chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram neck, Computerised tomogram thorax normal, Electrocardiogram normal, Fatigue, Feeling abnormal
Clinical narrative: Began with thunderclap migraine (patient has no history of headaches), abdominal pain, extremely high blood pressure. ER ordered CT scans of head, neck, chest and abdomen, labwork and ekg. All normal. Treated with migraine cocktail. Sent home, blood pressure still very high. Returned to ER on 10/4 with another migraine and extremely high blood pressure. Treated with another migraine cocktail. Returned to ER on 10/8 with spontaneous, hand-sized, very dark bruise in spleen area. Ordered another CT scan and referred to neurologist. Between 9/29 and 10/20, patient experienced burning on chest area, issues with memory, speech, balance, vision, brain fog, fatigue. Symptoms disappeared over last 3 weeks.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypertension, Laboratory test normal, Memory impairment, Migraine, Speech disorder
Clinical narrative: Began with thunderclap migraine (patient has no history of headaches), abdominal pain, extremely high blood pressure. ER ordered CT scans of head, neck, chest and abdomen, labwork and ekg. All normal. Treated with migraine cocktail. Sent home, blood pressure still very high. Returned to ER on 10/4 with another migraine and extremely high blood pressure. Treated with another migraine cocktail. Returned to ER on 10/8 with spontaneous, hand-sized, very dark bruise in spleen area. Ordered another CT scan and referred to neurologist. Between 9/29 and 10/20, patient experienced burning on chest area, issues with memory, speech, balance, vision, brain fog, fatigue. Symptoms disappeared over last 3 weeks.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Spleen contusion, Visual impairment
Clinical narrative: Began with thunderclap migraine (patient has no history of headaches), abdominal pain, extremely high blood pressure. ER ordered CT scans of head, neck, chest and abdomen, labwork and ekg. All normal. Treated with migraine cocktail. Sent home, blood pressure still very high. Returned to ER on 10/4 with another migraine and extremely high blood pressure. Treated with another migraine cocktail. Returned to ER on 10/8 with spontaneous, hand-sized, very dark bruise in spleen area. Ordered another CT scan and referred to neurologist. Between 9/29 and 10/20, patient experienced burning on chest area, issues with memory, speech, balance, vision, brain fog, fatigue. Symptoms disappeared over last 3 weeks.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: - Vaccine administration error. - child given 5-11 y.o. COVID Vaccine as 2nd dose   and was only 4 yrs 5 mos old-per chart record. - No side effects reported by family   (Lost # Recorded on card was appropriate for age.)
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Mental disorder, Tension headache, Tunnel vision, Visual field defect
Clinical narrative: Shortly after my second shot, I started to develop persistent headaches, visual distrubances (light sensitivity, difficulty reading), brain fog, and feelings of depersonalization (DPDR). These symptoms fluctuated over a 2 month period and then dissipated almost completely.   I got the booster in December 2021. Initially, I experienced some minor visual disturbances and depersonalization, especially after exercises, but mostly felt fine. Exactly a month later, all of the symptoms I described above came back in full force and did not let up (persistent headaches, visual distrubances (light sensitivity, difficulty reading), brain fog, and feelings of depersonalization (DPDR)).  I saw my optometrist about a month after symptoms came back? she diagnosed me with vertical heterophoria in my right eye (AKA strabismus). She said this explains all of my symptoms. I was prescribed prism lenses and took 2 months off of work via short term disability leave. My symptoms almost completely resolved after getting the prisms, and the break was at the time helpful.   I returned to work in Mid May 2022? after two days back, all of my symptoms returned, worse than they had been previously. It took me two months to find a new optometrist who could explain it. New Dr. did a series of eye tests and diagnosed me with Post Trauma Vision Syndrome, in addition to my vertical herterophoria. I had never had a head injury. During this time I was testing for covid multiple times a week for work using a cue device? so fair confident I did not catch covid during this period. From my own research, it seems to be somewhat known that Covid can cause symptoms similar to those of post trauma visual symptoms. It also  seems to becoming more widely known that the vaccine can cause long covid symptoms. This is why I beleive the vaccine may have caused what I am experiencing.   I have been seeing new Dr. weekly since late July, and I am doing an 1+ hours of vision therapy daily. I am making progress, but it is slow. My vision, cognitive functioning, reading ability and comprehension, and mood are all greatly compromised still.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Shortly after my second shot, I started to develop persistent headaches, visual distrubances (light sensitivity, difficulty reading), brain fog, and feelings of depersonalization (DPDR). These symptoms fluctuated over a 2 month period and then dissipated almost completely.   I got the booster in December 2021. Initially, I experienced some minor visual disturbances and depersonalization, especially after exercises, but mostly felt fine. Exactly a month later, all of the symptoms I described above came back in full force and did not let up (persistent headaches, visual distrubances (light sensitivity, difficulty reading), brain fog, and feelings of depersonalization (DPDR)).  I saw my optometrist about a month after symptoms came back? she diagnosed me with vertical heterophoria in my right eye (AKA strabismus). She said this explains all of my symptoms. I was prescribed prism lenses and took 2 months off of work via short term disability leave. My symptoms almost completely resolved after getting the prisms, and the break was at the time helpful.   I returned to work in Mid May 2022? after two days back, all of my symptoms returned, worse than they had been previously. It took me two months to find a new optometrist who could explain it. New Dr. did a series of eye tests and diagnosed me with Post Trauma Vision Syndrome, in addition to my vertical herterophoria. I had never had a head injury. During this time I was testing for covid multiple times a week for work using a cue device? so fair confident I did not catch covid during this period. From my own research, it seems to be somewhat known that Covid can cause symptoms similar to those of post trauma visual symptoms. It also  seems to becoming more widely known that the vaccine can cause long covid symptoms. This is why I beleive the vaccine may have caused what I am experiencing.   I have been seeing new Dr. weekly since late July, and I am doing an 1+ hours of vision therapy daily. I am making progress, but it is slow. My vision, cognitive functioning, reading ability and comprehension, and mood are all greatly compromised still.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Affective disorder, Cognitive disorder, Depersonalisation/derealisation disorder, Eye disorder, Feeling abnormal
Clinical narrative: Shortly after my second shot, I started to develop persistent headaches, visual distrubances (light sensitivity, difficulty reading), brain fog, and feelings of depersonalization (DPDR). These symptoms fluctuated over a 2 month period and then dissipated almost completely.   I got the booster in December 2021. Initially, I experienced some minor visual disturbances and depersonalization, especially after exercises, but mostly felt fine. Exactly a month later, all of the symptoms I described above came back in full force and did not let up (persistent headaches, visual distrubances (light sensitivity, difficulty reading), brain fog, and feelings of depersonalization (DPDR)).  I saw my optometrist about a month after symptoms came back? she diagnosed me with vertical heterophoria in my right eye (AKA strabismus). She said this explains all of my symptoms. I was prescribed prism lenses and took 2 months off of work via short term disability leave. My symptoms almost completely resolved after getting the prisms, and the break was at the time helpful.   I returned to work in Mid May 2022? after two days back, all of my symptoms returned, worse than they had been previously. It took me two months to find a new optometrist who could explain it. New Dr. did a series of eye tests and diagnosed me with Post Trauma Vision Syndrome, in addition to my vertical herterophoria. I had never had a head injury. During this time I was testing for covid multiple times a week for work using a cue device? so fair confident I did not catch covid during this period. From my own research, it seems to be somewhat known that Covid can cause symptoms similar to those of post trauma visual symptoms. It also  seems to becoming more widely known that the vaccine can cause long covid symptoms. This is why I beleive the vaccine may have caused what I am experiencing.   I have been seeing new Dr. weekly since late July, and I am doing an 1+ hours of vision therapy daily. I am making progress, but it is slow. My vision, cognitive functioning, reading ability and comprehension, and mood are all greatly compromised still.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Heterophoria, Impaired work ability, Ophthalmological examination abnormal, Photophobia
Clinical narrative: Shortly after my second shot, I started to develop persistent headaches, visual distrubances (light sensitivity, difficulty reading), brain fog, and feelings of depersonalization (DPDR). These symptoms fluctuated over a 2 month period and then dissipated almost completely.   I got the booster in December 2021. Initially, I experienced some minor visual disturbances and depersonalization, especially after exercises, but mostly felt fine. Exactly a month later, all of the symptoms I described above came back in full force and did not let up (persistent headaches, visual distrubances (light sensitivity, difficulty reading), brain fog, and feelings of depersonalization (DPDR)).  I saw my optometrist about a month after symptoms came back? she diagnosed me with vertical heterophoria in my right eye (AKA strabismus). She said this explains all of my symptoms. I was prescribed prism lenses and took 2 months off of work via short term disability leave. My symptoms almost completely resolved after getting the prisms, and the break was at the time helpful.   I returned to work in Mid May 2022? after two days back, all of my symptoms returned, worse than they had been previously. It took me two months to find a new optometrist who could explain it. New Dr. did a series of eye tests and diagnosed me with Post Trauma Vision Syndrome, in addition to my vertical herterophoria. I had never had a head injury. During this time I was testing for covid multiple times a week for work using a cue device? so fair confident I did not catch covid during this period. From my own research, it seems to be somewhat known that Covid can cause symptoms similar to those of post trauma visual symptoms. It also  seems to becoming more widely known that the vaccine can cause long covid symptoms. This is why I beleive the vaccine may have caused what I am experiencing.   I have been seeing new Dr. weekly since late July, and I am doing an 1+ hours of vision therapy daily. I am making progress, but it is slow. My vision, cognitive functioning, reading ability and comprehension, and mood are all greatly compromised still.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Reading disorder, SARS-CoV-2 test negative, Strabismus, Visual impairment
Clinical narrative: Shortly after my second shot, I started to develop persistent headaches, visual distrubances (light sensitivity, difficulty reading), brain fog, and feelings of depersonalization (DPDR). These symptoms fluctuated over a 2 month period and then dissipated almost completely.   I got the booster in December 2021. Initially, I experienced some minor visual disturbances and depersonalization, especially after exercises, but mostly felt fine. Exactly a month later, all of the symptoms I described above came back in full force and did not let up (persistent headaches, visual distrubances (light sensitivity, difficulty reading), brain fog, and feelings of depersonalization (DPDR)).  I saw my optometrist about a month after symptoms came back? she diagnosed me with vertical heterophoria in my right eye (AKA strabismus). She said this explains all of my symptoms. I was prescribed prism lenses and took 2 months off of work via short term disability leave. My symptoms almost completely resolved after getting the prisms, and the break was at the time helpful.   I returned to work in Mid May 2022? after two days back, all of my symptoms returned, worse than they had been previously. It took me two months to find a new optometrist who could explain it. New Dr. did a series of eye tests and diagnosed me with Post Trauma Vision Syndrome, in addition to my vertical herterophoria. I had never had a head injury. During this time I was testing for covid multiple times a week for work using a cue device? so fair confident I did not catch covid during this period. From my own research, it seems to be somewhat known that Covid can cause symptoms similar to those of post trauma visual symptoms. It also  seems to becoming more widely known that the vaccine can cause long covid symptoms. This is why I beleive the vaccine may have caused what I am experiencing.   I have been seeing new Dr. weekly since late July, and I am doing an 1+ hours of vision therapy daily. I am making progress, but it is slow. My vision, cognitive functioning, reading ability and comprehension, and mood are all greatly compromised still.
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLUX, COVID19-2
Symptoms: Feeling abnormal, Influenza like illness, Joint range of motion decreased, Myalgia, Sluggishness
Clinical narrative: Patient called yesterday and notified us that she was experiencing intense pain in the 1st week, could not move her arm because of the pain, taking motrin from the day of vaccination. Per her pain started 3 hours after the vaccination. even she has pain now on the 2to 3 on the scale of 10.Also she has been experiencing cold sweats until now. We called and informed her primary care physicians office She said doctor is going to follow up with her.
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLUX, COVID19-2
Symptoms: Cold sweat, Mobility decreased, Pain
Clinical narrative: Patient called yesterday and notified us that she was experiencing intense pain in the 1st week, could not move her arm because of the pain, taking motrin from the day of vaccination. Per her pain started 3 hours after the vaccination. even she has pain now on the 2to 3 on the scale of 10.Also she has been experiencing cold sweats until now. We called and informed her primary care physicians office She said doctor is going to follow up with her.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Started experiencing ringing in the ears 4-5 days after receiving my 3rd shot which has not gone away.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 06Dec2021 at 16:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 61 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6208; Vaccine administration site: Arm Right; Vaccine administration time: 13:00), administration date: 18Mar2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8732; Vaccine administration site: Arm Right; Vaccine administration time: 13:00), administration date: 09Sep2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Started experiencing ringing in the ears 4-5 days after receiving my 3rd shot which has not gone away.". The event "started experiencing ringing in the ears 4-5 days after receiving my 3rd shot which has not gone away." required physician office visit. Therapeutic measures were not taken as a result of tinnitus.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Started experiencing ringing in the ears 4-5 days after receiving my 3rd shot which has not gone away.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 06Dec2021 at 16:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 61 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6208; Vaccine administration site: Arm Right; Vaccine administration time: 13:00), administration date: 18Mar2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8732; Vaccine administration site: Arm Right; Vaccine administration time: 13:00), administration date: 09Sep2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Started experiencing ringing in the ears 4-5 days after receiving my 3rd shot which has not gone away.". The event "started experiencing ringing in the ears 4-5 days after receiving my 3rd shot which has not gone away." required physician office visit. Therapeutic measures were not taken as a result of tinnitus.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Started experiencing ringing in the ears 4-5 days after receiving my 3rd shot which has not gone away.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 06Dec2021 at 16:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 61 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6208; Vaccine administration site: Arm Right; Vaccine administration time: 13:00), administration date: 18Mar2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8732; Vaccine administration site: Arm Right; Vaccine administration time: 13:00), administration date: 09Sep2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Started experiencing ringing in the ears 4-5 days after receiving my 3rd shot which has not gone away.". The event "started experiencing ringing in the ears 4-5 days after receiving my 3rd shot which has not gone away." required physician office visit. Therapeutic measures were not taken as a result of tinnitus.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, Medication error, No adverse event, Product preparation error
Clinical narrative: No additional AE's reported; Medical Assistant called to report that an expired dose of ROTATEQ was administered to a patient today, 10/21/22. Vaccine expired on 10/14/22. Patient has had no known side effects. It was confirmed with the medical assistant that the administered do; indicate at which point in the process the medication error ocurred: preparation for administration; This spontaneous report has been received from a health professional and refers to a 6-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 21-OCT-2022, the patient was vaccinated with a expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, per prescribing information, lot 1742417, expiration date reported and internally validated as 14-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). It was reported that there was a medication error in the preparation to administration of the vaccine (product preparation error). No temperature excursion was reported, and no additional adverse event.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; MMR II underwent multiple temperature excursions was administered to a patient; This spontaneous report was received from a pharmacist and referring to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 13-OCT-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #U014656 with an expiration date on 07-MAY-2023), administered for prophylaxis (strength, anatomical location and route of administration were not provided).  The doses of vaccine underwent multiple temperature excursions of 9.13 °C (Celsius degrees) for 1 hour; and -8.45 °C for 37 hours and 15 minutes (incorrect product storage). No additional adverse event information was provided. No previous temperature excursions were reported.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; 13 year old patient was accidently administered PROQUAD; This spontaneous report was received from a medical assistant referring to a 13-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 28-OCT-2022, the patient was vaccinated accidently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters once (lot #W007747, with an expiration date on 04-SEP-2023), administered for prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age).  No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; HCP states that ROTATEQ was administered to a patient after temperature excursions.; This spontaneous report has been received from a pharmacist referring to a patient of unspecified age or gender. Information of concurrent condition, medical history, concomitant medication and drug reactions/allergies was not reported.  On 26-SEP-2022, the patient administered with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot# W002561, expiration date 07-OCT-2023, dose, frequency, anatomical location and strength were unknown) orally for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions at 9.13 degree Celsius (C) for 1 hour and at minimum minus 8.45 degree Celsius (C) for 37 hours and 15 minutes (product storage error). There were no previous temperature excursions. No additional adverse event (AE) was provided (no adverse event).
Age: 0.42
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: was administered to a 5 month old patient; No additional AE reported; This spontaneous report was received from a pharmacist concerning a 5-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unspecified date, at 5 months-old, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis (dose, route of administration, injection anatomical location, lot # and expiration date were not provided) (Product administered to patient of inappropriate age).  No additional adverse events were reported (No adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Dysgraphia, Dyspnoea, Gait disturbance, Guillain-Barre syndrome, Loss of personal independence in daily activities
Clinical narrative: Guillain-Barre syndrome; out of his life for a year/ had to learn how to Breathe, Talk, Walk, Write; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and activities of daily living impaired. On an unknown date, the outcome of the guillain barre syndrome and activities of daily living impaired were recovered/resolved.   The reporter considered the guillain barre syndrome and activities of daily living impaired to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: This case was reported by a patient's friend via interactive digital media. The patient got Guillain-Barre syndrome from the shingles vaccine and he was out of his life for a year and he had to learn how to breathe,talk,walk , write all over again. The patient stated that, you were absolutely correct the commercial states if you get shingles it was weeks of your life well. Additional Supportive Information: The follow up would not possible as no contact details were available. From the narrative it seems that the patient had GBS for 1 year hence outcome was captured as recovered for GBS and other related events.
Sex: M
Vaccine: VARZOS
Symptoms: Speech disorder
Clinical narrative: Guillain-Barre syndrome; out of his life for a year/ had to learn how to Breathe, Talk, Walk, Write; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and activities of daily living impaired. On an unknown date, the outcome of the guillain barre syndrome and activities of daily living impaired were recovered/resolved.   The reporter considered the guillain barre syndrome and activities of daily living impaired to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: This case was reported by a patient's friend via interactive digital media. The patient got Guillain-Barre syndrome from the shingles vaccine and he was out of his life for a year and he had to learn how to breathe,talk,walk , write all over again. The patient stated that, you were absolutely correct the commercial states if you get shingles it was weeks of your life well. Additional Supportive Information: The follow up would not possible as no contact details were available. From the narrative it seems that the patient had GBS for 1 year hence outcome was captured as recovered for GBS and other related events.
Sex: U
Vaccine: COVID19, FLUX, FLUX
Symptoms: COVID-19, Influenza, Pain, Vaccination failure
Clinical narrative: I just got the COVID and Flu shot, had symptoms of both; it hurt; had symptoms of both; had symptoms of both (Covid 19 on 7/2020); This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID 19 VACCINE PFIZER for prophylaxis.   The patient's past medical history included covid-19.   On an unknown date, the patient received the 2nd dose of Flu vaccine, the 1st dose of Flu vaccine and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Flu vaccine and Flu vaccine, the patient experienced vaccination failure (serious criteria medically significant), influenza, covid-19 and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown, and the outcome of the influenza and covid-19 were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza, covid-19 and pain to be related to Flu vaccine and Flu vaccine.     Additional Information: receipt date: 26-Oct-2022 Reporter's comment: The case was received from the patient via (social media) interactive digital media. The patient also got vaccinated in my left arm and it did not hurt in September and after 2 months the 2nd dose. The patient reported that they just applied him/her, the new one from Covid and derivatives, from Pfizer and the one from Fluo, yes it hurt. The patient had the symptoms of both for 3 days. Additional supportive information: It was unknown if the reporter considered the influenza, covid-19 and pain to be related to COVID 19 VACCINE PFIZER. This case was considered as suspected vaccination failure since the details regarding the completion time to onset and laboratory confirmation of influenza were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per reported information, it seems that the patient was reporting that target disease did not hurt in September and after 2nd dose therefore assumption could not be applied to considered that patient got the doses 2 months apart and according to the medication error was not coded.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/I have had the vaccines, they come back every 4 months; I have shingles for the millionth time//I have had the vaccines, they come back every 4 months; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccines and they still come back about every 4 months. The patient currently had shingles for the millionth time. The patient hate them.  The patient asked that what could he/she do to prevent them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: my arm sore as hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2022AMR153687).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. 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.     Linked case(s) involving the same patient:  US2022AMR153687   Additional Information: GSK receipt date: 23-OCT- 2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient stated he/she did not know but the 2 Shingrix shots made his/her arm sore as hell for a good 24 hours. Additional Supportive Information: Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR153687:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: very swollen arm/ reaction to vaccine; arm deep red/ reaction to vaccine; arm hot/ reaction to vaccine; arm painful/ reaction to vaccine; arm burning/ reaction to vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had shingles two times).   On 21st October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced swelling arm, erythema of extremities, feeling hot, pain in arm and burning sensation. On an unknown date, the outcome of the swelling arm, erythema of extremities, feeling hot, pain in arm and burning sensation were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, feeling hot, pain in arm and burning sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient prior to reporting had shingles two times. The patient prior to reporting would get vaccine 3 days ago. The patient had very swollen arm deep red, hot and painful burning. The patient would go to urgent care, never had reaction before any vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness around neck; This case was reported by a consumer via interactive digital media and described the occurrence of red neck in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced red neck. On an unknown date, the outcome of the red neck was unknown.   It was unknown if the reporter considered the red neck to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had redness around his/her neck. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient asked was it normal for the whole arm to be sore. Additional supportive information:  Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: This vaccine made me incredibly sick for about 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's comment: This case was reported by a patient via interactive digital media. This vaccine made the patient incredibly sick for about 2 days. Additional supportive information: The follow-up could not be possible as no contact detail were available.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Feeling abnormal
Clinical narrative: Vaccine was really quite awful; 5 days in bed; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful and bedridden. Shingles vaccine was discontinued. On an unknown date, the outcome of the feels awful was unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the feels awful and bedridden to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient reported that this vaccine was really quite awful for him/her. 5 days in bed.  The patient said second dose was supposed to be worse.  So, he/she did not take it.  The patient said fully vaxed otherwise, very pro vaccine, but just saying to prepare yourself if you do this vaccine. Additional Supportive Information: The follow-up would not possible, as no contact, details were available
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose more than a year after 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date, 1 year ago).   In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 25-OCT-2022 Reporter's comment:  This case was reported by a consumer via interactive digital media. The patient got his/her second shingles vaccination 2 months prior to the reporting.  That was over a year after he/she got first dose.  The reporter asked did he/she still need a booster. Additional supportive information:  The patient received 2nd dose of Shingrix that was over a year after first dose, which led to lengthening of the recommended interval between vaccine doses.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I had my shingles shots 7 months apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (on an unknown date received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.    Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had his/her shingles shots 7 months apart. The follow-up could not be possible as no contact details were available. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hypertension
Clinical narrative: Shivers; fatigue; blood pressure is 154/127; This case was reported by a consumer via call center representative and described the occurrence of shivers in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced shivers, fatigue and blood pressure high. On an unknown date, the outcome of the shivers, fatigue and blood pressure high were not recovered/not resolved.   It was unknown if the reporter considered the shivers, fatigue and blood pressure high to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient received a shingles shot the day before reporting. The patient had experienced shivers, fatigue and his/her blood pressure was 154/127.  The reporter wanted to know if it was normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: FLU4
Symptoms: Accidental underdose, Product complaint, Syringe issue
Clinical narrative: content leaked out, other dose administered; plunger issue/syringe leak/looked like the plunger was loose/content leaked out; pharmaceutical product complaint; This case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 9722R, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe issue and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: The reporter reported that the patient received a dose of Flulaval pre filled syringe where the vaccine ran out while she was depressing the plunger. The one nurse shared that it looked like it leaked out below the where you attach the syringe. The reporter started to report this as a quality issue at the GRC, on 13th October 2022. At that time, the reporter had limited information and it was not clear if this happened while the nurses were preparing the vaccine dose or while they were administering the dose. The reporter finally received feedback from the nurses that administered the vaccines, and they shared that the incidents happened while they were administering the vaccines.  The nurses said that it looked like the plunger was loose. Two times the vaccine contents leaked out of the top and 2 times the vaccine contents leaked out of the bottom.  The nurses shared that each time they felt that the patient did not receive any of the dose and it was a failed attempt, so they threw the dose away and administered another dose. The reporter shared that the patient did not have any reaction to the dose given. Although the patient did not have reactions to the vaccine dose given, the reporter reporting this in case it falls into the category of maladministration. The reporter did not consent to follow up. This was one of four cases, reported by the same reporter. Additional Supportive Information: The vaccine leaked out and had plunger issue, looked like the plunger was loose and other dose was administered, which led to accidental underdose, syringe issue and pharmaceutical product complaint.  This was 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR154684:Same reporter US-GSK-US2022AMR154683:Same reporter US-GSK-US2022AMR154685:Same reporter