chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle disorder, Neuropathy peripheral, Paraesthesia
Clinical narrative: Low body temperature (93.5*F) with chills 1 day after the vaccination, admitted to hospital 6 days after vaccination with the following symptoms: loss of control over facial and walking nerves/muscles, unable to walk, facial droop on one side, tingling/burning hands and feet, severe back/hip pain, high blood pressure (220/? ) and rapid pulse (140 bpm).  Diagnosed with Guillain-Barre Syndrome 10 days after vaccination and began IVIG (intravenous immunoglobulin) infusions immediately.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Local reaction, Nodule, Swelling
Clinical narrative: Localized reaction of redness and swelling with a nodule.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Incorrect route of product administration
Clinical narrative: the patient had bloodwork done and his Varicella titer was negative; unsure if he was previously vaccinated with VARIVAX on 01/23/2020 the same patient was administered a dose of VARN AX; the same patient was administered a dose of VARIVAX  intramuscularly; This spontaneous report has been received from  a nurse, referring to a male patient of unknown age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies was not provided.  On 23-JAN-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX),  by intramuscular administration (incorrect route of product administration) (conflicting information since it was also reported as "subcutaneous"); lot number R009821 and expiration date 03-APR-2020 for immunization from  varicella (strength, frequency, dose and anatomical location were not reported).  It was stated by the reporter, that the patient was unsure if he was previously vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), and underwent on an unspecified date a laboratory diagnostic procedure reported as "bloodwork", that showed his Varicella titer was negative (varicella virus test negative) (inappropriate schedule of product administration).  The patient did not receive any treatment for the event and did not seek medical attention.  At the time of reporting, the outcome of varicella virus test negative was not reported.  The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) and varicella virus test negative was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: an adult patient was inadvertently administered PROQUAD; No additional adverse event; This spontaneous report has been received from a medical assistant and refers to an adult patient of unknown age.      On an unknown date, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003864 and expiration date 08-AUG-2020 (dose and route of administration were not provided) for prophylaxis. No adverse event was reported.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Herpes zoster, Rash, Varicella virus test positive
Clinical narrative: rash on inner thigh of rigtht leg/rash test positive for shingles; This spontaneous report has been received from a pediatrician, referring to a 6-year-old male patient. The patient's medical history included hydrocele repair. The patient had no current condition and concomitant medication. The patient had no known allergy. The patient never had chickenpox, herps zoster or herps zoster ophthalmic before.  On 20-MAR-2014, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # and expiration date not available; dose, route, strength and frequency unknown) for prophylaxis. On 17-AUG-2018, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # N035175 with expiration date: 09-JUN-2019, therapy type: recombinant human albumin (RHA); dose, route, strength and frequency were unknown) in the right anterior lateral thigh for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown) (lot# M022416). There was no rash occurred at the site of injection following the vaccination.   On 20-JAN-2020, the patient developed a rash on inner thigh of right leg. There was no fever and the patient's temperature was 36.67 (units not provided). There was no other systemic symptoms. On 24-JAN-2020, the patient sought for medical attention and was seen by the another health care professional (HCP). The sample of the vesicle/lesion was collected and test was positive for shingles. The herpes zoster was on the dermatome of right groin and leg (near knee and above ankle), L2-3 and L3-4. On the same day, the patient was treated on acyclovir ointment (also reported as oral suspension x 7 days). Physician stated that the samples on swabs was in transport media and he did not have any dry samples. Also the patient's skin was healing and unfortunately there was no way to obtain any other sample. The outcome was considered as recovering. The causality assessment of events was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE information provided; The patient was administered the first dose of GARDASIL 9, on 3/27/2017 and the second dose of GARDASIL 9, on 6/20/2017 and did  not return for her third dose of GARDASIL 9 in September of 2017; This spontaneous report has been received from a medical assistant, referring to a female patient of unknown age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drug reactions or allergies were not provided.  On 27-MAR-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and on 20-JUN-2017, the patient received the second dose (lot number M037770 and expiration date 01-JUN-2019 for both vaccines); the third dose was given on 20-JAN-2020 (inappropriate schedule of product administration) (lot number and expiration date  not provided) for prophylaxis. Details about strength, route of administration and anatomical locations were not reported.  No additional adverse events were reported.
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, Mumps antibody test negative
Clinical narrative: I received MMR II 3 doses and had titers drawn which demonstrated mumps titers were low; This spontaneous report was received from a male physician of unknown age, regarding to himself. The patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies were not reported.  On unknown dates, the patient was vaccinated with three doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis. As concomitant medication, sterile diluent was used.  On an unspecified date, the patient had titers test (also reported as vaccine titers) done, which demonstrated that mump titers were low(mumps antibody test negative). Consequently, on an unknown date, the patient was vaccinated with a fourth dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis. It was reported that the patient sought medical attention and that no treatment was given for the adverse event.  The outcome of mumps antibody test negative was reported as not recovered. The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the aforementioned event was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Dry eye, Endocrine ophthalmopathy, Exophthalmos, Pain, Vision blurred
Clinical narrative: Graves' opthalmopathy; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 31-JAN-2020. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or around 30-MAR-2015, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, on an unspecified date, she suffered sudden onset of bulging and dry eyes, pain and blurry vision, which was diagnosed as Graves' ophthalmopathy. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient's symptoms had resulted in physical limitations not present prior to the vaccine, also mental and emotional distress due to resulting physical limitations and seriousness of her condition. Patient sustained severe and permanent personal injuries. Further, as a tragic consequence, patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. She also ha suffered and incurred damages, including medical expenses, loss of accumulations, and other economic and non-economic damages. At the reporting time, the outcome of Graves' ophthalmopathy was considered as not recovered. The reporters considered Graves' ophthalmopathy to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporters considered Graves' ophthalmopathy to be a disability event. Upon internal review, the event of Graves' ophthalmopathy was determined to  be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Dysarthria, Facial paralysis, Hemiparesis, Hypoaesthesia
Clinical narrative: cerebrovascular accident; This spontaneous report was received from a lawyer and a male patient of unknown age regarding a case in litigation on 31-JAN-2020. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or around 12-MAR-2015, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, on an unspecified date, he suffered left sided weakness and numbness, also suffered left sided facial droop and slurred speech. In consequence, he was hospitalized and was diagnosed with cerebrovascular accident. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient's symptoms had resulted in physical limitations not present prior to the vaccine, also mental and emotional distress due to resulting physical limitations and seriousness of his condition. Patient sustained severe and permanent personal injuries. Further, as a tragic consequence, patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. He also had suffered and incurred damages, including medical expenses, loss of accumulations, and other economic and non-economic damages. At the reporting time, the outcome of cerebrovascular accident was considered as not recovered. The reporters considered cerebrovascular accident to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporters considered cerebrovascular accident to be a disability event. Upon internal review, cerebrovascular accident was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: herpes zoster; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 20-JUL-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a shingles like rash on left back that went around her left breast and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event herpes zoster was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event herpes zoster to be disability.
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Balance disorder, Deafness neurosensory, Deafness unilateral, Tinnitus
Clinical narrative: sensorineural hearing loss; tinnitus; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or around 12-AUG-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss in left ear, balance problems and loss of taste. The patient was diagnosed with sensorineural hearing loss and tinnitus. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of sensorineural hearing loss and tinnitus was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of sensorineural hearing loss and tinnitus were considered to be disabling. Upon internal review, the event of sensorineural hearing loss was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: postherpetic neuralgia; shingles/herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications.  On or around 18-NOV-2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a severe painful, burning rash on the left upper quadrant of his abdomen. The patient was thereafter diagnosed with shingles/herpes zoster and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events of shingles/herpes zoster and postherpetic neuralgia was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of shingles/herpes zoster and postherpetic neuralgia were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: loss of hearing; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 07-FEB-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered from loss of hearing. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event loss of hearing was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event loss of hearing to be disability.  Upon internal review, loss of hearing was determined to be medically significant.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: General physical health deterioration, Postural orthostatic tachycardia syndrome, Staring
Clinical narrative: health decline; postural orthostatic tachycardia syndrome; This spontaneous report was received from a consumer (patient's mother) via other (journalist) through social media refers to a 12-year old female patient. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, dosing schedule, route, lot # and expiration date were not reported) for cancer prevention. On an unknown date, patient experienced health decline (general physical health deterioration) and postural orthostatic tachycardia syndrome (POTS). The consumer reported that her child was very active that she had swam before she could walk. The patient reported that she would scare her mom as she sank to the bottom and just stared at her. She proudly reported that she would kick herself back up and take a breath and would go back down to the water. After vaccination, she could walk but getting up to do something has been a challenge. The consumer concerned about her daughter and described what was going on with her. She added that her daughter's heart rate was one thing that she did not have enough blood volume or blood pressure to push back up to the brain like it was supposed to go. She also added that her child did not show any signs of before being vaccinated. The patient was treated with florinef. No product quality complaint was reported. The outcome of general physical health deterioration and postural orthostatic tachycardia syndrome was unknown. The reporter considered the events to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2002USA002380:
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema
Clinical narrative: headache which got worse in; injection site was quite red; This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced headache and injection site erythema. In January 2020, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the headache and injection site erythema to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix and experienced headache which got worse in the night, but subsided the next day of receiving vaccine. The patient's injection site was quite red, but was subsiding. The patient had no other issues. The patient wanted to know was the headache and red injection site considered an allergic reaction and should he/she avoid the 2nd dose or was it an expected side effect and safe to get the second dose.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: feeling this fatigued after the 1st dose back in November 2019; This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional information was provided as follows: The patient felt fatigue after receiving 1st dose of Shingrix. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020AMR017295.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling cold, Hyperhidrosis, Incomplete course of vaccination, Pyrexia
Clinical narrative: Fever; Sweating; Felt cold; Tired; it has been more than 6 months since the first Shingrix injection; This case was reported by a consumer via call center representative and described the occurrence of fever in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, sweating, feeling cold, tiredness and incomplete course of vaccination. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the sweating, feeling cold, tiredness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fever, sweating, feeling cold and tiredness to be related to Shingrix.  Additional information was provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received Shingrix vaccine 32 weeks before the time of reporting. The patient's wife could not recall if it was 24 or 48 hours after the injection, patient felt tired and developed a fever. The fever kept getting higher and reached 103 degrees Fahrenheit. The patient felt cold and then felt normal and then felt cold again during the time he had the fever. The patient had periods of profuse sweating during the fever and he sweat right through the mattress pad on their bed. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was not sure, if he is going to get the injection again. The reporter did not wish to provide patient information nor her mailing address.  The reporter did not consent to follow up.      Lab Comments: On an unknown date, the lab test was performed.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: redness of arm/ redness from the injection site and travelled down the arm to the wrist; arm felt warm; This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bee sting hypersensitivity and allergy to antibiotic.   On 6th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2019, 8 hrs after receiving Shingrix, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities and skin warm to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on the left arm. the patient experienced redness from the injection site and traveled down the arm to the wrist and also reported that the site felt warm. The events were resolved after 4 to 5 days. The reporter consented to follow up. The outcome of the events were reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in System.
Sex: U
Vaccine: MENB
Symptoms: Muscle disorder, Nervous system disorder
Clinical narrative: muscle problems; neurological problems; This case was reported by a other health professional via sales rep and described the occurrence of muscle disorder in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced muscle disorder and neurological disorder nos. On an unknown date, the outcome of the muscle disorder and neurological disorder nos were unknown.   It was unknown if the reporter considered the muscle disorder and neurological disorder nos to be related to Bexsero.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient had a severe reaction, the patient experienced muscle and neurologic problems and was sent to the emergency room. The reporter was unable to provide any additional information.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure / first injection on 5/25/18, and second injection on 9/14/18, and experienced shingles; shingles on back; muscle pain on back / back pain; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2018, the patient received the 1st dose of Shingrix. On 14th September 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 25th January 2020, 610 days after receiving Shingrix and 498 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and muscular back pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and muscular back pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and muscular back pain to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The patient received 2nd dose of vaccine in unknown arm. The patient had the Shingrix series and experienced shingles on her back. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation for shingles was not provided. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose abnormal, Blood ketone body present, Feeling abnormal, Loss of personal independence in daily activities, Vaccination complication
Clinical narrative: Patient and mom both had the flu shot on 1/17. Mom started with symptoms the night of 1/17 and patient the AM or 1/18. Patient has missed a lot of school. Mom said he was expected to be good enough to attend school yesterday. He didn't feel too good in the morning, but went to school. As the day went on he got worse and worse. Came home and was like a "lump." Has been needing multiple corrections in insulin while ill. Ketones always in range. Multiple kids and his teacher were sick when he was there yesterday.  Mom was diagnosed with shingles in her sinuses, ear and nose. This week she was told by her provider in internal med they believe her and patient had a reaction to the shot since their symptoms began the same time.
Age: 45.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Hypoaesthesia oral
Clinical narrative: Tongue numbness.  Given Benadryl 25mg IM.  Observed patient for 30 minutes.   Tongue numbness resolved within 30 minutes.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain
Clinical narrative: was very achy; my arm hurt at the injection site; I had the flu all night.; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 63-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th January 2020, the patient received Shingles vaccine. On 27th January 2020, less than a day after receiving Shingles vaccine, the patient experienced general body pain, injection site pain and influenza-like symptoms. On an unknown date, the outcome of the general body pain, injection site pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the general body pain, injection site pain and influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: The patient received Shingrix and had general body pain, injection site pain and influenza-like symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: i started with a rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2019, the patient received the 1st dose of Shingrix. On 9th January 2020, 30 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had rash. The reporter trying to determine what the rash may be coming from. The reporter wanted to know how long after the first shingles shot would side effects show up.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: He said it feels like the flu.; the shot area caused much pain; came the head ac; possible fever; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included unknown vaccination (had a shot for this maybe 5 yrs ago , some discomfort and after effects). Concomitant products included Herpes zoster (Shingrix).   On 28th January 2020, the patient received the 2nd dose of Shingrix. On 28th January 2020, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms, pain, headache and fever. On an unknown date, the outcome of the influenza-like symptoms, pain, headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, headache and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and within hours the shot area caused much pain, then came the headache along with possible fever. The shot before with no problem and the first time.
Age: 27.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age
Clinical narrative: shingles; I'm 27 years old; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 27-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On 28th January 2020, 30 days after receiving Shingrix, the patient experienced shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the shingles and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  The patient was vaccinated a month ago and got shingles. The patient was vaccinated at the age of 27 years which led to inappropriate age at vaccine administration. The patient inquired if he/she will be protected after the second dose.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Severe pain at the injection site; fever; flu like symptoms; This case was reported by a consumer and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (2 times breast cancer survivor).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, fever and influenza-like symptoms. On an unknown date, the outcome of the injection site pain, fever and influenza-like symptoms were unknown.   It was unknown if the reporter considered the injection site pain, fever and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient had severe pain at the injection site, fever and flu like symptoms. The patient was young for her age. Additional details were provided as follows: The patient had severe pain at the injection site, fever and flu like symptoms. The patient was young for her age.  The patient noted that she pretty much had all of the ones  adverse event listed in the labelling.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Fall, Herpes zoster, Orthosis user, Pruritus
Clinical narrative: suspected Vaccination failure; determined I have had a shingles outbreak; itching and blisters on my legs; right foot deformity (boot, brace); anxiety; fall; broke my arm; itching and blisters on my legs; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 80-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (in childhood) and mouth ulcer (susceptible to outbreaks for many years).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 3rd January 2020, less than 2 years after receiving Shingrix and Shingrix and an unknown time after starting calamine, the patient experienced arm fracture and fall. In January 2020, the patient experienced itchy legs. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, foot deformity and anxiety. The patient was treated with calamine and alprazolam (Xanax). On an unknown date, the outcome of the vaccination failure, shingles, itchy legs, blister, arm fracture, foot deformity, fall and anxiety were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, itchy legs, blister, arm fracture, foot deformity, fall and anxiety to be related to Shingrix and Shingrix.  Additional case details were reported as follows: This case was reported by patient. The age at vaccination was not reported. In 2019, the patient received the 2 doses of Shingrix and believed it prevent from attack. The patient fell and broke his/her arm. The patient had a right foot deformity (boot, brace) and developed itching on both legs. The patient finally determined he/she had a shingles outbreak with itching and blisters on legs. The patient enquired what could be done to completely dry up the itching and blisters. This case was considered as suspected vaccination failure as details regarding time to onset for the events and lab test confirming zoster virus was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Upper limb fracture, Vaccination failure
Clinical narrative: suspected Vaccination failure; determined I have had a shingles outbreak; itching and blisters on my legs; right foot deformity (boot, brace); anxiety; fall; broke my arm; itching and blisters on my legs; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 80-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (in childhood) and mouth ulcer (susceptible to outbreaks for many years).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 3rd January 2020, less than 2 years after receiving Shingrix and Shingrix and an unknown time after starting calamine, the patient experienced arm fracture and fall. In January 2020, the patient experienced itchy legs. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, foot deformity and anxiety. The patient was treated with calamine and alprazolam (Xanax). On an unknown date, the outcome of the vaccination failure, shingles, itchy legs, blister, arm fracture, foot deformity, fall and anxiety were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, itchy legs, blister, arm fracture, foot deformity, fall and anxiety to be related to Shingrix and Shingrix.  Additional case details were reported as follows: This case was reported by patient. The age at vaccination was not reported. In 2019, the patient received the 2 doses of Shingrix and believed it prevent from attack. The patient fell and broke his/her arm. The patient had a right foot deformity (boot, brace) and developed itching on both legs. The patient finally determined he/she had a shingles outbreak with itching and blisters on legs. The patient enquired what could be done to completely dry up the itching and blisters. This case was considered as suspected vaccination failure as details regarding time to onset for the events and lab test confirming zoster virus was unknown at the time of reporting.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Gait disturbance, Headache, Injection site pain, Nausea
Clinical narrative: Hard time walking to the kitchen; Injection site began to hurt; Headache; Body aches; Weakness; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 9737P, expiry date 19th March 2022) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th January 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, headache, general body pain, weakness and nausea. On 28th January 2020, the patient experienced walking difficulty. On an unknown date, the outcome of the injection site pain, headache, general body pain, weakness, nausea and walking difficulty were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, general body pain, weakness, nausea and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and that on same day around 6 pm, the injection site began to hurt. She started experiencing headache, body aches, weakness, and nausea. She took some medication and her symptoms are less, but she still has them. She said she had a hard time walking to the kitchen this on the morning of reporting date.  The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hard time walking to the kitchen; Injection site began to hurt; Headache; Body aches; Weakness; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 9737P, expiry date 19th March 2022) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th January 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, headache, general body pain, weakness and nausea. On 28th January 2020, the patient experienced walking difficulty. On an unknown date, the outcome of the injection site pain, headache, general body pain, weakness, nausea and walking difficulty were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, general body pain, weakness, nausea and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and that on same day around 6 pm, the injection site began to hurt. She started experiencing headache, body aches, weakness, and nausea. She took some medication and her symptoms are less, but she still has them. She said she had a hard time walking to the kitchen this on the morning of reporting date.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Headache, Hyperhidrosis, Incomplete course of vaccination
Clinical narrative: incomplete course of vaccination; felt very sick; shaking; shivering; feeling cold; fever; sweats; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of tremor in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In April 2019, 5 min after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tremor, shivering, feeling cold, fever, sweating, headache, nausea and feeling unwell. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the tremor, shivering, feeling cold, fever, sweating, headache and nausea were recovered/resolved and the outcome of the feeling unwell and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the tremor, shivering, feeling cold, fever, sweating, headache, nausea and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported, however it could be 70 or 71 years. The patient started to shake uncontrollably.  She was shivering, felt very cold and had severe headache.  The symptoms lasted 3 to 4 days. The patient felt very sick.  Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Nausea, Pyrexia, Tremor
Clinical narrative: incomplete course of vaccination; felt very sick; shaking; shivering; feeling cold; fever; sweats; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of tremor in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In April 2019, 5 min after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tremor, shivering, feeling cold, fever, sweating, headache, nausea and feeling unwell. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the tremor, shivering, feeling cold, fever, sweating, headache and nausea were recovered/resolved and the outcome of the feeling unwell and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the tremor, shivering, feeling cold, fever, sweating, headache, nausea and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported, however it could be 70 or 71 years. The patient started to shake uncontrollably.  She was shivering, felt very cold and had severe headache.  The symptoms lasted 3 to 4 days. The patient felt very sick.  Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.