chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Fatigue, Headache, Hypoaesthesia, Tremor
Clinical narrative: Headache; Shortness of breath that gets worst every week/ after he took a shower, he will experience shortness of breath immediately; Fatigue; Hands shake; Feet get numb at night/his feet go numb in the evening; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ9697) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: FATIGUE (non-serious) with onset 10Dec2022, outcome "not recovered"; HYPOAESTHESIA (non-serious) with onset 10Dec2022, outcome "not recovered", described as "Feet get numb at night/his feet go numb in the evening"; TREMOR (non-serious) with onset 10Dec2022, outcome "not recovered", described as "Hands shake"; DYSPNOEA EXERTIONAL (non-serious) with onset 10Dec2022, outcome "not recovered", described as "Shortness of breath that gets worst every week/ after he took a shower, he will experience shortness of breath immediately"; HEADACHE (non-serious) with onset 30Dec2022, outcome "not recovered". The events "shortness of breath that gets worst every week/ after he took a shower, he will experience shortness of breath immediately", "fatigue", "hands shake", "feet get numb at night/his feet go numb in the evening" and "headache" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of dyspnoea exertional, headache.  Additional information: Reporter was reporting side effects which he experienced with the Pfizer COVID Bivalent for 12 years and older. He had "shortness of breath that got worst every week, fatigue, his hands shake, feet got numb at night, got headache." Reporter needed to know if there was something he can do regarding these side effects to get taken care of. Reporter shared that he went to the doctor, and he was sent to the emergency room and that they could not find anything. He was referred to a cardiologist. As per Reporter it was the shortness of breath that bothers him, "it was almost that the patient could not function". He also gave an example that after he took a shower, he would experience shortness of breath immediately. There were no other investigations and other products. The events were really affecting the life adversely. Healthcare provider had no explanation every time he brings it up and said Covid they did not want to hear about it.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: 2nd stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 at 16:00 as dose 2, single (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, SINGLE, Batch/Lot No: EN6200, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 09Mar2021, for COVID-19 immunization, reaction(s): "Had 1st stroke". The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, life threatening) with onset 31Mar2021, outcome "recovered with sequelae", described as "2nd stroke". The patient was hospitalized for cerebrovascular accident (start date: 31Mar2021, discharge date: Apr2021, hospitalization duration: 4 day(s)). The event "2nd stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive; (Jan2023) Negative. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course: Patient had 2nd stroke on 31Mar2021. Went to Regional Emergency Room. Was advised of stroke, given medicines, then transported via ambulance to hospital and was admitted for 4 days. Everyone denied that the vaccine had anything to do with it and didn't even want to discuss it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143276 same vaccine/patient, different dose/event (Dose 1);US-PFIZER INC-202300145920 same vaccine/patient, different dose/event;
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 2nd stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 at 16:00 as dose 2, single (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, SINGLE, Batch/Lot No: EN6200, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 09Mar2021, for COVID-19 immunization, reaction(s): "Had 1st stroke". The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, life threatening) with onset 31Mar2021, outcome "recovered with sequelae", described as "2nd stroke". The patient was hospitalized for cerebrovascular accident (start date: 31Mar2021, discharge date: Apr2021, hospitalization duration: 4 day(s)). The event "2nd stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive; (Jan2023) Negative. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course: Patient had 2nd stroke on 31Mar2021. Went to Regional Emergency Room. Was advised of stroke, given medicines, then transported via ambulance to hospital and was admitted for 4 days. Everyone denied that the vaccine had anything to do with it and didn't even want to discuss it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143276 same vaccine/patient, different dose/event (Dose 1);US-PFIZER INC-202300145920 same vaccine/patient, different dose/event;
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; 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 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gabapentin, reaction(s): "Drug allergy"; Morphine, reaction(s): "Drug allergy". The following information was reported: COVID-19 (medically significant) with onset 28Mar2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 28Mar2023, outcome "unknown", described as "Drug ineffective ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Mar2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received no other medication in 2 weeks at the time of reporting. The patient was treated with Paxlovid (Batch/Lot number: GF7861) from 31Mar2023 to Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143213 Same patient, different product, different event;
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation; 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 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143235 Same patient, different product, different events;
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: Had 1st stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 at 12:00 as dose 1, single (Lot number: EN6200, Expiration Date: 30Jun2021) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergy" (unspecified if ongoing); "High BP" (unspecified if ongoing); "Cholesterol abnormal" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, life threatening) with onset 10Mar2021 at 13:00, outcome "recovered with sequelae", described as "Had 1st stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 3 day(s)). The event "had 1st stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive; (Jan2023) Negative. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical Course: Patient had 1st dosage of Pfizer Covid 19 vaccine on 09Mar2021, then had 1st stroke 10Mar2021. Went to Hospital Emergency Room. Was advised of stroke, given meds, then med-flighted to a Hospital and was admitted for 3 days. Adverse event treatment: treatment: Medications, testing, observation. Other medications in two weeks: YES, Facility type vaccine: Public Health Clinic.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143181 Same patient, same product, same event (Dose 2);
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 62 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Apr2022 at 12:30 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Feb2021 at 13:00 as dose 1, single (Lot number: EN6201), in left arm, on 29Sep2021 at 11:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 25Jan2022 at 15:00 as dose 3 (booster), single (Lot number: EL9261), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: Jan2015, stop date: 22Mar2023; VASCEPA, start date: Jan2015, stop date: 22Mar2023; FENOFIBRATE, start date:Jan2015, stop date: 22Mar2023; LISINOPRIL, start date: Jan2018; OMEPRAZOLE, start date: Jan2005; TADALAFIL, start date: Jan2022; DOXYCYCLINE, start date: Jun2022; MELOXICAM, start date: Apr2022; LORATADINE, start date: Jan2005; TESTOSTERONE, start date: Jan2000. Past drug history included: Tetracycline, reaction(s): "Known allergies Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Mar2023) Negative, notes: Testing negative for COVID using Antigen test on last day on Paxlovid treatment 26Mar2023; (28Mar2023) Negative, notes: tested negative again using Antigen test 28Mar2023; (30Mar2023) positive, notes: Tested positive for COVID using Antigen test 30Mar2023; (03Apr2023) positive, notes: test positive as of today, 03Apr2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with paxilovid for COVID 19 from 21Mar2023 to 26Mar2023.Testing negative for COVID using Antigen test on last day on Paxlovid treatment 26Mar2023 and tested negative again using Antigen test 28Mar2023. Tested positive for COVID using Antigen test 30Mar2023 and continue to test positive as of today, 03Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143686 Same parient/vaccine, different dose/event;
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 13:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient is treated with Paxlovid from 20Mar2023 to 24Mar2023 for COVID-19.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 10:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 76 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: C19265), in right arm, on 27Feb2021 as dose 2, single (Lot number: EN6203) and on 07Oct2021 as dose 3 (booster), single (Lot number: EW0191), in right arm for covid-19 immunisation. The patient's relevant medical history included: "season allergy" (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 Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Patient was not taking any other medications products within 2 weeks of starting COVID-19 treatment.
Age: 51.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; 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 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. 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. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.  Clinical course: The patient was treated with Paxlovid from 21Mar2023 to 26Mar2023 for covid-19.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive home test; Positive home test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Glaucoma" (unspecified if ongoing); "Covid-19" (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 03Apr2023 at 18:45, outcome "unknown" and all described as "Positive home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Apr2023) Positive, notes: Positive home test 10 days after starting Paxlovid. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event: Positive home test 10 days after starting Paxlovid. Adverse events start date 03Apr2023, adverse event start time 18:45. Patient did not have any known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Sinusitis
Clinical narrative: sinus infection; Breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy to many antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: ER8730, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 23Mar2021, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: ER8729, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 13Apr2021, for COVID-19 Immunization. The following information was reported: BREAST CANCER (medically significant) with onset 27Nov2021, outcome "recovered" (30Dec2022); SINUSITIS (non-serious) with onset 24Mar2022, outcome "not recovered", described as "sinus infection". Therapeutic measures were taken as a result of breast cancer, sinusitis. Clinical course: Completed treatment for Breast Cancer 30Dec2022 included chemo, radiation + immunotherapy + surgery (double mastectomy). Benadryl taken for corrective treatment of sinus infection, orally, Start date: 01Dec2022, ongoing. Patient received BNT162b2 (BNT162B2), on 10Nov2022 as dose 4 (booster), single (Lot number: GH9693) intramuscular, in right arm for covid-19 immunisation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300101355 same patient, different drug and different event.;US-PFIZER INC-202300101367 same patient/product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Flow cytometry, Positron emission tomogram, T-cell lymphoma
Clinical narrative: cytotoxic T-cell lymphoma; This is a literature report.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: T-CELL LYMPHOMA (medically significant), outcome "unknown", described as "cytotoxic T-cell lymphoma". The patient underwent the following laboratory tests and procedures: Flow cytometry: slightly elevated CD4/CD8 ratio; Positron emission tomogram: mildly hypermetabolic, notes: non-enlarged bilateral axillary and pelvic lymph nodes.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported event T-cell lymphoma. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 11.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Daptacel was inadvertently administered instead of Tdap with no reported adverse event; Daptacel was inadvertently administered to 11 year old patient with no reported adverse event; Initial information received on 31-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient to whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was inadvertently administered instead of (Tdap) diphtheria, tetanus and acellular pertussis vaccine 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 HPV vaccine (hpv vaccine) and influenza vaccine for Prophylactic vaccination.   On 28-Oct-2022, the patient received 0.5 ml dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (strength: unknown) (lot C5829BA; no expiration date available) via intramuscular route in the left deltoid for Immunization was inadvertently administered instead of Tdap with no reported adverse event (wrong product administered) (latency: on same day).  On 28-Oct-2022 the daptacel was inadvertently administered to 11 year old patient with no reported adverse event (product administered to patient of inappropriate age) (latency; on same day). It was reported that patient was supposed to get tdap. Medical assistant confirms that the patient has already completed their dtap series; states that daptacel was inadvertently administered instead of tdap.   Action taken : not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 2 patients who were administered post temperature excursion with no reported adverse event; twenty minute excursion of 0.8C with no reported adverse event; Initial information received on 31-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patients of unknown age and gender and it was reported twenty minute excursion of 0.8c and 2 patients who were administered poliomyelitis vaccine (inactivated) [IPOL] post temperature excursion with no reported adverse event.  On 01-Mar-2023, poliomyelitis vaccine (inactivated) suspension for injection (batch/lot number: V1B891M; expiry date: unknown) underwent twenty minute excursion of 0.8c with no reported adverse event (product storage error) (unknown latency).  On an unknown date, 2 patients who were administered poliomyelitis vaccine (inactivated) (unknown dose and route) in unknown administration site for Immunization post temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the events.  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: 12.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Third dose was supposed to be given on 01Apr2023 but the patient didn't come with no reported adverse event; Initial information received on 03-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient and reporter reported third dose of Rabies (Hdc) Vaccine [Imovax Rabies] was supposed to be given on 01apr2023 but the patient didn't come with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Mar-2023, the patient received a Dose 1  of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (with an unknown lot number, strength, dose, expiry date) via unknown route in unknown administration site for Immunization. On 28-Mar-2023 he also received a Dose 2 of the same vaccine .  On an unknown date, the reporter reported third dose of Rabies (Hdc) Vaccine was supposed to be given on 01apr2023 but the patient didn't come with no reported adverse event (Strength-Standard) (inappropriate schedule of product administration) (latency: unknown).  It was reported, Call received from pharmacy intern with questions on how to proceed with IMOVAX if the patient has deviated from the schedule for a post exposure dose series. Caller reports the first dose was administered on day zero on 22MAR2023, second dose was given 28MAR2023, and the third dose was supposed to be given on 01APR2023 but the patient didn't come in but is expected to come in today for their third dose.  Action taken: not applicable.  Outcome: Unknown  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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Magnetic resonance imaging, Malaise, Mobility decreased, Myalgia
Clinical narrative: Became unwell over a period of months in that his mobility  was severely affected - diagnosis, finally, is Polymyalgia which he is now having to be on medication for
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Became unwell over a period of months in that his mobility  was severely affected - diagnosis, finally, is Polymyalgia which he is now having to be on medication for
Age: 67.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Anticoagulant therapy, Atrial fibrillation, Cardiovascular evaluation, Cardioversion, Computerised tomogram abdomen
Clinical narrative: The patient received his covid vaccine+fluAD vaccine on 10/12/2022 He began to have SOB and dizziness on 11/03/2022 On Friday 11/04/2022, he went to the ER and was in Afib with RVR. His rate was brought down with medications and he was discharged with Eliquis and Metoprolol.  On Monday 11/07/2022, he had follow up with me at the clinic and was found to be in Afib with RVR again HR 118-130s with SOB and dizziness. He was sent to the ER again and then transferred to the hospital.  At the hospital, he was put on Amiodarone and ultimately he was shocked and went into normal rhythm. He was discharged with carvedilol 6.25mg BID, Amiodarone 200mg BID, and Eliquis 5mg BID.  Since that time his rhythm and rate have been controlled and he has undergone cardiac work up with cardiologist Dr.  The patient also developed significant lightheadedness with eating starting 11/03/2022 which did not resolve once Afib resolved.  He was hospitalized for this at the end of November 2022 where he had CT scans/HIDA scans which were largely normal. These symptoms have improved but are still present to some degree. The patient initially had significant weight loss due to being unable to eat without significant lightheadedness.
Age: 67.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Computerised tomogram abdomen normal, Computerised tomogram head normal, Computerised tomogram thorax normal, Dizziness, Dyspnoea
Clinical narrative: The patient received his covid vaccine+fluAD vaccine on 10/12/2022 He began to have SOB and dizziness on 11/03/2022 On Friday 11/04/2022, he went to the ER and was in Afib with RVR. His rate was brought down with medications and he was discharged with Eliquis and Metoprolol.  On Monday 11/07/2022, he had follow up with me at the clinic and was found to be in Afib with RVR again HR 118-130s with SOB and dizziness. He was sent to the ER again and then transferred to the hospital.  At the hospital, he was put on Amiodarone and ultimately he was shocked and went into normal rhythm. He was discharged with carvedilol 6.25mg BID, Amiodarone 200mg BID, and Eliquis 5mg BID.  Since that time his rhythm and rate have been controlled and he has undergone cardiac work up with cardiologist Dr.  The patient also developed significant lightheadedness with eating starting 11/03/2022 which did not resolve once Afib resolved.  He was hospitalized for this at the end of November 2022 where he had CT scans/HIDA scans which were largely normal. These symptoms have improved but are still present to some degree. The patient initially had significant weight loss due to being unable to eat without significant lightheadedness.
Age: 67.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Echocardiogram, Heart rate increased, Hepatobiliary scan normal, Laboratory test
Clinical narrative: The patient received his covid vaccine+fluAD vaccine on 10/12/2022 He began to have SOB and dizziness on 11/03/2022 On Friday 11/04/2022, he went to the ER and was in Afib with RVR. His rate was brought down with medications and he was discharged with Eliquis and Metoprolol.  On Monday 11/07/2022, he had follow up with me at the clinic and was found to be in Afib with RVR again HR 118-130s with SOB and dizziness. He was sent to the ER again and then transferred to the hospital.  At the hospital, he was put on Amiodarone and ultimately he was shocked and went into normal rhythm. He was discharged with carvedilol 6.25mg BID, Amiodarone 200mg BID, and Eliquis 5mg BID.  Since that time his rhythm and rate have been controlled and he has undergone cardiac work up with cardiologist Dr.  The patient also developed significant lightheadedness with eating starting 11/03/2022 which did not resolve once Afib resolved.  He was hospitalized for this at the end of November 2022 where he had CT scans/HIDA scans which were largely normal. These symptoms have improved but are still present to some degree. The patient initially had significant weight loss due to being unable to eat without significant lightheadedness.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Chest pain, Injection site pain, Insomnia, Sleep disorder
Clinical narrative: I have severe burning sensation in my chest and it disturbs my sleep. This started on Wednesday evening, a day after I took the vaccine. I  was awoken at 4:00 am on Thursday due to the burns to file this report. The chest burns is very serious. I cannot sleep.  I also feel a little pain in my right arm which is the site if injection.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot, shingles in less than a year/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional patient notes included The patient had no shingles for 70 plus years.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot, shingles in less than a year/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shot and got shingles in less than a year. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Accidental overdose
Clinical narrative: Pediarix and Engerix given on the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 2-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number FB9RH) for prophylaxis.   On 13-FEB-2023, the patient received Pediarix and Engerix B. On 13-FEB-2023, an unknown time after receiving Pediarix and Engerix B, the patient experienced accidental overdose (Verbatim: Pediarix and Engerix given on the same day). The outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-MAR-2023 The reporter was a medical assistant. The reporter consented to follow up. The patient received Engerix B and Pediarix on same day, which led to overdose.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given two weeks after 1st dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 6-year-old female patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 22-MAR-2023, the patient received the 2nd dose of Engerix B. On 22-MAR-2023, an unknown time after receiving Engerix B and an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given two weeks after 1st dose). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-MAR-2023 Lot number and expiration date were asked but declined. The reporter consented to follow up via email. The patient received 2nd dose of Engerix B, earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm swollen, red, warm to the touch at injection site, onset late the evening of 4/3/23, morning of 4/4/23.  Patient sought care at urgent care center after symptoms worsened and diagnosed with cellulitis the morning of 4/5/23.  Bactrim DS 800/160 twice daily for 10 days initiated 4/5/23.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: She had a fever, and we gave her TYLENOL through the night. Then, I started to hear a croup sound when she coughed. I took her to the doctor, and they gave her dexamethasone. She still has some congestion and coughing but she is starting to feel better.
Age: 73.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Cough, Headache, Malaise, Nasal congestion, Oropharyngeal pain
Clinical narrative: 3/3/23 I had a sore throat, headache, cough, nasal congestion, achy all over which lasted for several days. The cough got deeper and more productive. On 3/6/23 I went to the urgent care, and I was prescribed benzonatate for my cough and I took TYLENOL for fever and aches. I tested negative with a COVID 19 PCR test. I was ill for 10 days.
Age: 73.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Pain, Productive cough, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 3/3/23 I had a sore throat, headache, cough, nasal congestion, achy all over which lasted for several days. The cough got deeper and more productive. On 3/6/23 I went to the urgent care, and I was prescribed benzonatate for my cough and I took TYLENOL for fever and aches. I tested negative with a COVID 19 PCR test. I was ill for 10 days.
Age: 76.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Cough, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: I had a fever of 101 degrees (my temp is usually about 96.5), cough and congestion. I tested with a home COVID test kit and was positive. I repeated the test and confirmed that both were positive with my daughter. I had a telehealth appointment with an NP, who gave me a prescription for Paxlovid. I was able to get the Paxlovid from my pharmacy the next morning (25 March). In two days my temp was between 97 and 98. I finished the med course and no major symptoms have returned. I still have a cough and a runny nose. I quarantined and have not interacted with anyone without a mask. My wife tested positive on 27 March.
Age: 76.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a fever of 101 degrees (my temp is usually about 96.5), cough and congestion. I tested with a home COVID test kit and was positive. I repeated the test and confirmed that both were positive with my daughter. I had a telehealth appointment with an NP, who gave me a prescription for Paxlovid. I was able to get the Paxlovid from my pharmacy the next morning (25 March). In two days my temp was between 97 and 98. I finished the med course and no major symptoms have returned. I still have a cough and a runny nose. I quarantined and have not interacted with anyone without a mask. My wife tested positive on 27 March.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case    All Pfizer dose 1  2/24/21  EN6198 dose 2  3/17/21  EN6205 dose 3  10/22/21  FF2593
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Aspartate aminotransferase increased, Blood iron decreased, Borrelia test, C-reactive protein, Full blood count
Clinical narrative: pt developed limp on 8/6 suspected transient synovitis lasted about 1 day  pt had second covid vaccine on 8/11/2022 and developed limp again 8/26, lasted several days
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Gait disturbance, Metabolic function test, Pyrexia, Red blood cell sedimentation rate, Serum ferritin decreased
Clinical narrative: pt developed limp on 8/6 suspected transient synovitis lasted about 1 day  pt had second covid vaccine on 8/11/2022 and developed limp again 8/26, lasted several days
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Synovitis, X-ray limb, X-ray of pelvis and hip
Clinical narrative: pt developed limp on 8/6 suspected transient synovitis lasted about 1 day  pt had second covid vaccine on 8/11/2022 and developed limp again 8/26, lasted several days
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case  all Moderna dose 1  2/15/21  031L20A dose 2  3/15/21  030A21A dose 3  11/18/21  069F21A dose 4  7/8/22  017B22A
Age: 64.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Fatigue, Influenza virus test positive, Malaise, Myalgia
Clinical narrative: I experienced low grade fever, muscle aches and pains in November 2022. I did not have a cough but was very fatigued and tired. I took a COVID-19 test and a Flu test which was positive.  My symptoms lasted one week. After 3-4 days I got better. On the 5th day my COVID-19 test was negative.
Age: 64.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I experienced low grade fever, muscle aches and pains in November 2022. I did not have a cough but was very fatigued and tired. I took a COVID-19 test and a Flu test which was positive.  My symptoms lasted one week. After 3-4 days I got better. On the 5th day my COVID-19 test was negative.
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Non-Hodgkin's lymphoma, Tonsil cancer, Tonsillar hypertrophy
Clinical narrative: I was having problems with my tonsils; they were swelling, and I went to my doctor and the prescribed antibiotics.  That did not help so I went to an ENT and they diagnosed me with cancer.  Which it is Non-Hodgins Lymphoma of the Tonsils.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, No adverse event, SARS-CoV-2 test positive
Clinical narrative: I did not have a reaction to the vaccine. I tested positive for COVID-19 in 01/2023. I contacted my doctor and was prescribed PAXLOVID. I tolerated the medication without any complications. As of today, I feel better with no lingering symptoms.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Vomiting
Clinical narrative: nausea and vomiting
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature increased, COVID-19, Cough, Pharyngeal disorder, Respiratory tract congestion
Clinical narrative: I contracted COVID-19. My symptoms included congestion, a bad throat, and coughing for a few days. I had a high temperature as well. I took a COVID-19 test, but the result was negative. However, the symptoms continue to worsen. I took another COVID-19 test and it was positive. I went to urgent care and I received PAXLOVID.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I contracted COVID-19. My symptoms included congestion, a bad throat, and coughing for a few days. I had a high temperature as well. I took a COVID-19 test, but the result was negative. However, the symptoms continue to worsen. I took another COVID-19 test and it was positive. I went to urgent care and I received PAXLOVID.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Cough
Clinical narrative: I started coughing and hacking really bad. I was really tired. I am usually active. I started getting chills. So, I took a COVID-19 test. It came back positive. I was just ungodly tired. I lost my sense of smell and taste right away. I am just getting it back. I am still tired and coughing. I didn't have much of an appetite. I lost 12 pounds. My doctor prescribed me Paxlovid. I had to stop taking my Simvastatin medication until I finished my Paxlovid prescription. My doctor gave me albuterol to help with the coughing.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Decreased appetite, Fatigue, SARS-CoV-2 test positive, Weight decreased
Clinical narrative: I started coughing and hacking really bad. I was really tired. I am usually active. I started getting chills. So, I took a COVID-19 test. It came back positive. I was just ungodly tired. I lost my sense of smell and taste right away. I am just getting it back. I am still tired and coughing. I didn't have much of an appetite. I lost 12 pounds. My doctor prescribed me Paxlovid. I had to stop taking my Simvastatin medication until I finished my Paxlovid prescription. My doctor gave me albuterol to help with the coughing.
Age: 39.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: redness swelling soreness accompanied by itchiness at injection site a week after injection