chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 16:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 25 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications in 2 weeks. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with  Paxlovid from 12Feb2023 to 16Feb2023. Clinical course: After finishing Paxlovid and feeling better, COVID symptoms returned after 3 days and started testing positive again.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 15:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown), as dose 1, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: QVAR REDIHALER oral, start date: Jun2015 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2023) Positive; (21Feb2023) negative; (22Feb2023) negative; (23Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old 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; 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 was not reported. Concomitant medication(s) included: LEXAPRO. 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 from 14Feb2023 to 18Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
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) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 16:45 as dose 5 (booster), single (Lot number: GJ2524) at the age of 61 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: "GERD" (unspecified if ongoing), notes: Other medical history: GERD; "Anxiety" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient's concomitant medications were not reported. Past drug history included: Pseudoephedrine, reaction(s): "known allergies: Pseudoephedrine", notes: known allergies: Pseudoephedrine. 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.  Clinical course: Patient was Adult (18-64 Years). Patient received Paxlovid treatment for Covid-19. About 6 days after completion of the 5 day Paxlovid course she started to have symptoms. Felt feverish, achy, heady, sticky throat, fatigue, then developed nasal congestion and a cough, swollen glands. Generally feeling fluish.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2022 as dose 5 (booster), single (lot number unknown) at the age of 41 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (lot number unknown), as dose 2, single (lot number unknown), as dose 3 (booster), single (lot number unknown) and as dose 4 (booster), single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes mellitus" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication included: PROZAC. The following information was reported: DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) both with onset Feb2023, outcome "recovering" and  described as "treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective and covid-19 which included Paxlovid taken from 13Feb2023 to 17Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 15:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 at 15:00 as dose 1, single (Lot number: ER2613), in right arm, on 15Apr2021 at 15:00 as dose 2, single (Lot number: EW0151), in right arm, on 14Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 18May2022 at 15:00 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Septra, reaction(s): "Drug allergy"; Sulphur, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: Tested negative on tenth and eleventh days after original onset of COVID symptoms; negative, notes: Tested negative on tenth and eleventh days after original onset of COVID symptoms; Positive, notes: Tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.Clinical course: Paxlovid used for COVID 19 Treatment from 11Feb2023 to 16Feb2023. Paxlovid Covid rebound, asymptomatic. Seven days after finishing 5 days of Paxlovid. Tested negative on tenth and eleventh days after original onset of COVID symptoms. Two days later (today)tested again (no new symptoms or return of symptoms, just a precaution). Tested positive again.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "sjogrens" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Feb2023) Negative, notes: After initial 5 days of doses Paxlovid I tested negative; (16Feb2023) Positive, notes: 7days after completion have retested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Feb2023 to 15Feb2023.  Clinical course: The patient is on therapy with heart medications from 01Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
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 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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 Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment of Paxlovid started on 13Feb2023 and stopped on 18Feb2023. Known allergies: None.   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: Anosmia, Deafness, Dizziness, Gait disturbance, Post-acute COVID-19 syndrome
Clinical narrative: she lost her hearing; Rheumatoid arthritis; problems walking; terribly dizzy; can't smell; Long Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization, reaction(s): "diagnosed with Covid", "diagnosed with Covid"; Bnt162b2 (Dose 2, single), for COVID-19 Immunization, reaction(s): "diagnosed with Covid", "diagnosed with Covid"; Bnt162b2 (Dose 3 (booster), single), for COVID-19 Immunization, reaction(s): "diagnosed with Covid", "diagnosed with Covid"; Bnt162b2 (Dose 4 (booster), single), for COVID-19 Immunization, reaction(s): "diagnosed with Covid", "diagnosed with Covid". The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "she lost her hearing"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "problems walking"; DIZZINESS (non-serious), outcome "unknown", described as "terribly dizzy"; ANOSMIA (non-serious), outcome "unknown", described as "can't smell"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Long Covid".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300083013 Same patient/product, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: she lost her hearing; Rheumatoid arthritis; problems walking; terribly dizzy; can't smell; Long Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization, reaction(s): "diagnosed with Covid", "diagnosed with Covid"; Bnt162b2 (Dose 2, single), for COVID-19 Immunization, reaction(s): "diagnosed with Covid", "diagnosed with Covid"; Bnt162b2 (Dose 3 (booster), single), for COVID-19 Immunization, reaction(s): "diagnosed with Covid", "diagnosed with Covid"; Bnt162b2 (Dose 4 (booster), single), for COVID-19 Immunization, reaction(s): "diagnosed with Covid", "diagnosed with Covid". The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "she lost her hearing"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "problems walking"; DIZZINESS (non-serious), outcome "unknown", described as "terribly dizzy"; ANOSMIA (non-serious), outcome "unknown", described as "can't smell"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Long Covid".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300083013 Same patient/product, different dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77-year-old female 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 Aug2022, outcome "unknown" and all described as "diagnosed with Covid".  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-202300082993 Same patient/product, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: my son has developed PE; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "my son has developed PE". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Obstructive Sleep Apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydrochlorothiazide, reaction(s): "Known allergies: hydrochlorothiazide", notes: Known allergies: hydrochlorothiazide. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected..; Sender's Comments: Based on available information, a possible contributory role of the subject products  cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up 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: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: four people died from the same LOT#; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EW0170) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "four people died from the same LOT#". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300081243 same reporter/product/event, different patient;; Reported Cause(s) of Death: four people died from the same LOT#
Sex: F
Vaccine: COVID19-2
Symptoms: Rubber sensitivity
Clinical narrative: developed a latex allergy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID:   A 90-year-old 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 but unknown manufacturer), for COVID-19 Immunization. The following information was reported: RUBBER SENSITIVITY (non-serious), outcome "unknown", described as "developed a latex allergy".  Additional information: The pharmacist called from pharmacy mentioned that she has a 90 year old customer called her this morning who recently developed a latex allergy and was questioning whether there was any latex in the new bivalent adult vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Erythema
Clinical narrative: Redness; Yellow blistering; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):   A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; BLISTER (non-serious), outcome "unknown", described as "Yellow blistering".  Additional information: Reporter following information relating to vaccine COVID-19 Pfizer BioNTech received by one of our associates during the normal course of business.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: MENB
Symptoms: Headache, Nausea
Clinical narrative: Nausea; headache; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown". Additional information included: Event took place after use of product. The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Occipital neuralgia
Clinical narrative: Occipital neuralgia; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of migraines" (unspecified if ongoing), notes: History of migraines. The patient's concomitant medications were not reported. The following information was reported: OCCIPITAL NEURALGIA (non-serious), outcome "unknown".  Additional information: Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Arthritis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient. A patient (no qualifiers provided) 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01; Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02; Manufacturer unknown), for COVID-19 Immunization. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "inflammatory arthritis". Additional information: The patient received 3 of the Covid shots, after the 3rd one the patient developed inflammatory arthritis. The patient was receiving follow up texts from the (Name withheld), after the last one, where the patient let them know that patient had developed inflammatory arthritis, the patient never received another follow up text. The patient has read on the internet that other people have developed inflammatory arthritis too. The patient was wondering if Pfizer is looking into this. The patient has no family history of inflammatory arthritis and patient felt fine before the shots. Medical Information Forwarded to MI N/A, no medical inquiry asked. 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: DTAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: pregnant patient received an application of diphtheria, tetanus and acellular pertussis vaccine (unknown) with no reported adverse event; Initial information received on 21-Feb-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp(non-health care professional).  This case involves an unknown age female patient who was exposed to vaccine diphtheria, tetanus and acellular pertussis vaccine in context of pregnant patient received an application of diphtheria, tetanus and acellular pertussis vaccine (unknown) with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient received an application of diphtheria and tetanus and acellular pertussis vaccine (unknown) with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient had no past medical history. The patient medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received an unknown dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of pregnant patient received an application of diphtheria, tetanus and acellular pertussis vaccine (unknown) with no reported adverse event (exposure during pregnancy) (latency: same day) following the administration of diphtheria and tetanus and acellular pertussis vaccine.  Action taken : not applicable.  Outcome: Unknown  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature reached to 32.2F for a total excursion time of 39 hours with no reported adverse event; patient was treated with MENQUADFI post-excursion with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to cases 2023SA065072, 2023SA064856 and 2023SA064145.  This case involves a 11 years old male patient who experienced patient was treated with MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] post-excursion with no reported adverse event and temperature reached to 32.2f for a total excursion time of 39 hours 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 HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation.  On 14-Feb-2023, the patient received 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (frequency, once (1x), strength - standard, expiry date- 28-Feb-2025,  lot U7576AB) via intramuscular route in right deltoid for prophylactic vaccination.  On 14-FEB-2023 the patient developed a non-serious patient was treated with menquadfi post-excursion with no reported adverse event (poor quality product administered) (latency same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was reported that temperature reached to 32.2f for a total excursion time of 39 hours with no reported adverse event (product storage error).  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  At time of reporting, the outcome was Unknown for both 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.; Sender's Comments:  US-SA-2023SA064856:
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: The temperature reached was 32.2F for a total excursion time of 39 hours with no reported adverse event; MENQUADFI being administered post excursion with no reported adverse event; Initial information was received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 11 years old female patient who was being administered by meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] post excursion and the temperature reached was 32.2f for a total excursion time of 39 hours with no reported adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for immunisation; and HPV vaccine VLP RL1 9V (yeast) (Gardasil 9) for immunisation.  On an unknown date, the temperature reached was 32.2f for a total excursion time of 39 hours (product storage error) (latency: Unknown) and on 22-Feb-2023, the patient received 0.5 ml Total dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot number: U7576AB, expiration date: 28-Feb-2025, strength: unknown) via intramuscular route in the right deltoid for Immunization (immunization) post excursion with no reported adverse event (poor quality product administered) (latency: same day).  It was reported that "The caller advised the temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop. The products involved are MENQUADFI, PENTACEL, and FLUZONE QIV NP. The temperature reached was 32.2F for a total excursion time of 39 hours. The caller requested stability data. Extended stability data covers the excursion with the exception of the MENQUADFI. The caller advised there were 3 patient to receive MENQUADFI post-excursion and reported above temperature excursion, along with 4 patients that received MENQUADFI post excursion."  No lab data reported.  Action taken: not applicable.  Outcome: 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.; Sender's Comments:  US-SA-2023SA064856:01504785
Age: 71.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: RN states that she mistakenly administered a manectra vaccination to a patient instead of the intended MMR (with no reported adverse event); Initial information was received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 71 years old male patient who reported that RN states that she mistakenly administered a manectra vaccination to a patient instead of the intended MMR (with no reported adverse event) after receiving 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.  On 23-Feb-2023, the patient received a dose of 0.5 ml of suspect meningococcal a-c-y-w135 (d conj) vaccine(Solution for injection) (lot U7268AA, Expiry date : 22-Apr-2023) (strength : unknown) via intramuscular route in the left deltoid for Immunization.  On 23-Feb-2023 the patient developed a non-serious event of RN states that she mistakenly administered a manectra vaccination to a patient instead of the intended MMR (with no reported adverse event) (wrong product administered) (latency: same day) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken with meningococcal vaccine (Menactra) was not applicable.  At time of reporting, the outcome was Unknown for the event RN states that she mistakenly administered a manectra vaccination to a patient instead of the intended MMR (with no reported adverse event).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 18-month-old female patient received the ADACEL with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an 18-month-old female patient who received the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (OMPC) (PEDIAVAX) for Prophylactic vaccination.  On 23-Feb-2023, the patient received dose 1 at 0.5ml total of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (Strength: standard) (lot number: U7624AA and expiry date: 06-Dec-2024) via intramuscular route in the right thigh for Immunization and an 18-month-old female patient received the adacel with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, caller is wanting to know what to do. This situation is reported as a medication error due to giving to a child younger than 10 years old. First time product used: Yes. Still using product: No.   Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  At time of reporting, the outcome was 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: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Medication error, No adverse event
Clinical narrative: pt was given only the dtap ipv component of pentacel and it was not reconstituted with acthib with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who reported was given only the DTAP IPV component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] and it was not reconstituted with ACT HIB with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Feb-2022, the patient received a Dose 4 dose 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine Suspension for injection strength not reported lot U7331AA expiry date 16-Sep-2023  via intramuscular route in the right thigh for Immunization.  On an unknown date the patient developed a non-serious event "patient was given only the dtap ipv component of pentacel and it was not reconstituted with act hib with no reported adverse event" (incorrect product formulation administered) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient was given only the dtap ipv component of pentacel and it was not reconstituted with act hib with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: assistant gave ADACEL to a 3 year old with no reported adverse event; already received the 4 doses of DTaP and was mistakenly administered ADACEL with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old female patient and it was reported that assistant gave diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] to a 3 year old and already received the 4 doses of diphtheria, tetanus and acellular pertussis vaccine [Dtap] and was mistakenly administered Adacel with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (batch/lot number, expiry date, strength, formulation, route: not reported) in unknown administration site for prophylactic vaccination (immunization). 3 other doses of the same vaccine were administered on unknown dates.  On 21-Feb-2023, assistant gave 0.5 mL of suspect diphtheria-2/tetanus/5 AC pertussis vaccine suspension for injection (1X; batch/lot number: U7624AA and expiry date: 06-Dec-2024; strength: unknown) via intramuscular route in the left thigh for prophylactic vaccination (immunization) to a 3 year old (product administered to patient of inappropriate age) and the patient had already received the 4 doses of dtap and was mistakenly administered adacel with no reported adverse event (inappropriate schedule of product administration) (latency: same day).   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.
Sex: U
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 7-year-old child was given the daptacel vaccine with no reported Adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 7-year-old and unknown gender patient who was given the diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for immunization.  On an unknown date the patient had a non-serious event of  7-year-old child was given the daptacel vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of diphtheria-15/tetanus/5 AC Pertussis vaccine.  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) was 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: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: patient is receiving a 2-dose course of IMOVAX for pre-exposure prophylaxis; the patient will likely receive his 2nd dose of IMOVAX on day 10, with no reported adverse event; Initial information received on 24-Feb-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was receiving a 2-dose course of RABIES (HDC) VACCINE [IMOVAX RABIES] for pre-exposure prophylaxis; the patient will likely receive his 2nd dose of imovax on day 10, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE (strength, formulation, route, lot number and expiry date: not reported) in unknown administration site for pre-exposure prophylaxis (Immunisation) and patient was receiving a 2-dose course of imovax for pre-exposure prophylaxis; the patient will likely receive his 2nd dose of imovax on day 10, with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  It was reported, Pharmacist reports that the patient has received his 1st dose of IMOVAX and is due for his 2nd dose today (24Feb2023); reports that she does not have IMOVAX available today and cannot get IMOVAX until day 10. Pharmacist asks if there are any studies on how effective IMOVAX would be if the patient received the 2nd dose late? This situation is reported as an off-label use as per local labelling.   Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  At time of reporting, the outcome was 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUC3
Symptoms: Chest pain, Pain, Pain in extremity
Clinical narrative: Pain shooting down her left arm; Chest pain went away/reoccurred again; This spontaneous case was received on 21-Feb-2023 from other non-healthcare professional (consumer - patient's husband) (reference number: SEQW23-00689) and concerned a female patient of unreported age.   The patient's medical history and concomitant medications were not reported.  On 20-Feb-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM), anatomical location: left arm, dose: 0.5 ml) as influenza prophylaxis. The batch number reported was 942396 and the expiry date was 30-Jun-2023.  On the same date, about two hours after receiving Flucelvax Quadrivalent, the patient experienced chest pain which went away.  On 21-Feb-2023, one day after receiving Flucelvax Quadrivalent, the chest pain reoccurred again and was also accompanied by pain shooting down the patient's left arm. The patient received no treatment for the events.  The reporter called to see if these adverse events were something that had been seen before with Flucelvax Quadrivalent and what the patient should do regarding it.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A female patient of unreported age experienced chest pain which went away, two hours after vaccination with Flucelvax Quadrivalent. Reportedly, one day after vaccination the pain reoccurred and was accompanied by pain in the extremity. Information regarding the underlying medical history and concomitant medications has not been provided. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related for both events based on temporal and anatomical plausibility.; Sender's Comments: A female patient of unreported age experienced chest pain which went away, two hours after vaccination with Flucelvax Quadrivalent. Reportedly, one day after vaccination the pain reoccurred and was accompanied by pain in the extremity. Information regarding the underlying medical history and concomitant medications has not been provided. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related for both events based on temporal and anatomical plausibility.