chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Electromyogram, Magnetic resonance imaging abdominal, Magnetic resonance imaging brain, Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: Transverse Myelitis diagnosis s/p shingrix vaccine. Diagnosis of transverse myelitis affecting rt. flank : RLE s/p shingrix vaccine
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Neurological examination
Clinical narrative: Transverse Myelitis diagnosis s/p shingrix vaccine. Diagnosis of transverse myelitis affecting rt. flank : RLE s/p shingrix vaccine
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Periorbital pain
Clinical narrative: blisters appeared above lips into nostrils & lower eyelid/duct. HA w/pain over/under eye. Treatment w/Acyclovir & eye ointment
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Burning sensation, Diarrhoea, Dysstasia, Feeling cold
Clinical narrative: The day after I got the shot, when I went to get out of bed in the morning, I felt like I was going to pass out, so I waited. I got to the bathroom, sat down on the toilet and had some diarrhea and then I started to burn up, freeze and shake all at the same time. I've never had that happen before. I didn't know what was happening to me and I got scared. When I tried to stand up, I couldn't. My legs had no muscle strength. So I sat on the toilet for about 20 minutes, burning up, freezing, and shaking, all at the same time. Then I was finally able to get up. I put a wet wash cloth on my forehead and laid down in bed cause I was still burning up, freezing and shaking. After an hour or more I finally stopped shaking, freezing and burning up. I called the pharmacy and told the pharmacist what happened. She said I probably had a reaction to the shot and to call my Dr. I called the Dr. and they were out to lunch, so I called later at 2. I told the gal what happened and she said she would tell my Dr. and get back to me. They finally called back after 5 and said I should take some Tylenol. By that time I was feeling better, but I tool some Tylenol anyway. The next day, I was feeling almost back to normal. That was so scary for me since I was home alone and didn't know what the heck was happening to me!
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle strength abnormal, Tremor
Clinical narrative: The day after I got the shot, when I went to get out of bed in the morning, I felt like I was going to pass out, so I waited. I got to the bathroom, sat down on the toilet and had some diarrhea and then I started to burn up, freeze and shake all at the same time. I've never had that happen before. I didn't know what was happening to me and I got scared. When I tried to stand up, I couldn't. My legs had no muscle strength. So I sat on the toilet for about 20 minutes, burning up, freezing, and shaking, all at the same time. Then I was finally able to get up. I put a wet wash cloth on my forehead and laid down in bed cause I was still burning up, freezing and shaking. After an hour or more I finally stopped shaking, freezing and burning up. I called the pharmacy and told the pharmacist what happened. She said I probably had a reaction to the shot and to call my Dr. I called the Dr. and they were out to lunch, so I called later at 2. I told the gal what happened and she said she would tell my Dr. and get back to me. They finally called back after 5 and said I should take some Tylenol. By that time I was feeling better, but I tool some Tylenol anyway. The next day, I was feeling almost back to normal. That was so scary for me since I was home alone and didn't know what the heck was happening to me!
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Muscle spasms, Nausea, Pyrexia
Clinical narrative: Severe muscle crAmps And spAsms in Left Arm and Leg. Nausea and fever. Approximately for 8 - 10 dAy from Vaccines. I waited for VAERS material which took about 10 days, so I didn't go back to Hospital
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Rash, Rash maculo-papular, Rash pruritic, Urticaria
Clinical narrative: Fully body rash on chest, arms, face urticaria, maculopapular rash pruritic: Also on legs
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Dizziness, Muscle twitching
Clinical narrative: Muscle twitching; Unresponsive to stimuli; This report was identified from a line listing obtained on request by the Company from the FDA (VAER # 744310) under the Freedom of Information Act.   This report was originally received from FDA, referring to an 18 year old male patient. There was no concomitant therapy. The patient had no known allergy. Information about the patient's concurrent condition or medical history was not provided.         On 03-APR-2018, at the private doctor's office/hospital, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, strength, were unknown) lot # N004799 and expiration date not reported, but upon internal validation established as 15-NOV-2019, intramuscularly in left arm for prophylaxis. On the same day, the patient was vaccinated with the second dose of meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO) (lot # 168101) intramuscularly in right arm, the third dose of meningococcal acyw conj vaccine (crm197)(MENVEO) (lot # M16164) intramuscularly in left arm and the second dose of influenza virus split virion 4v vaccine inactivated(FLULAVAL (INFLUENZA VIRUS SPLIT VIRION 4V VACCINE INACTIVATED)) (lot # 51R3F) intramuscularly in right arm.   On 03-APR-2018, the patient was brought down to the floor, his head made some movements 3-4 times like twitching. After about 30-45 seconds, he responded when asked his name. Pulse 90/min regular, Heart regular rate and rhythm (RRR), no murmurs. 911 was called; And then they took him to emergency room (ER) for observation. The outcome of the events was recovered. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Follow-up information was rceived from a physician via Agency on 29-OCT-2019 regarding to patient.  Follow-up information was received from the physician on 03-JAN-2020. The expiration date of meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO) (lot # 168101), meningococcal acyw conj vaccine (crm197) (MENVEO) (lot # M16164) and influenza virus split virion 4v vaccine inactivated (FLULAVAL (INFLUENZA VIRUS SPLIT VIRION 4V VACCINE INACTIVATED)) (lot # 51R3F) were reported as 31-JAN-2019, 31-OCT-2018 and 30-JUN-2018 respectively. On 03-APR-2018, the patient was anxious before the vaccines were given and had not eaten anything that day. The vaccine syringe was dispensed in sharp container. The vaccine was used according to the instruction leaflet. The patient felt dizzy after the last vaccine was given. The patient was brought down to the floor, his head made some movement 3 to 4 times like twitching. After about 30 to 40 seconds, he responded when asked his name. 911 was called and went to ER. On 04-JAN-2018, according to mom, patient was discharged from hospital from ER. The patient did not stay overnight. There were no symptoms again. The patient had not returned to the Clinic again. The reporter considered the muscle twitching as related to the vaccines.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Angioedema, Headache, Rash, Rash pruritic, Syncope
Clinical narrative: angioedema 3 days after immunisation; HA; rash head to toe; faint itchy rash; vertigo; This report was identified from a line listing obtained on request by the Company from the FDA (HA # 810108) under the Freedom of Information Act and refers to a 13-year-old female patient. She had none diagnosed allergies, birth defects and medical conditions. The patient was not taking any medications within 4 weeks prior to vaccination.  On 08-APR-2019 (also reported as 24th) at 16:30 (reported as 4:30 p.m.), the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the left deltoid (lot # was reported as R005341 and expiry date was not reported, but upon internal validation it was established as 06-DEC-2020) for prophylaxis. On 09-APR-2019 at 17:00 (also reported as 24 hours after vaccination; 5:00 p.m.), she had vertigo and headache (reported as HA). The patient was fine for the next 24 hours. Then (also reported as today), she developed rash from head to toe, faint, itchy rash. She was better after 2 doses of prednisone. On 11-APR-2019 (reported as 3 days after immunization), she developed angioedema. No laboratory tests were performed. Approximately on 15-APR-2019(reported as x7 days), the patient recovered from the rash. On an unknown date in April 2019, the patient recovered from the events.  The causality assessment was not provided.  The agency considered this report to be non-serious.  Follow up information has been received from the physician on 03-JAN-2020. The physician reported that the mother of the patient reported a possible reaction to the "vaccine".
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Vertigo
Clinical narrative: angioedema 3 days after immunisation; HA; rash head to toe; faint itchy rash; vertigo; This report was identified from a line listing obtained on request by the Company from the FDA (HA # 810108) under the Freedom of Information Act and refers to a 13-year-old female patient. She had none diagnosed allergies, birth defects and medical conditions. The patient was not taking any medications within 4 weeks prior to vaccination.  On 08-APR-2019 (also reported as 24th) at 16:30 (reported as 4:30 p.m.), the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the left deltoid (lot # was reported as R005341 and expiry date was not reported, but upon internal validation it was established as 06-DEC-2020) for prophylaxis. On 09-APR-2019 at 17:00 (also reported as 24 hours after vaccination; 5:00 p.m.), she had vertigo and headache (reported as HA). The patient was fine for the next 24 hours. Then (also reported as today), she developed rash from head to toe, faint, itchy rash. She was better after 2 doses of prednisone. On 11-APR-2019 (reported as 3 days after immunization), she developed angioedema. No laboratory tests were performed. Approximately on 15-APR-2019(reported as x7 days), the patient recovered from the rash. On an unknown date in April 2019, the patient recovered from the events.  The causality assessment was not provided.  The agency considered this report to be non-serious.  Follow up information has been received from the physician on 03-JAN-2020. The physician reported that the mother of the patient reported a possible reaction to the "vaccine".
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Hypoaesthesia, Vomiting
Clinical narrative: Violent vomiting 5pm - 11pm 11-26-2019  11-27-2019 numbness in both hands and right side of body  11-27-2019 to 12-4-2019 joint pain through body
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: fever; fetl horrible; This case was reported by a consumer and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and feeling abnormal. On an unknown date, the outcome of the fever and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the fever and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter stated that, after 1st dose did not have specifics, but felt horrible for 12 hours but did not have fever like had 1st time. For tolerances of 2nd dose, refer case US2019AMR230419, reported by same reporter for the same patient.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Abdominal discomfort, Dyspnoea, Feeling hot, Hyperhidrosis, Influenza like illness
Clinical narrative: Nauseous; Felt like she would pass out; Sweating; Hyperventilating; Bladder Infection; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, feeling abnormal, sweating, hyperventilation and bladder infection. The patient was treated with anxiolytics (Antianxiety Medication (Nos)). On an unknown date, the outcome of the nausea, feeling abnormal, sweating, hyperventilation and bladder infection were unknown.   It was unknown if the reporter considered the nausea, feeling abnormal, sweating, hyperventilation and bladder infection to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccination and thinks that it was close to the time when she had to go to the emergency room because she felt like she was going to pass out, felt nauseous, sweaty, and was hyperventilating. The patient went to the emergency room on 23rd October 2019. The patient was given fluids, an anti-anxiety medication, and hot blankets were put on her. The patient did not have to stay overnight and was diagnosed with a bladder infection. This case has been linked with case US2019AMR225782, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Malaise, Migraine, Musculoskeletal pain, Palpitations, Tremor
Clinical narrative: Nauseous; Felt like she would pass out; Sweating; Hyperventilating; Bladder Infection; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, feeling abnormal, sweating, hyperventilation and bladder infection. The patient was treated with anxiolytics (Antianxiety Medication (Nos)). On an unknown date, the outcome of the nausea, feeling abnormal, sweating, hyperventilation and bladder infection were unknown.   It was unknown if the reporter considered the nausea, feeling abnormal, sweating, hyperventilation and bladder infection to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccination and thinks that it was close to the time when she had to go to the emergency room because she felt like she was going to pass out, felt nauseous, sweaty, and was hyperventilating. The patient went to the emergency room on 23rd October 2019. The patient was given fluids, an anti-anxiety medication, and hot blankets were put on her. The patient did not have to stay overnight and was diagnosed with a bladder infection. This case has been linked with case US2019AMR225782, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Vaccine positive rechallenge
Clinical narrative: Nauseous; Felt like she would pass out; Sweating; Hyperventilating; Bladder Infection; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, feeling abnormal, sweating, hyperventilation and bladder infection. The patient was treated with anxiolytics (Antianxiety Medication (Nos)). On an unknown date, the outcome of the nausea, feeling abnormal, sweating, hyperventilation and bladder infection were unknown.   It was unknown if the reporter considered the nausea, feeling abnormal, sweating, hyperventilation and bladder infection to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccination and thinks that it was close to the time when she had to go to the emergency room because she felt like she was going to pass out, felt nauseous, sweaty, and was hyperventilating. The patient went to the emergency room on 23rd October 2019. The patient was given fluids, an anti-anxiety medication, and hot blankets were put on her. The patient did not have to stay overnight and was diagnosed with a bladder infection. This case has been linked with case US2019AMR225782, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Cystitis, Feeling abnormal, Hyperhidrosis, Hyperventilation, Nausea
Clinical narrative: Nauseous; Felt like she would pass out; Sweating; Hyperventilating; Bladder Infection; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, feeling abnormal, sweating, hyperventilation and bladder infection. The patient was treated with anxiolytics (Antianxiety Medication (Nos)). On an unknown date, the outcome of the nausea, feeling abnormal, sweating, hyperventilation and bladder infection were unknown.   It was unknown if the reporter considered the nausea, feeling abnormal, sweating, hyperventilation and bladder infection to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccination and thinks that it was close to the time when she had to go to the emergency room because she felt like she was going to pass out, felt nauseous, sweaty, and was hyperventilating. The patient went to the emergency room on 23rd October 2019. The patient was given fluids, an anti-anxiety medication, and hot blankets were put on her. The patient did not have to stay overnight and was diagnosed with a bladder infection. This case has been linked with case US2019AMR225782, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Influenza like illness
Clinical narrative: Nauseous; Felt like she would pass out; Sweating; Hyperventilating; Bladder Infection; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, feeling abnormal, sweating, hyperventilation and bladder infection. The patient was treated with anxiolytics (Antianxiety Medication (Nos)). On an unknown date, the outcome of the nausea, feeling abnormal, sweating, hyperventilation and bladder infection were unknown.   It was unknown if the reporter considered the nausea, feeling abnormal, sweating, hyperventilation and bladder infection to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccination and thinks that it was close to the time when she had to go to the emergency room because she felt like she was going to pass out, felt nauseous, sweaty, and was hyperventilating. The patient went to the emergency room on 23rd October 2019. The patient was given fluids, an anti-anxiety medication, and hot blankets were put on her. The patient did not have to stay overnight and was diagnosed with a bladder infection. This case has been linked with case US2019AMR225782, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arteriosclerosis, Asthenia, Balance disorder, Coronary artery bypass, Costochondritis
Clinical narrative: cardiac injuries requiring triple bypass surgery; post herpetic neuralgia; balance injuries; neurological injuries; lesions on face; atherosclerosis; chondrocostal junction syndrome/tietze syndrome; painful and crippling shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age .The pt's medical history, concurrent conditions and concomitant medications were not provided. On 09-NOV-2016, the pt was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In March 2017 (reported as "approximately four (4) months after receiving zoster vaccine live(ZOSTAVAX)"), pt suffered debilitating injuries including painful and crippling shingles, post herpetic neuralgia, balance and other neurological injuries, lesions on her face, atherosclerosis and other cardiac injuries requiring triple bypass surgery, and eventually chondrocostal junction syndrome/Tietze syndrome, all as a result of zoster vaccine live(ZOSTAVAX). As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, 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), pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The events painful and crippling shingles, post herpetic neuralgia, balance and other neurological injuries, lesions on her face, atherosclerosis and other cardiac injuries requiring triple bypass surgery, and eventually chondrocostal junction syndrome/Tietze syndrome were considered as disability. Upon internal review, cardiac injuries requiring triple bypass surgery was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Heart injury, Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia
Clinical narrative: cardiac injuries requiring triple bypass surgery; post herpetic neuralgia; balance injuries; neurological injuries; lesions on face; atherosclerosis; chondrocostal junction syndrome/tietze syndrome; painful and crippling shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age .The pt's medical history, concurrent conditions and concomitant medications were not provided. On 09-NOV-2016, the pt was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In March 2017 (reported as "approximately four (4) months after receiving zoster vaccine live(ZOSTAVAX)"), pt suffered debilitating injuries including painful and crippling shingles, post herpetic neuralgia, balance and other neurological injuries, lesions on her face, atherosclerosis and other cardiac injuries requiring triple bypass surgery, and eventually chondrocostal junction syndrome/Tietze syndrome, all as a result of zoster vaccine live(ZOSTAVAX). As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, 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), pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The events painful and crippling shingles, post herpetic neuralgia, balance and other neurological injuries, lesions on her face, atherosclerosis and other cardiac injuries requiring triple bypass surgery, and eventually chondrocostal junction syndrome/Tietze syndrome were considered as disability. Upon internal review, cardiac injuries requiring triple bypass surgery was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: cardiac injuries requiring triple bypass surgery; post herpetic neuralgia; balance injuries; neurological injuries; lesions on face; atherosclerosis; chondrocostal junction syndrome/tietze syndrome; painful and crippling shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age .The pt's medical history, concurrent conditions and concomitant medications were not provided. On 09-NOV-2016, the pt was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In March 2017 (reported as "approximately four (4) months after receiving zoster vaccine live(ZOSTAVAX)"), pt suffered debilitating injuries including painful and crippling shingles, post herpetic neuralgia, balance and other neurological injuries, lesions on her face, atherosclerosis and other cardiac injuries requiring triple bypass surgery, and eventually chondrocostal junction syndrome/Tietze syndrome, all as a result of zoster vaccine live(ZOSTAVAX). As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, 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), pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The events painful and crippling shingles, post herpetic neuralgia, balance and other neurological injuries, lesions on her face, atherosclerosis and other cardiac injuries requiring triple bypass surgery, and eventually chondrocostal junction syndrome/Tietze syndrome were considered as disability. Upon internal review, cardiac injuries requiring triple bypass surgery was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Amaurosis fugax, Cerebrovascular accident, Hemiparesis, Hypoaesthesia, Keratitis
Clinical narrative: thalamic cerebrovascular accident with left sided weakness; keratoconjunctivitis of the left eye; amaurosis fugax of the left eye; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age .The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 01-SEP-2015, the pt was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In 2015 (reported as "shortly after receiving zoster vaccine live(ZOSTAVAX)"), pt suffered decreased vision and was diagnosed with amaurosis fugax of the left eye and keratoconjunctivitis of the left eye. Pt additionally experienced acute let sided weakness and numbness and was diagnosed with a thalamic cerebrovascular accident with left sided weakness. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt 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), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The events amaurosis fugax of the left eye, keratoconjunctivitis of the left eye, thalamic cerebrovascular accident with left sided weakness were considered as disability. Upon internal review, amaurosis fugax of the left eye, thalamic cerebrovascular accident with left sided weakness were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: thalamic cerebrovascular accident with left sided weakness; keratoconjunctivitis of the left eye; amaurosis fugax of the left eye; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age .The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 01-SEP-2015, the pt was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In 2015 (reported as "shortly after receiving zoster vaccine live(ZOSTAVAX)"), pt suffered decreased vision and was diagnosed with amaurosis fugax of the left eye and keratoconjunctivitis of the left eye. Pt additionally experienced acute let sided weakness and numbness and was diagnosed with a thalamic cerebrovascular accident with left sided weakness. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt 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), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The events amaurosis fugax of the left eye, keratoconjunctivitis of the left eye, thalamic cerebrovascular accident with left sided weakness were considered as disability. Upon internal review, amaurosis fugax of the left eye, thalamic cerebrovascular accident with left sided weakness were determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: He reported that an administered dose of VARIVAX underwent temperature excursions prior to being administered; no adverse effect; This spontaneous report as received from a physician refers to a patient of unknown age. The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S012036, expiry date: 17-APR-2021, strength, dosage information, route were not reported) for prophylaxis. The vaccine underwent temperature excursions prior to being administered to the temperature and time frame of 8 fahrenheit (F) for 40 minutes (product storage error). The previous temperature excursion was 14 F for 30 minutes. Data logger was involved. No known adverse effects were reported. No further information was reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; Administered intramuscularly; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 19-NOV-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose and frequency were not reported) (lot # R036582, expiration date 17-DEC-2020, albumin status recombinant Human albumin (rHA)) intramuscularly for prophylaxis (incorrect route of product administration). No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: fever; body aches/hurting too bad to stay in bed; arm red; swollen arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st December 2019, the patient received the 2nd dose of Shingrix. In December 2019, 1 day 14 hrs after receiving Shingrix and an unknown time after starting Acetaminophen and ibuprofen, the patient experienced fever, general body pain, erythema of extremities and swelling arm. The patient was treated with paracetamol (Acetaminophen) and ibuprofen. On an unknown date, the outcome of the fever, general body pain, erythema of extremities and swelling arm were unknown.   It was unknown if the reporter considered the fever, general body pain, erythema of extremities and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received shingrix vaccine around 1 PM on Saturday of this past week and awoke around 3 AM the following morning with a 103 degree temperature and multiple body aches.  The patient was hurting too bad to stay in bed. Since that time, the patient was rotating acetaminophen with ibuprofen to try to keep the fever down. The patient arm was red and swollen.  The patient asked was all trying to kill me. What was the death all from this shingrix vaccine. The reporter asked what to stop all this.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Pyrexia
Clinical narrative: feeling chill; Fever; Headache; This case was reported by a consumer and described the occurrence of chilliness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 1st January 2020, the patient received Shingles vaccine. On 1st January 2020, less than a day after receiving Shingles vaccine, the patient experienced chilliness, fever and headache. On an unknown date, the outcome of the chilliness, fever and headache were unknown.   It was unknown if the reporter considered the chilliness, fever and headache to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient took a shingle vaccine shot in morning and feeling chill, fever and headache. The patient asked if Ibuprofen or Tylenol would help for treatment.
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy site unspecified abnormal, Dermatitis contact, Hypersensitivity, Urticaria
Clinical narrative: hypersensitivity reaction; hives; looked like contact dermatitis; This case was reported by a physician via call center representative and described the occurrence of hypersensitivity reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 10 days after receiving Shingrix, the patient experienced hypersensitivity reaction, hives and contact dermatitis. The patient was treated with prednisone. On an unknown date, the outcome of the hypersensitivity reaction, hives and contact dermatitis were recovering/resolving.   It was unknown if the reporter considered the hypersensitivity reaction, hives and contact dermatitis to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reaction initially looked like contact dermatitis, then hives. It became widespread and severe so a biopsy was performed that showed it was a hypersensitivity reaction.  The patient took a couple courses of prednisone. It was at the time of reporting a couple months since he was first seen in the office and the reaction has improved a lot.  The emergency room visit required to the patient.      Lab Comments: Biopsy was performed on unknown date and that showed it was a hypersensitivity reaction
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Bursitis, Injection site erythema, Injection site swelling, Musculoskeletal pain
Clinical narrative: redness at injection site; swelling at injection site; joint pain/bursitis/ pain in elbow/ pain in the joint of the left hip / knee pain; started in the shoulder then in the elbow; bursitis; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included skin peeling (had skin pealed after contact cold tablet). Previously experienced adverse reactions included rash (had rash after contact cold tablet). Previously administered products included Contact cold (Received contact cold tablet).   On 14th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, joint pain, shoulder pain and bursitis. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the joint pain was not recovered/not resolved and the outcome of the shoulder pain and bursitis were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, joint pain, shoulder pain and bursitis to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. The patient did not have medical history of joint pain, did not fall or hurt. About 40 years ago, the patient took ontact Cold tablets and broke out into a rash in the groin area such that the skin pealed. The patient belived that this was due to a sulfa ingredient. After vaccination, the patient had injection site reaction of redness and swelling which resolved. a few weeks after vaccination the patient experienced joint pain. It started in the shoulder then in the elbow. The patient was working out and got severe pain in the joint of the left hip so stopped exercising for 4-5 weeks and that resolved. 3 weeks ago from the date of reporting, the patient had severe pain in the right hip and knee and these have not resolved and was diagnosed with bursitis. The bursitis pain has spread across his right leg between the knee and the hip.  The reporter did not consent to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: Shingles; Inappropriate Schedule of Vaccine; Circumstance or information capable of leading to medication error; This case was reported by a physician via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 4 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, drug dose administration interval too long and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the shingles, drug dose administration interval too long and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The patient had a mild case of shingles. The patient also planned to delay the 2nd dose by more than 6 months, which led to lengthening of vaccination schedule and circumstance or information capable of leading to medication error.  The reporter consented to follow up. This case has been linked with case US2020000362, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Moderately severe reactions like high fevers; This case was reported by a physician via call center representative and described the occurrence of fever in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the patients friend. The age at vaccination was not applicable for this report. The patient experienced moderately severe reactions like high fevers which lasted a few days.  No further details were provided.  Caller neglected to ask whether safety has permission to follow up.  This case has been linked with case US2020000344, reported by same reporter.      Lab Comments: on an unknown date, lab test was performed
Age: 76.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Back pain, Cardiac stress test abnormal, Erythema, Myalgia, Pain in extremity
Clinical narrative: Left arm became sore; Left arm became red; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included influenza virus vaccine inactivated (Fluzone Quadrivalent (Influenza Virus Vaccine)) for prophylaxis.   Concurrent medical conditions included arthritis and fibromyalgia.   On 8th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Fluzone Quadrivalent (Influenza Virus Vaccine) at an unknown dose and frequency. On 8th October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix vaccine and at the same time she also received Fluzone vaccine just below the Shingrix injection site. On same day, the patient's left arm became sore and red which lasted for at least 3 weeks. The patient stated that there were no symptoms from the Fluzone vaccine.   On November 27, 2019, the patient received her regular injection of the Depo Medrol which she gets once in month and informed that she got very little relief from the back pain and muscle pai. The back pain and muscle pain are conditions that were she had regularly prior to vaccinations due to arthritis and fibromyalgia.   The patient normally gets full relief from the pain when she receives the injection.   The patient also reported that she recently had a Nuclear Stress test that came back as abnormal.  The patient would be receiving heart catheterization to determine if there was something else wrong. The reporter was unable to provide any additional details. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Periorbital swelling, Rash, Somnolence, Vaccine positive rechallenge
Clinical narrative: Rash; swelling around the eyes; sleepy; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in April 2019, refer linked case US2020AMR000600).   On 24th September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced rash, periocular swelling and sleepiness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, periocular swelling and sleepiness were unknown.   It was unknown if the reporter considered the rash, periocular swelling and sleepiness to be related to Shingrix.  Additional details were provided as follows: The batch number and expiration dates were not provided as the patient received the vaccine in another facility. The patient that received the 2nd dose of Shingrix and experienced rash, swelling around the eyes and felt sleepy. The reporter requested information about how to proceed. The reporter to follow up.
Age: 26.0
Sex: F
Vaccine: TD, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was administered with Tenivac instead of Adacel, no AE.; Initial information received on 27-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 26 years old female patient who was vaccinated with 0.5 ml of vaccine Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] (lot number U6265AA and expiration date 19-April-2021) via intramuscular route in the left deltoid instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] (lot number and expiration date unknown) via unknown route in unknown administration site on 26-Dec-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong product administered.  No adverse event reported at the time of reporting.  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 and Module VI of the 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: 52.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Periarthritis, Product administered at inappropriate site
Clinical narrative: Shoulder is very sore with limited range of motion.  The shot was given high just below the bone.  felt the pain immediately.