chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Skin disorder, Skin haemorrhage
Clinical narrative: itching and now this skin pattern where it is easy to bleed/Skin bleeding; larger pattern of bruising/bruising; itching; Skin patching/Skin disorder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EP6955), administration date: 19Mar2021, for COVID-19 Immunization, reaction(s): "itching all over the body after rash formed", "rash on left arm above his wrist on forearm". The following information was reported: SKIN HAEMORRHAGE (non-serious), outcome "unknown", described as "itching and now this skin pattern where it is easy to bleed/Skin bleeding"; CONTUSION (non-serious), outcome "unknown", described as "larger pattern of bruising/bruising"; PRURITUS (non-serious), outcome "not recovered", described as "itching"; SKIN DISORDER (non-serious), outcome "unknown", described as "Skin patching/Skin disorder". The events "itching and now this skin pattern where it is easy to bleed/skin bleeding", "larger pattern of bruising/bruising" and "itching" required physician office visit. Clinical course: After second dose patient had itching which was probably to the top level of boosters that he had and where he was supposed to be and the condition of itching had increased dramatically and he had the skin condition to his forearms and it accelerated enough that it looks like if you were on a blood thinner where you had those kind of skin necrosis only he was not on a blood thinner. Pateint was seeing a dermatologist. The itching increased dramatically and he did not know when it began to increase dramatically but guesses it was when he first noticed it was just there and did not notice it being increased but noticed as of late there was a larger pattern of bruising, bleeding and patching that was bruised.   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-202300290360 same patient/drug, different dose/events (Dose 4);US-PFIZER INC-202300290361 same patient/drug, different dose/events (Dose 5);US-PFIZER INC-202300290359 same patient/drug, different dose/events (Dose 3);US-PFIZER INC-2021412848 same patient/drug, different dose/events (Dose 1);
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 80 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9263), on 23Feb2021 as dose 2, single (Batch/Lot number: unknown), on 24Sep2021 as dose 3 (booster), single (Lot number: EC3184) and on 05May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history included: "bloodwork was a little bit high" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN taken for blood test abnormal; LEVOTHYROXINE (ongoing). Vaccination history included: Flu shot (She got a flu shot each year; one thing she can say is she got the flu shot for over 65, the stronger one), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Aug2023, outcome "recovered" (30Aug2023) and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2023) Positive; (30Aug2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from 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), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Known allergies: Iodine" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC; ADAIR; METOPROLOL; VERAPAMIL; METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 15:45 as dose 2, single (Batch/Lot number: unknown) 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) for covid-19 immunisation. The patient's relevant medical history included: "no chronic conditions except year round allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (21Aug2023) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course:  The patient received COVID-19 treatment from 14Aug2023 to 18Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Apr2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: tested negative; positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Large intestine perforation, Musculoskeletal disorder, SARS-CoV-2 test
Clinical narrative: Colostomy/I lost part of my sigmoid colon, due to perforations; Skeletal symptoms; loss of a percentage of balance; joint & spine pain; joint & spine pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 immunization. The following information was reported: LARGE INTESTINE PERFORATION (medically significant), outcome "unknown", described as "Colostomy/I lost part of my sigmoid colon, due to perforations"; MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "Skeletal symptoms"; BALANCE DISORDER (non-serious), outcome "unknown", described as "loss of a percentage of balance"; SPINAL PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "joint & spine pain". The patient specified that 3 days after a positive Covid test, he/she lost part of sigmoid colon due to perforations that ended up with a colostomy.  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-PV202300149460 same patient/drug, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: Colostomy/I lost part of my sigmoid colon, due to perforations; Skeletal symptoms; loss of a percentage of balance; joint & spine pain; joint & spine pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 immunization. The following information was reported: LARGE INTESTINE PERFORATION (medically significant), outcome "unknown", described as "Colostomy/I lost part of my sigmoid colon, due to perforations"; MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "Skeletal symptoms"; BALANCE DISORDER (non-serious), outcome "unknown", described as "loss of a percentage of balance"; SPINAL PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "joint & spine pain". The patient specified that 3 days after a positive Covid test, he/she lost part of sigmoid colon due to perforations that ended up with a colostomy.  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-PV202300149460 same patient/drug, different dose/event;
Age: 60.0
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). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 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: "NASH" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: Sulfa, Eryromycin. Concomitant medication(s) included: LEVOTHYROXINE, start date: Jun2019; LOSARTIN, start date: Apr2018. Past drug history included: Keflex, reaction(s): "known allergies: Keflex", notes: known allergies: Keflex; Erythromycin, reaction(s): "known allergies: Eryromycin", notes: known allergies: Eryromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other vaccine and medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 26Aug2023 till 30 Aug2023  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a few sore arms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 Immunization; Bnt162b2 (dose 2), for COVID-19 Immunization; Bnt162b2 (dose 3), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a few sore arms".  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-PV202300149591 same patient/event/vaccine; different dose;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a few sore arms for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  An elderly female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a few sore arms for a day or two".  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-PV202300149591 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A few sore arms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  An elderly 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, reaction(s): "a few sore arms". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "A few sore arms". Additional information: The reporter stated both my wife (patient) and I (reporter) have receive our COVID-19 shots and boosters from this company and we have had practically no side effects to date; apart from a few sore arms for a day or two.  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-PV202300149591 same reporter/AE, different patient;
Age: 68.0
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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: 6H9705) at the age of 68 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Lot number: FJ4989), 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: "Osteopenia" (unspecified if ongoing); "Migraines" (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 Aug2023, outcome "recovered" (Aug2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: home test; Negative, notes: home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid for treatment of COVID-19 from 22Aug2023 to 26Aug2023; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291000 same patient/drug, different dose/events.;
Age: 63.0
Sex: F
Vaccine: 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 a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 63 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6201), on 25Mar2021 as dose 2, single (Lot number: ER8730), on 04Oct2021 as dose 3 (booster), single (Lot number: 301358A) and on 21May2022 as dose 4 (booster), single (Lot number: FM7553) for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetes" (unspecified if ongoing); "s/p breast ca" (unspecified if ongoing); "s/p endometrial ca" (unspecified if ongoing); "BMI 41/obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro family of abx, reaction(s): "Known Allergies: Cipro family of abx". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Aug2023 at 09:00, outcome "recovered" (28Aug2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Aug2023) Positive, notes: I tested positive for covid on 23Aug2023; (28Aug2023) Negative, notes: Tested negative on Monday28Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient tested positive for covid on 23Aug2023. Very mild sx. She got Paxlovid the same day and completed the full course. Tested negative on Monday28Aug. Got scratchy throat on Thursday 31Aug. Tested positive for covid, felt like sinus infection/head cold.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product  BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) and BNT162B2  to the reported events Drug ineffective COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300290977 same reporter/patient, different product/AE;
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; 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 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Aug2023, outcome "recovered" (23Aug2023); DRUG INEFFECTIVE (medically significant) with onset Aug2023, outcome "recovered" (23Aug2023). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Aug2023) Negative; (24Aug2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 19Aug2023 to 24Aug2023. Clinical course: The 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-202300290999 same patient, different product, different events;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-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. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "known allergies: Sulfa" (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 Aug2023, 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 from 22Aug2023 to 26Aug2023.  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-202300290992 Same patient, different product, different event;
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 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalosporin, reaction(s): "Known allergies: Cephalosporin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, 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. Clinical course: Patient received Paxlovid from 22Aug2023 to 27Aug2023.  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-202300291068 Same patient, different drug/AE;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 21Apr2021 as dose 2, single (Lot number: EW0164) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Nov2021 as dose 3 (booster), single (Lot number: O69f21a), in left arm, on 17May2022 as dose 4 (booster), single (Lot number: 03822a), in left arm and on 06Sep2022 as dose 5 (booster), single (Lot number: As7143c), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective which included paxlovid from 21Aug2023 to 25Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291042 same patient, different drug, different event;
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: J3274) at the age of 58 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 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 22Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Aug2023) Diagnosed with COVID, notes: Diagnosed with COVID 22Aug2023; (28Aug2023) Negative; (29Aug2023) Negative; (01Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: product: Paxlovid Taken as COVID 19 Treatment; treatment start date: 22Aug2023; treatment stop date: 26Aug2023. Diagnosed with COVID 22Aug2023. This was the first time I had ever gotten COVID. Began Paxlovid same day (22Aug2023). Took full course. Began to feel better, tested negative on 28Aug2023, 29Aug2023 and was continuing to feel better each day. Began to feel sick(er) 31Aug2023. Tested positive 01Sep23.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1: Janssen / Dose #2: Pfizer/ Dose #3: Pfizer.; 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 14Dec2021 as dose 2 (booster), single (Lot number: 33130BA), in right arm and on 30Jun2022 as dose 3 (booster), single (Lot number: FK9893) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 10Mar2021 as dose 1, single (Lot number: 1805029), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). Concomitant medication(s) included: MOUNJARO, start date: Aug2022; MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]; PHILLIPS COLON HEALTH; VITAMINE D, LILLY, ALLERGY PILL.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Dec2021, outcome "recovered", described as "Dose #1: Janssen / Dose #2: Pfizer/ Dose #3: Pfizer."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Negative, notes: Tested Negative 10 days after initial positive test; (Aug2023) Positive, notes: Tested Negative 10 days after initial positive test. Therapeutic measures (Paxlovid Treatment start date: 19Aug2023, stop date: 24Aug2023) were taken as a result of drug ineffective, covid-19. Clinical course: Patient tested Negative 10 days after initial positive test, took Paxlovid for 5 days.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291105 Same reporter/patient, different drug, different event.;
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). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "known allergies: Naproxen May cause hives". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 24Aug2023 till 28Aug2023.  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-202300291281 same patient, different product and event;
Sex: F
Vaccine: PNC20
Symptoms: Disease recurrence, Herpes virus infection, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: But 4 days later I got a fever 100.7 highest; Tingling fingertips; Bad recurrence of herpes; Bad recurrence of herpes; My upper arm hurt just for a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Pancreatic cancer" (unspecified if ongoing), notes: pancreatic cancer survivor; "Herpes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "My upper arm hurt just for a day"; PYREXIA (non-serious), outcome "unknown", described as "But 4 days later I got a fever 100.7 highest"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling fingertips"; HERPES VIRUS INFECTION (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "Bad recurrence of herpes". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.  Additional information: Patient reported that "I just thought I would give you the side effects I experienced after taking the Prevnar 20 vaccine. I am a 65-year-old female, pancreatic cancer survivor. My upper arm hurt just for a day but 4 days later I got a fever 100.7 highest, tingling fingertips, and bad recurrence of herpes".
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Crying, Injected limb mobility decreased, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: PCV15 vaccine administered in the R thigh; just above R knee(too low). Mother reported patient's inability to move R leg s/p vaccination for approx 12 hours. Also, experienced 2 days of crying in pain and excessive swelling above right knee. Patient continues with red area 2+ months later on 8/28/2023.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Crying, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain
Clinical narrative: PCV15 vaccine administered in the R thigh; just above R knee(too low). Mother reported patient's inability to move R leg s/p vaccination for approx 12 hours. Also, experienced 2 days of crying in pain and excessive swelling above right knee. Patient continues with red area 2+ months later on 8/28/2023.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Product administered at inappropriate site
Clinical narrative: PCV15 vaccine administered in the R thigh; just above R knee(too low). Mother reported patient's inability to move R leg s/p vaccination for approx 12 hours. Also, experienced 2 days of crying in pain and excessive swelling above right knee. Patient continues with red area 2+ months later on 8/28/2023.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose  of 1mL of Hepatitis B vaccine given to a 19 year old.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: On Item #17: dosing didn't indicate or not exactly sure but the dose was 0.5mL
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea
Clinical narrative: Diarrhea
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: swelling glands in under my right arm and neck; Achiness; Stayed in bed; Feeling extremely nauseated; Jaw hurt really bad; Headache/ head is killing me; chills; lost 6 pounds since second dose administration; Feeling crappy/ feeling worst; Arm hurt really bad; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 6th June 2023, refer case US2023AMR116960.).   On 17-AUG-2023, the patient received the 2nd dose of Shingrix (right arm). In AUG-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm hurt really bad), chills (Verbatim: chills), feeling abnormal (Verbatim: Feeling crappy/ feeling worst) and weight loss (Verbatim: lost 6 pounds since second dose administration). On 18-AUG-2023, the patient experienced jaw pain (Verbatim: Jaw hurt really bad), headache (Verbatim: Headache/ head is killing me) and nausea (Verbatim: Feeling extremely nauseated). On 19-AUG-2023, the patient experienced bedridden (Verbatim: Stayed in bed). On 25-AUG-2023, the patient experienced swollen glands (Verbatim: swelling glands in under my right arm and neck) and pain (Verbatim: Achiness).  Rechallenge with Shingrix was positive. On 20-AUG-2023, the outcome of the bedridden was resolved (duration 1 day). The outcome of the pain in arm, swollen glands, jaw pain, headache, chills, pain, feeling abnormal, nausea and weight loss were not resolved.   It was unknown if the reporter considered the pain in arm, swollen glands, jaw pain, headache, chills, pain, feeling abnormal, nausea, weight loss and bedridden to be related to Shingrix.     It was unknown if the company considered the pain in arm, swollen glands, jaw pain, headache, chills, pain, feeling abnormal, nausea, weight loss and bedridden to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR116960   Additional Information: GSK Receipt Date: 25-AUG-2023 The reporter reported that she received Shingrix vaccine on Thursday in her right arm and she woke up at mid night with chills, her arm hurt really bad and felt crappy.  The reporter stated that on 18th August 2023, next day patient had a horrible headache and her jaw hurt really bad and she felt extremely nauseated all day on Friday. On Saturday and Sunday patient was stayed in bed.  The reporter stated that on Monday patient had some relief of symptoms feeling better and noticed she lost 6 pounds since received second dose.  The reporter reported that on Wednesday and Thursday patient was felt worst again and today on Friday patient having all symptoms back again stated that she had chills, her head was killing her, swelling glands in under her right arm and neck and also had achiness. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR116960:1st dose case, same patient, same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with a sterile diluent instead of the supplied AS01b diluent; reconstituted with a sterile diluent instead of the supplied AS01b diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   In AUG-2023, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with a sterile diluent instead of the supplied AS01b diluent) and inappropriate dose of vaccine administered (Verbatim: reconstituted with a sterile diluent instead of the supplied AS01b diluent).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 25-AUG-2023 Clinical Operations Manager reported that a nurse administered a dose of Shingrix that was reconstituted with a sterile diluent instead of the supplied AS01b diluent, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.   They were not sure which patient it was that received this dose, they have it narrowed down to 4 patients.   The dose was given sometime between 05Aug2023 to 22Aug2023. At the time of reporting, no repeat doses had been administered. The reporter consented to follow up. This case has been linked to the case, US2023AMR116984, US2023116324 and US2023AMR116986 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR116984:same reporter US-GSK-US2023AMR116986:same reporter US-GSK-US2023116324:same reporter
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient has not reported signs/symptoms of adverse effects; PROQUAD was administered after the not supported TE.; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 17-JUL-2023, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (dose, route of administration and anatomical site of vaccination were not reported; lot number W038812 has been verified to be valid, expiration date reported and established as 04-JUN-2024) as prophylaxis.  The vaccine was exposed to a temperature exposure of 11 degrees Celsius during a time frame of 120 hours. There was no previous temperature excursion (product storage error), and no data logger was involved. No adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2308USA003217: US-009507513-2308USA003164: US-009507513-2308USA003164:
Age: 26.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC; HCP called to report inadvertent administration of PROQUAD to a 26-year-old patient.; This spontaneous report has been received from a medical assistant and refers to a 26-year-old female patient. Her pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided. The patient's historical vaccines included measles vaccine live (Enders-Edmonston) (+) mumps vaccine live (Jeryl Lynn) (+) rubella vaccine live (Wistar RA 27/3) (M M R II) and varicella zoster vaccine live (Oka/Merck) (VARIVAX).  On 25-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection 0.5 milliliter as prophylaxis (route of administration, anatomical location of vaccination, lot number and expiration date were not provided) (product administered to patient of inappropriate age).  There were no additional adverse events.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; a patient inadvertently received both VARIVAX and PROQUAD on 8/21/2023; they meant to give MMR II but instead gave PROQUAD; This spontaneous report was received from a medical assistant referring to a 12-month-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 21-AUG-2023, the patient was inadvertently vaccinated with one dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection and one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (strength, route of administration, lot#, and expiration date for both vaccines were not provided) (overdose). The reporter meant to give Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) but instead gave Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (wrong product administered). The patient did not have any symptoms and there was no additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient who received the first dose when they were 16 in September 2019 and just came in for his second dose today on 8/26/23; This spontaneous report was received from pharmacist and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  In September 2019, when the patient was 16, was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, vaccination scheme, anatomical location, dose description, lot #, expiry date, and route of administration were not provided).  On 26-AUG-2023, the subject went for the second dose (inappropriate schedule of product administration). At the reporting time, the outcome of the event was unknown.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient has not reported any side effects or symptoms at this time; Product was administered today, 31AUG2023 however it expired on 29AUG2023; This spontaneous report was received from a nurse referring to a 70-year-old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On 31-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #U032086 with an expiration date on 29-AUG-2023), administered for prophylaxis (strength, dose, and route of administration were not provided).  The patient did not report any side effects or symptoms at this time. Vaccine was administered however, it expired on 29-AUG-2023. No temperature excursions were reported.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: patient has not reported any side effects or symptoms at this time; Product was administered today, 31AUG2023 however it expired on 29AUG2023; This spontaneous report was received from a nurse referring to a 70-year-old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On 31-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #U032086 with an expiration date on 29-AUG-2023), administered for prophylaxis (strength, dose, and route of administration were not provided).  The patient did not report any side effects or symptoms at this time. Vaccine was administered however, it expired on 29-AUG-2023. No temperature excursions were reported.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: permenant lump in front of my armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AXILLARY MASS (non-serious), outcome "unknown", described as "permenant lump in front of my armpit". The action taken for BNT162b2 was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.