: On 1st November 2018, the patient received 1st dose of SHINGRIX (refer case US2019GSK016724). After receiving 2nd dose of SHINGRIX, the patient experienced burning sensation or burnt like fire while the vaccine was going into her skin for several days after that it was sore. Less than a month after receiving 2nd dose of SHINGRIX, the patient's left arm became swollen, the patient was left with an itching sensation where the vaccine was given and stated it hurts like the Dickens. The patient broke out with a rash and stated that she had sores on her arm due to the constant scratching she done to her arm from the itching. The patient had tried anti-itch cream but nothing worked. The patient declined permission to contact her doctor. The patient consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Scratch
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. On 7th January 2019, immediately after receiving SHINGRIX, the patient experienced burning sensation. In January 2019, the patient experienced injection site rash, injection site itching, swelling arm, pain in arm and scratch. The patient was treated with dermatologicals NOS (Anti-Itch Cream (Medication Unknown)). On an unknown date, the outcome of the burning sensation was recovered/resolved and the outcome of the injection site rash, injection site itching, swelling arm, pain in arm and scratch were unknown. It was unknown if the reporter considered the burning sensation, injection site rash, injection site itching, swelling arm, pain in arm and scratch to be related to SHINGRIX. Additional details were provided as follows: On 1st November 2018, the patient received 1st dose of SHINGRIX (refer case US2019GSK016724). After receiving 2nd dose of SHINGRIX, the patient experienced burning sensation or burnt like fire while the vaccine was going into her skin for several days after that it was sore. Less than a month after receiving 2nd dose of SHINGRIX, the patient's left arm became swollen, the patient was left with an itching sensation where the vaccine was given and stated it hurts like the Dickens. The patient broke out with a rash and stated that she had sores on her arm due to the constant scratching she done to her arm from the itching. The patient had tried anti-itch cream but nothing worked. The patient declined permission to contact her doctor. The patient consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erosion, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. On 7th January 2019, immediately after receiving SHINGRIX, the patient experienced burning sensation. In January 2019, the patient experienced injection site rash, injection site itching, swelling arm, pain in arm and scratch. The patient was treated with dermatologicals NOS (Anti-Itch Cream (Medication Unknown)). On an unknown date, the outcome of the burning sensation was recovered/resolved and the outcome of the injection site rash, injection site itching, swelling arm, pain in arm and scratch were unknown. It was unknown if the reporter considered the burning sensation, injection site rash, injection site itching, swelling arm, pain in arm and scratch to be related to SHINGRIX. Additional details were provided as follows: On 1st November 2018, the patient received 1st dose of SHINGRIX (refer case US2019GSK016724). After receiving 2nd dose of SHINGRIX, the patient experienced burning sensation or burnt like fire while the vaccine was going into her skin for several days after that it was sore. Less than a month after receiving 2nd dose of SHINGRIX, the patient's left arm became swollen, the patient was left with an itching sensation where the vaccine was given and stated it hurts like the Dickens. The patient broke out with a rash and stated that she had sores on her arm due to the constant scratching she done to her arm from the itching. The patient had tried anti-itch cream but nothing worked. The patient declined permission to contact her doctor. The patient consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Rash, Skin ulcer
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. On 7th January 2019, immediately after receiving SHINGRIX, the patient experienced burning sensation. In January 2019, the patient experienced injection site rash, injection site itching, swelling arm, pain in arm and scratch. The patient was treated with dermatologicals NOS (Anti-Itch Cream (Medication Unknown)). On an unknown date, the outcome of the burning sensation was recovered/resolved and the outcome of the injection site rash, injection site itching, swelling arm, pain in arm and scratch were unknown. It was unknown if the reporter considered the burning sensation, injection site rash, injection site itching, swelling arm, pain in arm and scratch to be related to SHINGRIX. Additional details were provided as follows: On 1st November 2018, the patient received 1st dose of SHINGRIX (refer case US2019GSK016724). After receiving 2nd dose of SHINGRIX, the patient experienced burning sensation or burnt like fire while the vaccine was going into her skin for several days after that it was sore. Less than a month after receiving 2nd dose of SHINGRIX, the patient's left arm became swollen, the patient was left with an itching sensation where the vaccine was given and stated it hurts like the Dickens. The patient broke out with a rash and stated that she had sores on her arm due to the constant scratching she done to her arm from the itching. The patient had tried anti-itch cream but nothing worked. The patient declined permission to contact her doctor. The patient consented to follow up.