chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Blood test, Blood test abnormal, Laboratory test, Urine analysis
Clinical narrative: she has discovered foreign particles in her urine and in her blood; she has discovered foreign particles in her urine and in her blood; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Lot number: 331308D) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol increased. Vaccination history included: comirnaty (DOSE 1, SINGLE; Lot number: EJ1686, Expiration date: Mar2021; Vaccination facility: university), administration date: 07Jan2021, for Covid-19 Immunization; comirnaty (DOSE 2, SINGLE; Lot number: EL8982, Vaccination facility: university), administration date: 27Jan2021, for Covid-19 Immunization. The following information was reported: URINE ANALYSIS ABNORMAL (non-serious), BLOOD TEST ABNORMAL (non-serious), outcome "unknown" and all described as "she has discovered foreign particles in her urine and in her blood". Relevant laboratory tests and procedures are available in the appropriate section.  Available information: The patient told that she has discovered foreign particles in her urine and in her blood. She was medical technologist and a patient. Lab test results were almost normal, the only high in the cholesterol. Because the media was pushing so hard, telling people that they are going to die that she went and took it three times. She found this technological or, they look like technological structures entering her red blood cells and she them in her urine. She had other structures that's been to be biologically modified and in seven days the amount of red blood cells that have those structures inside has grown exponentially. She was asking for help  because her life was at risk, their health department does not want to address the issue. So she can go again to them but they were not doing what they should be doing and her problem was increasing in risk and she want the people that did the recipe for those vials that were going to be injected in humans to tell her exactly what was exactly inside of those and she had seen that in a vial and wanted to know how to get this out of her body. That's her main concern.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis abnormal
Clinical narrative: she has discovered foreign particles in her urine and in her blood; she has discovered foreign particles in her urine and in her blood; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Lot number: 331308D) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol increased. Vaccination history included: comirnaty (DOSE 1, SINGLE; Lot number: EJ1686, Expiration date: Mar2021; Vaccination facility: university), administration date: 07Jan2021, for Covid-19 Immunization; comirnaty (DOSE 2, SINGLE; Lot number: EL8982, Vaccination facility: university), administration date: 27Jan2021, for Covid-19 Immunization. The following information was reported: URINE ANALYSIS ABNORMAL (non-serious), BLOOD TEST ABNORMAL (non-serious), outcome "unknown" and all described as "she has discovered foreign particles in her urine and in her blood". Relevant laboratory tests and procedures are available in the appropriate section.  Available information: The patient told that she has discovered foreign particles in her urine and in her blood. She was medical technologist and a patient. Lab test results were almost normal, the only high in the cholesterol. Because the media was pushing so hard, telling people that they are going to die that she went and took it three times. She found this technological or, they look like technological structures entering her red blood cells and she them in her urine. She had other structures that's been to be biologically modified and in seven days the amount of red blood cells that have those structures inside has grown exponentially. She was asking for help  because her life was at risk, their health department does not want to address the issue. So she can go again to them but they were not doing what they should be doing and her problem was increasing in risk and she want the people that did the recipe for those vials that were going to be injected in humans to tell her exactly what was exactly inside of those and she had seen that in a vial and wanted to know how to get this out of her body. That's her main concern.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Laboratory test
Clinical narrative: she has discovered foreign particles in her urine and in her blood; she has discovered foreign particles in her urine and in her blood; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Lot number: 331308D) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol increased. Vaccination history included: comirnaty (DOSE 1, SINGLE; Lot number: EJ1686, Expiration date: Mar2021; Vaccination facility: university), administration date: 07Jan2021, for Covid-19 Immunization; comirnaty (DOSE 2, SINGLE; Lot number: EL8982, Vaccination facility: university), administration date: 27Jan2021, for Covid-19 Immunization. The following information was reported: URINE ANALYSIS ABNORMAL (non-serious), BLOOD TEST ABNORMAL (non-serious), outcome "unknown" and all described as "she has discovered foreign particles in her urine and in her blood". Relevant laboratory tests and procedures are available in the appropriate section.  Available information: The patient told that she has discovered foreign particles in her urine and in her blood. She was medical technologist and a patient. Lab test results were almost normal, the only high in the cholesterol. Because the media was pushing so hard, telling people that they are going to die that she went and took it three times. She found this technological or, they look like technological structures entering her red blood cells and she them in her urine. She had other structures that's been to be biologically modified and in seven days the amount of red blood cells that have those structures inside has grown exponentially. She was asking for help  because her life was at risk, their health department does not want to address the issue. So she can go again to them but they were not doing what they should be doing and her problem was increasing in risk and she want the people that did the recipe for those vials that were going to be injected in humans to tell her exactly what was exactly inside of those and she had seen that in a vial and wanted to know how to get this out of her body. That's her main concern.
Age: 0.33
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any adverse issues or side effects from the administered dose of VAXNEUVANCE; A dose of VAXNEUVANCE affected by the unknown temperature conditions was then inadvertently administered to a patient; This spontaneous report was received from a nurse and refers to a 4-month-old patient of unknown gender.  The patient's medical history, concurrent conditions w, previous drug allergies or reactions and concomitant therapies were not reported.  On 08-MAR-2024, the vaccine refrigerator's data logger stopped working, (which was only noticed until 31-MAY-2024), and resulted into unknown temperature conditions for pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). On 14-APR-2024, a dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 milliliter injection, 0.5 milliliter, (lot #X019624, expiration date: 07-NOV-2025, valid lot number per internal review) administered for prophylaxis (route of administration was not provided) was administered to a patient (product storage error). The patient did not experience any adverse event. ; Sender's Comments:  US-009507513-2406USA001816: US-009507513-2406USA001829: US-009507513-2406USA001983: US-009507513-2406USA001859: US-009507513-2406USA001974:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: after she received the vaccine she experienced a sore arm and she had a hard time lifting her arm that was injected; Patient called to request information on PNEUMOVAX 23 and reported AE. Patient reports she received the PNEUMOVAX 23 vaccine on 08/10/2020. Patient reports after she received the vaccine she experienced a sore arm and she had a hard time lifting her; This spontaneous report was received from a consumer regarding herself, a 65-year-old patient. Her pertinent medical history, drug reactions, and or allergies, concurrent conditions, and concomitant therapies were reported as none.  On 10-AUG-2020, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, in her arm (unspecified), administered as prevention (strength, dose, lot #, expiry date, and exact route of administration were not provided).  On the same day (reported as ''after she received the vaccine''), she experienced a sore arm and she had a hard time lifting the arm that was injected. Patient reported she had a hard time putting in her contact lenses due to her arm being sore and hard to move (Vaccination site pain, Vaccination site movement impairment). Therefore, she called her health care professional (HCP) to let them know, but no treatment was received for the events. Moreover, she reported that it took 2 days, before the events started to subside, so on an unspecified date in August 2020, she recovered from vaccination site pain and from vaccination site movement impairment.   The causal relationship between the events of vaccination site pain and vaccination site movement impairment and the suspect vaccine was not provided.  Patient declined HCP details, so no additional information was expected.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported/No additional AE/PQC reported; HCP called to report PROQUAD was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; This spontaneous report was received from a nurse and refers to a 4-year-old patient (gender not provided).  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-MAR-2024, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter, lot #X022920, expiration date: 12-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided) after experienced a temperature excursion (Improper storage of product in use). No additional adverse event was provided.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported/No additional AE/PQC reported; HCP called to report PROQUAD was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; This spontaneous report was received from a nurse and refers to a 6-year-old patient (gender not provided).  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-MAR-2024, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5ml, lot #X022920, expiration date: 12-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided) after experiencing a temperature excursion (Improper storage of product in use). No additional adverse event.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called to report VARIVAX was administered to a patient after experiencing a T/E.; This spontaneous report was received from a registered nurse referring to a 16-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 05-MAR-2024, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X021930, expiration date: 29-AUG-2025, 0.5 milliliter, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). The vaccine experienced a temperature excursion (T/E) on an unknown date.  No symptoms were reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Pain, Scar, Skin disorder
Clinical narrative: dermatological issues; permanent scaring; resulted in pain; suffering; Information has been received from a lawyer regarding a case in litigation and referring to a female patient (pt) of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot#, expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as after receiving zoster vaccine live (ZOSTAVAX)), the pt suffered dermatological issues that resulted in pain, suffering and permanent scaring. As a result of these symptoms, pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX) by the lawyer.  The lawyer considered the events Skin disorder, Scar, Pain, Emotional distress to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had the vaccine, did not work/ Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had the vaccine, did not work/ Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUN-2024 This case was reported by a patient via (social media) interactive digital media. The patient had the vaccine and it did not work. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever 104-105; body ache; violent chills; This non-serious case was reported by a consumer via sales rep and described the occurrence of fever in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2021, the patient received the 1st dose of Shingrix (right deltoid). In JAN-2021, less than a month after receiving Shingrix, the patient experienced fever (Verbatim: Fever 104-105), general body pain (Verbatim: body ache) and chills (Verbatim: violent chills). The patient was treated with paracetamol (Tylenol). In JAN-2021, the outcome of the fever, general body pain and chills were resolved.   The reporter considered the fever, general body pain and chills to be related to Shingrix.     The company considered the fever, general body pain and chills to be related to Shingrix.   Additional Information: GSK receipt date: 27-JUN-2024 The patient received first dose and had fever, violent chills and body aches. The patient took Tylenol every 6 hours resolved within 24 hours.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: a few weeks later had a shingle; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: a few weeks later had a shingle). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-JUN-2024 This case was reported by a patient's son or daughter interactive digital media. The reporter reported that the patient received the shot, a few weeks later had a shingles outbreak for first time in her life. The reporter asked, was this was a coincidence.. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: MMR, TDAP
Symptoms: Restlessness, Stress
Clinical narrative: being restless-not being able to turn off her brain; This non-serious case was reported by a nurse via call center representative and described the occurrence of restlessness in a 44-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included MMR (Priorix) for prophylaxis.   Concurrent medical conditions included food allergy.   On 18-JUN-2024, the patient received Boostrix and Priorix. In JUN-2024, an unknown time after receiving Boostrix and Priorix, the patient experienced restlessness (Verbatim: being restless-not being able to turn off her brain). The outcome of the restlessness was not reported.   It was unknown if the reporter considered the restlessness to be related to Boostrix, Priorix and Priorix Pre-Filled Syringe Device.     It was unknown if the company considered the restlessness to be related to Boostrix, Priorix and Priorix Pre-Filled Syringe Device.   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: 20-JUN-2024 The patient has whole bunch of unusual allergies to several foods, ingredients and additives. The patient had symptoms of been restless, not been able to turn off her brain. The reporter consented to follow up.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure, Weight
Clinical narrative: Came down with Covid 20 days after vaccination; Came down with Covid 20 days after vaccination; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30May2024 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Comments: Asthma. Concomitant medication(s) included: SYMBICORT taken for asthma. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT#: EL3246), administration date: 17Jan2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, LOT#: EL3247), administration date: 07Feb2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, LOT#: FH8027), administration date: 02Nov2021, when the patient was 79-year-old, for Covid-19 immunization; moderna COVID-19 vaccine (DOSE 4 (BOOSTER), SINGLE, LOT#: 059A22A), administration date: 23Jun2022, when the patient was 79-year-old, for Covid-19 immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE, LOT#: GJ3275), administration date: 20Oct2022, when the patient was 80-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jun2024, outcome "not recovered" and all described as "Came down with Covid 20 days after vaccination". The patient underwent the following laboratory tests and procedures: Weight: 130. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: prescription for Paxlovid; prescription for Paxlovid; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "prescription for Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient got a prescription for nirmatrelvir, ritonavir (PAXLOVID) and had already gotten it twice this year, so her insurance was not covering it.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Blood test, Chills, Cough, Decreased appetite
Clinical narrative: itchy throat; coughing; dizziness; severe fatigue; no appetite; right sciatica; fever; chill; pain in both shoulder /arms; pain in both shoulder /arms; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Mar2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years for immunisation. The patient's relevant medical history included: "fungi in her blood" (ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 04Mar2024, outcome "recovered" (Mar2024), described as "chill"; PYREXIA (non-serious) with onset 04Mar2024, outcome "recovered" (Mar2024), described as "fever"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 04Mar2024, outcome "unknown" and all described as "pain in both shoulder /arms"; SCIATICA (non-serious) with onset 04Mar2024, outcome "unknown", described as "right sciatica"; DIZZINESS (non-serious) with onset 05Mar2024, outcome "unknown"; DECREASED APPETITE (non-serious) with onset 05Mar2024, outcome "unknown", described as "no appetite"; FATIGUE (non-serious) with onset 05Mar2024, outcome "not recovered", described as "severe fatigue"; COUGH (non-serious) with onset 06Mar2024, outcome "unknown", described as "coughing"; THROAT IRRITATION (non-serious) with onset 06Mar2024, outcome "unknown", described as "itchy throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills.  Additional information: On 04Mar2024, the patient's new primary doctor said its time for pneumonia vaccine, so she got it at his office. That night, patient had fever and chill, pain in both shoulders/arms, and right Sciatica. Next morning (05Mar2024) patient also had dizziness and severe fatigue. The patient stayed in bed the whole day and no any appetite. The next night I took a Tylenol for fever, so fever and chill gone, but severe fatigue continued. The 3rd night (06Mar2024), during sleeping, itchy throat and coughing began. The patient never had such experiences of severe side effects of vaccine for Pneumonia in past. The patient asked if it was related to fungi in her blood.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Fatigue, Pain in extremity, Pyrexia, Sciatica
Clinical narrative: itchy throat; coughing; dizziness; severe fatigue; no appetite; right sciatica; fever; chill; pain in both shoulder /arms; pain in both shoulder /arms; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Mar2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years for immunisation. The patient's relevant medical history included: "fungi in her blood" (ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 04Mar2024, outcome "recovered" (Mar2024), described as "chill"; PYREXIA (non-serious) with onset 04Mar2024, outcome "recovered" (Mar2024), described as "fever"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 04Mar2024, outcome "unknown" and all described as "pain in both shoulder /arms"; SCIATICA (non-serious) with onset 04Mar2024, outcome "unknown", described as "right sciatica"; DIZZINESS (non-serious) with onset 05Mar2024, outcome "unknown"; DECREASED APPETITE (non-serious) with onset 05Mar2024, outcome "unknown", described as "no appetite"; FATIGUE (non-serious) with onset 05Mar2024, outcome "not recovered", described as "severe fatigue"; COUGH (non-serious) with onset 06Mar2024, outcome "unknown", described as "coughing"; THROAT IRRITATION (non-serious) with onset 06Mar2024, outcome "unknown", described as "itchy throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills.  Additional information: On 04Mar2024, the patient's new primary doctor said its time for pneumonia vaccine, so she got it at his office. That night, patient had fever and chill, pain in both shoulders/arms, and right Sciatica. Next morning (05Mar2024) patient also had dizziness and severe fatigue. The patient stayed in bed the whole day and no any appetite. The next night I took a Tylenol for fever, so fever and chill gone, but severe fatigue continued. The 3rd night (06Mar2024), during sleeping, itchy throat and coughing began. The patient never had such experiences of severe side effects of vaccine for Pneumonia in past. The patient asked if it was related to fungi in her blood.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Throat irritation
Clinical narrative: itchy throat; coughing; dizziness; severe fatigue; no appetite; right sciatica; fever; chill; pain in both shoulder /arms; pain in both shoulder /arms; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Mar2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years for immunisation. The patient's relevant medical history included: "fungi in her blood" (ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 04Mar2024, outcome "recovered" (Mar2024), described as "chill"; PYREXIA (non-serious) with onset 04Mar2024, outcome "recovered" (Mar2024), described as "fever"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 04Mar2024, outcome "unknown" and all described as "pain in both shoulder /arms"; SCIATICA (non-serious) with onset 04Mar2024, outcome "unknown", described as "right sciatica"; DIZZINESS (non-serious) with onset 05Mar2024, outcome "unknown"; DECREASED APPETITE (non-serious) with onset 05Mar2024, outcome "unknown", described as "no appetite"; FATIGUE (non-serious) with onset 05Mar2024, outcome "not recovered", described as "severe fatigue"; COUGH (non-serious) with onset 06Mar2024, outcome "unknown", described as "coughing"; THROAT IRRITATION (non-serious) with onset 06Mar2024, outcome "unknown", described as "itchy throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills.  Additional information: On 04Mar2024, the patient's new primary doctor said its time for pneumonia vaccine, so she got it at his office. That night, patient had fever and chill, pain in both shoulders/arms, and right Sciatica. Next morning (05Mar2024) patient also had dizziness and severe fatigue. The patient stayed in bed the whole day and no any appetite. The next night I took a Tylenol for fever, so fever and chill gone, but severe fatigue continued. The 3rd night (06Mar2024), during sleeping, itchy throat and coughing began. The patient never had such experiences of severe side effects of vaccine for Pneumonia in past. The patient asked if it was related to fungi in her blood.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: RSV, RSV
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site reaction
Clinical narrative: reaction and issues from the site not healing and loss of use in the same arm; reaction and issues from the site not healing and loss of use in the same arm; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE REACTION (non-serious), outcome "not recovered", described as "reaction and issues from the site"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), outcome "not recovered", described as "loss of use in the same arm". Therapeutic measures were taken as a result of vaccination site reaction, vaccination site movement impairment.  Additional Information: The patient was given vaccine RSV from Privacy. Reported a reaction and issues from the site not healing and loss of use in the same arm. Patient was told to come in to report it and paperwork which was done. To date have not heard back from Privacy and the issue still arises. Patient have lost work due to this issue not being resolved. The doctor gave an ointment to apply and followed it exactly as prescribed. It is still not resolved.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: RSV, RSV
Symptoms: Impaired healing, Impaired work ability, Injection site reaction, Pain, Pain in extremity
Clinical narrative: reaction and issues from the site not healing and loss of use in the same arm; reaction and issues from the site not healing and loss of use in the same arm; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE REACTION (non-serious), outcome "not recovered", described as "reaction and issues from the site"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), outcome "not recovered", described as "loss of use in the same arm". Therapeutic measures were taken as a result of vaccination site reaction, vaccination site movement impairment.  Additional Information: The patient was given vaccine RSV from Privacy. Reported a reaction and issues from the site not healing and loss of use in the same arm. Patient was told to come in to report it and paperwork which was done. To date have not heard back from Privacy and the issue still arises. Patient have lost work due to this issue not being resolved. The doctor gave an ointment to apply and followed it exactly as prescribed. It is still not resolved.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Postural orthostatic tachycardia syndrome, Seizure
Clinical narrative: non-epileptic seizures; passing out; POTS Syndrome; This is a spontaneous report received from a Consumer or other non HCP.  A 16-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Aug2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (caused and prolonged hospitalization, medically significant), outcome "not recovered", described as "non-epileptic seizures"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passing out"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown", described as "POTS Syndrome". The patient was hospitalized and prolonged hospitalization for seizure (hospitalization duration: 14 day(s)).  Clinical course: The reporter stated that my niece who is 16 yrs young received her 1 Pfizer Covid Vaccine in Aug2023. A short time after she began passing out and was diagnosed with POTS Syndrome. She has had extensive hospital stays and just recently spent 2 weeks in name withheld because she began to have non-epileptic seizures. It has been almost a year, with no end in sight. treats with a doctor from withheld. We realize this is a pandemic of unknown proportions.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 16.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered ipol after the expiration date with no reported adverse event; Initial information received on 24-Jun-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 16 years old male patient who was inadvertently administered Poliomyelitis Vaccine (Inactivated) IPV (VERO) [IPOL] after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A), Hpv Vaccine (Hpv Vaccine), Meningococcal Vaccine C Conj (Crm197) (Meningitec) for Prophylactic vaccination  On 12-Jun-2024, the patient received 0.5 ml (dose 5) total of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot number: V1B901M) (Expiry date: 02-Jun-2024) (strength: standard) (frequency: once) via intramuscular route in the left deltoid for immunization.  On 12-JUN-2024, the patient was inadvertently administered Poliomyelitis Vaccine (Inactivated) after the expiration date with no reported adverse event (expired product administered) (latency: same day).  Reportedly, This situation is pre-assessed as a medication error/an inappropriate use due to the vaccine being administered after the expiration date Physician inadvertently administered IPOL after the expiration date, which is on 2JUNE2024.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administration PENTACEL (VERO) without supplied diluent with no reported adverse event.; Initial information received on 26-Jun-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who had administration Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] without supplied diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (powder and suspension for suspension for injection) without supplied diluent with no reported adverse event (single component of a two-component product administered) (latency: same day) (lot UK038AA) (expiry date:30-06-2025) strength not reported via unknown route in unknown administration site for Immunization.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Module of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Intercepted product administration error
Clinical narrative: pharmacist advised him to come back for Shingrix shot 2 one month after dose 1; feeling tired; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included Covid 19 vaccine (Prior vaccination with Covid-19, four shots).   On 19-JUN-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In JUN-2024, the patient received Tdap Vaccine. On 20-JUN-2024, 1 days after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after receiving Tdap Vaccine, the patient experienced tiredness (Verbatim: feeling tired). On an unknown date, the patient experienced intercepted drug administration error (Verbatim: pharmacist advised him to come back for Shingrix shot 2 one month after dose 1). The outcome of the tiredness was resolved and the outcome of the intercepted drug administration error was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix and Tdap Vaccine.     It was unknown if the company considered the tiredness to be related to Shingrix and Tdap Vaccine.   Additional Information: GSK Receipt Date: 21-JUN-2024 The reporter was the patient. He received Shingrix shot 1 on 19-Jun-2024. He reported that the evening of June 19th and the morning of June 20th he thinks that he felt tired. He was not sure if it was related to the vaccine or not. He said him feeling tired may not had been due to the Shingrix. He said it might have been due to not getting proper sleep the previous night.  He said him feeling tired was nothing meaning that it was mild and did not bother him.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Acute arthritis of L knee, L hand, and R shoulder.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mother stated her child as fine except for a mild fever, but also received 3 other vaccines that day. Mother was not upset, but RN explained the situation.
Age: 29.0
Sex: F
Vaccine: HEPA, HPV9, TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Pt had a brief spell of dizziness and nausea lasting about 5 minutes.  was able to leave on her own after resting and drinking a couple glasses of water.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Brain operation, Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Symptoms: arm hot and sore all the time.  It became stiff and numb and I could not raise it above my Waistline.  Soon I could not use the arm at all. Immediately after the shot it felt like the needle hit a bone. The technician even said she felt it hit something. I complained approximately three months after the shot to my doctor.  He sent me to physical therapy.  That helped my range of motion but I still had pain. I had a medical emergency so physical therapy was put on hold for a while.  I had brain surgery. When I recovered I complained again about my arm hurting. I was sent for an MRI and was diagnosed with two rotator cuff tears and a bicep tear. I did not injury my arm in any way to get these injuries.  My doctor explained he thinks I suffer from SIRVA because I complained numerous times about the shot and my arm. I also took the COVID shot on the same day, same arm. I took the shot in both arms because the first shingles shot was still painful and I didn't want to feel the same pain in my dominate arm.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Magnetic resonance imaging abnormal, Muscle injury, Musculoskeletal stiffness, Rotator cuff syndrome, Skin warm
Clinical narrative: Symptoms: arm hot and sore all the time.  It became stiff and numb and I could not raise it above my Waistline.  Soon I could not use the arm at all. Immediately after the shot it felt like the needle hit a bone. The technician even said she felt it hit something. I complained approximately three months after the shot to my doctor.  He sent me to physical therapy.  That helped my range of motion but I still had pain. I had a medical emergency so physical therapy was put on hold for a while.  I had brain surgery. When I recovered I complained again about my arm hurting. I was sent for an MRI and was diagnosed with two rotator cuff tears and a bicep tear. I did not injury my arm in any way to get these injuries.  My doctor explained he thinks I suffer from SIRVA because I complained numerous times about the shot and my arm. I also took the COVID shot on the same day, same arm. I took the shot in both arms because the first shingles shot was still painful and I didn't want to feel the same pain in my dominate arm.
Age: 69.0
Sex: F
Vaccine: RSV, VARZOS, RSV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: patient report itching and redness at site of injection
Age: 69.0
Sex: F
Vaccine: RSV, VARZOS, RSV, VARZOS
Symptoms: Rash
Clinical narrative: patient report itching and redness at site of injection
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Syncope
Clinical narrative: Pt and wife came in to get covid shots.  They came in soon after 2pm and were instructed to wait at waiting area for their shot.  I came in about 3 minutes later to give them their shots.  Shots were administered and they went on their way.  They were shopping in from of the pharmacy soon after when I heard someone fell down (fainted) and help was called for.  I ran out to see what had happened and witnessed the male who had gotten the shot on his back and his wife tried to break his fall.  I had him stay still on his back then he decided he wanted to sit down.  We got him a chair where he was resting.  He then began to lose consciousness again where I was ready to catch him if necessary.  It was then decided after talking to him that we should call 911 to assess him and his condition.  in the mean time the wife started to feel light headed and was sitting down and motionless.  It took the EMT's about 10 minutes to arrive.  They arrived and evaluated the couple and found them ok to be released after some more rest.  The patients left on their own approximately 35 minutes after the incident happened.  We don't believe their is any connection to the vaccination as this was their 5th shot of Moderna.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Diarrhoea, Fatigue, Mobility decreased
Clinical narrative: The patient reported 3 days of a low grade fever with a Tmax of 99.5 degrees Fahrenheit, severe fatigue almost preventing her from getting out of bed, arm, shoulder, shoulder blade and back pain, as well as diarrhea for 2 days.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: The patient reported 3 days of a low grade fever with a Tmax of 99.5 degrees Fahrenheit, severe fatigue almost preventing her from getting out of bed, arm, shoulder, shoulder blade and back pain, as well as diarrhea for 2 days.