chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive Covid Test after negative test; Positive Covid Test after negative test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: EW0170), in left arm and on 12May2021 as dose 2, single (Lot number: ER8736) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Nov2021 as dose 3 (booster), single (Lot number: 012F21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LESSINA; MELATONIN; L-THEANINE; MAGNESIUM. Past drug history included: Azithromycin, reaction(s): "known allergy: Azithromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Positive Covid Test after negative test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (11May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each; diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each; This is a spontaneous report received from contactable reporter(s) (Physician).  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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 "diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Their internist, who prescribed Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202200722831 same reporter/drug/event, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: tested positive for Covid approximately 3 days after her second booster shot.; tested positive for Covid approximately 3 days after her second booster shot(throat irritation, feeling abnormal, nasal congestion); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8737), on 30Apr2021 as dose 2, single (Lot number: EW0169), on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8762) and on 02May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 05May2022, outcome "unknown", described as "tested positive for Covid approximately 3 days after her second booster shot(throat irritation, feeling abnormal, nasal congestion)"; VACCINATION FAILURE (medically significant) with onset 05May2022, outcome "unknown", described as "tested positive for Covid approximately 3 days after her second booster shot.". The patient underwent the following laboratory tests and procedures: COVID-19: (05May2022) Positive, notes: she tested positive for Covid approximately 3 days after her second booster shot. She said her symptoms were mild - scratchy throat, head fog, congestion. She feels ok but still testing positive so remains quarantined. She received the Pfizer Covid Vaccine.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have the first two COVID shots I also had a booster so I tested positive on Friday; I have the first two COVID shots I also had a booster so I tested positive on Friday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. 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) all with onset 13May2022, outcome "unknown" and all described as "I have the first two COVID shots I also had a booster, so I tested positive on Friday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) positive, notes: PCR.  Additional information: On Thursday that's when patient not feeling well then patient tested myself Friday and patient took a home test and patient had a PCR to confirm. So, my doctors yesterday prescribed to me Paxlovid and I'm just reading you website patient just had a one question patient have been it effective on people who have been vaccinated, such as myself, like fully vaccinated versus people who were never vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: and got the booster and got sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2, received the first and second dose of the Pfizer covid 19 vaccine and then had an as ischemic stroke), for Covid-19 Immunization, reaction(s): "ischemic stroke"; Bnt162b2 (Dose: 1, received the first and second dose of the Pfizer covid 19 vaccine and then had an as ischemic stroke), for Covid-19 Immunization, reaction(s): "ischemic stroke". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "and got the booster and got sick".  Additional information:Caller stated that she read that the second dose of the Pfizer covid 19 vaccine was stronger and this could be why the patient had the stroke and stated she called a year ago and would not provide any demographics. Caller wanted to speak with someone in the lab. Caller wanted to know the data regarding a person in their early eighties that received the first and second dose of the Pfizer covid 19 vaccine and then had an as ischemic stroke and then got the booster. she heard that Pfizer and Moderna stopped doing trials on persons in their seventies. Caller asked if there were any specific trials for persons in their eighties. Caller wanted to know if there is any data on a person that had an ischemic stroke and got the booster and got sick, asking what is the adverse reaction and wanted to know if the vaccine is contraindicated in this person. Caller refused to be sent because she said it would not help and she is not here to help the company. Caller stated the patient would only agree to report to DSU if the patient got the information about persons having an ischemic stroke and then getting the booster. Caller stated the HCP does not have any information. That it is too bad that Pfizer does not have information about persons that are 65,75 or 85 because they are the ones in danger noting it is too bad that the trials were not done on the age group 80 and older. Caller stated this age group is the age group that needs the vaccine the most. Caller stated Pfizer has determined this age group to not be important because there is not any money in it. Caller stated that there were persons with autoimmune disease and still took the shot. Caller stated she was at ground zero because Pfizer did not have any specific information  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: severe insomnia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 04Jan2022 as dose number unknown (booster), single (Lot number: FL3198) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization.  Additional information: Description of Event: Severe insomnia   The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "severe insomnia".
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Feeling cold, Headache, Myalgia
Clinical narrative: I started freezing and shaking uncontrollably; I started freezing and shaking uncontrollably; severe muscle aches and headache; severe muscle aches and headache; After two hours I was able to take my temperature, it was 102; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series of immunization completed, but manufacturer unknown., Dose: 1), for Covid-19 immunization; Covid-19 vaccine (Primary series of immunization completed, but manufacturer unknown., Dose: 2), for Covid-19 immunization; Covid-19 vaccine (First booster shot/ Dose 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 11May2022, outcome "unknown", described as "After two hours I was able to take my temperature, it was 102"; FEELING COLD (non-serious), TREMOR (non-serious) all with onset 11May2022, outcome "unknown" and all described as "I started freezing and shaking uncontrollably"; MYALGIA (non-serious), HEADACHE (non-serious) all with onset 11May2022, outcome "unknown" and all described as "severe muscle aches and headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling cold, tremor, myalgia, headache, body temperature increased. Additional Information: After taking Tylenol finally went to sleep. The whole process lasted about 8 hours. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I started freezing and shaking uncontrollably; I started freezing and shaking uncontrollably; severe muscle aches and headache; severe muscle aches and headache; After two hours I was able to take my temperature, it was 102; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series of immunization completed, but manufacturer unknown., Dose: 1), for Covid-19 immunization; Covid-19 vaccine (Primary series of immunization completed, but manufacturer unknown., Dose: 2), for Covid-19 immunization; Covid-19 vaccine (First booster shot/ Dose 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 11May2022, outcome "unknown", described as "After two hours I was able to take my temperature, it was 102"; FEELING COLD (non-serious), TREMOR (non-serious) all with onset 11May2022, outcome "unknown" and all described as "I started freezing and shaking uncontrollably"; MYALGIA (non-serious), HEADACHE (non-serious) all with onset 11May2022, outcome "unknown" and all described as "severe muscle aches and headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling cold, tremor, myalgia, headache, body temperature increased. Additional Information: After taking Tylenol finally went to sleep. The whole process lasted about 8 hours. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: he started experiencing shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, Booster, unknown manufacturer), for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset May2022, outcome "not recovered", described as "he started experiencing shortness of breath".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Varicella
Clinical narrative: admitted to hospital last Friday for aFib with a resting HR of 200.; Caller describes this as a "measley chicken pox"; Caller describes this as a "measley chicken pox"; he developed a "really weird rash" on his left upper arm, left side of stomach/chest, and inner left thigh; Caller states he has COPD; I'm quite alarmed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer, Caller received two Covid vaccines administered in his left arm.), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (hospitalization, medically significant), outcome "unknown", described as "admitted to hospital last Friday for aFib with a resting HR of 200."; MEASLES (medically significant), VARICELLA (non-serious), outcome "unknown" and all described as "Caller describes this as a "measley chicken pox""; RASH (non-serious), outcome "unknown", described as "he developed a "really weird rash" on his left upper arm, left side of stomach/chest, and inner left thigh"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "Caller states he has COPD"; NERVOUSNESS (non-serious), outcome "unknown", described as "I'm quite alarmed". The patient underwent the following laboratory tests and procedures: Heart rate: resting HR of 200, notes: He has COPD, was admitted to hospital last Friday for aFib with a resting HR of 200. Therapeutic measures were taken as a result of atrial fibrillation, rash, chronic obstructive pulmonary disease.  Clinical information: The 63-year old male seeking information regarding possible side effects of Covid vaccine. Caller received two Covid vaccines administered in his left arm 6 months ago, maybe a month or maybe two months between them, has not received booster. Caller does not have vaccine card or dates of vaccines available. Caller states that six months after second dose, he developed a "really weird rash" on his left upper arm, left side of stomach/chest, and inner left thigh. Caller describes this as a "measley chicken pox rash". Caller states he has COPD, was admitted to hospital last Friday for aFib with a resting HR of 200. He was prescribed medication for this as well as clotrimazole cream for the rash. Caller states the clotrimazole cream has not made any difference in the rash. Caller states he was really scared and concerned", "he was quite alarmed", "he don't wanna die", "there always has to be a casualty". Caller states he has seen images on the internet that look like his rash, stating it is only on the left side of his body.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I contracted COVID; I contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EL3248), in right arm, on 26Mar2021 as dose 2, single (Lot number: EP6055), in right arm and on 24Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 38 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; OMEPRAZOLE; DYMISTA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Apr2022, outcome "recovered" and all described as "I contracted COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Positive, notes: Nasal Swab; (02May2022) I was aware it was specifically COVID, notes: I took a COVID test that I was aware it was specifically COVID. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: "when I took COVID I personally had moderate symptoms which included a high level of fatigue to the point I could barely get out of bed and I missed four days of work the following week". No known allergies.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Arthralgia, Chest pain, Feeling abnormal, Gastritis
Clinical narrative: arrhythmias; crushing chest pain; gastritis; brain fog; joint pain; trouble sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2021 at 15:00 as dose 2, single (Lot number: ER8736) at the age of 30 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 Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03Apr2021, when the patient was 30-year-old, for Covid-19 immunization, reaction(s): "irregular heart Beats", "tunnel vision", "Dizziness", "light headed", "Tachycardia 150BPM". The following information was reported: ARRHYTHMIA (disability, medically significant, life threatening), outcome "unknown", described as "arrhythmias"; CHEST PAIN (disability, life threatening), outcome "unknown", described as "crushing chest pain"; GASTRITIS (disability, life threatening), outcome "unknown"; FEELING ABNORMAL (disability, life threatening), outcome "unknown", described as "brain fog"; ARTHRALGIA (disability, life threatening), outcome "unknown", described as "joint pain"; INSOMNIA (disability, life threatening), outcome "unknown", described as "trouble sleeping". The events "arrhythmias", "crushing chest pain", "gastritis", "brain fog", "joint pain" and "trouble sleeping" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Negative, notes: Blood test.  Clinical course:  Patient did not receive any medications within two weeks of vaccination and also did not receive any vaccine within four weeks. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient have been tested for COVID-19 after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, SARS-CoV-2 test
Clinical narrative: arrhythmias; crushing chest pain; gastritis; brain fog; joint pain; trouble sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2021 at 15:00 as dose 2, single (Lot number: ER8736) at the age of 30 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 Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03Apr2021, when the patient was 30-year-old, for Covid-19 immunization, reaction(s): "irregular heart Beats", "tunnel vision", "Dizziness", "light headed", "Tachycardia 150BPM". The following information was reported: ARRHYTHMIA (disability, medically significant, life threatening), outcome "unknown", described as "arrhythmias"; CHEST PAIN (disability, life threatening), outcome "unknown", described as "crushing chest pain"; GASTRITIS (disability, life threatening), outcome "unknown"; FEELING ABNORMAL (disability, life threatening), outcome "unknown", described as "brain fog"; ARTHRALGIA (disability, life threatening), outcome "unknown", described as "joint pain"; INSOMNIA (disability, life threatening), outcome "unknown", described as "trouble sleeping". The events "arrhythmias", "crushing chest pain", "gastritis", "brain fog", "joint pain" and "trouble sleeping" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Negative, notes: Blood test.  Clinical course:  Patient did not receive any medications within two weeks of vaccination and also did not receive any vaccine within four weeks. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient have been tested for COVID-19 after vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Death, Erythrodermic psoriasis, Rash, Respiratory failure
Clinical narrative: Passed away; Respiratory failure; Congestive heart failure; Rash; Erythrodermic psoriasis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "Passed away"; RESPIRATORY FAILURE (death, medically significant), outcome "fatal"; CARDIAC FAILURE CONGESTIVE (death, medically significant), outcome "fatal", described as "Congestive heart failure"; RASH (non-serious), outcome "unknown"; ERYTHRODERMIC PSORIASIS (non-serious), outcome "unknown". The patient date of death was unknown. Reported cause of death: "Congestive heart failure". It was not reported if an autopsy was performed.  Clinical course: Patient passed away as a result of respiratory failure, due to congestive heart failure, due to a reaction from covid 19 vaccine. (That is from his death certificate). He apparently had a rash that was diagnosed as erythrodermic psoriasis, a rare psoriasis that his doctors said was a reaction to the vaccine. He had just had his second dose of the pfizer vaccine when the rash started. He had no pre existing conditions, no other health issues. He was 73 when he passed away.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Congestive heart failure
Sex: U
Vaccine: YF
Symptoms: CSF test, Death, Exposure via transplant, Neurological symptom
Clinical narrative: death; Neurologic symptoms; exposure via transplant; Initial information received on 11-May-2022 regarding an unsolicited valid serious case received from a other health professional.   This case involves Adult and unknown gender patient who experienced death, neurologic symptoms and exposure via transplant from an individual who received blood transfusion from the vaccinated individual who received vaccine yellow fever vaccine [YF-VAX].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received organ from an individual who received blood transfusion from the vaccinated individual (exposure via transplant) who received who received a dose of suspect yellow fever vaccine unknown formulation and strength lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, post organ transplant, the patient developed neurologic symptoms and YF virus was found in CSF or brain tissue (unknown latency).  On an unknown date, Patient died (death) (unknown latency. This event was assessed as medically significant and was leading to death.  Action taken: Not applicable for all.  It was not reported if the patient received a corrective treatment for any of the event.  At time of reporting, the outcome was Unknown for the event neurologic symptoms, was Fatal for the event death and was Unknown for the event exposure via transplant. The cause of death was reported as unknown.; Sender's Comments: Sanofi company comment dated 18-May-2022: This case involves an adult patient who died of an unknown cause. An unspecified time prior, the patient had received organ from an individual who received blood transfusion from a vaccinated individual who received vaccine yellow fever vaccine [YF-VAX]. There is limited information in the case. Further information regarding medical history, concurrent condition of patient, previous vaccination, concomitant medications and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: YF
Symptoms: Death, Exposure via transplant, Neurological symptom, Transfusion
Clinical narrative: death; Exposure via transplant; Initial information received from United States on 11-May-2022 regarding an unsolicited valid  serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced death and exposure via transplant while receiving vaccine YELLOW FEVER VACCINE [YF-VAX].  cluster case- 2022SA176292, 2022SA177055, 2022SA177145 and 2022SA177654   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect YELLOW FEVER VACCINE lot number not reported via unknown route in unknown administration site for unknown indiaction.  On an unknown date the patient developed a serious death and exposure via transplant (unknown latency) following the administration of YELLOW FEVER VACCINE. This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) death.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (death, Exposure via transplant).  At time of reporting, the outcome was Fatal for the event death and was Unknown for the event exposure via transplant. It is unknown if an autopsy was done. The cause of death was reported as Death.; Sender's Comments: Sanofi Company Comment on 17-May-2022:This case involves a patient of unknown age and unknown gender who experienced death subsequent to organ transplant. The organ transplant was received from an individual who had received a blood transfusion from a third individual who recently (within 1 week) was vaccinated with YF VAX. Neurologic symptoms were suspected in the patient. Available information is limited. Further information regarding symptoms, medical history, concurrent conditions, concomitant medication, laboratory investigations, autopsy and cause of death are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: death
Sex: U
Vaccine: YF
Symptoms: Craniocerebral injury, Death, Exposure via blood, Transfusion
Clinical narrative: traumatic brain injury; received blood transfusion from the vaccinated individual; Initial information received on 11-May-2022 regarding an unsolicited valid serious case received from a other health professional.   This case involves Adult and unknown gender patient who experienced traumatic brain injury and received blood transfusion from the vaccinated individual who received vaccine yellow fever vaccine - us [YF-VAX].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received blood transfusion from the vaccinated individual (exposure via blood) who received a dose of suspect yellow fever vaccine unknown formulation and strength lot number not reported via unknown route in unknown administration site for prophylactic vaccination and donated blood 6 days later.  On an unknown date, post blood transfusion, the patient died of traumatic brain injury (craniocerebral injury) (unknown latency). This event was assessed as medically significant and was leading to death.  Action taken: Not applicable for both  It was not reported if the patient received a corrective treatment for the event (traumatic brain injury).  At time of reporting, the outcome was Fatal for the event traumatic brain injury and unknown for the other.  It is unknown if an autopsy was done. The cause of death was reported as Traumatic brain injury.  Reporter causality: Not related for traumatic brain injury; Sender's Comments: Sanofi company comment dated 17-May-2022: This case involves an adult patient who died of traumatic brain injury. An unspecified time prior, the patient had received a blood transfusion from a vaccinated individual who received vaccine yellow fever vaccine - us [YF-VAX]. The traumatic brain injury was considered unrelated to the transfusion. There is limited information in the case. Further information regarding medical history, concurrent condition of patient, previous vaccination, concomitant medications and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed. SanofiPVPortal20220513000727: SanofiPVPortal20220513000741: SanofiPVPortal20220513000748: SanofiPVPortal20220513000757:; Reported Cause(s) of Death: traumatic brain injury
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pruritus, Pyrexia
Clinical narrative: Initial reaction was fever, headache, fatigue, body aches which lasted for 2 days. Symptoms went away, and this was the pattern for previous 2 Moderna vaccines.  On 28 December, I developed hives on my face, hips, genital area, and shoulder blades/back. The hives itched incredibly. I started taking Cetirizine prescribed by the doctor. The hives receded, but I must take Cetirizine every 24-48 hours or I have a persistent urticaria. Very itchy skin, raised welts on abrasive contact. Itching usually started on the palm of hands, eyes, and/or lip and mouth area. That is the sign I used to take another pill. I have since been diagnosed with urticaria officially by a dermatologist and prescribed cetirizine daily for 90 days, with a break afterward to see if symptoms cease.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular, Urticaria
Clinical narrative: Initial reaction was fever, headache, fatigue, body aches which lasted for 2 days. Symptoms went away, and this was the pattern for previous 2 Moderna vaccines.  On 28 December, I developed hives on my face, hips, genital area, and shoulder blades/back. The hives itched incredibly. I started taking Cetirizine prescribed by the doctor. The hives receded, but I must take Cetirizine every 24-48 hours or I have a persistent urticaria. Very itchy skin, raised welts on abrasive contact. Itching usually started on the palm of hands, eyes, and/or lip and mouth area. That is the sign I used to take another pill. I have since been diagnosed with urticaria officially by a dermatologist and prescribed cetirizine daily for 90 days, with a break afterward to see if symptoms cease.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient did not have observable reaction while in store, she called 2 hours post vaccination to report full body hives and itching. Patient did not have any itching/swelling/tightness of face/throat/chest. Instructed to take oral benadryl at home and go to ER if ANYTHING CHANGES. Will call at home tomorrow AM to check in on progress. No previous reactions of any kind to first 3 covid vaccine doses.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram liver abnormal, Hepatic vascular thrombosis
Clinical narrative: Blood clot in liver one month later. Had to take blood thinners for 6 months and be evaluated every 1-4 weeks.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia
Clinical narrative: Systemic: patient reported difficulty breathing and numbing of legs and arm. Severity unknown.s-Medium, Additional Details: Patient called and reported having difficulty breathing and legs and hands feeling numb. Severity Unknown.
Age: 31.0
Sex: M
Vaccine: RAB, TYP, YF
Symptoms: Urticaria
Clinical narrative: Per the Patient: "Hives present on the forehead, back of the neck, and triceps area of the right arm".
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted a few minutes after receiving the injection, he regained consiousness immediately. He was coherent, drinking water and eating candy. His mother was with him and they left after fifteen minutes.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case    dose 1 Moderna 2/8/21 007M20A dose 2 Moderna 3/8/21 010A21A
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient still experiences pain at the injection site and throughout her left arm. She has limited mobility and cannot lift her arm to the same extent as prior to the vaccination. She also experiences pain with any movement involving her left arm.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient received higher than the recommended dose of the vaccine due to accidentally reconstituting it with the Pfizer adult dose vaccine instead of saline.  0.20 micgrograms in 0.2 mL syringe given of both Pfizer vaccine lot Fl8094 Exp May 31, 2022 and vaccine lot Fk9894 Exp June 4,2022.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; two doses were administered after a temperature excursion that occurred on 4/29/2022.; This spontaneous report was received from a Licensed Practical Nurse, referring to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 02-MAY-2022, the patient was vaccinated with improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX)  for prophylaxis (lot # U022320, U026207, U028164, U015689 and U025791 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 15-JUL-2023, 24-AUG-2023, 09-SEP-2023, 18-MAY-2023 and 19-AUG-2023 respectively) (0.5 ml, strength, route of administration and anatomical location were not provided) (specific lot# was unspecified) (Product storage error). The temperature of storage and time frame of the excursion were 0.8 degree Celsius for 4 hours and 19 minutes respectively. There was no previous temperature excursion. No adverse event reported.   Another patient was capture in Case# 2205USA004796. This is one of some reports from same reporter.; Sender's Comments:  US-009507513-2205USA000806: US-009507513-2205USA004796:
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; two doses were administered after a temperature excursion that occurred on 4/29/2022.; This spontaneous report was received from a Licensed Practical Nurse, referring to a 11-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 02-MAY-2022, the patient was vaccinated with improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX)  for prophylaxis (lot # U022320, U026207, U028164, U015689 and U025791 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 15-JUL-2023, 24-AUG-2023, 09-SEP-2023, 18-MAY-2023 and 19-AUG-2023 respectively) (0.5 ml, strength, route of administration and anatomical location were not provided) (specific lot# was unspecified) (Product storage error). The temperature of storage and time frame of the excursion were 0.8 degree Celsius for 4 hours and 19 minutes respectively. There was no previous temperature excursion. No adverse event reported.   Another patient was capture in Case# 2205USA004267. This is one of some reports from same reporter.; Sender's Comments:  US-009507513-2205USA000806: US-009507513-2205USA004267:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forgot  second dose, initial vaccination in October 2021; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date in october 2021).   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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date: 17-MAY-2022 Reporter's comment: This case was reported by a consumer via call center representative. The patient received first shot of Shingles vaccine in October 2021 and completely forgot about the second vaccination. The patient said never received a reminder from the doctor office. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Horner's syndrome
Clinical narrative: horner's syndrome; This case was reported by a consumer and described the occurrence of horner's syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced horner's syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the horner's syndrome was unknown.   It was unknown if the reporter considered the horner's syndrome to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporters comment: The patient self-reported the case. The patient's other medical histories and any concomitant medications he might be taking were not reported. After receiving Shingrix, the patient experienced horners syndrome. No dates of the vaccination or the event start date were reported.  No other information was available at the time of the reporting.  The patient contact information was considered to be confidential as permission to forward it was not obtained. The AE associated with Shingrix would not be submitted to the Food and Drug Administration.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: mild symptoms of body aches; flu-like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain 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 general body pain and influenza-like symptoms. On an unknown date, the outcome of the general body pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the general body pain and influenza-like symptoms to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR080509   Additional Information: GSK Receipt Date: 13-May-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that he/she recently had the shingles vaccine, with the first injection he/she had mild symptoms of body aches and flu-like symptoms. Additional Supportive Information: The follow-up would not be possible as no contact details were available. For tolerance to 2nd dose, refer case US2022AMR080509, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR080509:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Influenza like illness, Malaise, Pain, Vaccine positive rechallenge
Clinical narrative: aches 3 to 4 days; flu-like symptoms; just not feeling well; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose  on an unknown date and experienced general bosy aches, for tolerance to 1st dose, refer case US2022AMR080503).   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 general body pain, influenza-like symptoms and feeling unwell. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the general body pain, influenza-like symptoms and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the general body pain, influenza-like symptoms and feeling unwell to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR080503   Additional Information: GSK Receipt Date: 13-May-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that with the second dose he/she had symptoms which were worse with 3 to 4 days aches and just not feeling well. The patient stated that for him/her, it was more than worth it he/she did not want the shingles and was convinced that he/she was right! Additional Supportive Information: The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR080503:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Dysphonia, Glossodynia, Mouth ulceration, Odynophagia
Clinical narrative: tongue sore; painful to swallow; sore in mouth; painful to talk; This case was reported by a consumer via call center representative and described the occurrence of tongue sore in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2022, the patient received the 2nd dose of Shingrix. On 18th May 2022, 2 days after receiving Shingrix, the patient experienced tongue sore, swallowing painful, mouth ulcer and dysphonia. On an unknown date, the outcome of the tongue sore, swallowing painful and dysphonia were unknown and the outcome of the mouth ulcer was not recovered/not resolved.   It was unknown if the reporter considered the tongue sore, swallowing painful, mouth ulcer and dysphonia to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-May-2022 Reporter's Comments: The patient self-reported this case. The patient had the 2nd shot of Shingrix vaccine on Monday and on the day of reporting the patient had a sore on the edge of her/his tongue that makes it painful to talk and swallow.  The patient wanted to know if it was a shingle sore and if there was anything, he/she could do to treat this sore in the mouth. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Experiencing hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingles vaccine. In May 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine approximately 10 days ago and now he/she was experiencing hives. The patient asked if this was possibly related. Additional supportive information: The follow-up would not possible, as no contact, details were available.