chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Pain in extremity
Clinical narrative: temp and upper arm soreness; temp and upper arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 23Mar2021 at 09:25 as dose 2, single (Lot number: ER8730) at the age of 72 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6200), administration date: 27Feb2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), BODY TEMPERATURE INCREASED (non-serious), outcome "unknown" and all described as "temp and upper arm soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, body temperature increased.  Additional information: Patient reported that the side effects were minor (temp and upper arm soreness). Patient had no medicines other than Tylenol taken day 1, 2 of vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101946 same patient, different vaccine dose/event;US-PFIZER INC-202300259176 same patient, different vaccine dose/event;US-PFIZER INC-202300259180 same patient, different vaccine dose/event;US-PFIZER INC-202300259179 same patient, different vaccine dose/event;US-PFIZER INC-PV202300128433 same patient, different vaccine dose/event;US-PFIZER INC-202300259178 same patient, different vaccine dose/event;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Pain in extremity
Clinical narrative: temp and upper arm soreness; temp and upper arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 73 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Product name/Manufacturer lot number: Pfizer Lot EN6200), administration date: 27Feb2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness"; BNT162b2 (DOSE 2, SINGLE, Product name / Manufacturer lot number: Pfizer Lot ER8730, Time: 9:25AM), administration date: 23Mar2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Pfizer Lot: FE3590, Expiration: 30Nov2021), administration date: 15Oct2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), BODY TEMPERATURE INCREASED (non-serious), outcome "unknown" and all described as "temp and upper arm soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, body temperature increased. Additional information: Patient reported that the side effects were minor (temp and upper arm soreness). Patient had no medicines other than Tylenol taken day 1, 2 of vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101946 same patient, different vaccine dose/event;US-PFIZER INC-202300259180 same patient, different vaccine dose/event;US-PFIZER INC-202300259177 same patient, different vaccine dose/event;US-PFIZER INC-202300259176 same patient, different vaccine dose/event;US-PFIZER INC-202300259178 same patient, different vaccine dose/event;US-PFIZER INC-PV202300128433 same patient, different vaccine dose/event;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Pain in extremity
Clinical narrative: temp and upper arm soreness; temp and upper arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Lot number: GH9693, Expiration Date: 30Jun2023) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "covid-19", start date: Apr2022 (unspecified if ongoing), notes: Date: Apr2022, Result: Positive, Date: Apr2022, Result: Negative. There were no concomitant medications. Vaccination history included: BNT162b2 (Vaccine: 1st dose, single covid-19, Product name/Manufacturer lot number: Pfizer Lot EN6200), administration date: 27Feb2021, when the patient was 71-year-old, for Covid-19 Immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness"; BNT162b2 (Vaccine: 2nd dose, single covid-19, Product name / Manufacturer lot number: Pfizer Lot ER8730, Time: 9:25AM), administration date: 23Mar2021, when the patient was 72-year-old, for Covid-19 Immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness"; BNT162b2 (Vaccine: dose 3, single, Pfizer Lot: FE3590, Expiration: 30Nov2021), administration date: 15Oct2021, when the patient was 72-year-old, for Covid-19 Immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness"; BNT162b2 (Vaccine: dose 4, single, Pfizer Lot: FK9894), administration date: 02May2022, when the patient was 73-year-old, for Covid-19 Immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness". The following information was reported: BODY TEMPERATURE INCREASED (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "temp and upper arm soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased, pain in extremity.  Additional information: no meds other than Tylenol taken day 1 02 of vaccine; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101946 same patient, different vaccine dose/event;US-PFIZER INC-202300259177 same patient, different vaccine dose/event;US-PFIZER INC-202300259176 same patient, different vaccine dose/event;US-PFIZER INC-202300259180 same patient, different vaccine dose/event;US-PFIZER INC-202300259179 same patient, different vaccine dose/event;US-PFIZER INC-PV202300128433 same patient, different vaccine dose/event;US-PFIZER INC-202300259178 same patient, different vaccine dose/event;US-PFIZER INC-202300259180 same patient, different vaccine dose/event;
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Ocular icterus, Oral mucosal discolouration, Skin discolouration
Clinical narrative: yellowing in eyes; Bilateral yellow discoloration on elbows, knees, toes, fingers.; Yellowing of hard palate in mouth; hair thinning/loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2021 as dose 2, single (Lot number: EW0179) at the age of 30 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, lot number: EW0173,, Location of injection: Arm Left), for COVID-19 Immunization. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Bilateral yellow discoloration on elbows, knees, toes, fingers."; ORAL MUCOSAL DISCOLOURATION (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Yellowing of hard palate in mouth"; ALOPECIA (non-serious) with onset 01Nov2021, outcome "not recovered", described as "hair thinning/loss"; OCULAR ICTERUS (non-serious) with onset 01Nov2021, outcome "not recovered", described as "yellowing in eyes". The events "yellowing in eyes", "bilateral yellow discoloration on elbows, knees, toes, fingers.", "yellowing of hard palate in mouth" and "hair thinning/loss" required physician office visit. Therapeutic measures were not taken as a result of ocular icterus, skin discolouration, oral mucosal discolouration, alopecia.  Additional information: Most recent dose details Product: COVID 19, brand: Pfizer, Brand unknown: False, is bivalent: False, Lot number: FJ5682, lot unknown: False, Administration date: 06Jan2022, Dose number: 3, Vaccine location: Left arm. If Other vaccine in four weeks was no. Other medications in two weeks birth control, zegerid OTC. The patient did not have COVID to prior vaccination. The patient was not tested for COVID post vaccination. Adverse event: Bilateral yellow discoloration on elbows, knees, toes, fingers. Yellowing of hard palate in mouth, yellowing in eyes and hair thinning/loss.
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue
Clinical narrative: see large and or small particulate floating in the prefilled syringe; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GT0538, Expiration Date: 31Oct2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "see large and or small particulate floating in the prefilled syringe". Additional information: Pharmacist was asking if it was normal to see large and or small particulate floating in the prefilled syringe (NDC 0005-2000-10, Lot #GT0538 Exp 31Oct2024). It was a little whitish or yellowish in color. They did shake the syringe 3 times and the particulate matter did not dissolve.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: twitching neck/right upper body/addomen/feet/all over body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28May2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FJ8762, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 09Dec2021, when the patient was 54-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM), administration date: 16Apr2021, when the patient was 53-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 26Mar2021, when the patient was 53-year-old, for Covid-19 Immunization. The following information was reported: MUSCLE TWITCHING (non-serious) with onset 29May2022 at 02:30, outcome "not recovered", described as "twitching neck/right upper body/addomen/feet/all over body". The event "twitching neck/right upper body/addomen/feet/all over body" required physician office visit. Therapeutic measures were taken as a result of muscle twitching.  Additional information: Patient started twitching within 24 hours of getting shot first in neck. This went on for two weeks. Then it spread to her right upper body and abdomen. Eventually, it reached her feet and has been all over her body. At the same time, she had been treated for Lyme Disease. There had been series of weeks (at the most 5 once, 3 another time, a couple weeks a few times) when the twitching has abated, but it has never gone away. Patient was not tested positive for covid prior and after vaccination. Patient was treated with antibiotics to hyperbari
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). 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 2, 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 1, Single; manufacturer unknown), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ringing ears". The event "ringing ears" required physician office visit.  Additional information: after getting second dose of Pfizer vaccine patient got ringing ears. Patient asked how patient can get rid of it as it's bothering patient and altering patient's daily life. The patient had doctor, but they couldn't do anything about it. Reportedly, serious: no.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nervous system disorder, Tinnitus
Clinical narrative: has neurological and systemic problems; Caller states she has permanent tinnitus where she has a constant whistling tea kettle in her brain and ears 24/7.; her legs and arms went numb/numbness resides in toes and fingertips; her legs and arms went numb/she has permanent numbness in her fingertips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, 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. The following information was reported: NERVOUS SYSTEM DISORDER (medically significant), outcome "unknown", described as "has neurological and systemic problems"; TINNITUS (medically significant), outcome "unknown", described as "Caller states she has permanent tinnitus where she has a constant whistling tea kettle in her brain and ears 24/7."; HYPOAESTHESIA (medically significant), outcome "unknown", described as "her legs and arms went numb/numbness resides in toes and fingertips"; HYPOAESTHESIA (medically significant), outcome "unknown", described as "her legs and arms went numb/she has permanent numbness in her fingertips".  Clinical course: The patient stated she was looking at the Prescribing Information for RSV vaccine, Abrysvo. She can not find in the PI if this vaccine was composed of an attenuated virus, a live virus or an mRNA genetic modality. Caller stated the information was hidden. Caller stated she works in the pharmaceutical industry as a medical editor. Caller stated she was permanently damaged, has neurological and systemic problems as a result from the Pfizer BioNTech Covid shots, stated she received 2 doses. Caller stated for the Covid shots her body was loaded with spike proteins, where her body started making its own spike protein and cross the brain blood barrier and created problems for her because they were toxic. Caller stated she had permanent tinnitus where she had a constant whistling tea kettle in her brain and ears 24/7. Caller stated she had permanent numbness in her fingertips, numbness resides in toes and fingertips. Caller stated her legs and arms went numb and it stayed that way for weeks and weeks. Caller stated she was 70 years old, considered an at risk population and her doctor will recommend her an RSV vaccine for her and she was not interested in any mRNA modalities. Caller was gathering information to make an informed choice since they were not given an informed choice for the Covid shots, caller stated some 30% of the people where she lived received saline for the first series of injections as well as different strengths given to different people.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
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 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" (Jul2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  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-202300261290 same patient, different drug/event;
Age: 66.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 4 (booster), single (Lot number: GJ6796) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "Known allergies: Bacitracin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Experienced a rebound of COVID symptoms approximately 3 days after finishing Paxlovid course.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300261669 same patient, different drug/event;
Age: 72.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 5 (booster), single (Lot number: GJ3275), in left arm and on 27Mar2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: COVID-19 VACCINE taken for covid-19 immunisation as dose 1, single as dose 2, single as dose 3 (booster), single as dose 4 (booster), single; VENLAFAXINE, start date: 03Nov2008; LISINOPRIL, start date: 06Jun2003; LAMOTRIGINE, start date: 15Jan2019. 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, notes: home Covid test was taken in afternoon & revealed a very positive band; Negative, notes: negative test was seen 1-2 days before. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Pateint took Osteo Bi-Flex joint health from Laila neutroceuticals and One-a-day multiple vitamins from bayer with batch/lot number reported as NAAARD8. Patient was treated with Paxlovid from 18Jul2023 to 22Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300261400 same reporter/patient, different drug/AE;
Age: 65.0
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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 15Jul2023 to 19Jul2023.  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-202300261988 Same patient, different drug, different event;
Age: 59.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 at 10:45 as dose 1, single (Lot number: En6198), in left arm, on 22Mar2021 at 10:45 as dose 2, single (Lot number: Ep7534), in left arm, on 27Sep2021 at 11:00 as dose 3 (booster), single (Lot number: Ff8839), in left arm and on 27May2022 at 11:00 as dose 4 (booster), single (Lot number: Fj4989) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "pancreatic pseudocysts" (unspecified if ongoing), notes: Other medical history: Previous pancreatic pseudocysts from acute pancreatitis from blocked duct; "acute pancreatitis" (unspecified if ongoing), notes: Other medical history: Previous pancreatic pseudocysts from acute pancreatitis from blocked duct. The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: morphine". 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 14Jul2023 to 19Jul2023 as treatment for the events.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Knee arthroplasty
Clinical narrative: Total knee replacement; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 12Sep2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical site of injection: Arm Left, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 09Mar2021, for COVID-19 Immunisation; BNT162b2 (DOSE 2, SINGLE, Time (24hr): 15:00, Anatomical site of injection: Shoulder (deltoid), Route of administration: Intramuscular, Batch/Lot number: EW0158), administration date: 12Sep2021, for COVID-19 Immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Time (24hr): 10:00, Anatomical site of injection: Shoulder (deltoid), Route of administration: Intramuscular, Batch/Lot number: EW0187), administration date: 05Nov2021, for COVID-19 Immunisation. The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 15Feb2023, outcome "not recovered", described as "Total knee replacement". Therapeutic measures were taken as a result of knee arthroplasty which included physical therapy. Clinical course: Anatomical site of injection was Shoulder.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300111188 same patient, different dose/event;
Sex: U
Vaccine: TTOX
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: tetanus vaccine was given to a patient that with expiration date of 1/22/2023 with no reported adverse events; Initial information received on 20-Jul-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient and expired Tetanus Toxoid was given to a patient with no reported adverse events.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number: U6922AA, Expiry date: 22-Jan-2023) (With an unknown formulation, strength) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, expired Tetanus toxoid was given to a patient with no reported adverse events (expired product administered) (latency: same day).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  It was reported, expiration date of 1/22/2023 NDC 49281- 215-88, Lot: U6922AA. Please advise of step that should be taken to care for patient if detrimental.  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: U
Vaccine: DTPPVHBHPB, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: administered with both pentacel and vaxelis at the same time with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and gender patient who was administered with both diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), HIB vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3V (vero), tetanus vaccine toxoid [Vaxelis] at the same time 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 unknown dose of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB(PRP/T) vaccine and vaxelis not produced by Sanofi Pasteur (batch number, expiry date, route, administration site) for immunization at the same time with no reported adverse event (Inappropriate schedule of product administration) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered with both pentacel and vaxelis at the same time 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.; Sender's Comments:  US-SA-2023SA223170:01697765
Age: 0.33
Sex: U
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: patient received a dose of Daptacel too early and that there was only a 10 day interval between doses with no reported adverse event; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old and unknown gender who received a dose of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] too early and that there was only a 10 day interval between doses 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 Rotavirus Vaccine Live Reassort Oral 5V (Rotateq) for Prophylactic vaccination.  On 20-Jul-2023, the patient received a dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine suspension for injection lot number not reported via unknown route in unknown administration site for prophylactic vaccination (Immunisation), too early and that there was only a 10 day interval between doses with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Information on the batch number was requested.  It was reported that "the patient did not experience any redness at the injection site or any fever after the most recent dose of Daptacel".  Action taken: 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: 0.42
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: extra dose of PENTACEL was administered to a patient instead of Prevnar with no reported adverse event; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 months old female patient to whom extra dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered instead of prevnar 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 rotavirus vaccine live reassort oral 5V (Rotateq) for Prophylactic vaccination.  On 21-Jul-2023, the patient received an extra 0.5 mL dose 2 of suspect diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(vero)/HIB(PRP/T) vaccine, Suspension for injection (batch number: UJ859AA; expiry date: 02-Apr-2024) via intramuscular route in the left thigh for immunization instead of prevnar with no reported adverse event (extra dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event extra dose of pentacel was administered to a patient instead of prevnar 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: 5.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion occured, temp. low of 1.85C for 30 min due to human error with no reported adverse event; opened ipol was administered to the patient with no reported adverse event; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 5 years old male patient who experienced temperature excursion occured, temp. low of 1.85c for 30 min due to human error and opened IPV (VERO) [IPOL] was administered to the patient 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 temperature excursion occurred for IPV (VERO), temp. low of 1.85c for 30 min due to human error with no reported adverse event (product storage error) (unknown latency).  On 11-May-2023, the patient received a dose of 0.5 ml (frequency: once) of standard strength suspect IPV (VERO) suspension for injection (lot: V1A021M, Expiry date: 27-Feb-2024) via intramuscular route in unknown administration site for immunization was administered to the patient with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.58
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 3 separate excursions with the same vaccines, total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes which was caused by human error with no reported adverse event; vaccines were administred to patients post excursion with no reported adverse event; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 7 months old female patient who experienced 3 separate excursions with the same vaccine, total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes which was caused by human error and vaccine was administered post excursion with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the 3 separate excursions with the same vaccine IPV (VERO), total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes which was caused by human error with no reported adverse event (product storage error) (unknown latency).  On 15-May-2023, the patient received a dose of 0.5 ml (frequency: once) of suspect of standard strength IPV (VERO) suspension for injection (lot: V1A021M, Expiry date: 27-Feb-2024) via intramuscular route in unknown administration site for Immunization, administered post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event; ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes administered to the patient: yes with no reported adverse event; Initial information was received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 18 months old male patient who reported that ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event and ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes administered to the patient: yes with no reported adverse event after receiving ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2023, the patient received a dose of 0.5 ml of suspect ipv (VERO) (Suspension for injection) (lot V1A021M, Expiry date :27-Feb-2024) (strength was unknown) via intramuscular route in unknown administration site for Immunization and developed a non-serious event of ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event (product storage error) and ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes administered to the patient: yes with no reported adverse event (poor quality product administered) (latency : same day) following the administration of ipv (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event and was Unknown for the event ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes administered to the patient: yes 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: 0.5
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: ipol (opened) exposed to a temperature excursion accidentally left the refrigerator door open too long. 3 separate excursions with the same vaccines. total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event; ipol (opened) exposed to a temperature excursion accidentally left the refrigerator door open too long. 3 separate excursions low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes administered to the patient: Yeswith no ae; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 months old male patient who received vaccine IPV (vero) [IPOL] (opened) that was exposed to a temperature excursion (accidentally left the refrigerator door open too long; 3 separate excursions with the same vaccines. total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes) 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 Pneumococcal Vaccine for Prophylactic vaccination.  On 05-Jun-2023, the patient received 0.5 mL dose of suspect IPV (vero), suspension for injection (batch number: V1A021M; Expiry date: 27-Feb-2024) via intramuscular route in unknown administration site for immunization that was exposed to a temperature excursion (accidentally left the refrigerator door open too long; 3 separate excursions with the same vaccines. total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes) with no reported adverse event (poor quality product administered) (same day latency) (product storage error) (unknown latency) following the administration of IPV (VERO).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: temperature excursion occured, low of 1.85C for 30 min due to human error with no reported adverse event; opened ipol was administered to patient with no reported adverse event; Initial information was received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 6 months old male patient who experienced temperature excursion occured, low of 1.85c for 30 min due to human error with no reported adverse event and opened ipol was administered to patient with no reported adverse event after receiving ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Jun-2023, the patient received a dose of 0.5 ml of suspect ipv (VERO) (Suspension for injection) (lot V1A021M, Expiry date : 27-Feb-2024) (strength was unknown) via intramuscular route in unknown administration site for Immunization and developed a non-serious event of temperature excursion occured, low of 1.85c for 30 min due to human error with no reported adverse event (product storage error) and opened ipol was administered to patient with no reported adverse event (poor quality product administered) (latency : same day) following the administration of ipv (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event temperature excursion occured, low of 1.85c for 30 min due to human error with no reported adverse event and was Unknown for the event opened ipol was administered to patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.