chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: RAB
Symptoms: Analgesic drug level, Arthralgia, Back pain, Blood creatine phosphokinase, Blood creatine phosphokinase MB
Clinical narrative: Severe non stop headache radiating down back of neck and into shoulders, sinus infection, sore throat, hard to swallow, back and joint pain, loss of appetite, extreme fatigue.
Age: 55.0
Sex: M
Vaccine: RAB
Symptoms: Blood lactate dehydrogenase, Blood lactic acid, C-reactive protein, Decreased appetite, Differential white blood cell count
Clinical narrative: Severe non stop headache radiating down back of neck and into shoulders, sinus infection, sore throat, hard to swallow, back and joint pain, loss of appetite, extreme fatigue.
Age: 55.0
Sex: M
Vaccine: RAB
Symptoms: Dysphagia, Fatigue, Fibrin D dimer, Full blood count, Headache
Clinical narrative: Severe non stop headache radiating down back of neck and into shoulders, sinus infection, sore throat, hard to swallow, back and joint pain, loss of appetite, extreme fatigue.
Age: 55.0
Sex: M
Vaccine: RAB
Symptoms: Metabolic function test, Musculoskeletal pain, Neck pain, Oropharyngeal pain, Pain
Clinical narrative: Severe non stop headache radiating down back of neck and into shoulders, sinus infection, sore throat, hard to swallow, back and joint pain, loss of appetite, extreme fatigue.
Age: 55.0
Sex: M
Vaccine: RAB
Symptoms: Procalcitonin, SARS-CoV-2 test, Serum ferritin, Sinusitis, Troponin I
Clinical narrative: Severe non stop headache radiating down back of neck and into shoulders, sinus infection, sore throat, hard to swallow, back and joint pain, loss of appetite, extreme fatigue.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Antiphospholipid antibodies positive, Bedridden, Condition aggravated, Disturbance in attention, Feeling abnormal
Clinical narrative: could not get out of bed  for months  or focus on anything, my kidneys were shutting down and P.E. up grade as   serious exacerbation of  2018  P.E.  I got the vaccination  for transition from a medical LOA  I was just starting to get better - when that vaccine nearly killed me.  I ended up losing  both my jobs as was returning from  2018  P.E.  personal medical  LOA  - I could not remember anything as it is one big blur.  I  could not fill out this form  before last month
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Loss of employment, Memory impairment, Renal impairment, Systemic lupus erythematosus, Thinking abnormal
Clinical narrative: could not get out of bed  for months  or focus on anything, my kidneys were shutting down and P.E. up grade as   serious exacerbation of  2018  P.E.  I got the vaccination  for transition from a medical LOA  I was just starting to get better - when that vaccine nearly killed me.  I ended up losing  both my jobs as was returning from  2018  P.E.  personal medical  LOA  - I could not remember anything as it is one big blur.  I  could not fill out this form  before last month
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Fatigue, Musculoskeletal pain, Nausea
Clinical narrative: Arm/shoulder pain, fever 101, chills, mild nausea, extreme fatigue, pain/tenderness under left armpit--lasted until Sunday, then diminishing. Fever gone on Monday though still feeling feverish.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Arm/shoulder pain, fever 101, chills, mild nausea, extreme fatigue, pain/tenderness under left armpit--lasted until Sunday, then diminishing. Fever gone on Monday though still feeling feverish.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Pt had HPV #2 on 7/7/2020. Started fever and pain on (L) knee on 7/8/2020. Fever resolved on 7/9/2020 but started to have pain on (L) knee and both feet. Symptoms persisted for 2 weeks with swelling on (R) hand and (R) foot. No cough, runny nose or fever noted. Seen in clinic on 7/24 for school PE. Child referred to hospital for admission 7/24/20
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation
Clinical narrative: Burning, still feel, as of 7/14/2020 never had a reaction to any flu shot
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Expired product administered
Clinical narrative: Hep A vaccine was expired. Expiration date was 7-26-2020, immunization given on 7-27-2020.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Pt presented the day after vaccine with redness and itching at injection site as well as other areas of chest, neck and back.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site warmth, Pain, Pyrexia, Swelling
Clinical narrative: Employee states redness, swelling, pain and left  arm site was warm to touch, Reports a fever of  101.0 oral. Employee states ice packs to site, Tylenol  and Benadryl helped to relieve symptoms. Reports to  employee health on 7/17/2020 symptoms resolved.
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Peripheral swelling, Skin mass, Skin warm
Clinical narrative: Right arm red, swelled, warm to touch, knot under skin,
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Maternal exposure during pregnancy, Medication error, No adverse event, Product storage error
Clinical narrative: patient received a dose of Adacel which was exposed to 52.6 degree Fahrenheit for seven days, no AE; A pregnant female received a dose of ADACEL, no AE; Initial information received on 20-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional (medical assistant).  This case is linked to cases 2020SA188909 and 2020SA189132 (same reporter).  This case involves a 34-year-old pregnant female patient who received 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6638AA, expiry date: 12-Apr-2022) via an intramuscular route in the right arm  for prophylactic vaccination on 13-Jul-2020, which was exposed to 52.6 degree Fahrenheit for seven days from 08-Jul-2020 to 15-Jul-2020 (exposure during pregnancy and Product storage error).   Data regarding this pregnancy were received prospectively i.e. before pregnancy outcome was known.  The patient received this vaccine at second trimester of pregnancy (data calculated based on vaccination date and due date).  The date of last menstrual period was not reported.  The estimated due date is 06-Oct-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. No concomitant medication was received.  It was an actual medication error case due to incorrect product storage and vaccine exposure during pregnancy.  At the time of reporting, the patient did not experience any adverse event.  At the time of report, pregnancy outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Medication error, No adverse event, Product storage error
Clinical narrative: Adacel exposed to 52.6 degree Fahrenheit for seven days and administered to patient/ No AE; pregnant female patient received Adacel/no AE; Initial information was received on 20-Jul-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2020SA188909, 2020SA189132, 2020SA189059 and 2020SA189085 (same reporter).  This case involves a 36 year old pregnant female patient who received 0.5 ml of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL](batch number U6638AA and expiry date 12-Apr-2022) via intramuscular route in the left arm on 15-Jul-2020 for prophylactic vaccination which was exposed at 52.6 degree Fahrenheit for seven days (exposure during pregnancy and product storage error).  Data regarding this pregnancy were received prospectively, that is before pregnancy outcome was known.   The patient received adacel vaccine at 27 Weeks of gestation.  The date of last menstrual period was reported as 03-Jan-2020.  The estimated due date is 09-Oct-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  It was an actual medication error due to incorrect product storage and was also a case of vaccine exposure during pregnancy.   Case details: It was reported that the excursion was for seven days and vaccine got exposed to 52.6 degrees Fahrenheit from 08-Jul-2020 to 15-Jul-2020 that was administered to five patients since the excursion.  The patient had no adverse reactions at the time of report.  The outcome of the pregnancy was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Medication error, No adverse event, Product storage error
Clinical narrative: patient received a dose of Adacel which was exposed to 52.6 degrees Fahrenheit for seven days,No AE; A pregnant female received a dose of ADACEL,No AE; Initial information was received on 20-Jul-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA188909, 2020SA189132 ,2020SA189059 and 2020SA189112 (same reporter).  This case involves a 30 years old pregnant female patient who on 15-Jul-2020 at 28 weeks of gestation received a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6638AA and expiry date 12-Apr-2022) via intramuscular route in the left arm for prophylactic vaccination and that vaccine was exposed to 52.6 degrees Fahrenheit for seven days (exposure during pregnancy and product storage error)  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The patient received Adacel vaccine at 28 Weeks of gestation.  The date of last menstrual period was reported as 01-Jan-2020.  The estimated due date is 07-Oct-2020.  Medical history, past medical treatment, vaccination and family history were not provided.  No other concomitant medications were reported.   It was an actual medication error due to incorrect product storage and was also a case of vaccine exposure during pregnancy.    Case details: It was reported that the excursion was for seven days and vaccine got exposed to 52.6 degrees Fahrenheit from 08-Jul-2020 to 15-Jul-2020 that was administered to five patients since the excursion. Reporter wanted to know about the possible side effects.  Laboratory details were not reported.  The patient had no adverse reactions at the time of report.   Additionally, at time of reporting, the outcome of the pregnancy was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 90.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fall, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness
Clinical narrative: All I know is that he received a vaccine for shingles at the pharmacy listed above. He began to lose muscle control in his toes, ankles, and legs about 7 days after.. We carried him to the doctor 10 days after the vaccine. That day he was diagnosed with Guillain-Barre Syndrome. He went straight to the hospital. Five weeks in the hospital with Covid 19 conditions and no family or visitors. Went to Nursing home. A day later, a high fever. Went to the ER. Died the next day, April 27, 2020. Tested several times for Covid19. Never tested positive.
Age: 90.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Death, Guillain-Barre syndrome, Loss of control of legs, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: All I know is that he received a vaccine for shingles at the pharmacy listed above. He began to lose muscle control in his toes, ankles, and legs about 7 days after.. We carried him to the doctor 10 days after the vaccine. That day he was diagnosed with Guillain-Barre Syndrome. He went straight to the hospital. Five weeks in the hospital with Covid 19 conditions and no family or visitors. Went to Nursing home. A day later, a high fever. Went to the ER. Died the next day, April 27, 2020. Tested several times for Covid19. Never tested positive.
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; on 06/23/2020 an improperly stored dose of PNEUMOVAX23 was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.     On 23-JUN-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# S029265, expiration date 31-MAR-2021; dose detail, strength and route were not provided) for prophylaxis (product storage error). The temperature excursion was 12.1 degree Celsius for 2 hours and 20 minutes. There was no previously temperature excursion. There was a data logger involved. No additional adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: PPV
Symptoms: Fatigue
Clinical narrative: Super Fatigue; This spontaneous report has been received from a consumer regarding to himself, a male patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug allergies or reaction were not provided.  On 22-JUL-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, strength, dose, route of administration and anatomical location of vaccine were not reported) for prophylaxis.         On the same date, the patient experienced fatigue; he said that he was feeling "super fatigue" after vaccination. The patient reporter that he was feeling good after sleeping for 10 hours. At the reporting time, the outcome of fatigue was reported as recovering.     The reporter considered fatigue to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) and not to the warm weather or exercise tolerance since he walked 1 mile most days.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue; Muscle ache; This case was reported by a nurse via sales rep and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) (batch number T44C7, expiry date 26th February 2022) for prophylaxis.   On 14th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fatigue and myalgia. On an unknown date, the outcome of the fatigue and myalgia were recovered/resolved.   It was unknown if the reporter considered the fatigue and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient experienced muscle ache and fatigue for several days. The patient received 2nd dose on 15th July 2020 (batch number: T44C7, expiry date: 26th February 2022). The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135104:same reporter US-GLAXOSMITHKLINE-US2020AMR135190:same reporter US-GLAXOSMITHKLINE-US2020AMR137983:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Abnormal swelling at the injection site; Abnormal redness at the injection site; Injection site is hot; Injection site is painful; This case was reported by a other health professional via other manufacturer and described the occurrence of injection site swelling in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date unknown) for prophylaxis.   Concurrent medical conditions included hypertension, depression, bladder cancer, chronic pain, infection and sulfonamide allergy. Concomitant products included fluticasone propionate (Fluticasone), salbutamol sulphate (Ventolin Hfa), umeclidinium bromide, vilanterol trifenatate (Anoro), sertraline, amoxicillin + clavulanic acid (Augmentin), hydrocodone bitartrate + paracetamol (Norco) and citalopram.   On 29th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th May 2019, 1 days after receiving Shingrix and an unknown time after starting Fluticasone, Ventolin Hfa, Anoro and sertraline, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported bit it could be 68 or 69 years. It was reported that patient had abnormal swelling and redness at the injection site 4 days post  Injection, the site was hot red and swollen. The patient advised to take appointment with physician. The patient said small amount of swelling started at day one had gotten worst in past few days, it was painful red and swollen.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Contusion, Injection site swelling, Pain in extremity, Product administration error
Clinical narrative: it look like shingles; small patch of blisters on my lower back / Smal blister on her waistline on her back; Left arm swelled up like a golf ball at the injection site; Muscle might not have been relaxed enough; Arm was bruised and sore; Arm was bruised and sore; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2020, the patient received the 1st dose of Shingrix. On 14th July 2020, immediately after receiving Shingrix, the patient experienced injection site swelling and pain in arm. In July 2020, the patient experienced bruising of arm and product administration error. On 17th July 2020, the patient experienced vesicular rash and blister. On an unknown date, the outcome of the vesicular rash, blister, injection site swelling and product administration error were unknown and the outcome of the bruising of arm and pain in arm were recovered/resolved.   It was unknown if the reporter considered the vesicular rash, blister, injection site swelling, bruising of arm and pain in arm to be related to Shingrix.  Additional details were reported as follows: Patient received Shingrix and her left arm swelled up like a golf ball at the injection site as the pharmacist was injecting the vaccine. The patient developed a small patch of blisters on patient's lower back. From everything patient had read, it looks like shingles. The pharmacist told her that the muscle might not relaxed enough at the time of vaccine administration Her arm was bruised and sore which resolved the following day.  The patient had a small blister on her waistline on her back.  She described it later as a patch of little blisters approximately 12 blisters and there had been no change at all. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: it look like shingles; small patch of blisters on my lower back / Smal blister on her waistline on her back; Left arm swelled up like a golf ball at the injection site; Muscle might not have been relaxed enough; Arm was bruised and sore; Arm was bruised and sore; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2020, the patient received the 1st dose of Shingrix. On 14th July 2020, immediately after receiving Shingrix, the patient experienced injection site swelling and pain in arm. In July 2020, the patient experienced bruising of arm and product administration error. On 17th July 2020, the patient experienced vesicular rash and blister. On an unknown date, the outcome of the vesicular rash, blister, injection site swelling and product administration error were unknown and the outcome of the bruising of arm and pain in arm were recovered/resolved.   It was unknown if the reporter considered the vesicular rash, blister, injection site swelling, bruising of arm and pain in arm to be related to Shingrix.  Additional details were reported as follows: Patient received Shingrix and her left arm swelled up like a golf ball at the injection site as the pharmacist was injecting the vaccine. The patient developed a small patch of blisters on patient's lower back. From everything patient had read, it looks like shingles. The pharmacist told her that the muscle might not relaxed enough at the time of vaccine administration Her arm was bruised and sore which resolved the following day.  The patient had a small blister on her waistline on her back.  She described it later as a patch of little blisters approximately 12 blisters and there had been no change at all. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Brain oedema, Brain stem syndrome, Central nervous system viral infection, Corneal reflex decreased
Clinical narrative: facial numbness/forehead; zoster encephalitis/focal  encephalitis; Central nervous system viral infection; inflamation brain stem; vasogenic edema/Vasogenic brain edema; face droop; Prominence of eyes/difficultly closing eye fully; Herpes encephalitis; Cerebellar  edema; Varicella-zoster; shingels; Eye irritated; blurry vision; tickling sensation in left ear/paresthesias; Eye swelling; facial weakness; trigeminal neuralgia; This case was reported by a lawyer and described the occurrence of encephalitis in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the encephalitis was unknown.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional information: The patient was diagnosed with zoster encephalitis.  The initial information was received on 21 July 2020, via medical records(the case was medically confirmed). The patient had family history of Parkinson's (father). The patient had allergy after second shot of Shingrix. As per pharmacy records the patient had injected shingrix 50 MCG injection on 30 December 2018. The patient had injected shingrix 50 mcg injection on 23 March 2019. The patient had injected Shingrix 50 MCG Suspension Reconstituted 1 Intramuscular x 1 now; second dose in 2-6 Months. The second dose of shinrix on April 2019. The patient got shingrix shot on 28 March 2019 with response to eye irritated and blurry vision. In May 2019, Shingrix shot caused inflammation response in brain stem, middle cerebellar peduncle/ Vasogenic (brain) edema. During 21 May 2019 to 22 May 2019 noted the patient had left face droop including forehead, face drooling, tickling sensation in her left ear.She was started on Decadron 4mg PO by her GP. Her symptoms improved over the next 10-14 days. As per progress, notes 28 May 2019 the patient had Eye swelling (left, Prominence of eyes and Cerebellar mass. The patient had hospitalization for facial numbness/possible reactive lesion (L) Pons from shingrix shot on September2019. As per Visit date, 17 July 2019 the patient had numbness on forehead and mid skull, facial weakness had improved, paresthesias, Herpes encephalitis, Varicella-zoster, focal encephalitis. The patient was admitted on 18 July 2019 and discharge on 19 July 2019 with diagnosis Zoster encephalitis/ encephalitis and Central nervous system viral infection (patient had procedures LUMBAR PUNCTURE). As per progress date 31 January 2020, the patient had shingels & trigeminal neuralgia left side difficultly closing eye fully(left), Cerebellar lesion(on May 2019 MRI)and Deficient blink reflex.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Drooling, Ear discomfort, Encephalitis, Eye irritation, Eye swelling
Clinical narrative: facial numbness/forehead; zoster encephalitis/focal  encephalitis; Central nervous system viral infection; inflamation brain stem; vasogenic edema/Vasogenic brain edema; face droop; Prominence of eyes/difficultly closing eye fully; Herpes encephalitis; Cerebellar  edema; Varicella-zoster; shingels; Eye irritated; blurry vision; tickling sensation in left ear/paresthesias; Eye swelling; facial weakness; trigeminal neuralgia; This case was reported by a lawyer and described the occurrence of encephalitis in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the encephalitis was unknown.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional information: The patient was diagnosed with zoster encephalitis.  The initial information was received on 21 July 2020, via medical records(the case was medically confirmed). The patient had family history of Parkinson's (father). The patient had allergy after second shot of Shingrix. As per pharmacy records the patient had injected shingrix 50 MCG injection on 30 December 2018. The patient had injected shingrix 50 mcg injection on 23 March 2019. The patient had injected Shingrix 50 MCG Suspension Reconstituted 1 Intramuscular x 1 now; second dose in 2-6 Months. The second dose of shinrix on April 2019. The patient got shingrix shot on 28 March 2019 with response to eye irritated and blurry vision. In May 2019, Shingrix shot caused inflammation response in brain stem, middle cerebellar peduncle/ Vasogenic (brain) edema. During 21 May 2019 to 22 May 2019 noted the patient had left face droop including forehead, face drooling, tickling sensation in her left ear.She was started on Decadron 4mg PO by her GP. Her symptoms improved over the next 10-14 days. As per progress, notes 28 May 2019 the patient had Eye swelling (left, Prominence of eyes and Cerebellar mass. The patient had hospitalization for facial numbness/possible reactive lesion (L) Pons from shingrix shot on September2019. As per Visit date, 17 July 2019 the patient had numbness on forehead and mid skull, facial weakness had improved, paresthesias, Herpes encephalitis, Varicella-zoster, focal encephalitis. The patient was admitted on 18 July 2019 and discharge on 19 July 2019 with diagnosis Zoster encephalitis/ encephalitis and Central nervous system viral infection (patient had procedures LUMBAR PUNCTURE). As per progress date 31 January 2020, the patient had shingels & trigeminal neuralgia left side difficultly closing eye fully(left), Cerebellar lesion(on May 2019 MRI)and Deficient blink reflex.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid function disorder, Facial paralysis, Facial paresis, Herpes zoster, Herpes zoster meningoencephalitis
Clinical narrative: facial numbness/forehead; zoster encephalitis/focal  encephalitis; Central nervous system viral infection; inflamation brain stem; vasogenic edema/Vasogenic brain edema; face droop; Prominence of eyes/difficultly closing eye fully; Herpes encephalitis; Cerebellar  edema; Varicella-zoster; shingels; Eye irritated; blurry vision; tickling sensation in left ear/paresthesias; Eye swelling; facial weakness; trigeminal neuralgia; This case was reported by a lawyer and described the occurrence of encephalitis in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the encephalitis was unknown.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional information: The patient was diagnosed with zoster encephalitis.  The initial information was received on 21 July 2020, via medical records(the case was medically confirmed). The patient had family history of Parkinson's (father). The patient had allergy after second shot of Shingrix. As per pharmacy records the patient had injected shingrix 50 MCG injection on 30 December 2018. The patient had injected shingrix 50 mcg injection on 23 March 2019. The patient had injected Shingrix 50 MCG Suspension Reconstituted 1 Intramuscular x 1 now; second dose in 2-6 Months. The second dose of shinrix on April 2019. The patient got shingrix shot on 28 March 2019 with response to eye irritated and blurry vision. In May 2019, Shingrix shot caused inflammation response in brain stem, middle cerebellar peduncle/ Vasogenic (brain) edema. During 21 May 2019 to 22 May 2019 noted the patient had left face droop including forehead, face drooling, tickling sensation in her left ear.She was started on Decadron 4mg PO by her GP. Her symptoms improved over the next 10-14 days. As per progress, notes 28 May 2019 the patient had Eye swelling (left, Prominence of eyes and Cerebellar mass. The patient had hospitalization for facial numbness/possible reactive lesion (L) Pons from shingrix shot on September2019. As per Visit date, 17 July 2019 the patient had numbness on forehead and mid skull, facial weakness had improved, paresthesias, Herpes encephalitis, Varicella-zoster, focal encephalitis. The patient was admitted on 18 July 2019 and discharge on 19 July 2019 with diagnosis Zoster encephalitis/ encephalitis and Central nervous system viral infection (patient had procedures LUMBAR PUNCTURE). As per progress date 31 January 2020, the patient had shingels & trigeminal neuralgia left side difficultly closing eye fully(left), Cerebellar lesion(on May 2019 MRI)and Deficient blink reflex.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Intracranial mass, Lumbar puncture, Magnetic resonance imaging brain abnormal, Paraesthesia
Clinical narrative: facial numbness/forehead; zoster encephalitis/focal  encephalitis; Central nervous system viral infection; inflamation brain stem; vasogenic edema/Vasogenic brain edema; face droop; Prominence of eyes/difficultly closing eye fully; Herpes encephalitis; Cerebellar  edema; Varicella-zoster; shingels; Eye irritated; blurry vision; tickling sensation in left ear/paresthesias; Eye swelling; facial weakness; trigeminal neuralgia; This case was reported by a lawyer and described the occurrence of encephalitis in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the encephalitis was unknown.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional information: The patient was diagnosed with zoster encephalitis.  The initial information was received on 21 July 2020, via medical records(the case was medically confirmed). The patient had family history of Parkinson's (father). The patient had allergy after second shot of Shingrix. As per pharmacy records the patient had injected shingrix 50 MCG injection on 30 December 2018. The patient had injected shingrix 50 mcg injection on 23 March 2019. The patient had injected Shingrix 50 MCG Suspension Reconstituted 1 Intramuscular x 1 now; second dose in 2-6 Months. The second dose of shinrix on April 2019. The patient got shingrix shot on 28 March 2019 with response to eye irritated and blurry vision. In May 2019, Shingrix shot caused inflammation response in brain stem, middle cerebellar peduncle/ Vasogenic (brain) edema. During 21 May 2019 to 22 May 2019 noted the patient had left face droop including forehead, face drooling, tickling sensation in her left ear.She was started on Decadron 4mg PO by her GP. Her symptoms improved over the next 10-14 days. As per progress, notes 28 May 2019 the patient had Eye swelling (left, Prominence of eyes and Cerebellar mass. The patient had hospitalization for facial numbness/possible reactive lesion (L) Pons from shingrix shot on September2019. As per Visit date, 17 July 2019 the patient had numbness on forehead and mid skull, facial weakness had improved, paresthesias, Herpes encephalitis, Varicella-zoster, focal encephalitis. The patient was admitted on 18 July 2019 and discharge on 19 July 2019 with diagnosis Zoster encephalitis/ encephalitis and Central nervous system viral infection (patient had procedures LUMBAR PUNCTURE). As per progress date 31 January 2020, the patient had shingels & trigeminal neuralgia left side difficultly closing eye fully(left), Cerebellar lesion(on May 2019 MRI)and Deficient blink reflex.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia, Vision blurred
Clinical narrative: facial numbness/forehead; zoster encephalitis/focal  encephalitis; Central nervous system viral infection; inflamation brain stem; vasogenic edema/Vasogenic brain edema; face droop; Prominence of eyes/difficultly closing eye fully; Herpes encephalitis; Cerebellar  edema; Varicella-zoster; shingels; Eye irritated; blurry vision; tickling sensation in left ear/paresthesias; Eye swelling; facial weakness; trigeminal neuralgia; This case was reported by a lawyer and described the occurrence of encephalitis in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the encephalitis was unknown.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional information: The patient was diagnosed with zoster encephalitis.  The initial information was received on 21 July 2020, via medical records(the case was medically confirmed). The patient had family history of Parkinson's (father). The patient had allergy after second shot of Shingrix. As per pharmacy records the patient had injected shingrix 50 MCG injection on 30 December 2018. The patient had injected shingrix 50 mcg injection on 23 March 2019. The patient had injected Shingrix 50 MCG Suspension Reconstituted 1 Intramuscular x 1 now; second dose in 2-6 Months. The second dose of shinrix on April 2019. The patient got shingrix shot on 28 March 2019 with response to eye irritated and blurry vision. In May 2019, Shingrix shot caused inflammation response in brain stem, middle cerebellar peduncle/ Vasogenic (brain) edema. During 21 May 2019 to 22 May 2019 noted the patient had left face droop including forehead, face drooling, tickling sensation in her left ear.She was started on Decadron 4mg PO by her GP. Her symptoms improved over the next 10-14 days. As per progress, notes 28 May 2019 the patient had Eye swelling (left, Prominence of eyes and Cerebellar mass. The patient had hospitalization for facial numbness/possible reactive lesion (L) Pons from shingrix shot on September2019. As per Visit date, 17 July 2019 the patient had numbness on forehead and mid skull, facial weakness had improved, paresthesias, Herpes encephalitis, Varicella-zoster, focal encephalitis. The patient was admitted on 18 July 2019 and discharge on 19 July 2019 with diagnosis Zoster encephalitis/ encephalitis and Central nervous system viral infection (patient had procedures LUMBAR PUNCTURE). As per progress date 31 January 2020, the patient had shingels & trigeminal neuralgia left side difficultly closing eye fully(left), Cerebellar lesion(on May 2019 MRI)and Deficient blink reflex.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Generalized itchiness; This case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix and the 1st dose of Influenza vaccine Quadrivalent 2019-2020 season. In September 2019, immediately after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was recovered/resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported. In September 2019, the patient received Shingrix and Flu shot, soon after the first dose of Shingrix the patient started experiencing generalized itchiness and as per the patient this symptom was manageable after first dose. The reporter consent to follow up. For tolerance after 2nd dose of Shingrix, refer case US2020AMR136308.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR136308:same reporter
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: No a loss of motion in the affected arm; Worsening arm pain; Injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On 3rd July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm and injection site pain. On an unknown date, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the pain in arm, injection site pain and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm, injection site pain and injected limb mobility decreased to be related to Shingrix.  Additional case details were reported as follows: After receiving the 2nd dose of Shingrix on left deltoid the patient experience worsening arm pain that progressed from left side injection site pain to no a loss of motion in the affected arm. The reporter consent to follow up.  The reported batch number 4702Z for Shingrix did not exist and was updated to 47D2Z as per the sales database.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Biopsy skin abnormal, Borrelia test positive, CSF test abnormal, Central nervous system lesion
Clinical narrative: previous to receiving the vaccine I was diagnosed with a high infection of Lyme disease, over time the symptoms worsened even after treatment , over a span of about ten years I have developed small fiber neuropathy, immune issues , chronic fatigue , muscle and joint pain , numbness and tingling in my hands and feet , issues with chronic weight and muscle loss . I was treated several times for the Lyme disease and even with treatments my symptoms never dissipated . In 2018 I started auto immune infusions and feel much better but still suffer with symptoms to this day . Before the vaccine I did not experience exacerbated symptoms . After the vaccine my symptoms worsened and I am unable to test negative for Lyme disease and Rocky Mountain spotted fever . It has been many years of testing high positive and experiencing symptoms .
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Electromyogram abnormal, Fatigue, Hypoaesthesia, Immune system disorder
Clinical narrative: previous to receiving the vaccine I was diagnosed with a high infection of Lyme disease, over time the symptoms worsened even after treatment , over a span of about ten years I have developed small fiber neuropathy, immune issues , chronic fatigue , muscle and joint pain , numbness and tingling in my hands and feet , issues with chronic weight and muscle loss . I was treated several times for the Lyme disease and even with treatments my symptoms never dissipated . In 2018 I started auto immune infusions and feel much better but still suffer with symptoms to this day . Before the vaccine I did not experience exacerbated symptoms . After the vaccine my symptoms worsened and I am unable to test negative for Lyme disease and Rocky Mountain spotted fever . It has been many years of testing high positive and experiencing symptoms .
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test abnormal, Lumbar puncture abnormal, Lyme disease, Magnetic resonance imaging brain abnormal, Muscle atrophy
Clinical narrative: previous to receiving the vaccine I was diagnosed with a high infection of Lyme disease, over time the symptoms worsened even after treatment , over a span of about ten years I have developed small fiber neuropathy, immune issues , chronic fatigue , muscle and joint pain , numbness and tingling in my hands and feet , issues with chronic weight and muscle loss . I was treated several times for the Lyme disease and even with treatments my symptoms never dissipated . In 2018 I started auto immune infusions and feel much better but still suffer with symptoms to this day . Before the vaccine I did not experience exacerbated symptoms . After the vaccine my symptoms worsened and I am unable to test negative for Lyme disease and Rocky Mountain spotted fever . It has been many years of testing high positive and experiencing symptoms .
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Myalgia, Nerve injury, Paraesthesia, Small fibre neuropathy, Weight decreased
Clinical narrative: previous to receiving the vaccine I was diagnosed with a high infection of Lyme disease, over time the symptoms worsened even after treatment , over a span of about ten years I have developed small fiber neuropathy, immune issues , chronic fatigue , muscle and joint pain , numbness and tingling in my hands and feet , issues with chronic weight and muscle loss . I was treated several times for the Lyme disease and even with treatments my symptoms never dissipated . In 2018 I started auto immune infusions and feel much better but still suffer with symptoms to this day . Before the vaccine I did not experience exacerbated symptoms . After the vaccine my symptoms worsened and I am unable to test negative for Lyme disease and Rocky Mountain spotted fever . It has been many years of testing high positive and experiencing symptoms .
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Ear swelling, Erythema, Pyrexia, Swelling face, Swelling of eyelid
Clinical narrative: Woke up 2 days later with hives on neck and swollen face with low grade fever. Eyes swollen shut and ear lobe swollen. Reported to office on the following day,  no fever but every time lays down her face gets more swollen on that side. Patient has history of peanut allergy and she works at an ice cream shop. Mom giving Benadryl, no breathing issues, can swallow fine. Redness on face better but back red and full of hives.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Woke up 2 days later with hives on neck and swollen face with low grade fever. Eyes swollen shut and ear lobe swollen. Reported to office on the following day,  no fever but every time lays down her face gets more swollen on that side. Patient has history of peanut allergy and she works at an ice cream shop. Mom giving Benadryl, no breathing issues, can swallow fine. Redness on face better but back red and full of hives.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; an adult patient received an expired dose of VAQTA; This spontaneous report was received from a medical assistant and refers to an adult patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 10-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 ml, lot number: S018772, expiration date: 07-JUL-2020, for prophylaxis (route of administration was not provided) (formulation was provided as vial but upon internal validation established as prefilled syringe). No additional adverse effects were reported in the patient. No product quality complaint was reported (PQC). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S018772; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability