chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Immunoglobulin therapy, Muscular weakness, Paraesthesia
Clinical narrative: Presented to ED with ascending BLE numbness/weakness 17 days after receiving influenza vaccine. Numbness went up to mid abdomen and also included tingling/numbness in both hands, progressed to pt being unable to walk. Neurology consulted - started on IVIG for suspected possible Guillain-Barre syndrome (received 5 doses inpatient). He was discharged to inpatient rehab, as he continued to have gait and balance problems, BLE weakness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, Erythema, Pain in extremity, Pyrexia
Clinical narrative: I was told by my physician to get the shingles shot. I got the injection at pharmacy. I woke up at 2:00 am the same night/next morning as the injection with fever of 102.9. Ran the fever for 2 days then 100.9 for two days. Arm sore badly with huge red splotch for a week. 4 days after the injection I woke up with double vision. It's not getting any better. I've seeked medical attention. No help at all.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Malaise, Middle insomnia
Clinical narrative: I received the SHINGRIX vaccine on 2/1/19 at 6pm and than night/morning I awoke at 2am with moderate aches and pains and I was unable to go back to sleep. Later that day, I experienced other flu-like symptoms (fever, extreme fatigue, chills, and aches) and malaise for approximately 36 hours until the symptoms resolved.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: I received the SHINGRIX vaccine on 2/1/19 at 6pm and than night/morning I awoke at 2am with moderate aches and pains and I was unable to go back to sleep. Later that day, I experienced other flu-like symptoms (fever, extreme fatigue, chills, and aches) and malaise for approximately 36 hours until the symptoms resolved.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction as of 2/5/19 at 1120 AM. Expired vaccine - 12/7/2018.
Age: 26.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site mass, Injection site rash
Clinical narrative: Pt said she feels the lumps in the injection site, there's a rash and the rash keeps getting worse on her left arm. Looks like pt is allergic to vaccines.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Injection site reaction, Nodule
Clinical narrative: A painful nodule appeared below site of injection. Pain persists after 2 months. Arm feels like it drops when picking moderately heavy items (not consistent). Flu shot received at pharmacy. Date of vaccination is an estimate. Pain symptoms emerging is an estimate. I was unclear whether this could be related to vaccine given the delay of symptom manifestation after vaccination. Contacted Health Department who indicated I submit a VAERS report. Recent reports by health officials indicate other patients have developed painful nodules at location of vaccination which made me question whether this nodule is vaccine related. I am looking for guidance.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site induration, Injection site papule, Skin lesion
Clinical narrative: Pt. got the MMR/Varicella/Hep A #1 on 1/25/19. Pt. has started with insect bite mark lesions on 2/2/19 back; (R) cheek; 2/3: (L) thigh on site of varicella shot without induration and tiny papules 2" x 3/4". 2/4/19: New one on (R) medial thigh/upper lip/forehead/2 fingers/chest.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 8 x 10 cm injection site erythema, warmth, tenderness, central clearing.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Flushing
Clinical narrative: Child became flushed which resolved quickly. EMS was called as a precaution no medical intervention (no meds etc) administered.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724861), concerns a 08-year-old, female child patient. On 25-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195245 and expiry date: not reported). On the same day, after vaccination, the patient passed out while she was standing up and watching her father get the flu shot. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729009), concerns a 72-year-old female patient. The patient's historical condition included Sjogren's syndrome. The patient was allergic to penicillin, Sulphur, clindamycin. The patient's concomitant medications included ranitidine, pravastatin sodium, hydroxychloroquine, amlodipine besylate, omeprazole DR aspirin. On 07-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml (unk as reported), route of administration and anatomical location not reported, batch number: 195128). On 20-Nov-2017, 14 days after vaccination, the patient woke up deaf in left ear (as reported). The patent was treated with high dose of prednisone. It was reported that, complete hearing was restored after 4 days. The outcome of the events was recovered. The reporter assessed the case non-serious.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 22nd October 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced eye swelling. On an unknown date, the outcome of the eye swelling was unknown. It was unknown if the reporter considered the eye swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient previously reported this event to VAERS.
Age: 40.0
Sex: M
Vaccine: FLUX, HEPA, PPV
Symptoms: Bacterial test, Fungal test, Gram stain, Incisional drainage, Injection site discharge
Clinical narrative: Patient is a 41-year-old male who presents for evaluation of right arm injection site reaction. Patient states he had hepatitis A, influenza, and pneumonia vaccination injections on 10/3/18. Patient states 6 weeks following the injections he noticed a reaction on the proximal right upper extremity near injection site. At that time, patient went to an urgent care and had the area lanced on the right proximal upper extremity. Patient states he has had this area lanced multiple times since. States he is currently on amoxicillin. Rates pain and proximal right upper extremity as 1/10. Denies fever, sweats, chills. Reports drainage when area on right upper extremity was lanced. Denies ever having a reaction like this before. I&D performed, Cultures obtained, WTD drsg BID.
Age: 40.0
Sex: M
Vaccine: FLUX, HEPA, PPV
Symptoms: Injection site pain, Injection site reaction, Mycobacterium test
Clinical narrative: Patient is a 41-year-old male who presents for evaluation of right arm injection site reaction. Patient states he had hepatitis A, influenza, and pneumonia vaccination injections on 10/3/18. Patient states 6 weeks following the injections he noticed a reaction on the proximal right upper extremity near injection site. At that time, patient went to an urgent care and had the area lanced on the right proximal upper extremity. Patient states he has had this area lanced multiple times since. States he is currently on amoxicillin. Rates pain and proximal right upper extremity as 1/10. Denies fever, sweats, chills. Reports drainage when area on right upper extremity was lanced. Denies ever having a reaction like this before. I&D performed, Cultures obtained, WTD drsg BID.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse, referring to a female patient of unknown age. No information was provided regarding the patient's medical history and concomitant medications. On 19-DEC-2018, the patient was vaccinated with a dose of VARIVAX lot # R018144 (expiration date: 25-JUN-2020), subcutaneously, for prophylaxis (strength and frequency was not reported), and she later discovered that she was pregnant, with a last menstrual period of 28-NOV-2018 and a estimated date of delivery of 04-SEP-2019. Initial exposure to VARIVAX was at 3 week (s). The pregnancy outcome was pending. The fetal outcome at the reporting was unknown. No adverse effects were reported in the patient.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse, referring to a female patient of unknown age. No information was provided regarding the patient's medical history and concomitant medications. On 19-DEC-2018, the patient was vaccinated with a dose of VARIVAX lot # R018144 (expiration date: 25-JUN-2020), subcutaneously, for prophylaxis (strength and frequency was not reported), and she later discovered that she was pregnant, with a last menstrual period of 28-NOV-2018 and a estimated date of delivery of 04-SEP-2019. Initial exposure to VARIVAX was at 3 week (s). The pregnancy outcome was pending. The fetal outcome at the reporting was unknown. No adverse effects were reported in the patient.
Age: 63.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Asthenia, Burning sensation, Chills, Faeces discoloured, Fatigue
Clinical narrative: Chills, headache, blotchy/itchy Rash from one side of the neck down to chest started within 24 hours of vaccine.
Age: 63.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pain, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: Chills, headache, blotchy/itchy Rash from one side of the neck down to chest started within 24 hours of vaccine.
Age: 63.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Chills, Headache, Rash, Rash macular, Rash pruritic
Clinical narrative: Chills, headache, blotchy/itchy Rash from one side of the neck down to chest started within 24 hours of vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: General malaise, extreme tiredness, dizziness, moderate headache, pain at injection site and surrounding area, swelling around and well outside of the injection site accompanied by redness, difficulty in starting urinating and weak stream, fleeting pain in various areas of the body.  NOTE:  same symptons appeared with ZOSTAVAX vaccine at age 59, and with 1st series SHINGRIX  vaccine two months ago, although symptons with SHINGRIX are much more pronounced, especially after this last shot. Major side effects abated after about 2 says, but residual symptoms lasted for several days.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Pain, Urinary hesitation, Urine flow decreased
Clinical narrative: General malaise, extreme tiredness, dizziness, moderate headache, pain at injection site and surrounding area, swelling around and well outside of the injection site accompanied by redness, difficulty in starting urinating and weak stream, fleeting pain in various areas of the body.  NOTE:  same symptons appeared with ZOSTAVAX vaccine at age 59, and with 1st series SHINGRIX  vaccine two months ago, although symptons with SHINGRIX are much more pronounced, especially after this last shot. Major side effects abated after about 2 says, but residual symptoms lasted for several days.
Age: 55.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Patient said he bled after receiving the SHINGRIX vaccine. He had a sweater on, and pulled the sweater down to expose the deltoid. Patient said he has had a sore left shoulder and limited range of shoulder movement  ever since he received the vaccine.
Sex: M
Vaccine: HEP
Symptoms: Death
Clinical narrative: This spontaneous report was received from a consumer and refers to a male patient who would be 5-year-old currently. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient died after receiving the hepatitis b vaccine (recombinant) (manufacturer unknown). The cause of death and information concerning autopsy were not reported. Causality assessment between the death and the hepatitis b vaccine (recombinant) (manufacturer unknown) was not provided. This is one of several reports from the same reporter.
Age: 63.0
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 was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 07-AUG-2014, the patient was treated by a healthcare provider for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 71 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-MAY-2015, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 20-MAY-2015, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Arthralgia, Asthenia, Back pain, Cerebrovascular accident
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of meningitis-like reaction in a female patient who received HAVRIX (batch number 37RY4, expiry date 3rd March 2021) for prophylaxis. In September 2018, the patient received HAVRIX. On an unknown date, 1 day after receiving HAVRIX, the patient experienced meningitis-like reaction (serious criteria disability), seizure (serious criteria GSK medically significant), stroke (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), headache, weakness, general body pain, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction. On an unknown date, the outcome of the meningitis-like reaction, seizure, stroke, passed out, headache, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction were unknown and the outcome of the weakness was recovered/resolved and the outcome of the general body pain was not recovered/not resolved. It was unknown if the reporter considered the meningitis-like reaction, seizure, stroke, passed out, headache, weakness, general body pain, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in the end of September 2018. The day after vaccination at night, the patient woke up with a severe headache, weakness and pain in her low back, arms, legs. She could barely get out of bed. All her joints were in severe pain. Then she had 4 sharp pains in the left side of my abdomen. The patient had severe nausea. She had an immediate need to have a bowel movement and throw up. But she did not throw up. The patient did have a small bowel movement. She started feeling like she was going away. She tried to keep talking to her husband. He got her to sit on the side of the bed. At that point the patient started shaking uncontrollably, her eyes rolled back in her head and she felt back on the bed passed out briefly. Her husband pulled her up and forced some water. This brought her back. The patient's husband thought that, she was having a seizure or a stroke. She stayed in bed and was terrified that this was going to continue to repeat. The pain in her low back, legs, neck, arms continues. The severe weakness lasted for 3 weeks. The patient did not have the flu or any sign of a cold prior to or since. The patient's neurosurgeon diagnosed it as a mini Meningitis severe inflammatory allergic reaction that attacked her nervous system. Since then she went through many test. CT scan, MRI, brain scan and an ultra sound on my arteries in her neck. Before this happened she had no low back pain, weakness, headaches or any of the symptoms, she now suffer on a daily basis.  The patient wanted to know what could be done to help her. Lab Comments: Lab test was done on an unknown date.
Sex: F
Vaccine: HEPA
Symptoms: Computerised tomogram, Defaecation urgency, Eye movement disorder, Feeling abnormal, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of meningitis-like reaction in a female patient who received HAVRIX (batch number 37RY4, expiry date 3rd March 2021) for prophylaxis. In September 2018, the patient received HAVRIX. On an unknown date, 1 day after receiving HAVRIX, the patient experienced meningitis-like reaction (serious criteria disability), seizure (serious criteria GSK medically significant), stroke (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), headache, weakness, general body pain, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction. On an unknown date, the outcome of the meningitis-like reaction, seizure, stroke, passed out, headache, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction were unknown and the outcome of the weakness was recovered/resolved and the outcome of the general body pain was not recovered/not resolved. It was unknown if the reporter considered the meningitis-like reaction, seizure, stroke, passed out, headache, weakness, general body pain, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in the end of September 2018. The day after vaccination at night, the patient woke up with a severe headache, weakness and pain in her low back, arms, legs. She could barely get out of bed. All her joints were in severe pain. Then she had 4 sharp pains in the left side of my abdomen. The patient had severe nausea. She had an immediate need to have a bowel movement and throw up. But she did not throw up. The patient did have a small bowel movement. She started feeling like she was going away. She tried to keep talking to her husband. He got her to sit on the side of the bed. At that point the patient started shaking uncontrollably, her eyes rolled back in her head and she felt back on the bed passed out briefly. Her husband pulled her up and forced some water. This brought her back. The patient's husband thought that, she was having a seizure or a stroke. She stayed in bed and was terrified that this was going to continue to repeat. The pain in her low back, legs, neck, arms continues. The severe weakness lasted for 3 weeks. The patient did not have the flu or any sign of a cold prior to or since. The patient's neurosurgeon diagnosed it as a mini Meningitis severe inflammatory allergic reaction that attacked her nervous system. Since then she went through many test. CT scan, MRI, brain scan and an ultra sound on my arteries in her neck. Before this happened she had no low back pain, weakness, headaches or any of the symptoms, she now suffer on a daily basis.  The patient wanted to know what could be done to help her. Lab Comments: Lab test was done on an unknown date.
Sex: F
Vaccine: HEPA
Symptoms: Hypersensitivity, Inflammation, Loss of consciousness, Meningism, Meningitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of meningitis-like reaction in a female patient who received HAVRIX (batch number 37RY4, expiry date 3rd March 2021) for prophylaxis. In September 2018, the patient received HAVRIX. On an unknown date, 1 day after receiving HAVRIX, the patient experienced meningitis-like reaction (serious criteria disability), seizure (serious criteria GSK medically significant), stroke (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), headache, weakness, general body pain, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction. On an unknown date, the outcome of the meningitis-like reaction, seizure, stroke, passed out, headache, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction were unknown and the outcome of the weakness was recovered/resolved and the outcome of the general body pain was not recovered/not resolved. It was unknown if the reporter considered the meningitis-like reaction, seizure, stroke, passed out, headache, weakness, general body pain, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in the end of September 2018. The day after vaccination at night, the patient woke up with a severe headache, weakness and pain in her low back, arms, legs. She could barely get out of bed. All her joints were in severe pain. Then she had 4 sharp pains in the left side of my abdomen. The patient had severe nausea. She had an immediate need to have a bowel movement and throw up. But she did not throw up. The patient did have a small bowel movement. She started feeling like she was going away. She tried to keep talking to her husband. He got her to sit on the side of the bed. At that point the patient started shaking uncontrollably, her eyes rolled back in her head and she felt back on the bed passed out briefly. Her husband pulled her up and forced some water. This brought her back. The patient's husband thought that, she was having a seizure or a stroke. She stayed in bed and was terrified that this was going to continue to repeat. The pain in her low back, legs, neck, arms continues. The severe weakness lasted for 3 weeks. The patient did not have the flu or any sign of a cold prior to or since. The patient's neurosurgeon diagnosed it as a mini Meningitis severe inflammatory allergic reaction that attacked her nervous system. Since then she went through many test. CT scan, MRI, brain scan and an ultra sound on my arteries in her neck. Before this happened she had no low back pain, weakness, headaches or any of the symptoms, she now suffer on a daily basis.  The patient wanted to know what could be done to help her. Lab Comments: Lab test was done on an unknown date.
Sex: F
Vaccine: HEPA
Symptoms: Mobility decreased, Nausea, Neck pain, Nuclear magnetic resonance imaging, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of meningitis-like reaction in a female patient who received HAVRIX (batch number 37RY4, expiry date 3rd March 2021) for prophylaxis. In September 2018, the patient received HAVRIX. On an unknown date, 1 day after receiving HAVRIX, the patient experienced meningitis-like reaction (serious criteria disability), seizure (serious criteria GSK medically significant), stroke (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), headache, weakness, general body pain, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction. On an unknown date, the outcome of the meningitis-like reaction, seizure, stroke, passed out, headache, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction were unknown and the outcome of the weakness was recovered/resolved and the outcome of the general body pain was not recovered/not resolved. It was unknown if the reporter considered the meningitis-like reaction, seizure, stroke, passed out, headache, weakness, general body pain, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in the end of September 2018. The day after vaccination at night, the patient woke up with a severe headache, weakness and pain in her low back, arms, legs. She could barely get out of bed. All her joints were in severe pain. Then she had 4 sharp pains in the left side of my abdomen. The patient had severe nausea. She had an immediate need to have a bowel movement and throw up. But she did not throw up. The patient did have a small bowel movement. She started feeling like she was going away. She tried to keep talking to her husband. He got her to sit on the side of the bed. At that point the patient started shaking uncontrollably, her eyes rolled back in her head and she felt back on the bed passed out briefly. Her husband pulled her up and forced some water. This brought her back. The patient's husband thought that, she was having a seizure or a stroke. She stayed in bed and was terrified that this was going to continue to repeat. The pain in her low back, legs, neck, arms continues. The severe weakness lasted for 3 weeks. The patient did not have the flu or any sign of a cold prior to or since. The patient's neurosurgeon diagnosed it as a mini Meningitis severe inflammatory allergic reaction that attacked her nervous system. Since then she went through many test. CT scan, MRI, brain scan and an ultra sound on my arteries in her neck. Before this happened she had no low back pain, weakness, headaches or any of the symptoms, she now suffer on a daily basis.  The patient wanted to know what could be done to help her. Lab Comments: Lab test was done on an unknown date.
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity, Scan brain, Seizure, Tremor, Ultrasound scan
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of meningitis-like reaction in a female patient who received HAVRIX (batch number 37RY4, expiry date 3rd March 2021) for prophylaxis. In September 2018, the patient received HAVRIX. On an unknown date, 1 day after receiving HAVRIX, the patient experienced meningitis-like reaction (serious criteria disability), seizure (serious criteria GSK medically significant), stroke (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), headache, weakness, general body pain, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction. On an unknown date, the outcome of the meningitis-like reaction, seizure, stroke, passed out, headache, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction were unknown and the outcome of the weakness was recovered/resolved and the outcome of the general body pain was not recovered/not resolved. It was unknown if the reporter considered the meningitis-like reaction, seizure, stroke, passed out, headache, weakness, general body pain, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in the end of September 2018. The day after vaccination at night, the patient woke up with a severe headache, weakness and pain in her low back, arms, legs. She could barely get out of bed. All her joints were in severe pain. Then she had 4 sharp pains in the left side of my abdomen. The patient had severe nausea. She had an immediate need to have a bowel movement and throw up. But she did not throw up. The patient did have a small bowel movement. She started feeling like she was going away. She tried to keep talking to her husband. He got her to sit on the side of the bed. At that point the patient started shaking uncontrollably, her eyes rolled back in her head and she felt back on the bed passed out briefly. Her husband pulled her up and forced some water. This brought her back. The patient's husband thought that, she was having a seizure or a stroke. She stayed in bed and was terrified that this was going to continue to repeat. The pain in her low back, legs, neck, arms continues. The severe weakness lasted for 3 weeks. The patient did not have the flu or any sign of a cold prior to or since. The patient's neurosurgeon diagnosed it as a mini Meningitis severe inflammatory allergic reaction that attacked her nervous system. Since then she went through many test. CT scan, MRI, brain scan and an ultra sound on my arteries in her neck. Before this happened she had no low back pain, weakness, headaches or any of the symptoms, she now suffer on a daily basis.  The patient wanted to know what could be done to help her. Lab Comments: Lab test was done on an unknown date.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received SHINGRIX (batch number 5G7A7, expiry date 8th May 2021) for prophylaxis. On 24th January 2019, the patient received the 1st dose of SHINGRIX. On 24th January 2019, 8 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, headache, general body pain, fatigue and injection site pain. On an unknown date, the outcome of the influenza-like symptoms, fever, headache, general body pain, fatigue and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, headache, general body pain, fatigue and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the right deltoid. The patient experienced flu-like symptoms, soreness at injection site, fever, headache, body ache, and fatigue following vaccination with SHINGRIX. The reporter gave consent to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received SHINGRIX (batch number 5G7A7, expiry date 8th May 2021) for prophylaxis. On 24th January 2019, the patient received the 1st dose of SHINGRIX. On 24th January 2019, 8 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, headache, general body pain, fatigue and injection site pain. On an unknown date, the outcome of the influenza-like symptoms, fever, headache, general body pain, fatigue and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, headache, general body pain, fatigue and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the right deltoid. The patient experienced flu-like symptoms, soreness at injection site, fever, headache, body ache, and fatigue following vaccination with SHINGRIX. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever 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, unknown after receiving SHINGRIX, the patient experienced fever and tremor. On an unknown date, the outcome of the fever and tremor were recovered/resolved. It was unknown if the reporter considered the fever and tremor to be related to SHINGRIX. Additional details were reported as follows: The patient experienced uncontrollable shaking and fever following administration of SHINGRIX. The patient notified to reporter of this on Saturday. The reporter had no additional information at the time of reporting. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Localised infection, Skin discolouration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of skin discoloration 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, unknown after receiving SHINGRIX, the patient experienced skin discoloration and leg infection. On an unknown date, the outcome of the skin discoloration and leg infection were unknown. It was unknown if the reporter considered the skin discoloration and leg infection to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist states that the patient got their dose of SHINGRIX and said recently after receiving SHINGRIX he developed discoloration on their lower leg and the leg became infected. The HCP could not remember the patient's name or demographic information since the initial reason for his call was to ask about timing of SHINGRIX vaccine in patients receiving steroid injection. The HCP mentioned 3 separate patients with rare side effects these patients were complaining about after receiving SHINGRIX but the HCP did not remember these patients names or demographic information the 3 separate Adverse events for three separate patients reported for this one HCP. This case linked with US2019015732 and US2019015728, reported by same reporter.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 53-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 8th January 2019, the patient received the 1st dose of SHINGRIX. On 26th January 2019, 18 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) states that the patient with a medical history of shingles received her 1st dose of SHINGRIX and 18 days later had an outbreak of shingles. The HCP declined to provide any further details other than the ones documented for this adverse event at the time of reporting. This call was transferred from the GSK Response Center (GRC) for Adverse event. Consented to follow up was provided.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain in my left arm from shoulder to fingers. Left arm was normal and strong, I had no problem before the shingle shot recommended by my primary Dr as a preventive measure.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches, shivering, fever like symptoms, arm pain for 5+ days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient gets a rash on the Torso, the rash starts to develop after 2 days of the vaccination, this happened after the 1st shot and she went to the ER, the ER provider said its too late for the shot to show up allergic reaction, so she did come and get the 2nd dose in the series. But, after two days of the shot she woke up again with a rash on her Torso, the rash is not progressing and is fading away now.
Age: 11.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Chest pain
Clinical narrative: Patient received the injection, grabbed his chest, states it hurt, and put his head down on the desk next to him. This RN went to get a provider and a MA heard me and grabbed MD. Dr. had the patient lie down and elevate feet. She listened to his heart rate, gave a gentle sternal rub and patient's eye fluttered and became aware of his surroundings. VSS, BG 105. EMS called. EMS arrived. Mom declined having patient transported to the hospital. Patient sat up leaning against the wall. VSS. Patient stood and sat in the chair and was doing well.  mmunization list printed and handed to mom. This RN walked patient and mom out.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Inflammation, Malaise, Myalgia
Clinical narrative: Patient reports she took her second SHINGRIX on 1/29/19 and broke out with a rash on right lower face 1/30/19. It was several blisters and very inflamed around it. She took an old CIPRO pill her husband had found and used ZOVIRAX from something else and used it. It has helped some. She felt sick with her vaccine- Muscle aches, headaches, and nausea. She did not have those symptoms with this injection. She is otherwise healthy. She has had shingles in this location in the late 90"s. She feels it is some better than it was. Not feeling sick otherwise. The are felt tingly when it first broke out.Treated with valacyclovir.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Paraesthesia, Rash
Clinical narrative: Patient reports she took her second SHINGRIX on 1/29/19 and broke out with a rash on right lower face 1/30/19. It was several blisters and very inflamed around it. She took an old CIPRO pill her husband had found and used ZOVIRAX from something else and used it. It has helped some. She felt sick with her vaccine- Muscle aches, headaches, and nausea. She did not have those symptoms with this injection. She is otherwise healthy. She has had shingles in this location in the late 90"s. She feels it is some better than it was. Not feeling sick otherwise. The are felt tingly when it first broke out.Treated with valacyclovir.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Seizure, Syncope
Clinical narrative: Patient received vaccine for flu and MENACTRA, one in each deltoid muscle, walked to waiting room unattended, sat in waiting room chair. Per mom's report, patient demonstrated seizure activity and fainting spell. Emergency team responded with PCP, patient response, vitals and color returned to her norm, PCP advised to go to local ER for evaluation. ER notified.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a veterinarian and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On 31-JAN-2019, the patient was inadvertently vaccinated with dose of PROQUAD (exact dose, route and site of administration, lot# and expiration date were not reported) instead of M-M-R II, concomitantly with a dose of VARIVAX (exact dose, route, site of administration, lot# and expiration date were not reported) for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 50-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received in December 2017, refer case US2019GSK020472). In February 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, injection site erythema and injection site itching. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, injection site erythema and injection site itching were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced significant pain at injection site, headache, swelling at injection site about size softball, the injection site was hot and red. The redness lasted 2 months and remained about the size of a 50 cent coin. Third day the said it itched. Itching lasted about 5 days. For both of these the sought no medical attention, and it resolved.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 50-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received in December 2017, refer case US2019GSK020472). In February 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, injection site erythema and injection site itching. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, injection site erythema and injection site itching were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced significant pain at injection site, headache, swelling at injection site about size softball, the injection site was hot and red. The redness lasted 2 months and remained about the size of a 50 cent coin. Third day the said it itched. Itching lasted about 5 days. For both of these the sought no medical attention, and it resolved.
Sex: F
Vaccine: HPVX, MENB
Symptoms: Hypoaesthesia, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of numbness of upper extremities in a female patient who received BEXSERO for prophylaxis. Co-suspect products included HPV Vaccine solution for injection for prophylaxis. On an unknown date, the patient received BEXSERO and HPV Vaccine. On an unknown date, less than a day after receiving BEXSERO and not applicable after starting HPV Vaccine, the patient experienced numbness of upper extremities and fever. On an unknown date, the outcome of the numbness of upper extremities and fever were unknown. The reporter considered the numbness of upper extremities to be related to BEXSERO. It was unknown if the reporter considered the fever to be related to BEXSERO and HPV Vaccine. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The patient received BEXSERO and HPV shot on the same day in different arms and the patient reported high fever and arm numbness and felt that she may need to go to the emergency room. According to reporter the patient did not go to the emergency room and they had not and would not give the 2nd dose of BEXSERO. She was sure of the arm and the cause being BEXSERO.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Malaise, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 88-year-old female patient who received SHINGRIX for prophylaxis. On 23rd January 2019, the patient received the 2nd dose of SHINGRIX. On 23rd January 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 24th January 2019, the patient experienced feeling unwell, appetite lost and nausea. On 25th January 2019, the patient experienced diarrhea and fatigue. On an unknown date, the outcome of the pain in arm, feeling unwell, nausea, diarrhea and fatigue were recovering/resolving and the outcome of the appetite lost was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, feeling unwell, appetite lost, nausea, diarrhea and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 87 or 88 year. The patient experienced arm soreness on Wednesday that worsened but doing better at the time of reporting. She also experienced not feeling well, no appetite and nausea on Thursday. By Friday she was sick, diarrhea and fatigue. The patient was feeling fair at time of reporting, but was unsure if it was the product or a bug she had caught. Prescribing information was reviewed for side effects and she was referred to her physician. The reporter consented to follow up.