chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Spinal pain, Tinnitus
Clinical narrative: Headache began within 1 hr., 102° temp next day, extreme soreness on entire body, injection site swelled & hardened, neck hurt on spine, could hear swooshing sounds in head, made me off balance, all passed after 3 days except left me lethargic for a few days. I;m still glad I took it: Shingles last much longer.
Age: 73.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Abdominal pain upper, Ageusia, Angiogram cerebral normal, Arteriogram carotid abnormal, Asthenia
Clinical narrative: Vaccine on the 30th and started feeling sick 2-3 days later. Patient states nausea, muscle pain, stomach pain, head hurt, standing up made him dizzy. No fevers. Patient presented to ED with weakness, gait difficulty, dizziness and nausea. Patient states his left hand is so weak he is unable to grip anything including a pen due to symptoms. Patient had extensive workup in hospital and was dx with ASEPTIC MENNIGITISwhich they feel could be related to flu vaccine as patient developed symptoms after having vaccine.XrayChest-No acute cardiopulmonary abnormally identified. CT Angiogram head, CT venogram head-Unremarkable.CT Angiogram Head, CT angiogram neck-No acute intracranial vascular occlusion or significant stenosis.MRI brain- There is no acute infarct in the brain.Suspect infection or inflammatory process such as herpex complex encephalitis, venous thrombosis,or vasculitis.TEE-NO cardiac sorce of embolus  identified. WBC-11.5.Patienthospitalized on 10/9/2020-10/13/2020 for aseptic meningitis possible related to recent flu vaccine. He was seen by neurology and infectious disease specialist.Patient reports decreased strength in left hand, reports loss spatial awareness on the left side reports he bumps into objects/furniture. Walking  isslower.Reports loss of sense of taste. His son reports he also has trouble with organization and complex reasoning.Pt seeing neurology and PT at this point.
Age: 73.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chest X-ray normal, Decreased gait velocity, Disorientation, Dizziness, Dizziness postural
Clinical narrative: Vaccine on the 30th and started feeling sick 2-3 days later. Patient states nausea, muscle pain, stomach pain, head hurt, standing up made him dizzy. No fevers. Patient presented to ED with weakness, gait difficulty, dizziness and nausea. Patient states his left hand is so weak he is unable to grip anything including a pen due to symptoms. Patient had extensive workup in hospital and was dx with ASEPTIC MENNIGITISwhich they feel could be related to flu vaccine as patient developed symptoms after having vaccine.XrayChest-No acute cardiopulmonary abnormally identified. CT Angiogram head, CT venogram head-Unremarkable.CT Angiogram Head, CT angiogram neck-No acute intracranial vascular occlusion or significant stenosis.MRI brain- There is no acute infarct in the brain.Suspect infection or inflammatory process such as herpex complex encephalitis, venous thrombosis,or vasculitis.TEE-NO cardiac sorce of embolus  identified. WBC-11.5.Patienthospitalized on 10/9/2020-10/13/2020 for aseptic meningitis possible related to recent flu vaccine. He was seen by neurology and infectious disease specialist.Patient reports decreased strength in left hand, reports loss spatial awareness on the left side reports he bumps into objects/furniture. Walking  isslower.Reports loss of sense of taste. His son reports he also has trouble with organization and complex reasoning.Pt seeing neurology and PT at this point.
Age: 73.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Echocardiogram, Gait disturbance, Grip strength decreased, Headache, Herpes simplex encephalitis
Clinical narrative: Vaccine on the 30th and started feeling sick 2-3 days later. Patient states nausea, muscle pain, stomach pain, head hurt, standing up made him dizzy. No fevers. Patient presented to ED with weakness, gait difficulty, dizziness and nausea. Patient states his left hand is so weak he is unable to grip anything including a pen due to symptoms. Patient had extensive workup in hospital and was dx with ASEPTIC MENNIGITISwhich they feel could be related to flu vaccine as patient developed symptoms after having vaccine.XrayChest-No acute cardiopulmonary abnormally identified. CT Angiogram head, CT venogram head-Unremarkable.CT Angiogram Head, CT angiogram neck-No acute intracranial vascular occlusion or significant stenosis.MRI brain- There is no acute infarct in the brain.Suspect infection or inflammatory process such as herpex complex encephalitis, venous thrombosis,or vasculitis.TEE-NO cardiac sorce of embolus  identified. WBC-11.5.Patienthospitalized on 10/9/2020-10/13/2020 for aseptic meningitis possible related to recent flu vaccine. He was seen by neurology and infectious disease specialist.Patient reports decreased strength in left hand, reports loss spatial awareness on the left side reports he bumps into objects/furniture. Walking  isslower.Reports loss of sense of taste. His son reports he also has trouble with organization and complex reasoning.Pt seeing neurology and PT at this point.
Age: 73.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Impaired reasoning, Magnetic resonance imaging brain abnormal, Malaise, Meningitis aseptic, Muscular weakness
Clinical narrative: Vaccine on the 30th and started feeling sick 2-3 days later. Patient states nausea, muscle pain, stomach pain, head hurt, standing up made him dizzy. No fevers. Patient presented to ED with weakness, gait difficulty, dizziness and nausea. Patient states his left hand is so weak he is unable to grip anything including a pen due to symptoms. Patient had extensive workup in hospital and was dx with ASEPTIC MENNIGITISwhich they feel could be related to flu vaccine as patient developed symptoms after having vaccine.XrayChest-No acute cardiopulmonary abnormally identified. CT Angiogram head, CT venogram head-Unremarkable.CT Angiogram Head, CT angiogram neck-No acute intracranial vascular occlusion or significant stenosis.MRI brain- There is no acute infarct in the brain.Suspect infection or inflammatory process such as herpex complex encephalitis, venous thrombosis,or vasculitis.TEE-NO cardiac sorce of embolus  identified. WBC-11.5.Patienthospitalized on 10/9/2020-10/13/2020 for aseptic meningitis possible related to recent flu vaccine. He was seen by neurology and infectious disease specialist.Patient reports decreased strength in left hand, reports loss spatial awareness on the left side reports he bumps into objects/furniture. Walking  isslower.Reports loss of sense of taste. His son reports he also has trouble with organization and complex reasoning.Pt seeing neurology and PT at this point.
Age: 73.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Myalgia, Nausea, Vasculitis, Venogram normal, Venous thrombosis
Clinical narrative: Vaccine on the 30th and started feeling sick 2-3 days later. Patient states nausea, muscle pain, stomach pain, head hurt, standing up made him dizzy. No fevers. Patient presented to ED with weakness, gait difficulty, dizziness and nausea. Patient states his left hand is so weak he is unable to grip anything including a pen due to symptoms. Patient had extensive workup in hospital and was dx with ASEPTIC MENNIGITISwhich they feel could be related to flu vaccine as patient developed symptoms after having vaccine.XrayChest-No acute cardiopulmonary abnormally identified. CT Angiogram head, CT venogram head-Unremarkable.CT Angiogram Head, CT angiogram neck-No acute intracranial vascular occlusion or significant stenosis.MRI brain- There is no acute infarct in the brain.Suspect infection or inflammatory process such as herpex complex encephalitis, venous thrombosis,or vasculitis.TEE-NO cardiac sorce of embolus  identified. WBC-11.5.Patienthospitalized on 10/9/2020-10/13/2020 for aseptic meningitis possible related to recent flu vaccine. He was seen by neurology and infectious disease specialist.Patient reports decreased strength in left hand, reports loss spatial awareness on the left side reports he bumps into objects/furniture. Walking  isslower.Reports loss of sense of taste. His son reports he also has trouble with organization and complex reasoning.Pt seeing neurology and PT at this point.
Age: 73.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: White blood cell count increased
Clinical narrative: Vaccine on the 30th and started feeling sick 2-3 days later. Patient states nausea, muscle pain, stomach pain, head hurt, standing up made him dizzy. No fevers. Patient presented to ED with weakness, gait difficulty, dizziness and nausea. Patient states his left hand is so weak he is unable to grip anything including a pen due to symptoms. Patient had extensive workup in hospital and was dx with ASEPTIC MENNIGITISwhich they feel could be related to flu vaccine as patient developed symptoms after having vaccine.XrayChest-No acute cardiopulmonary abnormally identified. CT Angiogram head, CT venogram head-Unremarkable.CT Angiogram Head, CT angiogram neck-No acute intracranial vascular occlusion or significant stenosis.MRI brain- There is no acute infarct in the brain.Suspect infection or inflammatory process such as herpex complex encephalitis, venous thrombosis,or vasculitis.TEE-NO cardiac sorce of embolus  identified. WBC-11.5.Patienthospitalized on 10/9/2020-10/13/2020 for aseptic meningitis possible related to recent flu vaccine. He was seen by neurology and infectious disease specialist.Patient reports decreased strength in left hand, reports loss spatial awareness on the left side reports he bumps into objects/furniture. Walking  isslower.Reports loss of sense of taste. His son reports he also has trouble with organization and complex reasoning.Pt seeing neurology and PT at this point.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: & neuropathy of hand
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Influenza
Clinical narrative: Patient received first Shingrix dose. 5 months later he cancelled appointment for second dose stating he had "flu symptoms" after his first Shingrix dose. No treatment required, second dose cancelled.
Age: 73.0
Sex: M
Vaccine: FLU4, HEPAB
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Magnetic resonance imaging abnormal, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Patient had severe pain after getting the vaccine, so he reached out to his doctor, he had to do a MRI on his shoulder and he was diagnosed with shoulder injury related to vaccine administration (SIRVA). He is currently getting physical therapy
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood test, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: cannot bend her hand or make a fist/She can bend her thumb and finger but not the other three. Stated that the knuckles of the other three have disappeared; Joint, bone and muscle pain all over; Her hand is swollen/stated that her left hand is swollen; Joint, bone and muscle pain all over; Joint, bone and muscle pain all over; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on 28Oct2020 at 0.5 mL single dose in her left arm for immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from 2010 and ongoing. Concomitant medication included ongoing fluticasone furoate/vilanterol trifenatate (BREO ELLIPTA) taking it three years ago. The patient had bed reaction on 28Oct2020. She was wondering if she would be crippled the rest of her life. The patient had joint, bone and muscle pain all over on 01Nov2020, stated the pain was like she got hit by a car. On the side that she got the shot that her hand was swollen on 01Nov2020 and she could not bend it. Her left hand had been pretty bad swollen all week. It was bad when it started and terrible now. She could not bend her hand or make a fist. She could bend her thumb and finger but not the other three (onset unknown). The knuckles of the other three had disappeared. She went to the doctor on 06Nov2020 and had not had any treatment. Her doctor did not give it but told her to go get it. The outcome of events was not recovered.    No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Bone pain, Injected limb mobility decreased, Myalgia, Peripheral swelling
Clinical narrative: cannot bend her hand or make a fist/She can bend her thumb and finger but not the other three. Stated that the knuckles of the other three have disappeared; Joint, bone and muscle pain all over; Her hand is swollen/stated that her left hand is swollen; Joint, bone and muscle pain all over; Joint, bone and muscle pain all over; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on 28Oct2020 at 0.5 mL single dose in her left arm for immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from 2010 and ongoing. Concomitant medication included ongoing fluticasone furoate/vilanterol trifenatate (BREO ELLIPTA) taking it three years ago. The patient had bed reaction on 28Oct2020. She was wondering if she would be crippled the rest of her life. The patient had joint, bone and muscle pain all over on 01Nov2020, stated the pain was like she got hit by a car. On the side that she got the shot that her hand was swollen on 01Nov2020 and she could not bend it. Her left hand had been pretty bad swollen all week. It was bad when it started and terrible now. She could not bend her hand or make a fist. She could bend her thumb and finger but not the other three (onset unknown). The knuckles of the other three had disappeared. She went to the doctor on 06Nov2020 and had not had any treatment. Her doctor did not give it but told her to go get it. The outcome of events was not recovered.    No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Patient had a baseball sized bruise.  Denied having fever or chills, not warm to the touch.
Age: 22.0
Sex: F
Vaccine: FLUR4
Symptoms: Loss of consciousness
Clinical narrative: Approximately 7 minutes after receiving a flu vaccine patient was walking in front of the pharmacy and told her husband she was feeling faint. She passed out shortly after and he helped guide her to the ground. She came to shortly afterwards. The pharmacist came to the patient's side and instructed her to lay on the ground as long as she needed and provided water (per patient's request). Assistance was called over the intercom system and the PIC and Store Director came to see if the patient was ok. She said that she had fainted once before when she was a child and has felt light headed after vaccines in the past but this was the first time she had fainted since childhood. The patient rested on the ground for about 5 minutes before getting to her feet and then rested another 10 minutes or so in the pharmacy lobby. Patient said she felt fine and left on her own accord with her husband. No medical personnel was called and patient did not request any additional medical treatment on site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pruritus, Urticaria
Clinical narrative: Broke out in hives some hours after receiving first dose; did not make connection to vaccine until next day. Suffered 15 - 20 hives, very itchy for days into weeks; would subside and then be itchy again. Very slow to go away.   It is now 9 days after receiving vaccine. I am still breaking out in new hives, not as many as before, but very itchy and uncomfortable. I don't see hives listed as a side effect, but there is nothing else that has changed in my environment or diet. This seems excessive and far too long to be suffering side effects.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Flu shot given right arm.Within 5 hrs I had itch accompanied by Hives that moved over body in 2x2 inch areas that each one resolved & moved to another spot within 20 minutes but within 16hrs the itch was increased with hives.Within 24hrs there was no release from itch & hives with Benedryl & Hydrocortisone so I notified Dr.The Hives had become bright red with welts.Eventually put on Steroid tapering pack and within 2 days the itch had greatly decreased along with Benedryl Q6hr ATC.Once off Steriod(complete11/4/20) The itch still present but not as bas,Zyrtec 1st dose 11/7/20 9am decreased itching but by 8pm HR tachy 120's at rest.I slept except for bathroom & fluids for 13 hrs then a switch seemed to go off & I no longer had itch.Still with hives but no longer bright red welts.
Age: 0.58
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 7 month old patient was administered with GARDASIL 9; This spontaneous report was received from a physician referring to a 7 month old patient of unknown gender. The patient's pertinent medical history or concomitant medications were not reported.  In the morning of 05-NOV-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dosage regimen information was not reported).
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Off label use, Product administered to patient of inappropriate age, Rash erythematous, Rash pruritic
Clinical narrative: very itchy, red rash/small, few dots of a rash / progressively gotten worse / is systemic / including / armpits; very itchy, red rash; received dose #1 of Shingrix on 10/28/2020.; received a prescription from her rheumatologist to receive Shingrix off-label; This case was reported by a pharmacist via sales rep and described the occurrence of itchy rash in a 48-year-old female patient who received Herpes zoster (Shingrix) (batch number CE4DE, expiry date 25th September 2022) for prophylaxis.   On 28th October 2020, the patient received the 1st dose of Shingrix. On 28th October 2020, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and off label use. On 29th October 2020, the patient experienced itchy rash and red rash. On an unknown date, the outcome of the itchy rash, red rash, inappropriate age at vaccine administration and off label use were unknown.   It was unknown if the reporter considered the itchy rash and red rash to be related to Shingrix.  Additional details were reported as follows: The patient received a prescription from her rheumatologist to receive Shingrix which led to off label. The patient received vaccine outside recommended age which led to inappropriate age at vaccine administration.  The patient received dose 1 of Shingrix  and stated that she experienced a small, few dots of a rash the day after injection which were progressively gotten worse each day. On day 5, the rash was systemic, including in her armpits. The rash was a very itchy and red spread all over. At the time of patient reported the rash to the pharmacist, the patient had not used any treatment for the rash, nor sought medical attention. The pharmacist suggested that the patient contact her doctor for follow-up since the rash has not gotten better.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: fever; achiness; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient wanted to know how long does the fever and achiness last after 2nd dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: following the 1st dose was a sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and the only symptom she remembers following the 1st dose was a sore arm. The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2020217470.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020217470:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: zoster like rash in her R breast after shingrix vaccine; This case was reported by a other health professional via interactive digital media and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. It was reported that the patient reacted with a zoster like rash on her right breast day after Shingrix vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: left upper arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension.   On 13th August 2020, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine in her left arm and she had left upper arm pain for 3 days and it resolved. The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2020220481; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220481:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Faeces discoloured, Fatigue, Headache, Pain
Clinical narrative: body aches; arm pain; discoloration in bowel movements; bowel changes; fatigue; headache; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced general body pain, pain in arm, stool discolored, bowel discomfort, fatigue and headache. On an unknown date, the outcome of the general body pain, pain in arm, stool discolored, bowel discomfort, fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the general body pain, pain in arm, stool discolored, bowel discomfort, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not want to provide their full date of birth and gave permission to follow up with their HCP. The patient received Shingrix and experienced body aches, arm pain, discoloration in bowel movements, bowel changes, fatigue and was not sure if she had a headache.  Adverse events had resolved and only lasted 4 to 5 days. The reporter consented to follow up. Not all information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: body aches; arm pain; discoloration in bowel movements; bowel changes; fatigue; headache; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced general body pain, pain in arm, stool discolored, bowel discomfort, fatigue and headache. On an unknown date, the outcome of the general body pain, pain in arm, stool discolored, bowel discomfort, fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the general body pain, pain in arm, stool discolored, bowel discomfort, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not want to provide their full date of birth and gave permission to follow up with their HCP. The patient received Shingrix and experienced body aches, arm pain, discoloration in bowel movements, bowel changes, fatigue and was not sure if she had a headache.  Adverse events had resolved and only lasted 4 to 5 days. The reporter consented to follow up. Not all information was available.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Herpes zoster, Rash, Sensitive skin, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; Extensive rash on right arm and chest; Pain in his back around the scapula area; Sensitivity in his right forearm; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In January 2019, the patient received the 1st dose of Shingrix. On 1st November 2020, 502 days after receiving Shingrix and between 1 and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, upper back pain and sensitive skin. On 5th November 2020, the outcome of the shingles, rash, upper back pain and sensitive skin were recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash, upper back pain and sensitive skin to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was a retired physician The patient received both doses of Shingrix on an unknown deltoid. The patient experienced shingles, back pain- around the scapula, extensive rash on right arm and chest (especially on pectoral region) and sensitivity in forearm. This case was considered as suspected vaccination failure since the details regarding confirmatory lab test for shingles were not unknown. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Pain in extremity, Product preparation issue
Clinical narrative: SORE ARM; Administered only the adjuvant suspension without reconstituting it w/antigen powder; Administered only the adjuvant suspension without reconstituting it w/antigen powder; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th September 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In October 2020, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The reporter stated that the her pharmacy is short one vial of diluent adjuvant suspension.  The reporter stated that another pharmacist thought that the Shingrix was pre-mixed and administered only the adjuvant suspension without first reconstituting it with the antigen powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter caught the error and notified the patient.  The reporter explained to the patient that she wanted to administer her the reconstituted product.  The reporter did administer the reconstituted product 2 weeks later.  The reporter stated that the reason it was two weeks was because the patient had reported a sore arm and did not want to come in sooner. This case has been linked with case US2020AMR221266, reported for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221266:Same reporter
Sex: F
Vaccine: FLUX
Symptoms: Bedridden, Vaccine positive rechallenge
Clinical narrative: ended up in bed for days; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves female patient (age unspecified) who ended up in bed for days (bedridden), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination twice.  On an unknown date, the patient ended up in bed for days (bedridden) (unknown latency) following the administration of INFLUENZA VACCINE. This happened both times after taking vaccine  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Respiratory tract infection viral
Clinical narrative: Flu; respitory virus; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/ non-health care professional via social media.  This case involves a 72 year old female patient who had flu (influenza) and respiratory virus (respiratory disorder), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and respiratory virus (respiratory disorder) (unknown latency) following the administration of INFLUENZA VACCINE that lasted for months. It was a year since she was vaccinated with flu shot  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, outcome of events was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: ill for a couple days; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves female patient (age not reported) who experienced ill for a couple days (illness), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious ill for a couple days (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Patient has arm pain going down arm. The pain started pretty immediately but it is not getting any better. I recommended patient get follow up with primary care Dr.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: Around 11 pm evening I got 2nd Shingrix I got chills so powerful they woke my husband. No fever, just chills. Next morning feel exhausted and really tired.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Myalgia
Clinical narrative: muscle pain, headache, shivering, stomach pain. theses happened after I wen to bed. I am not sure there was a fever.
Age: 21.0
Sex: F
Vaccine: FLUR4
Symptoms: Dyspnoea, Rash
Clinical narrative: PATIENT HAD A RASH AND SOB
Sex: F
Vaccine: VARCEL
Symptoms: Allergy test positive, Anaphylactic reaction, Antibody test negative, Flushing, Pharyngeal swelling
Clinical narrative: anaphylaxis; Literature report:.  This literature marketed report as received from a physician refers to a 19-year-old female patient. Information about medical history, concomitant therapy and concurrent conditions was unknown. The patient experienced throat swelling and pruritus which rapidly progressed to facial flushing and scattered non-injection site urticaria within 15 minutes of receiving varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route, lot# and expiration date unknown) for prophylaxis.   Symptoms resolved within one hour after treatment with antihistamine and the patient was referred to allergy clinic. The patient underwent skin testing to varicella virus vaccine live (Oka/Merck) (VARIVAX), bovine and porcine gelatin, and neomycin. Full strength skin prick testing (SPT) was negative to all. Intradermal testing (IDT) with 0.2ml of 1:10 varicella virus vaccine live (Oka/Merck) (VARIVAX) was positive as was 0.2ml of 1:100 gelatin. IDT to 1:100 gelatins of the control subject were negative. Four weeks post-vaccination, patient's varicella zoster virus (VZV) IgG titers remained negative.   Allergy work-up concluded that anaphylaxis was secondary to gelatin. Positive IDT to varicella virus vaccine live (Oka/Merck) (VARIVAX) 1:10 dilution indicated the vaccine contains sufficient gelatin to trigger mast cell degranulation in the patient. Anaphylaxis remains a rare adverse event following vaccine administration and gelatin must be considered as a culprit following live virus vaccination.   Upon internal review, the event anaphylaxis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin test positive, Urticaria
Clinical narrative: anaphylaxis; Literature report:.  This literature marketed report as received from a physician refers to a 19-year-old female patient. Information about medical history, concomitant therapy and concurrent conditions was unknown. The patient experienced throat swelling and pruritus which rapidly progressed to facial flushing and scattered non-injection site urticaria within 15 minutes of receiving varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route, lot# and expiration date unknown) for prophylaxis.   Symptoms resolved within one hour after treatment with antihistamine and the patient was referred to allergy clinic. The patient underwent skin testing to varicella virus vaccine live (Oka/Merck) (VARIVAX), bovine and porcine gelatin, and neomycin. Full strength skin prick testing (SPT) was negative to all. Intradermal testing (IDT) with 0.2ml of 1:10 varicella virus vaccine live (Oka/Merck) (VARIVAX) was positive as was 0.2ml of 1:100 gelatin. IDT to 1:100 gelatins of the control subject were negative. Four weeks post-vaccination, patient's varicella zoster virus (VZV) IgG titers remained negative.   Allergy work-up concluded that anaphylaxis was secondary to gelatin. Positive IDT to varicella virus vaccine live (Oka/Merck) (VARIVAX) 1:10 dilution indicated the vaccine contains sufficient gelatin to trigger mast cell degranulation in the patient. Anaphylaxis remains a rare adverse event following vaccine administration and gelatin must be considered as a culprit following live virus vaccination.   Upon internal review, the event anaphylaxis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: right arm was sore; This case was reported by a consumer and described the occurrence of pain in arm in a 78-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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After the 1st dose of Shingrix injection the patient experienced right arm was sore for a couple of days.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR219429:2nd dose US-GLAXOSMITHKLINE-US2020AMR222149:1st dose
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: had developed shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number T79D7, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient believes he received 1st dose of Shingrix and experienced shingles.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Chills
Clinical narrative: Chills; Backache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced chills and back pain. On an unknown date, the outcome of the chills and back pain were recovered/resolved.   It was unknown if the reporter considered the chills and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 23rd January 2020, the patient received the 1st dose. The patient reported after receiving the vaccine within 5 hours she had chills and a backache and these lasted a couple of days and then resolved.  For tolerance to 2nd dose refer linked case US2020AMR222005 and US2020AMR221923, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221342:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Chills, Confusional state, Dissociation, Disturbance in attention
Clinical narrative: Chills; Backache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced chills and back pain. On an unknown date, the outcome of the chills and back pain were recovered/resolved.   It was unknown if the reporter considered the chills and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 23rd January 2020, the patient received the 1st dose. The patient reported after receiving the vaccine within 5 hours she had chills and a backache and these lasted a couple of days and then resolved.  For tolerance to 2nd dose refer linked case US2020AMR222005 and US2020AMR221923, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221342:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dry mouth, Erythema, Feeling abnormal, Feeling hot, Flushing
Clinical narrative: Chills; Backache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced chills and back pain. On an unknown date, the outcome of the chills and back pain were recovered/resolved.   It was unknown if the reporter considered the chills and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 23rd January 2020, the patient received the 1st dose. The patient reported after receiving the vaccine within 5 hours she had chills and a backache and these lasted a couple of days and then resolved.  For tolerance to 2nd dose refer linked case US2020AMR222005 and US2020AMR221923, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221342:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Hot flush, Inappropriate schedule of product administration, Initial insomnia, Insomnia
Clinical narrative: Chills; Backache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced chills and back pain. On an unknown date, the outcome of the chills and back pain were recovered/resolved.   It was unknown if the reporter considered the chills and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 23rd January 2020, the patient received the 1st dose. The patient reported after receiving the vaccine within 5 hours she had chills and a backache and these lasted a couple of days and then resolved.  For tolerance to 2nd dose refer linked case US2020AMR222005 and US2020AMR221923, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221342:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Malaise, Nervous system disorder, Panic reaction, Pyrexia, Tinnitus
Clinical narrative: Chills; Backache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced chills and back pain. On an unknown date, the outcome of the chills and back pain were recovered/resolved.   It was unknown if the reporter considered the chills and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 23rd January 2020, the patient received the 1st dose. The patient reported after receiving the vaccine within 5 hours she had chills and a backache and these lasted a couple of days and then resolved.  For tolerance to 2nd dose refer linked case US2020AMR222005 and US2020AMR221923, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221342:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Disturbance in attention, Erythema, Flushing, Headache
Clinical narrative: Chills; Backache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced chills and back pain. On an unknown date, the outcome of the chills and back pain were recovered/resolved.   It was unknown if the reporter considered the chills and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 23rd January 2020, the patient received the 1st dose. The patient reported after receiving the vaccine within 5 hours she had chills and a backache and these lasted a couple of days and then resolved.  For tolerance to 2nd dose refer linked case US2020AMR222005 and US2020AMR221923, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221342:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Malaise, Tinnitus
Clinical narrative: Chills; Backache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced chills and back pain. On an unknown date, the outcome of the chills and back pain were recovered/resolved.   It was unknown if the reporter considered the chills and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 23rd January 2020, the patient received the 1st dose. The patient reported after receiving the vaccine within 5 hours she had chills and a backache and these lasted a couple of days and then resolved.  For tolerance to 2nd dose refer linked case US2020AMR222005 and US2020AMR221923, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221342:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:same reporter