chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he was 86 years old and supposedly goot all the boosters but he got COVID; he was 86 years old and supposedly goot all the boosters but he got COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team and product quality group.  An 86-year-old male 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. Vaccination history included: Covid-19 vaccine (Dose (BOOSTER), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (death, medically significant), SUSPECTED COVID-19 (death, medically significant), outcome "fatal" and all described as "he was 86 years old and supposedly goot all the boosters but he got COVID". The patient date of death was unknown. Reported cause of death: "he was 86 years old and supposedly goot all the boosters but he got COVID". It was not reported if an autopsy was performed.  Clinical information: Reporter stated that they had a next-door neighbor, he was 86 years old and supposedly got all the boosters, but he got COVID and was in the ICU unit and he passed away.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Reported Cause(s) of Death: he was 86 years old and supposedly goot all the boosters but he got COVID
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Cousin died four days after the Pfizer COVID shot; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: DEATH (death, medically significant), outcome "fatal", described as "Cousin died four days after the Pfizer COVID shot". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical information: Reporter stated, "I am just calling for some general information. Most people, everybody that I talk to, they are so sick from not only COVID shots but all the vaccines, all of them. The only people sick are the ones getting shots (Information about number of people involved was not available, hence split not made)." When probed to clarify that reporter is talking about Pfizer COVID-19 Vaccine, reporter stated, "People who get COVID shot, I had my cousin died four days after the Pfizer COVID shot (Clarified as COVID-19 Vaccine).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Cousin died four days after the Pfizer COVID shot
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Dose Number: 5, Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Have pacemaker" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing); "At risk for blood clots" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. Past drug history included: Pfizer / biontech, start date: 11Nov2020, stop date: 11Nov2020, for COVID-19 immunization, notes: Dose 1, Single, Lot No: Unknown, in the left arm; Pfizer / biontech, start date: 01Feb2021, stop date: 01Feb2021, for COVID-19 immunization, notes: Dose 2, Single, Lot No: Unknown, in the left arm; Pfizer / biontech, start date: 29Sep2021, stop date: 29Sep2021, for COVID-19 immunization, notes: Dose 3 (BOOSTER), Single, Lot No: Unknown, in the left arm; Pfizer / biontech, start date: 11Apr2022, stop date: 11Apr2022, for COVID-19 immunization, notes: Dose 4 (BOOSTER), Single, Lot No: Unknown, in the left arm. Vaccination history included: Moderna covid-19 vaccine (Dose 5 (BOOSTER), Single, Lot No: Unknown, in the left arm). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 5, Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (start date: 04Feb2024, stop date: 08Feb2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "GERD" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies: Mango" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 04Feb2024 to 08Feb2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 48-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 29Sep2022 as dose 3 (booster), single (Lot number: FH8030) at the age of 47 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Irritable Bowel Syndrome" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (06Feb2024) and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 30Jan2024 to 04Feb2024.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hoshimoto's thyroiditis" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; NP THYROID. The patient also took other concomitant therapy. Past drug history included: Erythromycin, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (Vaccine brand: Pfizer / BioNTech; Vaccine dose number unknown; Left arm), administration date: 25Oct2022, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (Vaccine brand: Pfizer / BioNTech; Vaccine dose number unknown; Left arm), administration date: 07Apr2022, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (Vaccine brand: Pfizer / BioNTech; Vaccine dose number unknown; Left arm), administration date: 02Dec2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Vaccine brand: Pfizer / BioNTech, Vaccine dose number: 2, in left leg), administration date: 02Apr2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Vaccine brand: Pfizer / BioNTech, Vaccine dose number: 1; left arm), administration date: 12Mar2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid treatment from 02Feb2024 to 06Feb2024 for COVID-19. Other concomitant medication included unspecified thyroid medication.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Nov2023 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19, which included Paxlovid from 04Feb2024 to 08Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19: the patient received treatment with Paxlovid from 04Feb2024 to 08Feb2024.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 31-year-old 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 included: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (Feb2024) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 05Feb2024 until 09Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Nov2023 as dose 1, single (Lot number: HD9876) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Concomitant medication(s) included: LOSARTAN; LEVOTHYROXINE. Vaccination history included: pfizer /biontech (DOSE 1; lot number: GJ3275; in left arm), administration date: 16Nov2022, when the patient was 57-year-old, for Covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as COVID-19 treatment from 03Feb2024 to 07Feb2024.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400041628 Same patient, different drug and event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: sick with Covid; sick with Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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 "sick with Covid".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400042690 Same reporter, Drug, Adverse event / Different Patient;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 74 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Jun2022 at 14:00 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 at 14:00 as dose 1, single (Lot number: EL9261), on 27Feb2021 at 14:00 as dose 2, single (Lot number: EW67W), in left arm and on 29Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FF2589), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Oct2023 at 14:00 as dose 6 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "HBP" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Drug Allergy: Keflex"; Erythromycin, reaction(s): "Drug allergy: Erythromycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Oct2023 at 14:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jan2024, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2024) negative; (13Feb2024) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Jul2023 as dose 5 (booster), single (Lot number: GK0928) at the age of 55 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Apr2021 as dose 1, single (Lot number: EW0172), in right arm, on 14May2021 as dose 2, single (Lot number: EW0183), in right arm, on 11Jan2022 as dose 3 (booster), single (Lot number: FJ5683), in right arm and on 18May2022 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with Paxlovid from  30Jan2024 to 04Feb2024.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 36-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 14:00 as dose 1 (toppac); single (Lot number: HG4628) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Ehlers-Danlos Syndrome" (unspecified if ongoing); "Asthma (from previous long term COVID)" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 5 (Booster), single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 1, single, Unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 05Feb2024 to 10Feb2024.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extreme fatigue; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2024US020459_OS (Novartis).  A 57-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Adderall for fatigue, notes: 60mg . The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue".  Additional information: Patient reported taking 60mg of Adderall daily due to her extreme fatigue, which she said worsened significantly after receiving the Covid-19 vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 77-year-old male 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. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunization; Bnt162b2 (DOSE 2), for Covid-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for Covid-19 Immunization. The patient reported he had taken all Pfizer shots and boosters. The patient's relevant medical history included: "motor function issues" (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The patient was prescribed nirmatrelvir, ritonavir (PAXLOVID) and have waited 5 days to start the medication after being diagnosed with COVID.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400021713 Same patient/reporter, different event/drug;
Sex: F
Vaccine: TDAP
Symptoms: Multiple sclerosis
Clinical narrative: multiple sclerosis; Initial information received on 09-Feb-2024 regarding an unsolicited valid Social Media serious case received from a physician.  This case involves an unknown age female patient who experienced multiple sclerosis after receiving vaccine Diphtheria-2/Tetanus/5 AC Pertussis vaccine [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection (strength, lot number and expiry: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information on batch number was requested.  On an unknown date, the patient developed multiple sclerosis (unknown latency) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis vaccine. This event was assessed as medically significant.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (multiple sclerosis).  At time of reporting, the outcome was Unknown for the event multiple sclerosis.; Sender's Comments: Sanofi company comment dated 15-Feb-2024: This case involves an unknown age female patient who experienced multiple sclerosis after receiving vaccine Diphtheria-2/Tetanus/5 AC Pertussis vaccine [ADACEL]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: given the vaccines post excursion involving FLUZONE HIGH DOSE Max/Low Temperature: 9 C Duration out of labelled range: 115 hours cumulative within 5 days duration Human Error: Unknown with no reported adverse event; Initial information received on 08-Feb-2024 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 85 years old female patient who was given the vaccine post excursion involving Influenza Quadrival A-B High dose HV vaccine [Fluzone High-Dose Quadrivalent] max/low temperature: 9 C duration out of labelled range: 115 hours cumulative within 5 days duration human error: unknown 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 an unknown dose of suspect Influenza Quadrival A-B High dose HV vaccine of lot U8162EA (strength, formulation and expiry: unknown) via unknown route in unknown administration site as prophylactic vaccination (immunization); post excursion dose max/low temperature: 9 C duration out of labelled range: 115 hours cumulative within 5 days duration human error: unknown with no reported adverse event (poor quality product administered) (latency: same day).  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.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: given the vaccines post excursion involving Fluzone Quadrivalent Max/Low Temperature: 9 C Duration out of labelled range: 115 hours cumulative within 5 days duration Human Error: Unknown with no reported adverse event; Initial information received on 08-Feb-2024 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 58 years old male patient who was given the vaccines post excursion; involving Influenza Quadrival A-B Vaccine [Fluzone QIV], max/low temperature: 9 C duration out of labelled range: 115 hours cumulative within 5 days duration human error: unknown 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 an unknown dose of suspect Influenza Quadrival A-B vaccine Suspension for injection of lot UT8129KA and expiry: 30-Jun-2024 via unknown route in unknown administration site for immunization; post excursion involving fluzone quadrivalent max/low temperature: 9 C duration out of labelled range: 115 hours cumulative within 5 days duration human error: unknown with no reported adverse event (poor quality product administered) (latency: same day).  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.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: fluzone quadrivalent exposed to 9C degrees upto 115 hours cumulative hours with no reported adverse event; patient have received product after excursion with no reported adverse event; Initial information received on 08-Feb-2024 regarding an unsolicited valid  non-serious case received from Nurse.  This case involves a 74 years old female patient who received Influenza Quadrival A-B Vaccine [Fluzone Qiv] after excursion which was exposed to 9c degrees upto 115 hours cumulative hours 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 it was reported that fluzone quadrivalent which was exposed to 9c degrees upto 115 hours cumulative hours due to unknown reason (product storage error).    On an unknown date, the patient received suspect Influenza Quadrival A-B Vaccine [Fluzone Qiv] suspension for injection (lot UT8129KA; dose, expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation) after excursion with no reported adverse event (poor quality product administered) ( latency: same day).   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: F
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: nurse reconstituted YF-VAX with sterile water diluent that is supposedly for Varivax/ administration of YF-VAX with the incorrect diluent with no reported adverse event; Initial information received on 13-Feb-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Adult female patient who experienced nurse reconstituted yellow fever vaccine - [YF-vax] with sterile water diluent that is supposedly for varivax/ administration of yf-vax with the incorrect diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Feb-2024, the patient received a dose of suspect yellow fever vaccine - us Solution for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (product preparation error) (latency- same day).  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.
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: YF Vax was inadvertently administered Intramuscularly in the deltoid instead of subcutaneously with no reported adverse event; Initial information received on 13-Feb-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 22 years old female patient who was inadvertently yellow fever vaccine - [YF-VAX] administered intramuscularly in the deltoid instead of subcutaneously 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 typhoid vaccine (Typhoid) for Immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Immunisation; and polio vaccine (Polio) for Immunisation.  On 06-Feb-2024, the patient received a dose of 0.5 ml once of suspect yellow fever vaccine - (Solution for injection) (lot: UJ951AA; expiry date: 30-Nov-2024) via intramuscular route in the left deltoid for Immunization.  On 06-Feb-2024 the patient was inadvertently administered yellow fever vaccine - intramuscularly in the deltoid instead of subcutaneously with no reported adverse event (incorrect route of product administration) (latency: same day).  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.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Cough, Dizziness, Headache, Lymphadenopathy
Clinical narrative: Began with coughing & wheezing followed by headache, lightheadedness, some weakness and fever and swollen glands in neck.  Vomited once.  Normal temp for patient is 97.6.  Temp went up to 101 on 02/16/24.  Still experiencing symptoms.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Vomiting, Wheezing
Clinical narrative: Began with coughing & wheezing followed by headache, lightheadedness, some weakness and fever and swollen glands in neck.  Vomited once.  Normal temp for patient is 97.6.  Temp went up to 101 on 02/16/24.  Still experiencing symptoms.
Age: 30.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Blood iron decreased, Chills, Exposure during pregnancy, Fatigue, Headache
Clinical narrative: 35 weeks pregnant spiked low grade fever of 99.7 at 3am had shivering, achyness, headache, and night sweats. Took Tylenol and woke up with essentially no symptoms except soreness and tiredness. Had no prior health concerns during entire pregnancy. I have been diagnosed with low iron and sometimes borderline low blood pressure.
Age: 30.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Hypertension, Night sweats, Pain
Clinical narrative: 35 weeks pregnant spiked low grade fever of 99.7 at 3am had shivering, achyness, headache, and night sweats. Took Tylenol and woke up with essentially no symptoms except soreness and tiredness. Had no prior health concerns during entire pregnancy. I have been diagnosed with low iron and sometimes borderline low blood pressure.
Age: 61.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash at site for 19 days
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood test normal, CSF test normal, Immunisation reaction, Myelitis transverse
Clinical narrative: Three days after receiving the vaccine I developed Transverse Myelitis. After a lot of negative blood and spinal fluid tests, neurologists at Hospital determined the cause to be vaccine induced.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Weakness, tiredness, sharp headache, chills, fever of 100.4 general feeling of being unwell
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Weakness, tiredness, sharp headache, chills, fever of 100.4 general feeling of being unwell
Age: 61.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Severe Shingles outbreak within 2 months of 3rd covid vaccine; suffering from PHN;  full shingrix  vaccination in 2021.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Basal cell carcinoma, Laboratory test abnormal, Muscular weakness, Pain in extremity, Skin neoplasm excision
Clinical narrative: Pain and weakness in left arm for a period of three months. Less than two months later, a malignant modular basal cell carcinoma was removed.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Pt states she started experiencing tingling/neuropathy type pain in her left calf the night of vaccination. She could feel this when laying down or sitting. Pt states she had normal arm soreness otherwise.  Pt said she was going to follow-up with her doctor Tuesday if the tingling does not subside. I advised her to seek medical attention should this worsen or persist. Origin of neuropathy is unknown. Pt also recently started leflunomide which has a side effect of neuropathy.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Breath sounds normal, Chest discomfort, Chills
Clinical narrative: Within first 24 hours of vaccine I experienced my typical reactions: fever, body aches, chills, headache, tiredness. Within 48 hours I began feeling shortness of breath, heaviness in my chest, complete exhaustion with any exertion, cough. I initially attributed these symptoms to asthma and began my rescue inhaler Albuterol but was not feeling the expected relief. I went to Urgent Care and was tested negative for both COVID and influenza and the provider stated that my lungs sounded clear. The provider recommended I continue Albuterol and since I had a planned vacation for 1/28 she advised me to contact her to get a Prednisone Rx to take with me in case I needed it. I was getting worse and requested the Rx and took it with me, along with my nebulizer and Albuterol on my trip. I also stayed in contact with my allergist who recommended I monitor my pulse ox which dipped below 95 on one occasion. My symptoms did not improve with the nebulizer treatments so I started Prednisone. Nothing made a difference and I continued to feel weaker and more short of breath.  I returned home on 2/2 and saw my primary care who increased my Prednisone dose, ordered a chest CT and blood work, and arranged a cardiology appointment for 2/5. The CT revealed pericardial effusion which was confirmed by echocardiogram on 2/5. Cardiologist added cholchicine. I saw a pulmonologist on 2/7 who concurred with other doctors that this is a likely COVID vaccine reaction. He ordered a bilateral venous Doppler to rule out DVT. No DVT was found. My pulmonologist is monitoring my Prednisone and seeing me weekly. My cardiologist will see me on March 1st. My progress is slow.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Cough, Dyspnoea, Echocardiogram abnormal, Fatigue
Clinical narrative: Within first 24 hours of vaccine I experienced my typical reactions: fever, body aches, chills, headache, tiredness. Within 48 hours I began feeling shortness of breath, heaviness in my chest, complete exhaustion with any exertion, cough. I initially attributed these symptoms to asthma and began my rescue inhaler Albuterol but was not feeling the expected relief. I went to Urgent Care and was tested negative for both COVID and influenza and the provider stated that my lungs sounded clear. The provider recommended I continue Albuterol and since I had a planned vacation for 1/28 she advised me to contact her to get a Prednisone Rx to take with me in case I needed it. I was getting worse and requested the Rx and took it with me, along with my nebulizer and Albuterol on my trip. I also stayed in contact with my allergist who recommended I monitor my pulse ox which dipped below 95 on one occasion. My symptoms did not improve with the nebulizer treatments so I started Prednisone. Nothing made a difference and I continued to feel weaker and more short of breath.  I returned home on 2/2 and saw my primary care who increased my Prednisone dose, ordered a chest CT and blood work, and arranged a cardiology appointment for 2/5. The CT revealed pericardial effusion which was confirmed by echocardiogram on 2/5. Cardiologist added cholchicine. I saw a pulmonologist on 2/7 who concurred with other doctors that this is a likely COVID vaccine reaction. He ordered a bilateral venous Doppler to rule out DVT. No DVT was found. My pulmonologist is monitoring my Prednisone and seeing me weekly. My cardiologist will see me on March 1st. My progress is slow.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza virus test negative, Oxygen saturation decreased, Pain, Pericardial effusion
Clinical narrative: Within first 24 hours of vaccine I experienced my typical reactions: fever, body aches, chills, headache, tiredness. Within 48 hours I began feeling shortness of breath, heaviness in my chest, complete exhaustion with any exertion, cough. I initially attributed these symptoms to asthma and began my rescue inhaler Albuterol but was not feeling the expected relief. I went to Urgent Care and was tested negative for both COVID and influenza and the provider stated that my lungs sounded clear. The provider recommended I continue Albuterol and since I had a planned vacation for 1/28 she advised me to contact her to get a Prednisone Rx to take with me in case I needed it. I was getting worse and requested the Rx and took it with me, along with my nebulizer and Albuterol on my trip. I also stayed in contact with my allergist who recommended I monitor my pulse ox which dipped below 95 on one occasion. My symptoms did not improve with the nebulizer treatments so I started Prednisone. Nothing made a difference and I continued to feel weaker and more short of breath.  I returned home on 2/2 and saw my primary care who increased my Prednisone dose, ordered a chest CT and blood work, and arranged a cardiology appointment for 2/5. The CT revealed pericardial effusion which was confirmed by echocardiogram on 2/5. Cardiologist added cholchicine. I saw a pulmonologist on 2/7 who concurred with other doctors that this is a likely COVID vaccine reaction. He ordered a bilateral venous Doppler to rule out DVT. No DVT was found. My pulmonologist is monitoring my Prednisone and seeing me weekly. My cardiologist will see me on March 1st. My progress is slow.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Ultrasound Doppler normal
Clinical narrative: Within first 24 hours of vaccine I experienced my typical reactions: fever, body aches, chills, headache, tiredness. Within 48 hours I began feeling shortness of breath, heaviness in my chest, complete exhaustion with any exertion, cough. I initially attributed these symptoms to asthma and began my rescue inhaler Albuterol but was not feeling the expected relief. I went to Urgent Care and was tested negative for both COVID and influenza and the provider stated that my lungs sounded clear. The provider recommended I continue Albuterol and since I had a planned vacation for 1/28 she advised me to contact her to get a Prednisone Rx to take with me in case I needed it. I was getting worse and requested the Rx and took it with me, along with my nebulizer and Albuterol on my trip. I also stayed in contact with my allergist who recommended I monitor my pulse ox which dipped below 95 on one occasion. My symptoms did not improve with the nebulizer treatments so I started Prednisone. Nothing made a difference and I continued to feel weaker and more short of breath.  I returned home on 2/2 and saw my primary care who increased my Prednisone dose, ordered a chest CT and blood work, and arranged a cardiology appointment for 2/5. The CT revealed pericardial effusion which was confirmed by echocardiogram on 2/5. Cardiologist added cholchicine. I saw a pulmonologist on 2/7 who concurred with other doctors that this is a likely COVID vaccine reaction. He ordered a bilateral venous Doppler to rule out DVT. No DVT was found. My pulmonologist is monitoring my Prednisone and seeing me weekly. My cardiologist will see me on March 1st. My progress is slow.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Paranasal sinus hypersecretion, Parotid gland enlargement, Respiratory tract congestion
Clinical narrative: NDC:00069239210, sudden parotid lymph node pain and swelling that coincided with sinus drainage and chest congestion. Headache and body aches.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Salivary gland pain
Clinical narrative: NDC:00069239210, sudden parotid lymph node pain and swelling that coincided with sinus drainage and chest congestion. Headache and body aches.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Laboratory test, Magnetic resonance imaging head, Migraine, Surgery
Clinical narrative: about 3 weeks after the second shot I started getting debilitating migraine headaches that no over the counter medication would relieve. Finally found prescription medication for migraines that relieves the pain and prevents the headaches the majority of the time. Then, about 2 years after the vaccine, I was hospitalized due to Atrial fibrillation and then had surgery to try and fix the Atrial fibrillation.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Pallor, Tremor
Clinical narrative: Patient received 2 vaccinations. The first vaccine given was the influenza vaccine and the second one was Gardasil. After 5 minutes the Gardasil was administered,  the patient complained of dizziness and subsequently became pale. He was also noted with fine tremors Vital signs: HR- 80/min, BP 100/60, RR- 20/min., O2sat. 98%. The patient was put in a supine position. The patient was given a sports drink and protein bar. After 20 minutes of observation, the patient recovered well. VS: HR- 78/min., BP 110/65, RR 18/min and O2 sat. 99%
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Contusion, Granuloma annulare, Rash, Treatment failure
Clinical narrative: A wide-ranging rash on the inner thighs and inner arms that is persistent to this day 02.17.2024 Diagnosed as Granuloma Annulare.  First appeared as bruising of the inner thigh.  The gynecologist suggested Ringworm, but treatment failed. A Visit to the Primary care Doctor suggested the use of a steroid cream.  Slight recovery but then returned with vengeance.  The second and new Doctor suggested Eczema, although I said, "It does not itch."  Dermatologist took a biopsy to determine it was Granuloma Annulare,
Age: 75.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red Rash itchy rash under both armpits
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Ageusia, Anxiety, Bell's palsy, Blepharospasm, Capillary nail refill test
Clinical narrative: 5-6 days of loss of taste in the right tongue, eye twitching and lip twitching on right side. 8 days post vaccine, noticed R sided facial weakness since waking this AM at 0730. Diagnosed with bells palsy at the ER.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Cerebrovascular accident, Coma scale, Computerised tomogram head normal, Contraceptive implant, Eyelid function disorder
Clinical narrative: 5-6 days of loss of taste in the right tongue, eye twitching and lip twitching on right side. 8 days post vaccine, noticed R sided facial weakness since waking this AM at 0730. Diagnosed with bells palsy at the ER.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Facial paralysis, Mobility decreased, Muscle twitching, Nervous system disorder, Protein urine present
Clinical narrative: 5-6 days of loss of taste in the right tongue, eye twitching and lip twitching on right side. 8 days post vaccine, noticed R sided facial weakness since waking this AM at 0730. Diagnosed with bells palsy at the ER.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Skin implant removal, Tearfulness
Clinical narrative: 5-6 days of loss of taste in the right tongue, eye twitching and lip twitching on right side. 8 days post vaccine, noticed R sided facial weakness since waking this AM at 0730. Diagnosed with bells palsy at the ER.