chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Moderna Dose Number 4. Pfizer / BioNTech Dose Number 3; 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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL330), in left arm, on 08Feb2021 as dose 2, single (Lot number: EL9265), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 64 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 21Apr2022 as dose 4 (booster), single (Lot number: MOD / 001M) and on 30Sep2022 as dose 5 (booster), single (Lot number: MOD / AS7162B), in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna Dose Number 4. Pfizer / BioNTech Dose Number 3"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure. Additional information: The patient had no treatment and no known allergies. No chronic health conditions or illness.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Full blood count, SARS-CoV-2 test
Clinical narrative: she got COVID; she got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in arm and as dose 4 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm and as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she got COVID". The patient underwent the following laboratory tests and procedures: Full blood count: Unknown results; SARS-CoV-2 test: Positive; Positive. Clinical course: It was reported that the patient has had both vaccinations shot and then each of the booster shot she had a breakthrough case about a month ago. The patient takes a lot of medications. It was also reported that the patient experienced cold symptoms. The reporter (patient's child) will have to look at the list. Not at this time, the reporter has to look at that. For the lab tests, it was reported that yes, they run all kinds of test and the patient just got diagnosed with cancer not that long ago and then she got COVID. There was about 20 different tests she has been going through. You just want blood test or, because they did like a complete CBC they did all kind of thing because they were getting ready to treat her for cancer.   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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300155487 same patient/drug, different drug dose/event;US-PFIZER INC-202300155299 same patient/drug/event, different drug dose;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Full blood count, Investigation, Neoplasm malignant
Clinical narrative: she got COVID; she got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in arm and as dose 4 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm and as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she got COVID". The patient underwent the following laboratory tests and procedures: Full blood count: Unknown results; SARS-CoV-2 test: Positive; Positive. Clinical course: It was reported that the patient has had both vaccinations shot and then each of the booster shot she had a breakthrough case about a month ago. The patient takes a lot of medications. It was also reported that the patient experienced cold symptoms. The reporter (patient's child) will have to look at the list. Not at this time, the reporter has to look at that. For the lab tests, it was reported that yes, they run all kinds of test and the patient just got diagnosed with cancer not that long ago and then she got COVID. There was about 20 different tests she has been going through. You just want blood test or, because they did like a complete CBC they did all kind of thing because they were getting ready to treat her for cancer.   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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300155487 same patient/drug, different drug dose/event;US-PFIZER INC-202300155299 same patient/drug/event, different drug dose;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Full blood count, SARS-CoV-2 test
Clinical narrative: cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Full blood count: Unknown results; all kind of test: Unknown results.  Clinical course details: The reporter stated that they ran all kind of tests as the patient just got diagnosed with cancer not that long ago and then she got COVID. There was about 20 different test she has been going through. They did like a complete CBC, they did all kinds of things because they were getting ready to treat her for cancer.  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-202300155299 same patient/drug, different dose/event;US-PFIZER INC-202300155486 same patient/drug, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Full blood count, Investigation, Neoplasm malignant
Clinical narrative: cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Full blood count: Unknown results; all kind of test: Unknown results.  Clinical course details: The reporter stated that they ran all kind of tests as the patient just got diagnosed with cancer not that long ago and then she got COVID. There was about 20 different test she has been going through. They did like a complete CBC, they did all kinds of things because they were getting ready to treat her for cancer.  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-202300155299 same patient/drug, different dose/event;US-PFIZER INC-202300155486 same patient/drug, different dose/event;
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: cellulitis; had an allergic reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 56-year-old (reported as "I am 56") patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN), reported as "pneumonia vaccination"), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing); "SLL lymphoma" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu, reaction(s): "no reaction"; Shingrix, reaction(s): "no reaction". The patient also received the Flu & Shingrix vaccinations with no reaction. In fact, the patient received the Shingrix vaccination at the same location as the pneumonia vaccination.  The following information was reported: CELLULITIS (intervention required, medically significant), outcome "unknown"; HYPERSENSITIVITY (intervention required, medically significant), outcome "unknown", described as "had an allergic reaction". Clinical course: the patient had received the pneumonia vaccination on 25Mar(year unspecified). The patient thought she/he had an allergic reaction, as the patient ended up with cellulitis. This is the same reaction to the pneumonia vaccination the patient had 6-7 years ago. This is the only vaccination in which the patient get cellulitis.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: There is a reasonable possibility that the event hypersensitivity was related to PNEUMOCOCCAL 13-VAL CONJ VAC based on known drug safety profile. The association between the event cellulitis with PNEUMOCOCCAL 13-VAL CONJ VAC can not be fully excluded.  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.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: broke out with rash on mine chest and back with cream it when away then it went down to mine arms both of them and cannot get rid of this rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "not recovered", described as "broke out with rash on mine chest and back with cream it when away then it went down to mine arms both of then and can not get rid of this rash". Therapeutic measures were taken as a result of rash.  Additional information: Patient took Pfizer booster shot in Jan2022 and broke out with rash on chest and back with cream it when away then it went down to mine arms both of then and can not get rid of this rash.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Condition aggravated, Rash papular
Clinical narrative: I went to the hospital for a week it did nit go well with my blood sugar; bumps on my buty / it is starting to go up the side of my back and down my legs; it is getting worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bumps on buty" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), for COVID-19 immunization. The following information was reported: BLOOD GLUCOSE ABNORMAL (hospitalization), outcome "not recovered", described as "I went to the hospital for a week it did nit go well with my blood sugar"; RASH PAPULAR (non-serious), outcome "not recovered", described as "bumps on my buty / it is starting to go up the side of my back and down my legs"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "it is getting worse". The patient was hospitalized for blood glucose abnormal (hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: Blood glucose abnormal: Unknown results. Additional information: Patient have gotton all covid shots and booster from your company after 2nd shoot patient went to the Hospital for a week it did not go well with blood sugar after that paitent was getting bumps on buty have had doctors give patient things tha dont work Mar2019 and it is getting worse it is starting to go up the side of back and down legs. Patient was looking for help this is bad you are last resort no dr. seem to know what to do   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Positron emission tomogram
Clinical narrative: Right axilla and supraclavicular lymphadenopathy; This is a literature report for the following literature source(s):  A 53-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "Right axilla and supraclavicular lymphadenopathy". The patient underwent the following laboratory tests and procedures: Positron emission tomogram: Unknown results; Sender's Comments: Based on the available information, the company considers that a causal relationship between lymphadenopathy and BNT162b2 vaccination cannot be excluded due to plausible temporal association. 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.
Sex: M
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: vitiligo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VITILIGO (non-serious) with onset 2021, outcome "unknown".  Additional information: Patient developed vitiligo right after the Pfizer booster on 2021. He was 53-year-old male healthy never had a problem with COVID-19 (mild symptoms) but now he was hiding my face with this disease. Patient only had the vaccine done for travel.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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: DEATH (death), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Caller said he didn't get the vaccine but some of his family members did and he was wondering if he could have a refund for the COVID vaccine. He said they saved up from months to buy that vaccine and said he knew little (patient name withheld) died after took that shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: On Dec2022, the patient experienced Covid.; On Dec2022, the patient experienced Covid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-21K-163-4105453-00 (Abbvie).  A 59-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular 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) all with onset Dec2022, outcome "recovered" and all described as "On Dec2022, the patient experienced Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Dec2022, the patient experienced Covid.  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-202101352838 same reporter/patient, different drug/event;
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: wife tested positive for Covid-19 "about a month ago"; wife tested positive for Covid-19 "about a month ago"; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 78 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Lot number: 039K20A), on 09Feb2021 as dose 2, single (Lot number: 028L20A), on 24Aug2021 as dose 3 (booster), single (Lot number: 014C21A) and on 04Apr2022 as dose 4 (booster), single (Lot number: 065K21A) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Allergic reaction to bee sting" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "wife tested positive for Covid-19 "about a month ago"". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: only the diluent portion of pentacel had been administered with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient and reporter reported only the diluent portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] had been administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Apr-2023, the patient received an unknow dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (with an unknown strength, expirty date, lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On 06-Apr-2023, the patient received only the diluent portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine had been administered with no reported adverse event (Product preparation error) (Latency: same day).  It was reported, Sales rep states that she spoke with a nurse that said she discovered that only the diluent portion of Pentacel had been administered to a 4-month-old male, administered on 06-Apr-2023.  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 guidelines. 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: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient administered acthib with expired diluent with no reported adverse events; Initial information received on 11-Apr-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a patient of an unknown age and gender who was administered HIB (PRP/T) VACCINE [ACT-HIB] with expired diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Apr-2023, the patient received an unknown dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (Vaccine-lot number: UJ653AAB; Expiry date: 24-Apr-2023) (Diluent: Lot number- U7261AD, expiration date: 07-Apr-2023) (with an unknown strength) via unknown route in unknown administration site for Immunization.  On 10-Apr-2023, the patient developed a non-serious patient was administered HIB (PRP/T) VACCINE with expired diluent with no reported adverse event (poor quality product administered) (Latency: same day).  It was reported, Caller states the expiration on the diluent and vaccine have different expiration dates. Caller states a physician was looking at the expiration date on the vaccine (24APR2023) and gave the vaccine to a patient not realizing that the diluent expired on (7APR2023). Wanting to know next steps to take and any harm to patient. Caller does not have patients information at time of call.This situation is reported as a medication error due to ACTHIB being administered to a patient that was reconstituted with expired diluent  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 guidelines. 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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: a patient receiving an expired ACT-HIB with no reported adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1-year-old male patient who was receiving an expired HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPA [HEPATITIS A VACCINE]) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 11-Apr-2023, the patient received dose 4 at 0.5ml total of suspect HIB (PRP/T) VACCINE (Strength: standard) (lot number: UJ650AAB, expiry date: 10-Apr-2023) via intramuscular route in the left thigh for Immunization and on the same day patient receiving an expired act-hib with no reported adverse event (expired product administered).  It was reported, caller asked for information on how to proceed in this situation?   Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was 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 guidelines. 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: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: NONE COVID VACCINE EXPIRED 11/22/2022 GIVEN: 01/11/2023
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: NONE COVID 19 VACCINE EXPIRED 11/22/2022 GIVEN: 01-10-2023
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: NONE COVID-19 VACCINE EXPIRED 11/22/2022 GIVEN 01/06/2023
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: NONE; NONE; OUTCOME NONE; S/S NONE.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: NONE NONE NONE NONE
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Dizziness, Magnetic resonance imaging head abnormal, Muscular weakness
Clinical narrative: Medullary CVA. Dizziness, weakness in bilateral arms
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Influenza like illness, Injection site erythema, Injection site rash, Injection site swelling, Limb discomfort
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Body Aches Generalized-Medium, Additional Details: Patient reported flu-like symptoms that developed with-in 24 hours of vaccine administration, on day 2 her arm "felt heavy" by day 3 rash developed that started at injection site and spread over the next days until she reported to pharmacy on 04/11/2023 in the afternoon. rash has spread on both side of injection site and down  the arm to the wrist, rash was warm to the touch, skin not affected by rash on arm was not warm. Patient was advised to seeek medical attention at nearby urgent care.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Rash
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Body Aches Generalized-Medium, Additional Details: Patient reported flu-like symptoms that developed with-in 24 hours of vaccine administration, on day 2 her arm "felt heavy" by day 3 rash developed that started at injection site and spread over the next days until she reported to pharmacy on 04/11/2023 in the afternoon. rash has spread on both side of injection site and down  the arm to the wrist, rash was warm to the touch, skin not affected by rash on arm was not warm. Patient was advised to seeek medical attention at nearby urgent care.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, X-ray normal
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: spoke to staff at dr office.  dr has diagnosed pt with severe pain of left shoulder icd10 m23.512. pt has had an xray that doesn't show any foreign object in shoulder. dr has ordered cmp and gamma gt tests at labs but pt has not had them done when i last spoke to dr office.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Ear pain, Facial pain, Headache, Neck pain
Clinical narrative: Headache, neck ache, ear and face nerve pain, joint pain
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Headache, neck ache, ear and face nerve pain, joint pain
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus with no other symptoms and no known cause
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: When asked if Pt was there for a booster, not a vaccine, the mother of Pt insisted Pt was there for her Moderna vaccine.  She was then administered her third dose of the Moderna primary series. The mother of Pt made a mistake because Pt needed a booster, not a vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram abnormal, Arterial occlusive disease, Autoimmune disorder, Blood test, Fatigue
Clinical narrative: I don't know if my medical issues are a result of the vaccines, I'm just reporting so that this information can be noted.  #1. At the end of November I started to have fatigue in my arms and hands went into spasms if I used them very much.  An ultrasound of arms showed 100% blockage in axillary arteries in both arms with some blood still flowing through collateral arteries. After an angiogram this blockage was determined to be caused by inflammation.  Cardiologist and Rheumatologist believe it's caused by an autoimmune, but it hasn't been confirmed which one.  #2. In February 2023 I was also diagnosed with hyperthyroidism caused by Graves Disease, which is also an autoimmune.  I did have the shots administered in both arms.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Graves' disease, Hyperthyroidism, Inflammation, Muscle spasms, Ultrasound Doppler abnormal
Clinical narrative: I don't know if my medical issues are a result of the vaccines, I'm just reporting so that this information can be noted.  #1. At the end of November I started to have fatigue in my arms and hands went into spasms if I used them very much.  An ultrasound of arms showed 100% blockage in axillary arteries in both arms with some blood still flowing through collateral arteries. After an angiogram this blockage was determined to be caused by inflammation.  Cardiologist and Rheumatologist believe it's caused by an autoimmune, but it hasn't been confirmed which one.  #2. In February 2023 I was also diagnosed with hyperthyroidism caused by Graves Disease, which is also an autoimmune.  I did have the shots administered in both arms.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Skin reaction
Clinical narrative: PATIENT  NOTIFY TO THE FACILITY ON 04/14/23 WHEN HE CAME TO RECEIVE THE SECOND DOSE OF SHINGRIX. HE SAID THAT AFTER THE FIRST DOSE HE PRESENT A SKIN REACTION SIMILAR TO A CELLULITIS ON THE ADMINISTRATION SITE. HE VISITED A DOCTOR FOR A FOLLOW UP OF OTHER CONDITIONS AND THE DOCTOR ONLY SAID  TO HIM TO OBSERV THAT DO NOT GROW ANY MORE, AFTER THAT, THE REACTION BEGINS TO REDUCE UNTIL DISAPPEAR.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Exposure to SARS-CoV-2, Fatigue, Headache
Clinical narrative: Tested positive for Covid on 3/20. Husband tested positive on 3/18 after spending several hours at a buffet on 3/15.  I always wear a mask and avoid gatherings so I am pretty sure I caught it from him.  We were both prescribed Paxlovid within a day of testing positive.  Initial symptoms were headache, chills, fever, nasal drainage, fatigue.  Within a day of starting Paxlovid, systems began to resolve.  Within 3 days we were getting back to normal activities with just continuous nasal drainage and some tiredness. My symptoms were done on 4/3.  Both of us tested negative on 4/09 morning in preparation for family event. I am sure this would have been much worse without the Paxlovid.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid on 3/20. Husband tested positive on 3/18 after spending several hours at a buffet on 3/15.  I always wear a mask and avoid gatherings so I am pretty sure I caught it from him.  We were both prescribed Paxlovid within a day of testing positive.  Initial symptoms were headache, chills, fever, nasal drainage, fatigue.  Within a day of starting Paxlovid, systems began to resolve.  Within 3 days we were getting back to normal activities with just continuous nasal drainage and some tiredness. My symptoms were done on 4/3.  Both of us tested negative on 4/09 morning in preparation for family event. I am sure this would have been much worse without the Paxlovid.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was given 3 doses of the Shingrix vaccine on 7/26/22, 9/30/22, and 12/8/22
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a 3rd does of the shingrix vaccine.  No adverse events were reported by the patient.
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient had received the bivalent booster rather than the first dose in the monovalent series. patient went to a different facility in order to get a J&J shot and the mistake was caught.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dehydration, Diarrhoea, Headache, Nausea
Clinical narrative: pt explained that for 2 or 3 days after the vaccine administration, she had fever and chills and diarrhea and nausea and dehydration and headache
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: pt explained that for 2 or 3 days after the vaccine administration, she had fever and chills and diarrhea and nausea and dehydration and headache
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Injection site erythema, Injection site inflammation, Injection site swelling, Pain
Clinical narrative: Patient still has a raised, red, and inflamed area on her right deltoid.  Patient reports having a pain that stems from deep inside her arm, she believes it to be radiating from her bone.  Patient reports that her pain gets worse when it is about to rain.  Patient states that she has to take an Aleve everyday now to control the pain and inflammation.  This patient got her last dose on 06/09/2022 and she has been suffering from these symptoms ever since her Moderna Covid-19 booster dose.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient still has a raised, red, and inflamed area on her right deltoid.  Patient reports having a pain that stems from deep inside her arm, she believes it to be radiating from her bone.  Patient reports that her pain gets worse when it is about to rain.  Patient states that she has to take an Aleve everyday now to control the pain and inflammation.  This patient got her last dose on 06/09/2022 and she has been suffering from these symptoms ever since her Moderna Covid-19 booster dose.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: NONE.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: NONE NONE NONE NONE
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: NONE NONE NONE
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: NONE NONE NONE
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site mass, Paraesthesia
Clinical narrative: I did not have any adverse reactions after shot 1.   I had a delayed reaction after shot 2. About 2-3 days after I received the second dose, I had a hard lump and deep bruising at the injection site, and tingling down my arm. It lasted until April 13 (about 6 days). Now it has subsided and there is only a faint bruise at the injection site.   I spoke with the pharmacist/manager of pharmacy where I got the vaccine, and she told me to report it.
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: NONE NONE NONE
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Heart rate increased, Hot flush, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Immediate numbness of arm, Immediate hot flashes with blurred vision, increased heart rate, possible drop in blood pressure, Immediate nausea, Immediate fatigue. All within 5 minutes of injection.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Vision blurred
Clinical narrative: Immediate numbness of arm, Immediate hot flashes with blurred vision, increased heart rate, possible drop in blood pressure, Immediate nausea, Immediate fatigue. All within 5 minutes of injection.
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: NONE NONE NONE
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: N/A PATIENT WAS ACCIDENTALLY GIVEN PFIZER BIVALENT INSTEAD OF MONOVALENT
Age: 34.0
Sex: M
Vaccine: COVID19, HEP, TDAP
Symptoms: Urticaria
Clinical narrative: HIVES ON ARMS AND FACE MAYBE ABOUT 2 HOURS AFTER SHOT
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: None None None
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Fatigue, Nausea, Peripheral swelling
Clinical narrative: Client reports first night left arm became swollen about fist size and reddened.  Client then had nausea and a fever up to 102 degrees.  Client took Tylenol.  By 4-5-23 client started having diarrhea and then from 4:30 to 10 PM client had projectile vomiting and the temperature continued and the diarrhea continued.  By the late PM client was home alone with no one to care for her and she felt worn out so she went the the local ER and was given IV fluids.  Client called to report this on 4-7-23.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: Client reports first night left arm became swollen about fist size and reddened.  Client then had nausea and a fever up to 102 degrees.  Client took Tylenol.  By 4-5-23 client started having diarrhea and then from 4:30 to 10 PM client had projectile vomiting and the temperature continued and the diarrhea continued.  By the late PM client was home alone with no one to care for her and she felt worn out so she went the the local ER and was given IV fluids.  Client called to report this on 4-7-23.
Age: 57.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Headache, Hypertension, Hypoaesthesia, Pain
Clinical narrative: extremely high blood pressure 220/120 , body aches, headache 'severe' numbness in left arm,  hand and  face,blood pressure went back to normal, after medication around midnight, the other symptoms are still present, its been around 50 hours
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acoustic stimulation tests abnormal, Deafness bilateral, Hearing aid user, Magnetic resonance imaging head normal, SARS-CoV-2 test negative
Clinical narrative: 1/17/23-all of sudden i lost my hearing in left ear 2/3/23-primary doctor gave me Prednisone 20mg 3times daily/10 days 2/16/23-saw ENT. have lost of hearing in both ears (left ear 80%). Said i could live with it, get a shot in ear but don't really recommend or get a hearing aid.  I went with a hearing aid ($860.00)  Had Covid on 12/13/22. tested negative 10 days later
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sudden hearing loss
Clinical narrative: 1/17/23-all of sudden i lost my hearing in left ear 2/3/23-primary doctor gave me Prednisone 20mg 3times daily/10 days 2/16/23-saw ENT. have lost of hearing in both ears (left ear 80%). Said i could live with it, get a shot in ear but don't really recommend or get a hearing aid.  I went with a hearing aid ($860.00)  Had Covid on 12/13/22. tested negative 10 days later
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Muscle spasms, Pain in extremity
Clinical narrative: Dizzy, even when turning over in bed. Chills, shaking, though it was not cold weather. Muscle spasms from waist, down the legs ( like restless legs) Headache Very sore arm
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Restless legs syndrome, Tremor
Clinical narrative: Dizzy, even when turning over in bed. Chills, shaking, though it was not cold weather. Muscle spasms from waist, down the legs ( like restless legs) Headache Very sore arm
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Parent stated that patient needed the vaccinations to be in school, she did not disclose that he had them before.  When charting after they were given, it was discovered that the patient was given these last year.  The patient had NO adverse effects in the exam room. The parent was called and a message left for her to return our call.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain fog, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Fibrin D dimer normal
Clinical narrative: Started to feel lightheaded, with a headache and foggy on Wednesday April 13. Woke up on April 14th with dizziness, later that day I noticed tiny blood spots on my right thigh. Call the pharmacy where I got the vaccine and was advised to go to the hospital right away. I did.  Today, April 15, I?m still feeling dizzy and have brain fog.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Skin haemorrhage
Clinical narrative: Started to feel lightheaded, with a headache and foggy on Wednesday April 13. Woke up on April 14th with dizziness, later that day I noticed tiny blood spots on my right thigh. Call the pharmacy where I got the vaccine and was advised to go to the hospital right away. I did.  Today, April 15, I?m still feeling dizzy and have brain fog.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Headache
Clinical narrative: Started to feel lightheaded, with a headache and foggy on Wednesday April 13. Woke up on April 14th with dizziness, later that day I noticed tiny blood spots on my right thigh. Call the pharmacy where I got the vaccine and was advised to go to the hospital right away. I did.  Today, April 15, I?m still feeling dizzy and have brain fog.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient got a second COVID19 bivalent booster in error
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received COVID bivalent vaccine instead of monovalent 2nd dose  of primary series
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Palpitations
Clinical narrative: I had Moderna vaccination and right after that I started feeling a heart race and when I went to see my doctor he told me that I had AFib. This was a surprise as my heart was very healthy with a very steady heart rate and blood pressure. My heart had been checked prior to that and had no structural problems.
Age: 76.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blister, Hypoaesthesia, Pain in extremity, Pruritus
Clinical narrative: SHE REPORT PAIN AND NUMBNESS ON BOTH ARMS, ITCHY SPOTS AND BLISTERS ON BOTH ARMS. SHE REPORT SYMPTOMS BEGAN TWO WEEKS AFTER ADMINISTRATION OF VACCINES
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Rash, Rash pruritic
Clinical narrative: Skin rashes over arms around elbow/hands, legs mostly over knees and low thighs, buttocks, flanks. Started since July 2022 and still appearing, each lasting weeks. Very itch. It looks like Pityriasis Rosea as reported in an article
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Myalgia, Oral herpes
Clinical narrative: sore, red arm, fever, chills, headache, muscle aches started within hours after receiving shot - fever blisters on lip appeared the next day, started feeling better within a few days
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: sore, red arm, fever, chills, headache, muscle aches started within hours after receiving shot - fever blisters on lip appeared the next day, started feeling better within a few days
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypertension, Photopsia
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: Pt was given the Shingrix vaccine and states she begin to "see stars" and feel dizzy/lightheaded. Pt was monitored while resting in upright position in chair. Patient never lost consciousness and did not get rash, shortness of breath, clammy skin, etc. Pt took blood pressure several times and was moderately elevated at ~160/95. Pt was seated in pharmacy area for 2 hours and never got any other symptoms, but BP remained slightly elevated. Pt took BP monitor home. Husband with her to monitor.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death. Found dead.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Dyspnoea, Flushing, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: numbness in extremeties