chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines administered after temperature excursion that occurred on 8/1/2023.  Vaccines were administered to unknown patients on unknown dates. No additional AEs; vaccines administered after temperature excursion that occurred on 8/1/2023.  Vaccines were administered to unknown patients on unknown dates. No additional AEs; This spontaneous report was received from a registered nurse referring to an unspecified number of unknown patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, an unspecified number of unknown patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot#W030849, expiry date: 26-MAR-2024 and lot#; X004371, expiry date: 07-AUG-2024 (recombinant Human albumin (rHA)) and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#W018829, expiry date: 14-JUN-2024 as prophylaxis (dose and route of administration for both vaccines were not provided) that were exposed to temperature excursion of -11.8 Celsius degree, for 29 minutes that occurred on 01-AUG-2023. There were no previous temperature excursions. No additional Adverse events reported.  This is a non-valid case due to lack of patient's identifiers.  Follow-up information was received from the registered nurse regarding the 4-year-old female patient.  The patient historical vaccines included varicella virus vaccine live (VARIVAX). The patient's current conditions included functional heart murmur.  She had no known drug allergies (NKDA). Concomitant therapies included cetirizine.   On 29-AUG-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (administered subcutaneously in the left upper arm, lot number W030849, expiration date 26-MAR-2024) and with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) (administered intramuscularly at the right deltoid, lot number U7908AB, expiration date 03-OCT-2025). Both vaccines experienced a previous temperature excursion.    Furthermore, the nurse reported that there were ongoing issues with the freezer and auto-defrost. On 01-AUG-2023, the temperatures on state supplied data blogger reached -11.8 degree Celsius for 29 minutes.  She was unaware of temperature excursion until temporarily moving the vaccines to another office for temporary storage to manually defrost and had unit serviced on 16-AUG-2023.  The patient received immunization impacted by excursion prior to notification.  There were no known adverse events.   This case was previously considered non-valid, but upon receipt of follow-up patient identifiers were received and it was determined that the case is now valid.  This is one of three cases from the same reporter (2309USA002333 and 2311USA005370).
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Drug ineffective
Clinical narrative: We both did come down with Covid-19 4 week's ago; We both did come down with Covid-19 4 week's ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 78-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "We both did come down with Covid-19 4 week's ago". Patient husband and herself have gotten all 3 of the Covid-19 shots last year (2022) ending with the booster in Nov2022. They both did come down with Covid-19 4 week's ago (Oct2023) just 5 days after getting the high strength flu shot that Dr's give the elderly.   The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5/BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300184856 same reporter/drug/event different patient;
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Knee arthroplasty, Rash
Clinical narrative: Has had 2 new knees put in/ Knee replacement; Rash on legs, back and arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 82-year-old male patient received bnt162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 82 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization. The following information was reported: RASH (non-serious) with onset Sep2021, 2 days after the suspect product(s) administration, outcome "not recovered", described as "Rash on legs, back and arms"; KNEE ARTHROPLASTY (medically significant) with onset 2022, outcome "unknown", described as "Has had 2 new knees put in/ Knee replacement". The events "rash on legs, back and arms" required physician office visit. Therapeutic measures were taken as a result of rash. Clinical course: Patient was also prescribed Clobetasol Propionate USP 0.05% by dermatologist, but it did not help him. It made it worse.   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-202300362819 same reporter/drug/event, different patient.;
Age: 46.0
Sex: F
Vaccine: COVID19, 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) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 46 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "Anemia" (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 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid started from 02Nov2023 to 06Nov2023 Clinical course: Patient had no Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300362697 Same reporter/patient, different drug, different event.;
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "latex protien allegy" (unspecified if ongoing), notes: known allergies: Latex; "Migraines" (unspecified if ongoing); "small fiber neuropathy" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "hypermobility spectrum disorder" (unspecified if ongoing); "allergies: nickel" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 31Oct2023 to 04Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300362549 Same patient, different product/event;
Sex: M
Vaccine: COVID19
Symptoms: Clostridium difficile infection, Condition aggravated, Gastrointestinal disorder, Salmonellosis
Clinical narrative: c-diff; salmonella; Gastrointestinal problems for 35 years but it was manageable. However, about after a week or two after his 2nd Pfizer vaccine, he got a whole lot worse; Gastrointestinal problems for 35 years but it was manageable. However, about after a week or two after his 2nd Pfizer vaccine, he got a whole lot worse; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "he's had gastrointestinal problems for 35 years" (ongoing), notes: he's had gastrointestinal problems for 35 years but it was manageable. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for Covid-19 immunization. The following information was reported: CLOSTRIDIUM DIFFICILE INFECTION (medically significant), outcome "not recovered", described as "c-diff"; SALMONELLOSIS (medically significant), outcome "not recovered", described as "salmonella"; GASTROINTESTINAL DISORDER (medically significant), CONDITION AGGRAVATED (medically significant), outcome "not recovered" and all described as "Gastrointestinal problems for 35 years but it was manageable. However, about after a week or two after his 2nd Pfizer vaccine, he got a whole lot worse". Clinical Course: Patient stated he took "the 2 Pfizer vaccines in '21" and mentioned he's had gastrointestinal problems for 35 years but it was manageable. However, about after a week or two after his 2nd Pfizer vaccine, he got a whole lot worse. He said he got salmonella, c-diff, which were mild cases but persistent and he's been sick basically for the last 2 and a half years so he's had some reemissions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID/tested positive; COVID/tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 83-year-old female patient received bnt162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EL3246), on 29Jan2021 as dose 2, single (Lot number: EL9261) and on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Dec2022) and all described as "COVID/tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Dec2022) Negative. Clinical course: The patient was very okay when she had COVID last year. She tested positive and was still okay.   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-202300366141 same patient, different dose/event;
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Head discomfort, Malaise, Musculoskeletal discomfort, SARS-CoV-2 test
Clinical narrative: COVID/tested positive; COVID/tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 83-year-old female patient received bnt162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EL3246), on 29Jan2021 as dose 2, single (Lot number: EL9261) and on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Dec2022) and all described as "COVID/tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Dec2022) Negative. Clinical course: The patient was very okay when she had COVID last year. She tested positive and was still okay.   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-202300366141 same patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Ear pain, SARS-CoV-2 test
Clinical narrative: got tested positive for covid; got tested positive for covid; Earache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2 NOS), 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), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (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 "got tested positive for covid"; EAR PAIN (non-serious), outcome "unknown", described as "Earache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: got tested positive for covid. Clinical course: Caller's wife had 5 doses of Pfizer covid 19 vaccine and a booster. She got tested positive for covid and experienced sore throat and an earache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300185908 different patient, same product/events.;
Age: 71.0
Sex: F
Vaccine: COVID19, 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 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GJ5372), in left arm and on 06Jun2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 71 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: "Latex allergy" (unspecified if ongoing); "Breast cancer", start date: 2004 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered from 02Nov2023 to 06Nov2023.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Dysgeusia
Clinical narrative: loss of smell; most foods have no flavor except for the taste on tongue/pleasure of eating a good meal is lost; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  An elderly male patient received bnt162b2 (COMIRNATY), on 31Mar2021 as dose 2, single (Lot number: ER2613) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NOVOLIN 70/30 (ongoing); PRESERVISION AREDS 2 (ongoing). Vaccination history included: comirnaty (DOSE 1; Lot number: EN6198 in the left upper arm), administration date: 20Feb2021, when the patient was 83-year-old, for COVID-19 immunisation. The following information was reported: ANOSMIA (non-serious) with onset 2021, outcome "unknown", described as "loss of smell"; DYSGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "most foods have no flavor except for the taste on tongue/pleasure of eating a good meal is lost".  Additional information: The patient received Pfizer's COVID-19 vaccine for each of the injections made available to the American public. The first injection, and each of the following, thereafter affected sense of smell. The patient states that if this continues, he will never smell again. This is frustrating for him as most foods have no flavor except for the taste on his tongue. The pleasure of eating a good meal is lost. Every vaccine he has received, he has a loss of smell and gets a little better and gets next dose or booster vaccine and loses sense of smell again. Just got latest Pfizer Covid vaccine and it happened again.  He cannot identify any smells and can tell difference between some foods but not what they are; it makes a big difference on what he enjoys. The first time noticed the loss of smell was after the first two initial vaccinations he got a month apart. He remembers it was after the 2nd dose is when he realized what was going on. It has stayed about the same, it got a little better and when he got the next booster shot it went back. That happens each time he gets booster shot. He doesn't know how to explain improvement, he can tell a little difference between fruit or maple syrup but not the flavors for example. If he has a hot cup coffee in front of him, he can't smell it. But it tastes different, something there but doesn't know what it is.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very hurtful for a couple of days on right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received bnt162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EM9810) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "very hurtful for a couple of days on right arm".  Additional information: The patient had her first dose of vaccine on 06Feb2021 (Lot Number: EM9810) and was administered in her right arm  about noon. On 27Feb2021, the patient received the second dose of vaccine with reported lot number EM9810 and expiration date of 30Jun2021 . The second dose was administered in her left arm as her right arm  was very hurtful for a couple of days. The patient used her right arm for everything so the second dose was administered in her left arm.  The third dose was administered on 11Nov2021 (Lot Number: EN6202 and Expiration date: 01Apr2022), administered about noon in her left arm. The fourth dose was administered on 01Apr2022 (Lot Number: FJ9943), administered about noon in her left arm.. The fifth dose was administered on 08Sep2022 (Lot Number: GH9694) and administered in her left arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300185381 Same patient, same drug/different dose, different AE.;
Sex: U
Vaccine: COVID19, 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) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Lot number: GJ3277), 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 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered from 02Nov2023 to  06Nov2023. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Jun2023 at 17:30 as dose 4 (booster), single (Lot number: GJ3268) at the age of 56 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: "Other medical history: Asthma" (unspecified if ongoing); "Other medical history: Bronchietasis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Knonw allergies: erythromycin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Sex: F
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: extremely tired; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative. An 80-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: FATIGUE (non-serious), outcome "unknown", described as "extremely tired". It was unknown if therapeutic measures were taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300370236 same reporter/vaccine/event, different patients;
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Had gotten mild version Corona virus a while back, got over it, was ok; Had gotten mild version Corona virus a while back, got over it, was ok; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) . The reporter is the patient.  A 63-year-old male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown, Expiration Date: 31Jul2021), on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 04Jan2022 as dose 3 (booster), single (Lot number: FD0809) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Broken hip" (unspecified if ongoing); "Anxiety" (unspecified if ongoing), notes: anti anxiety medication; "blood pressure" (unspecified if ongoing), notes: blood pressure medication. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had gotten mild version Corona virus a while back, got over it, was ok". Clinical course was reported as follows: reporter stated that he was unable to clarify if he had mild version Corona, as previously stated, before or after Corona virus shots, believed it was before the booster, has no way of getting that information.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the patient did end up getting covid virus in 2022; the patient did end up getting covid virus in 2022; The initial case was missing the following minimum criteria: adverse event and suspect drug (unspecified). Upon receipt of follow-up information on 13Nov2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter(s) (Consumer) from product quality group, Program ID:. The reporter is the parent. A 23-year-old male patient received bnt162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 21 years for covid-19 immunization. The patient's relevant medical history included: "dialysis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: PFIZER covid vaccine (Dose 1, Lot: EN9581), administration date: 24Feb2021, when the patient was 21-year-old, for COVID-19 immunization; PFIZER covid vaccine (Dose 2, Lot: EP7534), administration date: 17Mar2021, when the patient was 21-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "the patient did end up getting covid virus in 2022".
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Ear pain, SARS-CoV-2 test
Clinical narrative: got tested positive for covid; got tested positive for covid; earache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2 NOS), 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), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing); "sugar type 2" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got tested positive for covid"; EAR PAIN (non-serious), outcome "unknown", described as "earache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: got tested positive for covid. Clinical course: Reporter and his wife had 5 doses of Pfizer covid 19 vaccine and a booster. Reporter mentioned that they got tested positive for covid and they experienced sore throat and an earache. Caller mentioned that he had a bunch of underlying condition like blood pressure sugar type 2 and Obesity. Reporter wanted to know if when will he be sick with covid 19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366293 same reporter product AE different patient;
Sex: U
Vaccine: COVID19
Symptoms: Nerve injury
Clinical narrative: Nerve damage; 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 number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation. The following information was reported: NERVE INJURY (disability), outcome "not recovered", described as "Nerve damage".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia
Clinical narrative: bronchial pneumonia along with Covid; bronchial pneumonia along with Covid; bronchial pneumonia along with Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "bronchial pneumonia along with Covid".  Additional information: reporter's daughter ended up with bronchial pneumonia along with Covid and was very ill which makes the reporter even more opposed to the Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Immunisation reaction
Clinical narrative: can barely walk/dragging their feet; slowly getting reactions; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (can barely walk/dragging their feet) and IMMUNISATION REACTION (slowly getting reactions) in an 80-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. 039021A and 1006HZIA) for COVID-19 prophylaxis.     Patient was in good health.  The patient's past medical history included Sneezing. Concurrent medical conditions included Thyroid disorder (Patient had thyroid and was taking medication for it.) and Seasonal allergy (Patient was allergic in the beginning of the summer and they start sneezing.).   On 25-Oct-2021, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 17-Apr-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (can barely walk/dragging their feet) and IMMUNISATION REACTION (slowly getting reactions). At the time of the report, GAIT DISTURBANCE (can barely walk/dragging their feet) and IMMUNISATION REACTION (slowly getting reactions) had not resolved.            Concomitant product included unspecified medication for thyroid.  It was reported that patient had Moderna vaccination for Covid 2 years ago and slowly getting reactions and at the time of reporting patient could barely walk. Patient was having trouble walking. Patient got the vaccine 2 years ago and it was affecting their walking. Patient was dragging, had no numbness, just dragging her feet. Patient went to the hospital to check and see if she had Parkinson and she did not.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-749086, US-MODERNATX, INC.-MOD-2023-749085 (E2B Linked Report). This case was linked to MOD-2023-749086, MOD-2023-749085, MOD-2023-749085 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749086:same patient Bivalent case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus
Clinical narrative: swollen lips; Body itchiness; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (swollen lips) and PRURITUS (Body itchiness) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031419) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 03-Jan-2022.    On 10-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 12-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced LIP SWELLING (swollen lips). In November 2023, the patient experienced PRURITUS (Body itchiness). At the time of the report, LIP SWELLING (swollen lips) was resolving and PRURITUS (Body itchiness) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. It was reported that the patient experienced allergy-like symptoms. It was unknown if the patient experienced any additional symptoms/events.  Treatment medication was not reported.
Age: 27.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: At time of vaccine administration, "very painful" R deltoid IM pain with decreased R arm range of motion x 3-7 days. Since then, pain has improved but is still present - most notably while washing hair (arm in extended, adducted, externally rotated position)
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Fatigue, Mouth swelling, Swelling, Swelling face
Clinical narrative: The patient reports that with thin an hour or so of receiving both influenza and RSV vaccinations she developed a sensation of swelling in her mouth and face and generalized weakness.  It is unclear if the patient had a fever the symptoms lasted several days.  She reported local swelling at the RSV vaccination site and persistent fatigue that lasted a week.  She reported to me that she had previously tolerated influenza vaccination with out reaction.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Vaccination site swelling
Clinical narrative: The patient reports that with thin an hour or so of receiving both influenza and RSV vaccinations she developed a sensation of swelling in her mouth and face and generalized weakness.  It is unclear if the patient had a fever the symptoms lasted several days.  She reported local swelling at the RSV vaccination site and persistent fatigue that lasted a week.  She reported to me that she had previously tolerated influenza vaccination with out reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I got my shingles shot about 16 months ago and forgot to go back for the second round/ I recevied the first dose about 18 months ago and forgot to get the second. Should I start over?; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received the first dose about 18 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I got my shingles shot about 16 months ago and forgot to go back for the second round/ I recevied the first dose about 18 months ago and forgot to get the second. Should I start over?). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2023 This case was reported the patient via interactive digital media. The reporter asked she start over The PCP told to reached out to get the answer The patient received the 1st dose about 18 months ago and forgot to get the second, which led to incomplete course of vaccination. Follow-up not possible as no contact details provided.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Felt Cruddy; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31-JUL-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: Felt Cruddy). The outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR154098   Additional Information: GSK Receipt Date: 07-NOV-2023 The patient reported that after dose 1 he felt cruddy but no stomach issues like with dose 2. For tolerance of dose 2, refer case US2023AMR154098.; Sender's Comments:  US-GSK-US2023AMR154098:Same Patient Same reporter Different Dose
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Mouth swelling, Pharyngeal swelling
Clinical narrative: Swollen mouth and throat after 1st dose; Swollen mouth and throat after 1st dose; not receive the 2nd dose, thus, leaving the vaccination scheme incomplete; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of throat swelling in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced throat swelling (Verbatim: Swollen mouth and throat after 1st dose), swollen mouth (Verbatim: Swollen mouth and throat after 1st dose) and incomplete course of vaccination (Verbatim: not receive the 2nd dose, thus, leaving the vaccination scheme incomplete). The outcome of the throat swelling, swollen mouth and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the throat swelling and swollen mouth to be related to Shingrix.     It was unknown if the company considered the throat swelling and swollen mouth to be related to Shingrix.   Additional Information: GSK receipt date: 7-Nov-2023 A pharmacist called to inform that a patient got their mouth and throat swollen after getting the 1st dose of Shingrix.  After this, the patient's doctor told the patient that he should not receive the 2nd dose, thus, leaving the vaccination scheme incomplete. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not provide any dates or lot number, since the product had been administered at an unknown facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: only diluent as administered to a patient a week ago; only diluent as administered to a patient a week ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 73-year-old female patient who received Herpes zoster (Shingrix) (expiry date 27-SEP-2025) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only diluent as administered to a patient a week ago) and inappropriate dose of vaccine administered (Verbatim: only diluent as administered to a patient a week ago). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 7-NOV-2023 A pharmacist reported that only diluent was administered to a patient a week ago.  That was Dose 1. The reporter consented to follow up. The patient received a dose of Shingrix diluent alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: expired dose of Shingrix was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 9Y92A, expiry date 02-JUN-2023) for prophylaxis.   On 08-NOV-2023, the patient received Shingrix. On 08-NOV-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: expired dose of Shingrix was administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 8-Nov-2023 The reporter consented to follow-up via email. The patient received an expired dose of Shingrix, which led to expired vaccine used.
Age: 10.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10 years of age patient received a dose of Kinrix on July 5th 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2TP74, expiry date 10-JUN-2024) for prophylaxis.   Previously administered products included dTap (received 4 doses of dTap vaccine on an unknown date) and IPV (received 3 doses of IPV vaccine on an unknown date).   On 05-JUL-2023, the patient received Kinrix. On 05-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 10 years of age patient received a dose of Kinrix on July 5th 2023). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Nov-2023 The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Boostrix was administered instead of Infanrix to 22 year old; Boostrix was administered instead of Infanrix to 22 year old; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 22-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 35S2S, expiry date 06-FEB-2026) for prophylaxis.   On 08-NOV-2023, the patient received Boostrix. On 08-NOV-2023, an unknown time after receiving Boostrix, the patient experienced adult product administered to child (Verbatim: Boostrix was administered instead of Infanrix to 22 year old) and overdose (Verbatim: Boostrix was administered instead of Infanrix to 22 year old). The outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-NOV-2023 The nurse reported that Boostrix was administered by mistake instead of Infanrix to a patient 22 month of age which led to adult product administered to child and overdose. The reporter did not consent to follow-up. The vaccine administration facility is the same as primary reporter.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: use of Engerix B 10 mcg; use of Engerix B 10 mcg; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 45-year-old male patient who received HBV (Engerix B Junior) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 09-NOV-2023, the patient received Engerix B Junior 10 mg. On 09-NOV-2023, an unknown time after receiving Engerix B Junior, the patient experienced underdose (Verbatim: use of Engerix B 10 mcg) and adult use of a child product (Verbatim: use of Engerix B 10 mcg). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-NOV-2023 A medical assistant enquired about Engerix-B and what information was available about the information available for the use of Engerix B 10 mcg in adults, the usage of other brands after Engerix-B and the interval to administer the next dose after a dose of Engerix-B which led to underdose and adult use of child product. They provided partial information about vaccine, event and patient. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.