chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy/my arm having severe pain then my hands; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 2, single (Lot number: EN6198, Expiration Date: Jun2021) at the age of 67 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Vaccine: 1st Dose COVID-19, Product name/manufacturer: Pfizer, Lot number: EL3249, Date: 10Jan2021), administration date: 10Jan2021, when the patient was 67-year-old, for Covid-19 Immunization.  The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset Feb2021, outcome "unknown", described as "neuropathy/my arm having severe pain then my hands". The event "neuropathy/my arm having severe pain then my hands" required physician office visit. Therapeutic measures were taken as a result of neuropathy peripheral.  Clinical course: The reporter stated that they owned a construction business for 25 years. They worked as a team just the (2) two (she and her husband) neither one of us have taken any prescription drug ever. The report stated how to move forward to COVID. Everyone was going to die if we don't take the vaccine. So, they did, twenty days after the 2nd dose. She noticed both her arms having severe pain them my hands. I received a shot in each arm as did her husband. Her husband's hands and feet severe pain. They went to the doctor at urgent care. She told me she sees patients like every day all day. The patient was diagnosed with neuropathy. Prescribed gabapentin. This was the first prescription drug she had taken, and she was 70 years old not a diabetic and no other problems. The reporter's husband had the same, not a diabetic or any other problems. She went to a hand specialist, thinking I have arthritis nope no arthritis he also prescribed gabapentin. The patient never dreamed that when she turned 70 years old, she would be in severe pain all day and night and constantly be applying whatever, shale oil is recommended, my husband refuses to take any medication or "Shale oil". The reporter stated that she truly thinks Pfizer was responsible for our misery and should be held accountable.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300109696 same reporter/drug/AE., different patients.;
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caught COVID (tested positive in home test); Caught COVID (tested positive in home test); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 at 14:15 as dose 5 (booster), single (Lot number: GJ6742) at the age of 63 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Mar2021 at 10:30 as dose 1, single (Lot number: EN5318), in left arm, on 23Mar2021 at 15:15 as dose 2, single (Lot number: EN6199), in left arm, on 30Sep2021 at 10:45 as dose 3 (booster), single (Lot number: EP6955), in left arm and on 26May2022 at 11:00 as dose 4 (booster), single (Lot number: FH8028), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX; FOLIC ACID; METHOTREXATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2023 at 18:00, outcome "recovering" and all described as "Caught COVID (tested positive in home test)". The event "caught covid (tested positive in home test)" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2023) Positive, notes: Nasal Swab; (16Jun2023) Positive, notes: tested positive in home test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Adverse event resulted in: [Doctor or other healthcare professional office/clinic visit] and treated with Paxlovid, Flonase. The patient did not have Covid prior vaccination. The patient had no known allergies.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 at 18:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfur drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iodine, reaction(s): "known allergies: Iodine", notes: known allergies: Iodine; Betadine, reaction(s): "known allergies: Betadine", notes: known allergies: Betadine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started from 07Jun2023 to 11Jun2023.  Clinical course: Covid-19 rebound after Paxlovid on 19Jun2023.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Inappropriate schedule of product administration, SARS-CoV-2 test, Tinnitus
Clinical narrative: Continuous Loud Ringing In Both Right & Left Ears; Tightness in the Chest; Headaches; Dose 1 vaccination date 05Apr2021, Dose 2 Vaccination date 31Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 31Aug2021 at 10:00 as dose 2, single (Lot number: FC3182) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Bi-Polar" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 05Apr2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Aug2021 at 10:00, outcome "unknown", described as "Dose 1 vaccination date 05Apr2021, Dose 2 Vaccination date 31Aug2021"; TINNITUS (non-serious) with onset 31Oct2021 at 12:15, outcome "not recovered", described as "Continuous Loud Ringing In Both Right & Left Ears"; HEADACHE (non-serious) with onset 31Oct2021 at 12:15, outcome "not recovered", described as "Headaches"; CHEST DISCOMFORT (non-serious) with onset 31Oct2021 at 12:15, outcome "not recovered", described as "Tightness in the Chest". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, chest discomfort, headache.  Additional information: Patient had continuous loud ringing in both right and left ears, tightness in the chest early mornings and headaches. Patient had no known allergies. Patient did not received other vaccine in four weeks and did received other medications in two weeks. Patient did not had covid prior vaccination.
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) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 was not reported. There were no concomitant medications. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with PAXLOVID from 16Jun2023 to 19Jun2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect products cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I got COVID-19 because I got lazy. I made a mistake, and I did not follow up to schedule the next dose in time; I got COVID-19 because I got lazy. I made a mistake, and I did not follow up to schedule the next dose in time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID-19 because I got lazy. I made a mistake, and I did not follow up to schedule the next dose in time".  Clinical information: The patient would like to know how long to wait between a current COVID-19 infection and the next dose of the COVID-19 vaccine. The patient got COVID-19 because she got lazy. she made a mistake, and she did not follow up to schedule the next dose in time. It's her fault, that's all she have to say.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: developed symptoms and tested positive for Covid on Saturday; developed symptoms and tested positive for Covid on Saturday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Lot number: GH9702) for covid-19 immunisation; BNT162b2 (COMIRNATY), on 14Mar2021 as dose 1, single (Batch/Lot number: unknown), on 04Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 15Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jun2023, outcome "recovering" and all described as "developed symptoms and tested positive for Covid on Saturday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient reported that she got vaccinated with Pfizer COVID-19 vaccines on 14Mar2021, on 04Apr2021, and on 15Apr2022 as "Pfizer gray cap", and the most recent one was on 19Sep2022 as "Pfizer bivalent, lot GH9702".  She developed symptoms and tested positive for Covid on Saturday, 17Jun2023. She took Paxlovid and it helped. She also reported that her husband was also vaccinated with Pfizer COVID-19 vaccines (dates not provided), and he also got COVID and is recovering with treatment including Paxlovid. She mentioned that she and her husband were just getting over it.  The reporter further asked, "How long do we have to wait after COVID infection until we can get another booster, either the new booster that just came out or another Pfizer Covid 19 bivalent booster?".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300228787 Same reporter, product, events; different patient;
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Congenital Heat Disease" (unspecified if ongoing); "Allergy: Walnuts" (unspecified if ongoing); "Allergy: shea butter" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOLSUCCINAT AL, start date: 21Apr2023; GABAPENTIN, start date: 01Jun2022; XARELTO, start date: 24May2023, stop date: 12Jun2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (lot number: GG7223) from Jun2023 to Jun2023.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (DRUG INEFFECTIVE,COVID 19) and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine administration time: 12:00 AM. No other medication in 2 weeks. Patient received Paxlovid for COVID 19 Treatment from 10Jun2023 to 15Jun2023, no known allergies and no other medical history.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he also got COVID; he also got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient in his 70's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "has high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "he also got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter stated her husband and she developed Covid and they were just getting over it. She also reported that her husband was also vaccinated with Pfizer Covid 19 vaccines (dates not provided) and he also got Covid and was recovering. Patient took Paxlovid as soon as they tested positive and had symptoms. Patient took Paxlovid and it helped.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300228656 same reporter/product, different patient / event.;
Age: 52.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Dec2022 as dose 3 (booster), single (Lot number: GJ6742) at the age of 52 years, 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: "Hypertension" (unspecified if ongoing); "Gout" (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 Jun2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Paxlovid (lot number: 00069-0345-30) from 13Jun2023 to 18Jun2023 for the treatment of COVID-19.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Neuritis
Clinical narrative: Neuritis developed in arm, swollen, weak hand and arm; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 75 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "low back pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: NEURITIS (non-serious) with onset 13May2023, outcome "recovered", described as "Neuritis developed in arm, swollen, weak hand and arm". The events "neuritis developed in arm, swollen, weak hand and arm" required physician office visit. Therapeutic measures were not taken as a result of neuritis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negligible, notes: antigen test was negligible. Today, it is dark and my symptoms have returned; (21Jun2023) dark, notes: antigen test was negligible. Today, it is dark and my symptoms have returned; (unspecified date) Positive, notes: positive test result rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral details: Product: COVID 19 Treatment: From 11Jun2023 to 15Jun2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive for Covid. She has had 4 doses of the Pfizer vaccine; she tested positive for Covid. She has had 4 doses of the Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2023, outcome "recovering" and all described as "she tested positive for Covid. She has had 4 doses of the Pfizer vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229460 same reporter/drug/ae, different patient.;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My nephew tested positive for Covid. He has received the Pfizer covid vaccine. I believe he has received 3 doses but I am not sure. I do not have any information about the date he received the vaccine; My nephew tested positive for Covid. He has received the Pfizer covid vaccine. I believe he has received 3 doses but I am not sure. I do not have any information about the date he received the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2023, outcome "recovering" and all described as "My nephew tested positive for Covid. He has received the Pfizer covid vaccine. I believe he has received 3 doses but I am not sure. I do not have any information about the date he received the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2023) Positive, notes: Type: Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229460 same reporter/drug/ae, different patient.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My niece testes positive for Covid.; My niece testes positive for Covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2023, outcome "recovering" and all described as "My niece testes positive for Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2023) Positive, notes: type: Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229381 same reporter/drug/ae, different patient.;US-PFIZER INC-202300229421 same reporter/drug/ae, different patient.;
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Computerised tomogram, Interchange of vaccine products
Clinical narrative: Minor hair loss; dose1, dose 2, dose 3: Moderna Dose 4: Comirnaty; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 15Jul2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 28 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure", start date: 15Oct2012 (ongoing), notes: Pertinent details: None; "Acute Psychosis" (unspecified if ongoing); "Altered mental status" (unspecified if ongoing); "Hallucinations" (unspecified if ongoing), notes: X 3 days. There were no concomitant medications. Vaccination history included: moderna (Dose: 1, Lot 046A21A), administration date: 24Mar2021, when the patient was 27-year-old, for COVID-19 immunization; moderna (Dose: 2, Lot 046A21A), administration date: 28Apr2021, when the patient was 27-year-old, for COVID-19 immunization; moderna (Dose: 3, Lot# 033F21A, Expiry date: 02Feb2022), administration date: 17Nov2021, when the patient was 28-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Jul2022, outcome "unknown", described as "dose1, dose 2, dose 3: Moderna Dose 4: Comirnaty"; ALOPECIA (non-serious), outcome "unknown", described as "Minor hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient did not received prior Vaccinations. Booster dose due to a weakened immune system. No specific relevant test for thromboembolic events with thrombocytopenia. Patient had first 3 Moderna vaccines without incident. Patient had minor hair loss after Pfizer vaccine on 15Jul2022. Technique was CT images acquired through the Head without contrast. Multiplanar reconstructions were performed. All CT scans are performed using dose optimization techniques as appropriate to the exam being performed. These techniques include automatic exposure control and/or standardized protocols utilizing dose matching according to exam type and patient size.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300098133 same reporter/patient/vaccine, different dose/AE.;
Sex: F
Vaccine: COVID19
Symptoms: Chronic kidney disease
Clinical narrative: chronic kidney disease; 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.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 immunisation. The following information was reported: CHRONIC KIDNEY DISEASE (medically significant), outcome "unknown". Clinical course: Patient would like to know if she could get another booster shot. Patient also stated that she had a chronic kidney disease. She took the Covid 19 vaccine and she had a chronic disease.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: Neuropathy; Hands and feet's severe pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 62-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 2, single (Lot number: EN6198, Expiration Date: Jun2021) at the age of 62 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EL3249, Anatomical location: Arm), administration date: 18Jan2021, for COVID-19 immunisation. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Hands and feet's severe pain". The events "neuropathy" and "hands and feet's severe pain" required physician office visit. Clinical course: Patient's wife reported that neither one of them have taken any prescription drug ever. Patient received shot in arm. Her husband's hands and feet's had severe pain. Went to the Dr. (name withheld) at urgent care in (city, state withheld) and diagnosed neuropathy and prescribed gabapentin. Her husband was not a diabetic and did not had any other problems. Her husband refused to take any medication or Shale oil.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300228069 same reporter/drug, different patient/events;
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Diabetes mellitus, Interchange of vaccine products
Clinical narrative: interchange of vaccine products; Diabetes Mellitus; Asthma; This is a spontaneous report received from contactable reporter(s) (Nurse). Other Case identifier(s): MOD-2023-727302.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jul2022 as dose 3 (booster), single (Lot number: FM7553) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Allergies to medications, food, and other products: penicillins" (unspecified if ongoing), notes: Allergies to medications, food, and other products: penicillins, sulfa; "Allergies to medications, food, and other products: sulfa" (unspecified if ongoing), notes: Allergies to medications, food, and other products: penicillins, sulfa; "Essential Hypertension", start date: 07Mar2018 (unspecified if ongoing), notes: recent changes in condition status? If yes describe: No; "Obstructive Sleep Apnea", start date: 09Oct2018 (unspecified if ongoing), notes: recent changes in condition status? If yes describe: No; "Dyslipidemia", start date: 12Mar2018 (unspecified if ongoing), notes: recent changes in condition status? If yes describe: No. Concomitant medication(s) included: LISINOPRIL AND HYDROCHLOROTHIAZIDE oral taken for essential hypertension (ongoing); SIMVASTATIN oral taken for dyslipidaemia. Vaccination history included: janssen (DOSE 1, SINGLE, Lot/Batch #: 042A21A), administration date: 02Apr2021, for COVID-19 immunization; BNT162b2 (DOSE 2 (BOOSTER), SINGLE, Lot/Batch #: FJ1611, Route & Body site: IM LEFT DELTOID), administration date: 23Dec2021, for COVID-19 immunization. The following information was reported: ASTHMA (non-serious) with onset 02Aug2022, outcome "unknown"; DIABETES MELLITUS (medically significant) with onset 06Jan2023 at 07:23, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were not taken as a result of diabetes mellitus. Therapeutic measures were taken as a result of asthma.   Additional information: No acute illness at the time of vaccination and up to one month before. Patient was seen in clinic on 01Jun2023 for a lab draw/ nurse visit. After checking in for her visit, she mentioned that she wanted to update her COVID Vaccine status and receive the bivalent vaccine. Prescription, over-the counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event:; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (DIABETES MELLITUS,INTERCHANGE OF VACCINE PRODUCTS) and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site warmth
Clinical narrative: she had an injection site reaction from a Pfizer COVID booster injection/it was "like a spider bite" and that her upper arm was warm to the touch; she had an injection site reaction from a Pfizer COVID booster injection/it was "like a spider bite" and that her upper arm was warm to the touch; 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 54-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE REACTION (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "she had an injection site reaction from a Pfizer COVID booster injection/it was "like a spider bite" and that her upper arm was warm to the touch".  Additional information: Patient had an injection site reaction from a Pfizer COVID booster injection. She reported that it was "like a spider bite" and that her upper arm was warm to the touch. No intervention was required.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product lot number issue, Single component of a two-component product administered
Clinical narrative: only the Dtap-IPV being administered without HIB component with no reported adverse event; Initial information received  on 19-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had only the DTAP-IPV being administered without HIB component with no reported adverse event for diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ842AA, expiry date- 11-FEB-2024) (with an unknown dosage, strength) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date the patient developed a event of only the DTAP-IPV being administered without HIB component with no reported adverse event (single component of a two-component product administered) (latency- same day)) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  Reportedly, Due to patient safety concerns with the two different vials DTap-IPV (blue cap) and Hib (green cap) in one box with no attachment for administering staff to be alerted, we have always documented the lot numbers of both vials DTap-IPV and Hib separately to confirm both vials have been given in one dose. Now it has been noted both vials (blue cap and green cap) have the same lot number causing additional concerns for patient safety. Is there a reason for this change? Why are the vials not banded or shrink wrapper together? is Vaxelis going to soon replace the 15 month dose of Pentacel.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient should receive an ADACEL instead of a DAPTACEL, DAPTACEL was incorrectly administered with no reported adverse event; DAPTACEL was incorrectly administered to 11 to 12 yrs old with no reported adverse event; Initial information was received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA190290.  This case involves 12 years Adolescent female patient who received an DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Adacel] instead of a DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] was incorrectly administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection) (Lot: U7549AA, Expiry date: 04-Nov-2024, strength: standard) via intramuscular route in the left arm for Immunization and received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on the batch number will not be requested.  On an unknown date the patient receive an adacel instead of a daptacel, daptacel was incorrectly administered with no reported adverse event (wrong product administered) (Product administered to patient of inappropriate age) (latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 12.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: daptacel was incorrectly administered to 3 different patients ages between 11 to 12 yrs old, patients should receive an adacel instead of a daptacel with no reported adverse event; vaccine administered to 12 year old patient with no adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA190320.  This case involves a 12 years old female patient to whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was incorrectly administered to 3 different patients ages between 11 to 12 yrs old, patients should receive diphtheria, tetanus and acellular pertussis vaccine [Adacel] instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (dip tox) (Menactra); HPV vaccine (HPV Vaccine); and tozinameran (Pfizer Biontech Covid-19 Vaccine), all for Immunisation.  On 15-Jun-2023, the 12 year old patient incorrectly received 0.5 mL dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: U7549AA; expiry date: 04-Nov-2024) via intramuscular route in the left arm for immunization to 3 different patients ages between 11 to 12 yrs old, patients should receive an diphtheria, tetanus and acellular pertussis vaccine (adacel), (batch number, expiry, route, administration site unknown) instead of a daptacel with no reported adverse event (wrong product administered) (Product administered to patient of inappropriate age) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: reconstituted ActHIB with a sterile water and administered it to a patient with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient who was administered with reconstituted HIB (PRP/T) vaccine [ACT-HIB] with a sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number: UJ801AA; Expiry date: 31-Oct-2023) via unknown route in unknown administration site for immunization reconstituted with a sterile water 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 reconstituted acthib with a sterile water and administered it to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.