chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Aug2022, outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective and COVID-19 and included treatment with PAXLOVID. The patient stated he was feeling well and experiencing very mild symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: patient experienced Allergic reaction; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000002791 (Mft.).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "patient experienced Allergic reaction".  Additional information: On 29Jul2022, it was reported that a patient started treatment on an unspecified  date with Pfizer covid-19 vaccine at unspecified dose/ frequency for an unknown indication. It was reported the patient experienced Allergic reaction.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Diagnosed with COVID again; Diagnosed with COVID again; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4501159-00.  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for ankylosing spondylitis. 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 Jul2022, outcome "unknown" and all described as "Diagnosed with COVID again". The action taken for adalimumab was unknown.  The reporter considered "diagnosed with covid again" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the  reported events and  suspect drug  cannot be excluded. The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Pain, Urinary tract inflammation
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, program ID: (005570). A male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jun 7, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine for immunization. Within a few days, his whole urinary tract from the bladder down has been inflamed. He had 4 operations and still in pain. They are suggesting he have his bladder removed. Therapeutic measures were taken as a result of urinary tract inflammation. The outcome of the events: unknown. Information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test, Transient global amnesia
Clinical narrative: Interchange of vaccine products; Transient global amnesia; COVID-19; COVID-19; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. 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 Jul2022, outcome "recovered" (2022) and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; TRANSIENT GLOBAL AMNESIA (non-serious), outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positiive, notes: Contracted Covid. The action taken for adalimumab was unknown.  Clinical course: It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB)-The reporter's causality for the event(s) of COVID-19 was not provided. Causality: Transient global amnesia (Transient global amnesia)-Causality as per reporter (Drug/Vaccine): Not Related. COVID-19 (COVID-19) Causality as per reporter (Drug/Vaccine): Not Related. Transient global amnesia (Transient global amnesia)-Causality as per reporter (Drug/Vaccine): Possible. COVID-19 (COVID-19) Causality as per reporter (Drug/Vaccine): Possible.  The reporter considered "covid-19", "interchange of vaccine products" and "transient global amnesia" related to BNT162b2.  The reporter's assessment of the causal relationship of "interchange of vaccine products" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Drug ineffective, covid-19, transient global amnesia, interchange of vaccine products.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia, Upper respiratory tract congestion
Clinical narrative: congestion, throat; I'm feeling really bad, you know, like fluey kind of thing; low grade fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First Booster but Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: UPPER RESPIRATORY TRACT CONGESTION (non-serious), outcome "unknown", described as "congestion, throat"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "I'm feeling really crappy, you know, like fluey kind of thing"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: During the phone call received, the patient stated, "On Thursday I got my second booster shot for Pfizer and um, I (inaudible) more than 6 months. I didn't realize it's been 9 months since I've gotten the last booster and, um, I don't know if its coincidence or not but I'm feeling really bad, you know, like fluey kind of thing. I've got a low grade fever too. Its 98.4, um, you know, congestion, throat and all that kind of stuff."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Vaccination site pain
Clinical narrative: Patient felt warm this morning, but did not have fever; her arm is tender and sore after receiving the Pfizer vaccine; her arm is tender and sore after receiving the Pfizer vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the parent. Other Case identifier(s): 146400 (Moderna), MOD22-020994 (Moderna), U1076693 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 13Aug2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE, Batch Number: 064A22A, Dose Form: Injection, Dose Unit Route: Intramuscular), administration date: 15Jul2022, for COVID-19 immunization, reaction(s): "did not have any adverse reactions". The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 13Aug2022, outcome "unknown" and all described as "her arm is tender and sore after receiving the Pfizer vaccine"; FEELING HOT (non-serious) with onset 15Aug2022, outcome "unknown", described as "Patient felt warm this morning, but did not have fever".  Additional information: Caller was a registered nurse but was calling to ask a question for her daughter. She stated that her daughter received a mixed primary series. Her 1st dose was the Moderna COVID-19 vaccine, administered on 15Jul2022. Her 2nd dose was the Pfizer COVID-19 vaccine, administered on 13Aug2022. The patient did not have any adverse reactions from the 1st dose of Moderna. However, her arm was tender and sore after receiving the Pfizer vaccine. Patient also felt warm this morning, but did not have a fever. Patient was not on any concomitant medications. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: body aches; fever; fatigue; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A male patient received BNT162b2 (BNT162B2), 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: PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Vestibular neuronitis
Clinical narrative: Chest tightness; She started to experience dizziness/ lightheadedness and was diagnosed with vestibular neuritis; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient. Other Case identifier: US2022AMR107598 (GlaxoSmithKline).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years for COVID-19 immunisation; mepolizumab (NUCALA), since 2019 (Batch/Lot number: unknown) for asthma; budesonide, formoterol fumarate (SYMBICORT), (Batch/Lot number: unknown). The patient's relevant medical history included: "Severe asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 Vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; COVID-19 Vaccine (DOSE 2; MANUFACTURER UNKNOWN), administration date: Apr2021, for COVID-19 immunisation, reaction: "Thyroiditis". The following information was reported: VESTIBULAR NEURONITIS (medically significant) with onset 28Apr2022, outcome "recovering", described as "She started to experience dizziness/ lightheadedness and was diagnosed with vestibular neuritis"; CHEST DISCOMFORT (non-serious) with onset 26Jul2022, outcome "recovered" (29Jul2022), described as "Chest tightness". The action taken for mepolizumab was unknown and post-therapy for budesonide, formoterol fumarate. Therapeutic measures were taken as a result of vestibular neuronitis. Clinical course: The patient received the booster dose of Pfizer vaccine on 18Apr2022 and 10 days later, she started to experience dizziness/ lightheadedness and was diagnosed with vestibular neuritis. She was taking ibuprofen for it. The patient was also taking SYMBICORT with NUCALA. She did not take SYMBICORT for a few days because she ran out of it and so, from 26Jul2022 to 29Jul2022, she was having some chest tightness. The patient attributed the chest tightness to maybe not taking SYMBICORT or due to receiving underdose of NUCALA.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201065278 same patient and drug, different dose and event;
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4504309-00.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), on 20May2021 as dose 2, single (Batch/Lot number: unknown) and on 03Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Lot number: 0740020), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was dosage not changed. clinical course: Solicited report by a consumer of an adult male with an event of non-serious covid-19 with Humira (Adalimumab). On an unknown date, the patient experienced covid-19. Pfizer Biontech covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of covid-19 with Humira (Adalimumab) Was a reasonable possibility. Causality: COVID-19 (COVID-19). Causality as per reporter (Drug/Vaccine): Possible.  The reporter considered "covid-19" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162b2 cannot be excluded. ,Linked Report(s) : US-PFIZER INC-202201065448 Same Patient, different drug/AE;
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4503591-00 (AbbVie).  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) till 10Jul2022 at cf, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: the patient experienced COVID. The action taken for adalimumab was dosage permanently withdrawn on 10Jul2022. Additional information It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The reporter's causality for the event(s) of COVID with Humira was not provided. Causality as per reporter (Vaccine): Possible.   The reporter considered "covid-19" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002798 Regulatory authority.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PEG allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown".  Clinical course: On 01Aug2022, it was reported that a patient started treatment on an unreported date with an mRNA covid vaccine. It was reported that patients with PEG allergy experienced anaphylactic reaction to mRNA Covid Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Sinus congestion
Clinical narrative: Sinus congestion; minor cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP),   A female patient received BNT162b2 (BNT162B2), 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: SINUS CONGESTION (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "minor cough".  Additional information: After a trip, my wife and I tested positive for Covid. Thanks to our Pfizer vaccinations and booster shots, we breezed through recovery. Except for a little sinus congestion, and a minor cough, we had no other symptoms. No fever, no loss of taste, no tiredness, nothing. We have had colds that were worse. Considering over a million died from this virus, we feel very fortunate. The vaccine works.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: we have two different strains of covid going around in my town already and I caught it.; we have two different strains of covid going around in my town already and I caught it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I am a type one diabetic" (unspecified if ongoing). The patient's 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 "we have two different strains of covid going around in my town already and I caught it.".  Clinical course: The patient stated Last year the patient had hard year and the patient was type one diabetic and as like housebound cause of all the real bad covid and he patient just recovered from it and out ran it but it was terrible. The patient was a real bad diabetic and the patient have been having a rough time. Patient later stated Now we have two different strains of covid going around in their town already and the patient caught it. The patient had vaccinations and reporter think that kept from getting really sick cause patient is a type one diabetic and that really scary and was sick for 14 days. Its a terrible thing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: swelling, warmth to the touch, and hardness at the injection site; swelling, warmth to the touch, and hardness at the injection site; swelling, warmth to the touch, and hardness at the injection site; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 5 years old and unknown gender patient who had swelling, warmth to the touch, and hardness at the injection site after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious  event of swelling, warmth to the touch, and hardness at the injection site (vaccination site induration, vaccination site warmth and vaccination site swelling) (latency: unknown) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: Unknown for all events.; Sender's Comments:  SanofiPVPortal20220809000954:PORTAL ID SanofiPVPortal20220811000466:PORTAL ID
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Influenza, Injection site mass, Injection site pain
Clinical narrative: flu symptoms; lump in the shoulder at injection site; drowsiness; fever; headache; Tired; pain in left arm down to hand; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 63 years old female patient who experienced flu symptoms, fever, headache, tired, drowsiness, pain in left arm down to hand and lump in the shoulder at injection site while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 01-Sep-2016, the patient received a  0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (lot number: not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  On 02-SEP-2016 the patient developed a non-serious events flu symptoms (influenza), fever (pyrexia),  headache, tired (fatigue), drowsiness (somnolence), pain in left arm down to hand (pain in extremity) and lump in the shoulder at injection site (vaccination site mass) (latency: 1 day) following the administration of 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 (pyrexia, headache, fatigue, somnolence, pain in extremity, vaccination site mass, influenza).  At time of reporting, the outcome was Not Recovered / Not Resolved for all the event s.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Somnolence
Clinical narrative: flu symptoms; lump in the shoulder at injection site; drowsiness; fever; headache; Tired; pain in left arm down to hand; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 63 years old female patient who experienced flu symptoms, fever, headache, tired, drowsiness, pain in left arm down to hand and lump in the shoulder at injection site while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 01-Sep-2016, the patient received a  0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (lot number: not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  On 02-SEP-2016 the patient developed a non-serious events flu symptoms (influenza), fever (pyrexia),  headache, tired (fatigue), drowsiness (somnolence), pain in left arm down to hand (pain in extremity) and lump in the shoulder at injection site (vaccination site mass) (latency: 1 day) following the administration of 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 (pyrexia, headache, fatigue, somnolence, pain in extremity, vaccination site mass, influenza).  At time of reporting, the outcome was Not Recovered / Not Resolved for all the event s.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: administered 2nd MENACTRA dose only 4 months later with no reported adverse event; Initial information received on 10-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old female patient who administered 2nd menactra dose only 4 months later with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 06-Apr-2022, the patient received a  dose number 1 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE followed by second dose of 10-Aug-2022 ( lot number not reported) at a dose of 0.5ml twice via intramuscular route in unknown administration site for immunization.  On 10-Aug-2022 ,the patient administered 2nd menactra dose only 4 months later with no reported adverse event (inappropriate schedule of product administration)(latency: 4 months 4 days) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken : not applicable  It was not reported if the patient received a corrective treatment for the event .   Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: had first dose of Ipol on 15OCT2021 and second on 09AUG2022 with no reported adverse event; Initial information received on 11-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who had first dose of IPV (VERO) [IPOL] on 15oct2021 and second on 09aug2022 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 MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination; HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 15-Oct-2021 Patient had received a 0.5ml (dose 1) 1X (once) first dose of IPV (VERO) vaccine (strength, formulation was unknown, lot T1E871M and expiry date: 10-Oct-2022) via intramuscular route in the left deltoid for Immunization and on 09-Aug-2022, the patient received a second dose of 0.5ml 1X(once) dose of same vaccine (strength, formulation, lot number and expiry date was unknown) via intramuscular route in the left deltoid for Immunization (inappropriate schedule of product administration, Latency: 9 months 25 days).  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: delayed scheduled for Ipol vaccine, with no adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Infant male patient who had delayed scheduled for ipol vaccine, with no adverse event after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5ml dose of suspect IPV (VERO) (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of delayed scheduled for ipol vaccine, with no adverse event (inappropriate schedule of product administration) (latency: unknown) following the administration of IPV (VERO). Reportedly stated that reporter asks does Ipol contain mercury or thimerosal, She asks if it is a MDV and what does that mean, How was maintained for cleanliness if accessed more than once , Is it only good for 30 days, Is it given in the thigh or arm and  Is there still proper immunity if given off schedule.  Action taken : not applicable.  Outcome: Unknown for inappropriate schedule of product administration   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: 11.0
Sex: M
Vaccine: MNQ, UNK
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: an 11 year old patient received the MENINGOCOCCAL B instead of the MENACTRA. with no adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient received the meningococcal b instead of the menactra. with no adverse event.   The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.  It was reported that an 11-year-old patient received the meningococcal b instead of the menactra (strength, formulation, route, administration site, route was unknown) with no adverse event (wrong product administered) (onset and latency: unknown) for prophylactic vaccination.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: quadracel was administered to a 3 yr old patient with no other reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient who was administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no other reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Aug-2022, the patient received 0.5 mL dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (formulation, strength, lot number not reported) via intramuscular route in the left vastus lateralis for immunization.  On 08-Aug-2022, the patient was administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no other reported adverse event (product administered to patient of inappropriate age).  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: 15.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired Ipol was given to patient with no reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid non-serious case received from health professional (Medical assistant). (GMI number: 01233715)  This case involves a 15-year-old female patient who experienced an expired IPV (VERO) [IPOL] was given to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Aug-2022, the patient received 1st Dose of suspect IPOL at dose 0.5 ml once via intramuscular route in the right arm (Lot: T1D482M, Expiration Date: 25-JUL-2022) for Immunization (expired product administered) at latency same day. No adverse event was reported. It was the first-time product was used. Patient was no more using the product.  Action taken: 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: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 21 month old baby was given the quadracel with no reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 1 years old male patient who experienced 21 month old baby was given the quadracel with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), HEPATITIS A VACCINE (HEPATITIS A)  and HEPATITIS B VACCINE (HEPATITIS B VACCINE) all for Prophylactic vaccination.  On 22-Jun-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE once (lot C59708AA; expiry date: 02-feb-2024) via intramuscular route in the left thigh (left leg) for prophylactic vaccination.  On 22-JUN-2022 the patient reported 21 month old baby was given the quadracel with no reported adverse event (product administered to patient of inappropriate age) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.    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: 6.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Medication error, Product administered to patient of inappropriate age
Clinical narrative: redness and swelling in the injection site; redness and swelling in the injection site; PENTACEL to a child that is 6 years old; Initial information received on 12-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. (GMI number: 01233778)  This case involves a 6-year-old male child who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] and experienced redness and swelling in the injection site, redness and swelling in the injection site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant was administered.   On 02-Aug-2022, the 6-year-old male child received suspect Pentacel vaccine at dose 0.5 ml once via intramuscular route in the left deltoid (Lot: UJ648AA, expiry: 25-Feb-2023) for prophylactic vaccination (product administered to patient of inappropriate age, latency same day). First time product used: No  On 02-AUG-2022, the patient developed a non-serious redness and swelling in the injection site (vaccination site erythema, vaccination site swelling) same day latency following the administration of vaccine. At time of report, product was discontinued.  Action taken: Not applicable.  No corrective treatment was received for the events (vaccination site erythema, vaccination site swelling).  At time of reporting, the outcome was Unknown for all 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: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Feeling hot, Tremor, Vaccination site erythema
Clinical narrative: had left arm had red arm that night; uncontrollable shakes; hot all over for the one night; kept feeling tired for 3-4 days afterwards; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 80 years old female patient who experienced had left arm had red arm that night, uncontrollable shakes, hot all over for the one night and kept feeling tired for 3-4 days afterwards while receiving vaccine INFLUENZA VACCINE.    The patient's past medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation, route, lot number not reported) in unknown administration site for prophylactic vaccination.  On an unknown date the patient experienced  a non-serious events had left arm had red arm that night (vaccination site erythema), uncontrollable shakes (tremor), hot all over for the one night (feeling hot), kept feeling tired for 3-4 days afterwards (fatigue) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (vaccination site erythema, tremor, feeling hot, fatigue).  At time of reporting, the outcome was Unknown for the events.
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: got doses out of the box of expired tenivac single-dose syringes with no reported adverse event; Initial information  received on 15-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 43 years old male patient who got dose out of the box of expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] single-dose syringes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jul-2022, the patient received 0.5 mL dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult single-dose syringes (lot U5856AA, expiry date: 26-Jan-2020) via intramuscular route in the left deltoid for immunization.  On 25-Jul-2022, the patient got dose out of the box of expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult single-dose syringes with no reported adverse event (expired product administered).  It was reported, "would like to verify an expiration date on a box of TENIVAC SINGLE-DOSE SYRINGES that was confusing. Pharmacist states that the expiration date is 26Jan20. Pharmacist asking about the follow-up and if someone should get another dose if they were to get an expired dose of the vaccine. Pharmacist states that four people got doses out of the box of expired TENIVAC SINGLE-DOSE SYRINGES".  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: got doses out of the box of expired tenivac single-dose syringes with no adverse event; Initial information received on 15-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist. Agency Inquiry Number: 01235545  This case involves a 27-year-old male patient who got doses out of the box of expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] single-dose syringes with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA342354, 2022SA341716, and 2022SA340696.  On 05-Aug-2022, the patient received suspect Tenivac single-dose syringes at dose 0.5ml once via intramuscular route in the left deltoid (lot U5856AA, expiry date: 26-Jan-2022) for immunization (expired product administered) same day latency. No adverse event was reported.  Action taken: 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.