chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 13:15 as dose 4 (booster), single (Lot number: GJ6665) at the age of 38 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Long covid previously" (unspecified if ongoing); "known allergies: Penicillin reaction" (unspecified if ongoing), notes: decades ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid : treatment start date: 15Jul2023; treatment stop date: 19Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258965 same patient, different drug, different event;
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Got COVID; Got COVID; Previous dose brand: Moderna; Previous dose administration date: 11Dec2021; Previous dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: EL3247) and on 21Apr2021 as dose 2, single (Lot number: EL3247) at the age of 21 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Dec2021 as dose 3 (booster), single (Lot number: 060H21A) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 01Oct2022 as dose 4 (booster), single (Lot number: A3716313) 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 11Dec2021, outcome "unknown", described as "Previous dose brand: Moderna; Previous dose administration date: 11Dec2021; Previous dose number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jul2023, outcome "unknown" and all described as "Got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2023) Positive.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died from the Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died from the Covid vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: As per the reporter, the vaccine has killed a lot of people and destroyed a lot of peoples lives, including reporter's family. He has family members that had taken 4 shots of the Pfizer Covid vaccine and got cancer. The cancer was getting worse and they continue to got vaccines because of it. Two of his grandparents died from the Covid vaccine. Family members now had auto immune disorders and have had heart attacks and the doctor had said it was due to the vaccine. Caller references a "Pfizer" Pregnancy and Lactation Cumulative Review from Apr2023 by the FDA that documents deaths of pregnant women and their children from the vaccine. He reported that members of his family who have miscarried from the vaccine and are now can no longer have children. He stated there was a list of over 8,000 side effects but he could not find it.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300259502 Same reporter/ AE, different patient;; Reported Cause(s) of Death: Died from the Covid vaccine
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2 NOS), in 2022 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: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2023, outcome "unknown", described as "heart attack". The patient underwent the following laboratory tests and procedures: heart tests: Unknown results.Clinical course: Patient had heart attack after getting the shot. It was reported that patient had 1 shot and 1 booster and he was in perfect health, 179 pounds and nothing wrong with him before getting shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Metabolic function test, Metabolic function test abnormal
Clinical narrative: C-reactive protein and Comprehensive metabolic panel with date 04Jan2022 result high; C-reactive protein and Comprehensive metabolic panel with date 04Jan2022 result high; 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 09Apr2021 as dose 2, single (Lot number: ER8727), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose1, Single, Anatomical Site of Injection: Left arm, Batch /Lot Number: EN6207), administration date: 11Mar2021, for COVID-19 Immunization. The following information was reported: C-REACTIVE PROTEIN INCREASED (disability), METABOLIC FUNCTION TEST ABNORMAL (disability) all with onset 04Jan2022, outcome "not recovered" and all described as "C-reactive protein and Comprehensive metabolic panel with date 04Jan2022 result high". The events "c-reactive protein and comprehensive metabolic panel with date 04jan2022 result high" required physician office visit. The patient underwent the following laboratory tests and procedures: C-reactive protein: (04Jan2022) High, notes: Rheumatologist ordered several tests; Metabolic function test: (04Jan2022) High, notes: Rheumatologist ordered several tests. Therapeutic measures were taken as a result of c-reactive protein increased, metabolic function test abnormal. Clinical course: Vaccination Facility Type: Pharmacy or Drug Store. Patient was seeing a rheumatologist and taking medications. Patient denied for taking any prior vaccinations. Patient had no family history of rheumatoid arthritis.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300036627 same patient, different dose/event.;
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: This time my blood pressure has gone much higher than normal/his blood pressure skyrocketed. His reading this morning was 156/81; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jul2023 as dose 6 (booster), single (Lot number: GK0923) at the age of 76 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "kidney cancer" (ongoing), notes: I do have kidney cancer.; "Diabetic" (ongoing), notes: I am Diabetic, my numbers are getting around 9 to 10 each day.; "lose weight" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; TAMSULOSIN; AMLODIPINE BESYLATE; ALLOPURINOL; METFORMIN; GLIPIZIDE; CARVEDILOL; SIMVASTATIN; BABY ASPIRIN; VITAMIN A [RETINOL]; CALCIUM; VITAMIN B12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "had no problems"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "had no problems"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "had no problems"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "had no problems"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "had no problems". The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset Jul2023, outcome "unknown", described as "This time my blood pressure has gone much higher than normal/his blood pressure skyrocketed. His reading this morning was 156/81". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure increased. Clinical course: The patient stated, "Yes, I have been reduced on my blood pressure medicine my heart doctor reduced me on my heart medication and that is why I have been checking my blood pressure daily and I have been doing excellent for the last months and so I have got, I have checked for my heart, I do have kidney cancer. I am Diabetic, my numbers are getting around 9 to 10 each day. The patient said that his medication had been dropped because he has been able to lose weight and been doing much better but his blood sugar and blood pressure. He has done really well but just had a Pfizer covid shot last Friday which was his 6th shot and his blood pressure skyrocketed. His reading this morning was 156/81. Reading online he knows that it affects some people. He wants to know how long it will last.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) and on 02Jun2023 as dose 6 (booster), single (Lot number: GJ6743) at the age of 73 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198), on 21Mar2021 as dose 2, single (Lot number: ER8727), on 11Oct2021 as dose 3 (booster), single (Lot number: 2593) and on 26Apr2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "Atherosclerosis" (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 Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment from 14Jul2023 to 19Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300259116 Same patient, different drug/AE.;US-PFIZER INC-202300259186 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: 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 female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Jul2023 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Jul2023, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Additional information: No issue with the vaccine. Patient received Paxlovid from 08Jul2023 to 13Jul2023 as treatment for covid-19. known allergies no  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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Magnetic resonance imaging, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing); "High cholesterol" (ongoing). There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 21Jul2023, outcome "recovering" and all described as "tested positive for Covid 19". The patient was hospitalized for vaccination failure, covid-19 (start date: 21Jul2023). The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test: (21Jul2023) Positive, notes: tested positive for Covid-19.  Clinical course: This report was related to a study or programme. Details. HCP Type: Cardiologist. Investigations and other products stated as No. Agent stated she was calling with a patient on the other line because he just told her that he was in the hospital because he had Covid. Physician: Full Contact Details Unknown. Caller stated he tested positive for Covid-19 on Friday evening, and he was admitted to the hospital on Friday evening. Caller stated they did an MRI this morning and if it all come back normal on the results of everything, they will discharge him the day after this report (stated as tomorrow). Caller stated he has had all 5 Pfizer Covid 19 vaccines.  Caller stated he didn't even know he had Covid until he visited his daughter and he had a cough and that was it. Caller stated one time when they took his temperature he had a fever, but it went down the next time. He had no aches or anything. Caller stated his Daughter brought his Vyndamax to the hospital so that he could take it. Therapy Start Date: Caller states he started taking it a long time ago. He stated his older daughter died in 2015 and the doctor suggested checking the family for that gene that killed his daughter and he had it, so he contacted Pfizer and he had been getting his Vyndamax and has been on it since 2016 of 2017.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died from the Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died from the Covid vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: As per the reporter, the vaccine has killed a lot of people and destroyed a lot of peoples lives, including reporter's family. He has family members that had taken 4 shots of the Pfizer Covid vaccine and got cancer. The cancer was getting worse and they continue to got vaccines because of it. Two of his grandparents died from the Covid vaccine. Family members now had auto immune disorders and have had heart attacks and the doctor had said it was due to the vaccine. Caller references a "Pfizer" Pregnancy and Lactation Cumulative Review from Apr2023 by the FDA that documents deaths of pregnant women and their children from the vaccine. He reported that members of his family who have miscarried from the vaccine and are now can no longer have children. He stated there was a list of over 8,000 side effects but he could not find it.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300259085 Same reporter/ Adverse Event, different patient;; Reported Cause(s) of Death: Died from the Covid vaccine
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: covid vaccine which killed many people and probably my dear wife; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An elderly 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: DEATH (death, medically significant), outcome "fatal", described as "covid vaccine which killed many people and probably my dear wife". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: "Continued hatred abd dusdain die the faulty Pfizer so called covid vaccine which killed many people and probably my dear wife". Reporter consider event caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: covid vaccine which killed many people and probably my dear wife
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna, Date: 23Oct2021/ Pfizer, Date: 02Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Lot number: 037K20A), in left arm, on 23Feb2021 as dose 2, single (Lot number: 002A21A), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: 047C21A), in left arm and on 06Jun2023 as dose 6 (booster), single (Lot number: 065H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "H pylori (recovered)" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Apr2022, outcome "not recovered", described as "Moderna, Date: 23Oct2021/ Pfizer, Date: 02Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Jun2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2023) Positive, notes: tested positive; (25Jul2023) Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test/result +/ date Apr2022; covid test/result +/ date Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6200), on 23Mar2021 as dose 2, single (Lot number: ER8730) and on 15Oct2021 as dose 3 (booster), single (Lot number: FE3590, Expiration Date: 30Nov2021) at the age of 72 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovered" (Apr2022) and all described as "covid test/result +/ date Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive; (Apr2022) Negative, notes: 2 weeks from above.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101946 same patient, different vaccine dose/event;
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: covid test/result +/ date Apr2022; covid test/result +/ date Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6200), on 23Mar2021 as dose 2, single (Lot number: ER8730) and on 15Oct2021 as dose 3 (booster), single (Lot number: FE3590, Expiration Date: 30Nov2021) at the age of 72 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovered" (Apr2022) and all described as "covid test/result +/ date Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive; (Apr2022) Negative, notes: 2 weeks from above.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101946 same patient, different vaccine dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19, Vitreous floaters
Clinical narrative: COVID; COVID; floaters in my eyes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID"; VITREOUS FLOATERS (non-serious), outcome "unknown", described as "floaters in my eyes".  Clinical course: Reporter was considered event as caused by suspect product(s). Well I was fine until I took the vaccine; then I got COVID. Mild and now a have floaters in my eyes  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  Clinical course: It was reported that patient get Covid but very mild.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Pro. The reporter is the patient.  An elderly male 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: ILLNESS (non-serious), outcome "unknown", described as "sick". Additional information: How sick I was back then when I got the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: virus x 2; virus x 2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "virus x 2".  Clinical course: The reporter considers event as caused by suspect product(s). I don't believe any vaccine is 100%. Had them and still got virus x 2. CSP Name: COVID-19 Patient Community for 2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid; covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "covid".  Clinical course: Patient reported that her first covid vaccines were Pfizer. She got covid but she did not end up in the hospital. She was attribute that to her vaccine. The reporter consider event as caused by suspect product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (COMIRNATY 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: FATIGUE (non-serious), outcome "unknown", described as "tired".  Additional information: Nothing much other than it's difficult to run after having the vaccine because it makes patient tired. Patient considered event as caused by suspect product(s).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: given pentacel to a patient using only the liquid component, without the hib component with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old male patient who was given only the liquid component of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)], without the HIB component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitants: None  On 19-Jul-2023, the patient received 0.5 mL dose 2 of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB (PRP/T) vaccine, suspension for injection (Strength: standard) (Batch number: UJ8778AA; Expiry date: 22-Mar-2024) via intramuscular route in the left thigh for Immunization only the liquid component was given, without the hib component with no reported adverse event (product preparation error) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product preparation error.  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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: No adverse event.  Monovalent COVID vaccine given at 4/19/2023 date,
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Pateint received vaccine after BUD
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pateint received vaccine after BUD
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Vaccine was given to the patient expired. Vaccine expiration date was 07/20/23 patient received vaccine on 07/26/23 So far patient feeling ok, just pain in left arm.
Age: 85.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling at the injection site.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Pateint received vaccine after BUD
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pateint received vaccine after BUD
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Herpes zoster, Lethargy, Rash
Clinical narrative: Rash on left side of trunk.    Shingles outbreak - no blisters  lethargic, chest tightness
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Arm was swollen
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: At their 18 year physical patient received a third dose of bexsero when they had already gotten two doses last year. No adverse reaction occurred.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccines after BUD
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccines after BUD
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: Patient received vaccine after BUD
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Postictal state, Pyrexia, Rash, Rash erythematous, Seizure
Clinical narrative: It was Hepatitis A Vaccine,  He had a Seizure with a fever of 100.8 at the time. Seizure lasted 5-10 seconds or so, had a postictal state. Came to ED, ibuprofen given, monitored no other seizure, no sign of other source of fever or seizure.  He also had a red rash on his upper legs. Went home
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Laboratory test, Periorbital swelling, Rash, Swelling face
Clinical narrative: 2 days after vaccination, developed slight facial swelling and facial rash.  By day 3 facial swelling included around eyes.  Denies difficulty swallowing or breathing.   Seen in ED. Patient treated with Benadryl and Pepcid PO.  Discharged from ED to take Benadryl every 6 hours as needed.  Spoke to this patient about incident 1 week later and she has reported that symptoms are almost completely resolved.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, HIBV, MMRV, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: PATIENT FOR PHYSICAL EXAM AND SHOT VACCINE ( NEVER HAD IT  BEFORE EXCEPT HEP B AT BIRTH) VACCINES GIVEN AROUND 11:30 AM, IBUPROFEN ORAL SUSPENSION 100MG PER 5ML AGES 2 TO 11 YEARS 4 FL OZ (118 ML) BOTTLE ( 0.75 ML GIVEN TO PATIENT AFTER SHOT) , LEFT OFFICE AFTERWARDS, WENT TO DONUT SHOP AT 12:00, HE ATE 4 DONUT HOLES GLAZED.. HE ALSO ATE GREEN DUM DUM LOLLIPOP AFTER THE SHOT AND DRANK CHOCOLATE MILK WITH DONUT. HOME BY ABOUT 2 PM  + RASH, HIVES. SEEN BACK 3:30 PM  BENADRYL 10ML GIVEN AT OUR OFFICE
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Dysgeusia, Peripheral swelling, Pyrexia
Clinical narrative: Fever, metallic taste in mouth, swelling in hands and feet, joint pain. Symptoms improved with ibuprofen the next day. Was advised to see his primary care provider, which he did. Pt. reports his PCP did not prescribe any meds or tests and cleared him to return to work
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Laboratory test, Thrombosis
Clinical narrative: blood clots and heart problems
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Swelling
Clinical narrative: Pt had swollen red spots on the arm of administration as well as her back.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: No adverse event
Clinical narrative: No Adverse event happened reported.
Age: 71.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Burning sensation
Clinical narrative: patient said she is having burning down her legs, and her but and her back and that it started after she got the shots yesterday.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Nerve injury, Paraesthesia, Product administered at inappropriate site
Clinical narrative: Vaccine was administered too high on the arm and poked the nerve.  Patient reported tingling and numbness down the left arm.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Diarrhoea, Mood altered, Nausea, Vomiting
Clinical narrative: Nausea. Vomiting. Diarrhea 7+ days. Behavioral changes(mood).  Loss of appetite.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site inflammation, Injection site pain, Myalgia
Clinical narrative: Muscle pain, inflammation and sore at injection shot, headache, tired
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Fatigue, Gait disturbance
Clinical narrative: A couple of days after receiving my second Shingrix vaccine I feel fatigued, dizzy, unsteady on my feet and mildly confused. It's been 5 days since the vaccine and I feel these symptoms more intensely now.
Sex: U
Vaccine: RAB
Symptoms: Product lot number issue
Clinical narrative: The ink used to print the lot# and expiration date smears/smudges if the product gets wet. The product can frequently arrive wet from the wholesaler due to ice packs included in the packaging. The quality of the ink used needs to be improved. Otherwise it renders the product unusable.
Age: 46.0
Sex: F
Vaccine: HPV9
Symptoms: Therapeutic response unexpected
Clinical narrative: Hello, actually reporting a great side effect. My dermatologist recommended the Gardacil vaccine for my plantar warts (feet, legs, hands) that I'd been battling for 15 yrs. You have no idea what I went through. With an immune deficiency, "freezing" & "over the counter" remedies didn't touch the warts. I did so many step therapies that didn't work, culminating in laser surgery, and then a 14 month extremely painful process at the teaching institution. I spent thousand in copays, parking tickets, gas & tolls, etc. Finally got rid of the wart on my toe only to have warts come back with a vengeance spreading up & down my legs and hands. I had at least 40 wards. I did not hold out much hope for Gardacil. I received 3 doses. After a year, just saw a different dermatologist and she said I had ZERO warts. I am beyond thrilled. Hope this can help other battling warts.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product lot number issue
Clinical narrative: I received the Janssen covid vaccine on 6/12/21. A few months ago, I was looking around online and found I could search my lot number on the manufacturer's website. Our of curiosity, I searched it and found it was not a valid lot number. The pharmacy said they couldn't help me and wasn't particularly interested in doing so. I reached out to Janssen. They confirmed that it was not a valid lot number, but didn't have much more to provide and said I may want to out to you as the vaccine has been discontinued. I've attached a picture of my vaccine card with the full details. I haven't experienced any negative affects, but I'm not entirely sure what I exactly received when I got vaccinated.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: The MMR went out of tempature to 55/4F and the manufacturer said to not give it and we did before knowing it was n't usable.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Statins), Sulfonamide allergy (Sulfas), Non-alcoholic fatty liver since 22-Dec-2021, Obesity since 16-Jun-2021 and Hepatomegaly since 22-Dec-2021.    On 12-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2021, 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 considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    Concomitant medication was not provided. Patient received first dose on 11-Mar-2021 at a dose of 0.5ml, from batch no: 002A21A through Intramuscular route to Right arm. Patient received second dose on 07-Apr-2021 at a dose of 0.5ml, from batch no: 01721A through Intramuscular route to Left arm. Patient received third dose on 03-Dec-2021 at a dose of 0.25ml, from batch no: 013F21A through Intramuscular route to Right arm. Patient received fourth dose on 16-Oct-2021 at a dose of 0.5ml, from batch no: 062F22A through Intramuscular route to Left arm. The 2.5ml vial was initially stored in refrigerator on 09-Jun-2023 and did not underwent temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2023: Follow-up received and added primary reporter details, added patient details, added suspect details and updated narrative.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Guillain-Barre syndrome, Intensive care, Laboratory test abnormal, Mechanical ventilation
Clinical narrative: Within less than a week I was in the bathroom and fell and couldn't move anything from the waist down.  I went to several hospitals and they thought it was a muscle problem. I kept getting sent home and it was gradually working its way up my body and getting worse and my doctor insisted i go to the hospital/ER and  because my throat was closing up. So my wife took me and I was in ICU on a vent and a trach and I don't know how long I was there (several months). I went to another hospital for Rehab to come off the vent and trach and I was there several months. I was in rehab on a walker and then a cane.  Dr. knows more details.