chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife)) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 02-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife)).    Patient did not received any other vaccine 4 weeks prior to Covid-19 vaccine. No concomitant medication details was reported. It was reported that the patient received 5 previous Moderna doses. The vial was initially stored in the refrigerator 19-May-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-727348 (E2B Linked Report). This case was linked to MOD-2023-727348 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727348:Wife case
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Moderna COVID vaccine for the first dose, and now they know the second dose is no longer manufactured. He wants to know what second dose he should take; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Moderna COVID vaccine for the first dose, and now they know the second dose is no longer manufactured. He wants to know what second dose he should take) and NO ADVERSE EVENT (no adverse event) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Moderna COVID vaccine for the first dose, and now they know the second dose is no longer manufactured. He wants to know what second dose he should take) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Moderna COVID vaccine for the first dose, and now they know the second dose is no longer manufactured. He wants to know what second dose he should take) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Moderna COVID vaccine for the first dose, and now they know the second dose is no longer manufactured. He wants to know what second dose he should take).    No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received expired blue cap Bivalent booster of Moderna COVID-19 vaccine two days after beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired blue cap Bivalent booster of Moderna COVID-19 vaccine two days after beyond use date) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1), COVID-19 VACCINE JANSSEN (Dose 3 booster) and PFIZER BIONTECH COVID-19 VACCINE (Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 01-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired blue cap Bivalent booster of Moderna COVID-19 vaccine two days after beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired blue cap Bivalent booster of Moderna COVID-19 vaccine two days after beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired blue cap Bivalent booster of Moderna COVID-19 vaccine two days after beyond use date).    No concomitant medications were provided. The vial size was 2.5 ml. It was unknown when the vial was initially stored in the refrigerator. But received as liquid on 28-Apr-2023. The vial did not undergo any temperature excursions.  No treatment medication was provided.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: The injection site had redness the size of a pencil eraser and is very hard.; The injection site had redness the size of a pencil eraser and is very hard.; The size of the swelling is about half an inch by an inch.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (The injection site had redness the size of a pencil eraser and is very hard.), VACCINATION SITE INDURATION (The injection site had redness the size of a pencil eraser and is very hard.) and VACCINATION SITE SWELLING (The size of the swelling is about half an inch by an inch.) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Merkel cell carcinoma.    On 25-May-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Jun-2023, the patient experienced VACCINATION SITE ERYTHEMA (The injection site had redness the size of a pencil eraser and is very hard.), VACCINATION SITE INDURATION (The injection site had redness the size of a pencil eraser and is very hard.) and VACCINATION SITE SWELLING (The size of the swelling is about half an inch by an inch.). At the time of the report, VACCINATION SITE ERYTHEMA (The injection site had redness the size of a pencil eraser and is very hard.), VACCINATION SITE INDURATION (The injection site had redness the size of a pencil eraser and is very hard.) and VACCINATION SITE SWELLING (The size of the swelling is about half an inch by an inch.) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. It was reported that for the past 5 yrs patient had been receiving cancer treatment for Merkel Cell Carcinoma diagnosis. Patient last treatment was 04-May-2023.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood glucose, Blood glucose increased, Ketosis
Clinical narrative: Increase of blood sugar by at least 6; ketosis; This spontaneous case was reported by a consumer and describes the occurrence of KETOSIS (ketosis) and BLOOD GLUCOSE INCREASED (Increase of blood sugar by at least 6) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-May-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 30-May-2023, the patient experienced KETOSIS (ketosis). On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Increase of blood sugar by at least 6). On 02-Jun-2023, KETOSIS (ketosis) had resolved with sequelae. At the time of the report, BLOOD GLUCOSE INCREASED (Increase of blood sugar by at least 6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: Increased.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had Increase of blood sugar by at least 6, end of ketosis. It was unknown if the patient experienced any additional symptoms/events.   No treatment medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife).; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife).) and NO ADVERSE EVENT (no adverse event) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 02-Jun-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 02-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife).). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife).) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife).).    No concomitant medication details was reported. It was reported that the patient received 5 previous Moderna doses. The vial was initially stored in the refrigerator 19-May-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to MOD-2023-727336 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: No reported symptoms.; Syringe was somewhat faulty and vaccine leaked out as I was giving it to them; Patient received lower than authorized dose; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (Syringe was somewhat faulty and vaccine leaked out as I was giving it to them), UNDERDOSE (Patient received lower than authorized dose) and NO ADVERSE EVENT (No reported symptoms.) in a 38-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-May-2023, the patient experienced SYRINGE ISSUE (Syringe was somewhat faulty and vaccine leaked out as I was giving it to them) and UNDERDOSE (Patient received lower than authorized dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No reported symptoms.). At the time of the report, SYRINGE ISSUE (Syringe was somewhat faulty and vaccine leaked out as I was giving it to them), UNDERDOSE (Patient received lower than authorized dose) and NO ADVERSE EVENT (No reported symptoms.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No reported symptoms.) to be not related. No further causality assessments were provided for SYRINGE ISSUE (Syringe was somewhat faulty and vaccine leaked out as I was giving it to them) and UNDERDOSE (Patient received lower than authorized dose).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. It was reported that no additional doses or treatments have been administered at this time. They previously called the provided recommendation to repeat dose or wait 8 weeks for risk of myocarditis or pericarditis.  This error was for the first bivalent booster and 4th dose in total. No other symptoms were reported . No treatment medication was reported.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I tested positive for COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested positive for COVID) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.  Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) from 02-Jun-2023 to an unknown date for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 31-May-2023, the patient experienced COVID-19 (I tested positive for COVID). At the time of the report, COVID-19 (I tested positive for COVID) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient was tested positive for COVID.  The patient did not experience any additional symptoms/events.  No treatment details were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25May2023 at 14:30 as dose 6 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cataract surgery", start date: 23May2023 (not ongoing). Concomitant medication(s) included: METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID] oral (ongoing); GLUCOSAMINE oral (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , Lot number and expiration date not provided.), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE , Lot number and expiration date not provided.), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE , Lot number and expiration date not provided.), for COVID-19 immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE , Lot number and expiration date not provided.), for COVID-19 immunisation; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE , Lot number and expiration date not provided.), for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 26May2023 at 06:30, outcome "unknown", described as "Dizzy". Therapeutic measures were taken as a result of dizziness.  Additional Information: It was reported that she noticed when she first got up. It was about 6:30 in the morning. Treatment/ Intervention was only lying down. There were no prior vaccinations within 4 weeks. Indication for use of metamucil was reported as regularity and for glucosamine it was reported as to give flexibility. The report was not related to study. No investigations reported.  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.
Sex: F
Vaccine: MENB
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm was red, like a rash and warm to the touch; arm was red, like a rash and warm to the touch; arm was red, like a rash and warm to the touch/rash appeared to be spreading and swelling; arm was red, like a rash and warm to the touch/rash appeared to be spreading and swelling; arm was painful to move; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the parent.  A female patient received meningococcal group b Rlp2086 (TRUMENBA), on 30May2023 as dose 1, single (batch/lot number: GF4142, Expiration Date: Aug2025) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "arm was painful to move"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2023, outcome "not recovered", VACCINATION SITE WARMTH (non-serious) with onset 2023, outcome "unknown" and all described as "arm was red, like a rash and warm to the touch"; VACCINATION SITE RASH (non-serious) with onset 2023, outcome "not recovered", VACCINATION SITE SWELLING (non-serious) with onset 2023, outcome "unknown" and all described as "arm was red, like a rash and warm to the touch/rash appeared to be spreading and swelling". Therapeutic measures were taken as a result of vaccination site rash, vaccination site swelling.  Additional information: The nurse informed that her daughter received her first dose of Trumenba on Tuesday and had a significant reaction to it. She confirmed she became aware this morning on 01Jun2023. The patient was 16 (unit unspecified), she was getting her second dose of the other meningococcal ACWY, unsure which brand and her first dose of Trumenba. The nurse informed that the reaction was that her arm was red, like a rash and warm to the touch. The rash appeared to be spreading and swelling. The arm was painful to move, unknown which arm. The patient received the dose of Trumenba Tuesday afternoon (unspecified). The reporter informed worsening, sounds like it was continuing to spread even after administering Benadryl. The reporter informed that the mother plans to have her daughter seen tomorrow morning by the doctor.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Apr2022 as dose 6 (booster), single (Lot number: GL2042) at the age of 61 years, in right 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DVT" (unspecified if ongoing); "PE in 2007", start date: 2007 (unspecified if ongoing); "Factor V Leiden" (unspecified if ongoing); "Prothombrin Mutation (Factor 2)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known alergies: Codeine", notes: possibly. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid started on 24May2023 and stopped on 28May2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Pain assessment, SARS-CoV-2 test
Clinical narrative: Wife gets covid 11May2023; Wife gets covid 11May2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (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 11May2023, outcome "unknown" and all described as "Wife gets covid 11May2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2023) Wife gets covid, notes: Wife gets covid 11May2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took got 2nd Pfizer booster 29Dec2022. Got covid 11May2023, with fever, headache & body aches at pain level 8.75. Took Paxlovid early 12May & on 13May is out of bed with no fever, minimal headache.  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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) and on 23Apr2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 39 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6200), on 10Mar2021 as dose 2, single (Lot number: EN6206), on 15Oct2021 as dose 3 (booster), single (Lot number: FH8020) and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "PID (primary immunodeficiency, SAD subtype)" (unspecified if ongoing); "PID (primary immunodeficiency, SAD subtype)" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "non-allergenic rhinitis" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing); "Known allergies: lactose intolerance" (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 May2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 treated with Paxlovid started on 24May2023 and stopped on 29May2023.; Sender's Comments: Based on the available information, COVID-19, Vaccination failure were assessed as related to the suspect product due to a plausible temporal association.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; Pfizer, Administration date: 01Oct2021/Moderna, Administration date: 15Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 30Sep2022 as dose 5 (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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Apr2022, outcome "unknown", described as "Pfizer, Administration date: 01Oct2021/Moderna, Administration date: 15Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID from 21May2023 to 26May2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Minocycline, reaction(s): "allergies Minocycline"; Cephalexin, reaction(s): "allergies cephalexin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: positive test with symptoms 7 days after finishing paxlovid and previous negative test; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient started Paxlovid from 19May2023 to 24May2023 for treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ear ringing Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). 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 20Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing); "border High BP" (unspecified if ongoing); "Spinal condition" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; HYDROCHLOROTHIAZIDE; METFOR; JANUVIA. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FK9894, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 15Apr2022, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FG3527, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 10Nov2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FH8020, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 20Oct2021, when the patient was 65-year-old, for Covid-19 immunization. The following information was reported: TINNITUS (disability) with onset 08Dec2022 at 12:00, outcome "not recovered", described as "ear ringing Tinnitus". The event "ear ringing tinnitus" required physician office visit. Therapeutic measures were taken as a result of tinnitus. Clinical course:Initiation of ear ringing Tinnitus after patient's most recent Pfizer covid vaccine that has not stopped to date. Patient was currently seeing an ENT Dr. with authorizations for allergy tests and an upcoming auditory hearing test. The FDA just granted in Apr2023 the Tinnitus Treatment Medical Device that reduces the symptoms of Tinnitus significantly. Because this is a new treatment, only the hearing doctor in patient's area had availability of this new coveted device. It costs patient a minimum of (dollar) 5,000.00 to obtain this device. Other insurance combo does not provide authorization for this new device. Finally in this world there is Tinnitus relief. Patient was requesting Pfizer to fund this product for him despite Pfizer's denial of tinnitus symptoms after vaccine receipt by many. If other vaccine in four weeks: Unknown. Ae treatment: Referral to ENT, Audiologist. If covid prior vaccination: No If covid tested post vaccination: No. Known allergies: Not Known.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: My cousin now has Myocarditis; Safety information originally reported under manufacturer case 202300047624 has been nullified and re-entered under this new manufacturer report number 202300211750.  This is a spontaneous report received from a non-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: MYOCARDITIS (medically significant), outcome "unknown", described as "My cousin now has Myocarditis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment : This follow-up report is being submitted to amend previously reported information: (Patient's gender was removed)  Follow-up (05Jun2023): This is a follow-up report to notify that the case 202300047624 and case 202300211750  are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202300211750.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Nausea, Psychotic disorder, Rash, Vomiting
Clinical narrative: My daughter has had total hair loss; psychotic episodes; rash; nausea; severe vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: ALOPECIA (non-serious), outcome "unknown", described as "My daughter has had total hair loss"; PSYCHOTIC DISORDER (non-serious), outcome "unknown", described as "psychotic episodes"; RASH (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown", described as "severe vomiting".  Additional information: It was reported that patient (reporter's daughter) has had total hair loss, rash, psychotic episodes, nausea and severe vomiting since taking the last booster Covid 19 vaccine.  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.
Sex: M
Vaccine: PNC20
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Soreness at injection site; Mild fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), 6 hrs after the suspect product(s) administration, outcome "unknown", described as "Soreness at injection site"; FATIGUE (non-serious), 6 hrs after the suspect product(s) administration, outcome "unknown", described as "Mild fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot".  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: Drug ineffective, Suspected COVID-19
Clinical narrative: Received a COVID-19 vaccine and contracted COVID shortly afterwards; Received a COVID-19 vaccine and contracted COVID shortly afterwards; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Received a COVID-19 vaccine and contracted COVID shortly afterwards".  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: 0.33
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: child was administered expired pentacel in the left thigh with no adverse event reported; Initial information received on 22-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 months old male patient who was administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] in the left thigh with no adverse event reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine polysacch 23V (Pneumovax) and Rotavirus Vaccine for Prophylactic vaccination (immunization).  On 22-May-2023, the patient received 0.5ml expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/ IPV (vero)/HIB (PRP/T) vaccine (batch number: UJ670AAA; expiry date: 13-May-2023) via unknown route in the left thigh for immunization with no adverse event reported (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event child was administered expired pentacel in the left thigh with no adverse event reported.  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: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: they have given a patient an extra dose of Adacel, with no reported adverse event; Initial information received on 02-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 17 years old male patient who was given an extra dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], 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 meningococcal vaccine conj (Meningococcal Conjugate); and HPV vaccine for Prophylactic vaccination.  On 24-May-2023, the patient received an extra 0.5 mL dose 2 of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (Strength: Standard) (batch number: U7548AA; expiry date: 14-Oct-2024) via intramuscular route in the left deltoid for immunization with no reported adverse event (extra dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event they have given a patient an extra dose of adacel, with no reported adverse event.  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: UNK
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: received vaccines after a temperature excursion with no reported adverse event; Initial information received on 02-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves at 6 patients received vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection expiry date not reported lot UJ840AA via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious received vaccines after a temperature excursion with no reported adverse event (poor quality product administered) on the same day following the administration of IPV (VERO).  It was reported "The batteries went bad Max/low temperature reached: Negative 4.8C Human error? No Does extended stability data cover the excursion? No If negative advice, was the product administered to a patient? Yes".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event received vaccines after a temperature excursion with no reported adverse event.  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: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiac failure acute, Left ventricular failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 4/11/2023 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Dyspnoea, Hypothyroidism, Hypoxia, Lung adenocarcinoma
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 4/8/2023 ADENOCARCINOMA RIGHT LUNG, UNSPECIFIED PART R09.02 HYPOXIA 4/8/2023 ADENOCARCINOMA RIGHT LUNG, UNSPECIFIED PART J96.00 ACUTE RESPIRATORY FAILURE 4/8/2023 HYPOTHYROIDISM R09.02 HYPOXIA 4/8/2023 HYPOTHYROIDISM J96.00 ACUTE RESPIRATORY FAILURE 4/8/2023 SHORTNESS OF BREATH R09.02 HYPOXIA 4/8/2023 SHORTNESS OF BREATH J96.00 ACUTE RESPIRATORY FAILURE 4/8/2023 RIGHT FOOT DROP R09.02 HYPOXIA 4/8/2023 RIGHT FOOT DROP
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Peroneal nerve palsy
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 4/8/2023 ADENOCARCINOMA RIGHT LUNG, UNSPECIFIED PART R09.02 HYPOXIA 4/8/2023 ADENOCARCINOMA RIGHT LUNG, UNSPECIFIED PART J96.00 ACUTE RESPIRATORY FAILURE 4/8/2023 HYPOTHYROIDISM R09.02 HYPOXIA 4/8/2023 HYPOTHYROIDISM J96.00 ACUTE RESPIRATORY FAILURE 4/8/2023 SHORTNESS OF BREATH R09.02 HYPOXIA 4/8/2023 SHORTNESS OF BREATH J96.00 ACUTE RESPIRATORY FAILURE 4/8/2023 RIGHT FOOT DROP R09.02 HYPOXIA 4/8/2023 RIGHT FOOT DROP
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Appendicectomy, Appendicitis, Blood test
Clinical narrative: Appendicitis Emergency Appendectomy performed on 10/31/2021 Severe abdominal pain, hurt to move, to touch  Eye Pain Significant GI distress
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Eye pain, Laboratory test, Pain
Clinical narrative: Appendicitis Emergency Appendectomy performed on 10/31/2021 Severe abdominal pain, hurt to move, to touch  Eye Pain Significant GI distress
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Extradural abscess, Intensive care, Intervertebral disc degeneration
Clinical narrative: Received 3 dose vaccine on 5/3/22. Within first 24 hours experienced some discomfort and pain in back and neck. Some nausea an upset stomach. By 5/6/22 I went to ER. Over the next 11 days the pain became excruciating and paralysis started to set in on my extremities. In total I made 6-7 attempts to get help from multiple ERs, Urgent car, Orthopedic Care before finally being admitted to ER on 5/17/22. Diagnosis, many Epidural Abscess of cervical thoracic and  lumbar spine. Sepsis. Septic shock. MSSA. Spinal Cord Compression. DDD. Osteomyelitis. And others problems . Was rushed to emergency surgery had multiple disc removed. Cages pins screws placed. Spinal decompression. ICU 2 weeks. Extended Hospital stay and rehabilitation. Recurrent condition and symptoms led to more stays. Life long injuries. Morbidities Mortalities
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc operation, Musculoskeletal discomfort, Nausea, Neck pain, Osteomyelitis
Clinical narrative: Received 3 dose vaccine on 5/3/22. Within first 24 hours experienced some discomfort and pain in back and neck. Some nausea an upset stomach. By 5/6/22 I went to ER. Over the next 11 days the pain became excruciating and paralysis started to set in on my extremities. In total I made 6-7 attempts to get help from multiple ERs, Urgent car, Orthopedic Care before finally being admitted to ER on 5/17/22. Diagnosis, many Epidural Abscess of cervical thoracic and  lumbar spine. Sepsis. Septic shock. MSSA. Spinal Cord Compression. DDD. Osteomyelitis. And others problems . Was rushed to emergency surgery had multiple disc removed. Cages pins screws placed. Spinal decompression. ICU 2 weeks. Extended Hospital stay and rehabilitation. Recurrent condition and symptoms led to more stays. Life long injuries. Morbidities Mortalities
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral paralysis, Sepsis, Septic shock, Spinal cord abscess, Spinal cord compression
Clinical narrative: Received 3 dose vaccine on 5/3/22. Within first 24 hours experienced some discomfort and pain in back and neck. Some nausea an upset stomach. By 5/6/22 I went to ER. Over the next 11 days the pain became excruciating and paralysis started to set in on my extremities. In total I made 6-7 attempts to get help from multiple ERs, Urgent car, Orthopedic Care before finally being admitted to ER on 5/17/22. Diagnosis, many Epidural Abscess of cervical thoracic and  lumbar spine. Sepsis. Septic shock. MSSA. Spinal Cord Compression. DDD. Osteomyelitis. And others problems . Was rushed to emergency surgery had multiple disc removed. Cages pins screws placed. Spinal decompression. ICU 2 weeks. Extended Hospital stay and rehabilitation. Recurrent condition and symptoms led to more stays. Life long injuries. Morbidities Mortalities