chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: PNC10, VARZOS
Symptoms: Discomfort, Rash, Rash macular, Rash papular, Scab
Clinical narrative: Narrative:  Patient contacted telephone triage nurse today requesting to speak with PCP clinic for c/o rash. Patient states he had 2 injections on 4/15/2022, he is wondering if it could be a reaction. States the following day, he woke up and noticed a localized rash, L trunk area, "on my side.: States rash is "spotty, covers a size about the size of a football - blotchy - raised bumps - with some scabs." States some discomfort only with palpation. States no itching or redness. Has been applying eucerin cream, "think it's helping because it is getting better."
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Narrative:  Male 64 yo patient died on 3/25/2022 of cardiac arrest at outside community hospital on 3/25/2022. Pt had received a covid EUA vaccine on 7/30/2021 (J&J). See pt's problem list below per medical chart: 12 Problems ST PROBLEM LAST MOD PROVIDER A Alcohol dependence (SCT 66590003) (ICD-10-CM 06/17/2021 F10.29) A Severe alcohol dependence (SCT 713862009) 12/23/2020 (ICD-10-CM F10.20) A Pulmonary emphysema (SCT 87433001) (ICD-10-CM 03/31/2020 J43.9) A House rented from housing association (SCT 04/06/2018 160939001) (ICD-10-CM Z59.9) A Unemployed (SCT 73438004) (ICD-10-CM Z56.0) 04/06/2018 A Full thickness rotator cuff tear (SCT 202843000) 12/01/2017 (ICD-10-CM M75.122) A Tear of left rotator cuff (SCT 08/20/2017 11892411000119102) (ICD-10-CM S46.092S) A Glaucoma (SCT 23986001) (ICD-10-CM H40.9) 08/20/2017 A Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.5) 02/23/2017 A History of mechanical aortic valve replacement 10/26/2015 (SCT 125411000119107) (ICD-10-CM I35.0) A Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.0) 10/26/2015 A Persistent alcohol abuse (SCT 284591009) 10/13/2015 (ICD-10-CM F10.10) Likely vaccine not related to pt's death given history of heart condition. Info in chart regarding ER admission to community hospital below: Patient self-presented to community emergency facility Emergency Notification Intake Date Presenting to the Facility: 3/16/2022 Hospital Chief complaint: CARDIAC ARREST Primary Diagnosis:CARDIAC ARREST Patient Admitted? Yes Route of Admission: ER Date/Time of Admission:3/16/2022 Admitting Diagnosis:CARDIAC ARREST Community Care Provider: Confirm Level of Care: Acute Inpatient Care
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:  73yr old male died on 5/12/2022. No other info in chart. Pt had only received a covid vaccine EUA (J&J) from the agency on 6/16/2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Skin burning sensation
Clinical narrative: One day post shot #2 Awoke dizzy, had n/v X2,  then numbness/facial burning. All Symptoms resolved after 24 hours  excetp for Right sided facial numbness/burning- which              lasted until May 2022
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Fall, Nasal injury, Pallor, Tremor, Unresponsive to stimuli
Clinical narrative: Patient was unresponsive and shaking for approx 5 seconds; Patient was unresponsive and shaking for approx 5 seconds; Hit nose on chair; Patient appears pale; Fell down on floor; Information has been received from Food & Drug Administration (VAERS # 855308-1) on 04-FEB-2022.   This spontaneous report has been received from a registered nurse (also reported as staff), referring to a 16-year-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  On 03-JAN-2020 10:30:00, the patient was vaccinated with the second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #S005524, expiration date: 29-SEP-2021, administered intramuscularly in the right arm for prophylaxis (dose was not provided); with influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), lot number UT6657MA, administered intramuscularly in the left arm for prophylaxis (dose, dose number, and expiry date were not provided); and with the second dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), lot number U6522AB, administered intramuscularly in the right arm for prophylaxis (dose and expiry date were not provided).   On 03-JAN-2020 10:35:00, approximately five minutes after vaccination the patient watched that another child received vaccinations and fell down on the floor, hit his nose on a chair. The patient was unresponsive and shaking for approximately five seconds.  Then the patient was assisted off the floor and into a chair. Subsequently, the patient was assessed, was responding to questions, appear pale. A sucker and a glass of orange juice were given to the patient which he consumed with no assistance.  Five- or ten-minutes post-incident the patient was assessed and was observed for 20 minutes after the incident.  Ice was given for the nose.  After that, the patient stated that he felt normal and left the office with no assistance.  At the time of the report, the patient was recovered.  The causal relationship between the events and the suspect vaccines was not reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 2 on 20-Apr-2021 and third dose on 21-Aug-2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 039B21A and 030A21A) for COVID-19 vaccination. The patient's past medical history included Inclusion body myositis, Irritable bowel syndrome and Sleep apnea. Concurrent medical conditions included Rheumatoid arthritis and Drug allergy (Allergy to unspecified medications). On 22-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021 at 3:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021 at 3:30 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 2 on 20-Apr-2021 and third dose on 21-Aug-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 2 on 20-Apr-2021 and third dose on 21-Aug-2021) outcome was unknown. Concomitant medication was not reported. Treatment information was not reported. This case was linked to MOD-2022-583523 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myositis
Clinical narrative: Severe myositis in legs, shoulders, arms, hands and upper back; 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), on 18Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FE3592) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "known allergies: Cipro". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 20Mar2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 27Feb2021, when the patient was 65-year-old, for COVID-19 immunization.  The following information was reported: MYOSITIS (non-serious) with onset 09Nov2021 at 08:00, outcome "recovering", described as "Severe myositis in legs, shoulders, arms, hands and upper back". The events "severe myositis in legs, shoulders, arms, hands and upper back" required physician office visit. Therapeutic measures were taken as a result of myositis.  Additional information:Severe myositis in legs, shoulders, arms, hands and upper back. With Physical therapy lessened over time. Symptoms lasted nearly seven months from onset.If covid prior vaccination: No  No follow up attempts possible. No further information is required
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Severe myositis in legs, shoulders, arms, hands and upper back; 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), on 18Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FE3592) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "known allergies: Cipro". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 20Mar2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 27Feb2021, when the patient was 65-year-old, for COVID-19 immunization.  The following information was reported: MYOSITIS (non-serious) with onset 09Nov2021 at 08:00, outcome "recovering", described as "Severe myositis in legs, shoulders, arms, hands and upper back". The events "severe myositis in legs, shoulders, arms, hands and upper back" required physician office visit. Therapeutic measures were taken as a result of myositis.  Additional information:Severe myositis in legs, shoulders, arms, hands and upper back. With Physical therapy lessened over time. Symptoms lasted nearly seven months from onset.If covid prior vaccination: No  No follow up attempts possible. No further information is required
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Bladder cancer, Cardiac failure
Clinical narrative: 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), on 19Feb2021 as dose 1, single (Lot number: EN6201), in arm, on 12Mar2021 as dose 2, single (Lot number: EN6204), in arm and on 08Dec2021 as dose 3 (booster), single (Lot number: 330308D), in arm, all intramuscular for Covid-19 immunisation. The patient's relevant medical history included: "HBP", start date: 2000 (ongoing); "Cardiovascular", start date: Jun2010 (ongoing), notes: Pertinent Details: Dec2012- CABG6; "never having smoke" (unspecified if ongoing). There were no concomitant medications. The following information was reported: BLADDER CANCER (medically significant) with onset Dec2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (28Mar2022) cancer; (20May2022) cancer; Ejection fraction: (Dec2021) Unknown results; Urine analysis: (Dec2021) blood appear. Additional information: Patient Age at Time of Vaccination was 68/69 (Years). I am not Technically Knowledgeable enough to answer some of these questions. The bottom line is- I received 3 doses of the Pfizer Vaccine in 2021, in 2022, I was diagnosed with Bladder cancer, despite never having smoke so much as a single cigarette. If I need a Physician to complete this please let me know. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Vaccination Facility Type was Pharmacy or Drug Store. Patient had not Vaccine Administered at Military Facility. Follow-Up (06Jun2022): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Bladder cancer, Computerised tomogram, Ejection fraction, Urine analysis
Clinical narrative: 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), on 19Feb2021 as dose 1, single (Lot number: EN6201), in arm, on 12Mar2021 as dose 2, single (Lot number: EN6204), in arm and on 08Dec2021 as dose 3 (booster), single (Lot number: 330308D), in arm, all intramuscular for Covid-19 immunisation. The patient's relevant medical history included: "HBP", start date: 2000 (ongoing); "Cardiovascular", start date: Jun2010 (ongoing), notes: Pertinent Details: Dec2012- CABG6; "never having smoke" (unspecified if ongoing). There were no concomitant medications. The following information was reported: BLADDER CANCER (medically significant) with onset Dec2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (28Mar2022) cancer; (20May2022) cancer; Ejection fraction: (Dec2021) Unknown results; Urine analysis: (Dec2021) blood appear. Additional information: Patient Age at Time of Vaccination was 68/69 (Years). I am not Technically Knowledgeable enough to answer some of these questions. The bottom line is- I received 3 doses of the Pfizer Vaccine in 2021, in 2022, I was diagnosed with Bladder cancer, despite never having smoke so much as a single cigarette. If I need a Physician to complete this please let me know. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Vaccination Facility Type was Pharmacy or Drug Store. Patient had not Vaccine Administered at Military Facility. Follow-Up (06Jun2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram thorax abnormal, Endoscopy, Hepatomegaly
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 , in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: Jan2017. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, treatment start date: 27May2022, treatment stop date: 01Jun2022.  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, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging abdominal abnormal, Pain
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 , in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: Jan2017. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, treatment start date: 27May2022, treatment stop date: 01Jun2022.  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, COVID19, 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 , in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: Jan2017. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, treatment start date: 27May2022, treatment stop date: 01Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Heart rate, Heart rate increased, Palpitations, Pyrexia
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 at 22:30 as dose 1, single (Batch/Lot number: unknown), in right arm, on 30Apr2021 at 21:50 as dose 2, single (Batch/Lot number: unknown), in right arm, on 21Oct2021 at 12:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 11Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2011 (unspecified if ongoing), notes: had surgery chemo and radiation; "surgery" (unspecified if ongoing); "chemo" (unspecified if ongoing); "Radiation" (unspecified if ongoing). The patient's concomitant medications were not reported.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive.   Clinical course: Patient was very grateful to have the vaccine. She have had two doses and 2 boosters.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 at 22:30 as dose 1, single (Batch/Lot number: unknown), in right arm, on 30Apr2021 at 21:50 as dose 2, single (Batch/Lot number: unknown), in right arm, on 21Oct2021 at 12:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 11Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2011 (unspecified if ongoing), notes: had surgery chemo and radiation; "surgery" (unspecified if ongoing); "chemo" (unspecified if ongoing); "Radiation" (unspecified if ongoing). The patient's concomitant medications were not reported.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive.   Clinical course: Patient was very grateful to have the vaccine. She have had two doses and 2 boosters.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 15.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: WRONG VACCINE GIVEN HEP B ORDERED HEP A ADMISTERED
Age: 15.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Wrong product administered
Clinical narrative: WRONG VACCINE GIVEN HEP B ORDERED HEP A ADMISTERED
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Dysgeusia
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 at 15:00 as dose number 3 (booster), single (Lot number: FM9992) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: 029A21A), in right arm and on 31Mar2021 as dose 2, single (Lot number: 019B21A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation:The complaint for "Pfizer Biontech Covid-19 Vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 at 15:00 as dose number 3 (booster), single (Lot number: FM9992) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: 029A21A), in right arm and on 31Mar2021 as dose 2, single (Lot number: 019B21A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation:The complaint for "Pfizer Biontech Covid-19 Vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: HIV test, HIV test false positive
Clinical narrative: was very stressed out about positive HIV reactive test; had a needle stick injury on her finger; This spontaneous case was reported by a patient and describes the occurrence of STRESS (was very stressed out about positive HIV reactive test) and INJURY ASSOCIATED WITH DEVICE (had a needle stick injury on her finger) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] and BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) for an unknown indication.    On 06-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STRESS (was very stressed out about positive HIV reactive test) and INJURY ASSOCIATED WITH DEVICE (had a needle stick injury on her finger). At the time of the report, STRESS (was very stressed out about positive HIV reactive test) and INJURY ASSOCIATED WITH DEVICE (had a needle stick injury on her finger) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. On 15-Feb-2022, SARS-CoV-2 test: positive (Positive) Positive. On 23-May-2022, HIV test: positive (Positive) reactive for antibodies. On 28-May-2022, HIV test: negative (Negative) confirmatory test was done on the same day which came back negative on 28-MAY-2022. On an unknown date, Weight: lost weight (abnormal) lost 5 lbs in a week because patient was very stressed out about positive HIV reactive test..         Patient did not take any other vaccines within 1 month prior to Moderna COVID-19 vaccine  Patient had a needle stick injury on finger, so as per protocol patient had to get tested for infectious diseases. Patient stated that patient was not having any symptoms which prompted to take this test. When providing the weight, patient stated that patient lost 5 lbs in a week because patient was very stressed out about positive HIV reactive test.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-583190 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: HIV test, Injury associated with device, SARS-CoV-2 test, Stress, Weight
Clinical narrative: was very stressed out about positive HIV reactive test; had a needle stick injury on her finger; This spontaneous case was reported by a patient and describes the occurrence of STRESS (was very stressed out about positive HIV reactive test) and INJURY ASSOCIATED WITH DEVICE (had a needle stick injury on her finger) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] and BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) for an unknown indication.    On 06-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STRESS (was very stressed out about positive HIV reactive test) and INJURY ASSOCIATED WITH DEVICE (had a needle stick injury on her finger). At the time of the report, STRESS (was very stressed out about positive HIV reactive test) and INJURY ASSOCIATED WITH DEVICE (had a needle stick injury on her finger) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. On 15-Feb-2022, SARS-CoV-2 test: positive (Positive) Positive. On 23-May-2022, HIV test: positive (Positive) reactive for antibodies. On 28-May-2022, HIV test: negative (Negative) confirmatory test was done on the same day which came back negative on 28-MAY-2022. On an unknown date, Weight: lost weight (abnormal) lost 5 lbs in a week because patient was very stressed out about positive HIV reactive test..         Patient did not take any other vaccines within 1 month prior to Moderna COVID-19 vaccine  Patient had a needle stick injury on finger, so as per protocol patient had to get tested for infectious diseases. Patient stated that patient was not having any symptoms which prompted to take this test. When providing the weight, patient stated that patient lost 5 lbs in a week because patient was very stressed out about positive HIV reactive test.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-583190 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness
Clinical narrative: was very stressed out about positive HIV reactive test; had a needle stick injury on her finger; This spontaneous case was reported by a patient and describes the occurrence of STRESS (was very stressed out about positive HIV reactive test) and INJURY ASSOCIATED WITH DEVICE (had a needle stick injury on her finger) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] and BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) for an unknown indication.    On 06-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STRESS (was very stressed out about positive HIV reactive test) and INJURY ASSOCIATED WITH DEVICE (had a needle stick injury on her finger). At the time of the report, STRESS (was very stressed out about positive HIV reactive test) and INJURY ASSOCIATED WITH DEVICE (had a needle stick injury on her finger) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. On 15-Feb-2022, SARS-CoV-2 test: positive (Positive) Positive. On 23-May-2022, HIV test: positive (Positive) reactive for antibodies. On 28-May-2022, HIV test: negative (Negative) confirmatory test was done on the same day which came back negative on 28-MAY-2022. On an unknown date, Weight: lost weight (abnormal) lost 5 lbs in a week because patient was very stressed out about positive HIV reactive test..         Patient did not take any other vaccines within 1 month prior to Moderna COVID-19 vaccine  Patient had a needle stick injury on finger, so as per protocol patient had to get tested for infectious diseases. Patient stated that patient was not having any symptoms which prompted to take this test. When providing the weight, patient stated that patient lost 5 lbs in a week because patient was very stressed out about positive HIV reactive test.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-583190 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 12:00 as dose 1, single (Lot number: EN6207), in left arm, on 08Apr2021 at 14:00 as dose 2, single (Lot number: EN6207), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04May2022 at 21:00 as dose 4 (booster), single (Lot number: 001M21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATHLETIC GREENS, start date: 01Sep2020, stop date: 01Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive; (23May2022) Negative; (28May2022) Positive, notes: Symptomatic. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had no known allergies. The patient had received other medication (Athletic Greens) in 2 weeks and received Paxlovid for treatment of COVID-19 (Treatment start date: 18May2022, Treatment stop date: 23May2022) for 5 days.
Age: 59.0
Sex: M
Vaccine: COVID19, 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) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 12:00 as dose 1, single (Lot number: EN6207), in left arm, on 08Apr2021 at 14:00 as dose 2, single (Lot number: EN6207), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04May2022 at 21:00 as dose 4 (booster), single (Lot number: 001M21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATHLETIC GREENS, start date: 01Sep2020, stop date: 01Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive; (23May2022) Negative; (28May2022) Positive, notes: Symptomatic. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had no known allergies. The patient had received other medication (Athletic Greens) in 2 weeks and received Paxlovid for treatment of COVID-19 (Treatment start date: 18May2022, Treatment stop date: 23May2022) for 5 days.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache
Clinical narrative: fatigue; Headache for a head; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue) and HEADACHE (Headache for a head) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue) and HEADACHE (Headache for a head). At the time of the report, FATIGUE (fatigue) and HEADACHE (Headache for a head) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  The patient did not have major side effects related to the Moderna vaccine.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-579137, MOD-2022-582889 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 51-year-old female patient received BNT162b2 (PFIZER-BIONTECH MRNA COVID-19 VACCINE), on 22Dec2020 as dose 1, single (Lot number: EL0140, Expiration Date: 31Mar2021), on 12Jan2021 as dose 2, single (Lot number: EK9231, Expiration Date: 30Apr2021) and on 28Aug2021 as dose 3 (booster), single (Lot number: FA7484) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 51-year-old female patient received BNT162b2 (PFIZER-BIONTECH MRNA COVID-19 VACCINE), on 22Dec2020 as dose 1, single (Lot number: EL0140, Expiration Date: 31Mar2021), on 12Jan2021 as dose 2, single (Lot number: EK9231, Expiration Date: 30Apr2021) and on 28Aug2021 as dose 3 (booster), single (Lot number: FA7484) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lipoma
Clinical narrative: Approximately 12 days after the Johnson & Johnson injection, I developed lipomas all over my body. Previous to the vaccine, I had had a few lipomas, but suddenly I had a hundred, and more have continued to grow every day.  They are disfiguring and unsightly.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blindness, Chest discomfort, Dizziness, Hyperhidrosis
Clinical narrative: Became lightheaded/dizzy/weak within the first 5 minutes of receiving vaccination. Began sweating and had chest tightness. Began seeing red spots which progressively filled field of vision/everything turned red and couldn?t see anything for a few minutes. Pharmacist checked on me periodically and gave me cold water to drink. Vision slowly returned after drinking water/placing cold water bottle on forehead. This all occurred within 15 minutes of receiving vaccination. I stayed at pharmacy for an hour before I started feeling well enough to drive home.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Became lightheaded/dizzy/weak within the first 5 minutes of receiving vaccination. Began sweating and had chest tightness. Began seeing red spots which progressively filled field of vision/everything turned red and couldn?t see anything for a few minutes. Pharmacist checked on me periodically and gave me cold water to drink. Vision slowly returned after drinking water/placing cold water bottle on forehead. This all occurred within 15 minutes of receiving vaccination. I stayed at pharmacy for an hour before I started feeling well enough to drive home.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Fever, fatigue, swollen lymph nodes in armpit of left arm - began afternoon on the date of vaccination. Fever resolved by evening of 6/5. Swollen lymph nodes persisted until morning of 6/7
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Feeling cold, Rhinorrhoea
Clinical narrative: We have been on vacation since, 5/21/22. On 5/31/22, we were staying at my inlaws, I had a runny nose and slight cough that I attributed to allergies or the sniffles after get wet and cold on 5/30/22. On 6/1/22, my nose was running again and I was tired, but we went golfing. On 6/2/22, I took a Home Covid Self Test, just to rule out Covid. It was positive. I made an appointment online at a nearby Clinic to get a Rapid Antigen Test. I was able to be tested that afternoon. Again, I tested positive. Because of my Type 2 Diabetes, the Nurse Practitioner said I was eligible for an antiviral medication. My symptoms are gone, as is the medication.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: We have been on vacation since, 5/21/22. On 5/31/22, we were staying at my inlaws, I had a runny nose and slight cough that I attributed to allergies or the sniffles after get wet and cold on 5/30/22. On 6/1/22, my nose was running again and I was tired, but we went golfing. On 6/2/22, I took a Home Covid Self Test, just to rule out Covid. It was positive. I made an appointment online at a nearby Clinic to get a Rapid Antigen Test. I was able to be tested that afternoon. Again, I tested positive. Because of my Type 2 Diabetes, the Nurse Practitioner said I was eligible for an antiviral medication. My symptoms are gone, as is the medication.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD being administered after an excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concomitant medications, medical history, concurrent conditions, drug reactions or allergies were not reported.  On 03-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5 ml, lot #U029319, expiration date: 19-MAR-2023 (anatomical location and route of administration were not provided) for prophylaxis, after the vaccine undergone temperature excursion in -2 Celsius degrees (C) for 1 hour and 12 minutes (on 25-APR-2022) (Product storage error). Previous temperature excursions were as follows: -10 C up to 8 C (7.3C) for 2 hours 37 minutes 0 seconds, and -10 C up to 8 C (0.7C) for 2 hours 56 minutes 0 seconds.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA002581: US-009507513-2205USA002473: US-009507513-2205USA002531: US-009507513-2205USA002678: US-009507513-2205USA002635:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; During temperature excursion case, customer reported that improperly stored vaccine was administered to 10 separate patients. No additional AE reported, No PQC reported.  Names of vaccines involved (including lot/exp) PEDVAX HIB T042013 exp 07/22/202; This spontaneous report was received from an office manager and refers to a 9-month-old patient of unknown gender.  The patient's medical, concurrent conditions, and concomitant therapies were not reported.  On 18-APR-2022, the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) vaccine (lot # T042013, expiration date 22-JUL-2023) presented a temperature excursion of 11.43 Celsius degrees for 4 hours and 45 minutes (there were no previous temperature excursion). On an unknown date in 2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #T042013, expiration date 22-JUL-2023, (route of administration was not reported) administered for prophylaxis (product storage error). No additional adverse event was reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2205USA003131:
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE details.; administered GARDASIL 9 too soon inadvertently; This spontaneous report was received from an other health professional, referring to a 22-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 04-FEB-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot # T036442, expiration date: 09-APR-2023, dose, strength and route were not provided) for prophylaxis. On 08-APR-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot # T036442, expiration date: 09-APR-2023, dose, strength and route were not provided) for prophylaxis. On 13-MAY-2022, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot # T036442, expiration date: 09-APR-2023, dose, strength and route were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event details.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; VAQTA was administered after the expiry date; Incorrect dose administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 16-MAY-2022, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 1 mL, expiration date: 11-APR-2022, was administered to the patient as prophylaxis (expired vaccine used) (incorrect dose administered) (strength, route of administration, vaccination scheme, and lot number were not reported). No previous temperature excursion occurred. There was no adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; VAQTA was administered after the expiry date; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 16-MAY-2022, Hepatitis A Vaccine, Inactivated (VAQTA) 1 mL, (which expired on 11-APR-2022) was administered to the patient as prophylaxis (expired vaccine used) (strength, route of administration, vaccination scheme, and lot number were not reported). No previous temperature excursion occurred. There was no adverse event reported.