chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Illness, Nausea, Vaccination site reaction
Clinical narrative: Within 10 hours patient was extremely nauseated; had an upset stomach; 8 days after the first dose she had COVID arm; The 2nd dose made patient extremely ill /was sick after the 1st and 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (8 days after the first dose she had COVID arm), ILLNESS (The 2nd dose made patient extremely ill /was sick after the 1st and 2nd dose), NAUSEA (Within 10 hours patient was extremely nauseated) and ABDOMINAL DISCOMFORT (had an upset stomach) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (highly allergic to sulfa drug.).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE REACTION (8 days after the first dose she had COVID arm). In April 2021, the patient experienced NAUSEA (Within 10 hours patient was extremely nauseated) and ABDOMINAL DISCOMFORT (had an upset stomach). In 2021, the patient experienced ILLNESS (The 2nd dose made patient extremely ill /was sick after the 1st and 2nd dose). At the time of the report, VACCINATION SITE REACTION (8 days after the first dose she had COVID arm), ILLNESS (The 2nd dose made patient extremely ill /was sick after the 1st and 2nd dose), NAUSEA (Within 10 hours patient was extremely nauseated) and ABDOMINAL DISCOMFORT (had an upset stomach) outcome was unknown.            Concomitant medication not reported.   8 days after the first dose she had COVID arm. The 2nd dose made her extremely ill. Within 10 hours she was extremely nauseated, very ill and she had an upset stomach. Since she was sick after the 1st and 2nd dose. She did not get the 1st booster or the 2nd booster.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-736311 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736311:Bivalent Case
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Wrong product administered
Clinical narrative: Burning sensation in my feet; Felt very weak; Wrong Vaccine Administered; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2022 as dose 3 (orange cap, booster), single (Lot number: FF9442Z) at the age of 35 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE, Anatomical location: Right arm), administration date: 30Nov2021, for COVID-19 immunisation; Comirnaty (DOSE 2, SINGLE, Batch/Lot number: Fd7639, Anatomical location: Left arm), administration date: 02Sep2022, for COVID-19 immunisation. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 01Nov2022, outcome "unknown", described as "Wrong Vaccine Administered"; BURNING SENSATION (non-serious), outcome "not recovered", described as "Burning sensation in my feet"; ASTHENIA (non-serious), outcome "not recovered", described as "Felt very weak". The events "burning sensation in my feet" and "felt very weak" required physician office visit. Therapeutic measures were taken as a result of burning sensation, asthenia.  Additional Information: Patient had administered booster dose and since after 3 month has burning sensation in feet. Patient feel it every day in evening and felt very weak, ice massage help him out. Patient's doctor prescribed him multivitamin for that but nothing helped. And issue still persist.  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-202300273026 same patient, different dose/event (LOE);US-PFIZER INC-202300273025 same patient, different dose/event (At Risk);US-PFIZER INC-202300273027 same reporter, different patient/event/dose;
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation
Clinical narrative: burning sensation in feet; Felt very weak; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "burning sensation in feet"; ASTHENIA (non-serious), outcome "unknown", described as "Felt very weak".  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-202300272957 Different patient/drug, different dose/events (Dose 3);US-PFIZER INC-202300273026 Different patient/drug, different dose/events (LOE);US-PFIZER INC-202300273025 Different patient/drug, different dose/events (DOSE 2);
Sex: F
Vaccine: MENB
Symptoms: New daily persistent headache
Clinical narrative: After shot, got severe headache.; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An 18-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), in Oct2021 as dose 1, single (Batch/Lot number: unknown) for immunisation; meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), in Oct2021 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (disability) with onset Oct2021, outcome "not recovered", described as "After shot, got severe headache.". The event "after shot, got severe headache." required emergency room visit. Therapeutic measures were taken as a result of headache. Clinical course: After shot, got severe headache. The patient went to ER. Multiple daily headaches, ever since that day, for 2 years.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: There is a reasonable possibility that the event headache was related to TRUMENBA based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
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) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 18:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 34 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: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "endometriosis" (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 "recovering" 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 details: Patient had no known allergies. Patient was treated with Paxlovid from 01Aug2023 to 05Aug2023 for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: has a lump on her upper arm where she got the injection, but it is not near the injection site. It is 1-2 inches further down and is solid; Her upper part of arm was red and itchy; Her upper part of arm was red and itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 07Aug2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "allergic to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINAITON SITE ERYTHEMA (non-serious) all with onset 08Aug2023, outcome "unknown" and all described as "Her upper part of arm was red and itchy"; LIMB MASS (non-serious) with onset 09Aug2023, outcome "unknown", described as "has a lump on her upper arm where she got the injection, but it is not near the injection site. It is 1-2 inches further down and is solid and swollen from that point down to my elbow".  Additional information: The patient got a Prevnar 20 shot 3 days ago on Monday, 07Aug2023 at withheld. She has a lump on her upper arm where she got the injection, but it is not near the injection site. It is 1-2 inches further down and is solid and swollen from that point down to her elbow. Her upper part of arm was red and itchy on Tuesday (08Aug2023) and the lump appeared yesterday (09Aug2023). She called her doctor who suggested she go to the nearest walk-in clinic.   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.
Sex: F
Vaccine: PNC20
Symptoms: Limb mass, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: has a lump on her upper arm where she got the injection, but it is not near the injection site. It is 1-2 inches further down and is solid; Her upper part of arm was red and itchy; Her upper part of arm was red and itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 07Aug2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "allergic to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINAITON SITE ERYTHEMA (non-serious) all with onset 08Aug2023, outcome "unknown" and all described as "Her upper part of arm was red and itchy"; LIMB MASS (non-serious) with onset 09Aug2023, outcome "unknown", described as "has a lump on her upper arm where she got the injection, but it is not near the injection site. It is 1-2 inches further down and is solid and swollen from that point down to my elbow".  Additional information: The patient got a Prevnar 20 shot 3 days ago on Monday, 07Aug2023 at withheld. She has a lump on her upper arm where she got the injection, but it is not near the injection site. It is 1-2 inches further down and is solid and swollen from that point down to her elbow. Her upper part of arm was red and itchy on Tuesday (08Aug2023) and the lump appeared yesterday (09Aug2023). She called her doctor who suggested she go to the nearest walk-in clinic.   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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable healthcare professional. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 02Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Functional heart murmur" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered with sequelae" (2023) and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID; Lot Number: GK2931) from 25Jul2023 to 30Jul2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Illness
Clinical narrative: She has been sick for a long time; Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: ILLNESS (non-serious), outcome "unknown", described as "She has been sick for a long time"; BRONCHITIS (non-serious), outcome "unknown".  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: 44.0
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) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective.  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: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 66.0
Sex: M
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 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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), outcome "not recovered" and all described as "Treatment of Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (07Aug2023) negative; (09Aug2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31Jul2023 to 05Aug2023.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899), in right arm, on 11Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 17Apr2022 as dose 4 (booster), single (Lot number: Fj4991) at the age of 64 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Dec2022 as dose 5 (booster), single (Lot number: 041H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Dec2022, outcome "unknown", described as "vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid as treatment from 02Aug2023 to 07Aug2023. The patient started Paxlovid day 2 of COVID 19, 2 days after 5 day course of Paxlovid (day 7 of onset of symptoms), developed sore throat & runny nose, fatigue.
Age: 63.0
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 a contactable reporter(s) (Consumer or other non HCP). 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 09Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 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: "Breast cancer", start date: 2009 (unspecified if ongoing), notes: treatment. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31Jul2023 to 04Aug2023.  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, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna= 01Jul2022/ Pfizer= 03Nov2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 at 15:30 as dose 5 (booster), single (Lot number: GJ6739), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Mar2021 at 12:30 as dose 1, single (Lot number: 04SA21A), in left arm, on 16Apr2021 at 12:30 as dose 2, single (Lot number: 042B21A), in left arm, on 04Nov2021 at 15:00 as dose 3 (booster), single (Lot number: 071F21A), in left arm and on 01Jul2022 as dose 4 (booster), single (Lot number: 014B22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic hives (autoimmune)", start date: Jan2010 (unspecified if ongoing), notes: chronic hives (autoimmune) diagnosed Jan2010; "Outdoor allergies" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for urticaria, start date: 31Jul2023, stop date: 03Aug2023; CLARITINE, start date: May2023, stop date: 02Aug2023; NATURE'S WAY ACTIVATED CHARCOAL, start date: 02Aug2023, stop date: 04Aug2023; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity, start date: Jan2010, stop date: 02Aug2023; ZINC. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Nov2022 at 15:30, outcome "unknown", described as "Moderna= 01Jul2022/ Pfizer= 03Nov2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jul2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID-19 Treatment included Paxlovid from 01Aug2023 to 05Aug2023. Clinical course: Tested positive at home initially Mon 31Jul2023 after sore throat started 30Jul2023 and we learned of an exposure. Symptoms worsened, got Paxlovid Tues 01Aug2023, took it through the entire course on Sat 05Aug2023. Tested using throat-then-nose swab as recommended by epidemiologists. All at-home rapid tests were BinaxNow; Paxlovid given after in-office rapid test positive at [Name-withheld] in [Name], MD.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-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: 6H9693) at the age of 55 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), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures included Paxlovid from 01Aug2023 to 06Aug2023 were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "IPF (Idiopathic Pulmonary Fibrosis)" (unspecified if ongoing), notes: Other medical history: IPF (Idiopathic Pulmonary Fibrosis), heart disease; "heart disease" (unspecified if ongoing), notes: Other medical history: IPF (Idiopathic Pulmonary Fibrosis), heart disease; "Known allergies: Sulphur" (unspecified if ongoing), notes: Known allergies: Sulphur. 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 "COVID 19 Treatment". Therapeutic measures included Paxlovid from  02Aug2023 to 06Aug2023 were taken as a result of drug ineffective, 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: Congenital anomaly, Exposure during pregnancy
Clinical narrative: his son was born in several airway birth defects; his son was born in several airway birth defects; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A neonate male patient was exposed to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), transplacental, administration details for the mother: as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE DURING PREGNANCY (congenital anomaly), CONGENITAL ANOMALY (congenital anomaly), outcome "unknown" and all described as "his son was born in several airway birth defects".  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-202300274748 same reporter/drug, different patient/event;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Immune system disorder, Induration, Nasopharyngitis
Clinical narrative: Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high; Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days; Arm had a massive [hard painful] swelling for days; Arm had a massive [hard painful] swelling for days; Chronic fatigue; wiped out for a couple of days; wiped out for a month; Cold; Knocked my immune system off; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001049 (Novavax).  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days"; PERIPHERAL SWELLING (non-serious), INDURATION (non-serious), outcome "unknown" and all described as "Arm had a massive [hard painful] swelling for days"; FATIGUE (non-serious), outcome "unknown", described as "Chronic fatigue; wiped out for a couple of days; wiped out for a month"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Knocked my immune system off". Relevant laboratory tests and procedures are available in the appropriate section.  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-202300272287 same patient/event, different vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high; Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days; Arm had a massive [hard painful] swelling for days; Arm had a massive [hard painful] swelling for days; Chronic fatigue; wiped out for a couple of days; wiped out for a month; Cold; Knocked my immune system off; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001049 (Novavax).  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days"; PERIPHERAL SWELLING (non-serious), INDURATION (non-serious), outcome "unknown" and all described as "Arm had a massive [hard painful] swelling for days"; FATIGUE (non-serious), outcome "unknown", described as "Chronic fatigue; wiped out for a couple of days; wiped out for a month"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Knocked my immune system off". Relevant laboratory tests and procedures are available in the appropriate section.  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-202300272287 same patient/event, different vaccine dose;
Sex: F
Vaccine: TDAP
Symptoms: Skin laceration, Syringe issue
Clinical narrative: tdap (adacel) vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age female patient, diphtheria-2/tetanus/5 AC pertussis vaccine [adacel] vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date: unknown) (lot: U7869AA) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had event of tdap (adacel) vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger (skin laceration) (unknown latency) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  It was reported "Yesterday we had a nurse that was given a Tdap (Adacel) vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger. We did need to re-administer the vaccine as she was unable to give the medication".  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Adacel) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Age: 0.33
Sex: F
Vaccine: HIBV, UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: used the HIB component of ACT-HIB with the diluent of PENTACEL and administered it to a patient with no reported adverse event; Initial information received on 08-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 4 months old female patient for whom HIB component of HIB (PRP/T) vaccine [ACT-HIB] was used with the diluent of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] and administered it to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered a standard dose 2 (0.5 ml) of HIB component of HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ8566AA, expiry date- 26-MAR-2024) with the diluent of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ851AA, expiry date- 04-JAN-2024) via intramuscular route in unknown administration site for Immunization with no reported adverse event (product preparation error) (latency- same day).  Reportedly, Patient care supervisor called to ask if the HIB components of ACT-HIB and PENTACEL were the same because a medical assistant used the HIB component of ACT-HIB with the diluent of PENTACEL and administered it to a patient.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: door was left open/vaccines were being organized Max temperature reached: 9°C. Duration out of labelled range: 9 minutes 1st excursion: 26 minutes with no Adverse event; ipolwas administered to patient after excursion with no reported adverse event; Initial information received on 09-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom ipol was administered after excursion with no reported adverse event and door was left open/vaccines were being organized Max temperature reached: 9°C. Duration out of labelled range: 9 minutes 1st excursion: 26 minutes with no Adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the suspect IPV (VERO), Suspension for injection via unknown route in unknown administration site for prophylactic vaccination (strength, dose, batch number and expiry date: unknown) ipol was administered to patient after excursion with no reported adverse (Poor quality vaccine administered) (latency same day). Information on the batch number was requested  On an unknown date door was left open/vaccines were being organized Max temperature reached: 9°C. Duration out of labelled range: 9 minutes 1st excursion: 26 minutes with no Adverse event (product storage error) (unknown latency).  Reportedly, extended stability data cover the excursion- No Administered to a patient- Yes Previous excursion: Yes  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events product storage error and poor quality vaccine administered  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: ACTHIB vial that expired was inadvertently administered to a patient with no reported adverse event; Initial information received on 10-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who experienced HIB (PRP/T) vaccine [ACT-HIB] vial that expired was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Aug-2023, the patient inadvertently received an expired dose of 0.5 ml (frequency: once) suspect of standard strength HIB (PRP/T) vaccine powder and solvent for solution for injection (lot: UJ735AA, Expiry date: 07-Aug-2023) via intramuscular route in the left deltoid for Immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of Adacel that has expired on 29Jul2023 with no reported adverse event; Initial information was received on 10-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 82 years old female patient who received diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] that has expired on 29jul2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Aug-2023, the patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (strength was unknown) (frequency : once, lot C5921AA, Expiry date : 29-Jul-2023) via intramuscular route in the right deltoid for Immunization and administration of adacel that has expired on 29-jul-2023 with no reported adverse event (expired product administered) (latency : same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administration of adacel that has expired on 29jul2023 with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Records indicate she was given an expired vaccine. However, it is unclear if that is the case or if it was just documented incorrectly. The EHR at the time auto-populated with dates and lot numbers and it is possible they were entered incorrectly. No known adverse event associated with it. She has had a Tdap since then and so I didn't not offer to revaccinate.
Age: 3.0
Sex: F
Vaccine: HIBV, IPV, PNC13
Symptoms: Product preparation error
Clinical narrative: There was no adverse reaction as of time of this report. Just a vaccination error. The wrong diluent was used with the HIB. Sterile water was used instead of the saline diluent that came with the HIb. CDC was called and they stated as long as it was not a live virus then pt could come back in at anytime to be re vaccinated. I asked if there could be adverse reactions with this and was told none were found.
Age: 13.0
Sex: M
Vaccine: MMRV, TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: TDap, MMR, and Varicella ordered. TDap, Proquad, and Varicella given. The error was discovered after the patient and his mother left so we are unaware of any adverse reactions but we know he got those vaccines and we are reporting that fact in this submission.  Tried to notify family x5 but cannot reach them on phone number provided. We will discuss when they present for follow up on 8/18/2023.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Unfortunately our records indicate pt was given an expired vaccination. The confounding factor is that our EHR used to autopopulate lot numbers and expiration dates, so if the MA didn't catch it to change it, it could be entered incorrectly. It is more likely this is the case than she actually received an expired vaccine, but we can't say for sure. I explained the situation to the MOP and offered to repeat pt.'s vaccination. MOP is thinking about it. MOP can't remember any adverse events at the time.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arrhythmia, Fatigue, Hypertension, Injection site rash, Injection site swelling
Clinical narrative: Each vaccine dose and booster I received resulted in tennis ball sized swelling and rash at the injection site (with pictures to document), and intense fatigue, body aches, fever, fainting, high blood pressure, and arrhythmia (irregular heartbeat) for 7-10 days after each dose with necessary bed rest.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia, Syncope, Vaccine positive rechallenge
Clinical narrative: Each vaccine dose and booster I received resulted in tennis ball sized swelling and rash at the injection site (with pictures to document), and intense fatigue, body aches, fever, fainting, high blood pressure, and arrhythmia (irregular heartbeat) for 7-10 days after each dose with necessary bed rest.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: Extra dose of Bexero was given.
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received dose on 8/5/23 from a vial that was punctured on 8/3/23. Patient has no symptoms to report. Stability information from Moderna states the vaccine provided the activity necessary to protect against the SARS-CoV-2.  Patient does not need an additional dose.
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Product closure issue
Clinical narrative: Patient received dose on 8/5/23 from a vial that was punctured on 8/3/23. Patient has no symptoms to report. Stability information from Moderna states the vaccine provided the activity necessary to protect against the SARS-CoV-2.  Patient does not need an additional dose.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Unfortunately on review of patient's vaccine record it was noted that he had received expired vaccinations. The confounding factor is that our EHR used to autopopulate lot numbers and expiration dates and if the MA didn't change it, it would default to the wrong information. It is more likely this is the case than an expired vaccination was given. I explained the situation to MOP. He did not have any unusual side effects that she remembers. He has had subsequent doses of all of the vaccines that were marked as expired, except the rotavirus vaccine which is obsolete for his age group, so I did not recommend revaccinating.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site reaction, Local reaction, Skin irritation
Clinical narrative: Patient experienced redness/irritation on arm of injection site for 7 days following immunization. Did not appear to be an allergic reaction as no hives, itching, or involvement of throat/lips/face. Localized reaction encompassed injection site on arm as well as surrounding area of upper arm.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Exposure during pregnancy, Fatigue, Palpitations
Clinical narrative: 32 weeks pregnant. 2nd pregnancy. EDD 10/09/23. Starting 3 days after vaccine, experienced severe diarrhea throughout the day - liquid, at least 5x. Extreme fatigue and heart racing throughout the afternoon.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain, Abdominal pain upper, Angiogram, Barium swallow, Blood test
Clinical narrative: Chest pain, difficulty swallowing, choking sensation, stomach and abdominal pain.  Heart stent Oct 5, 2022. Heart stent April 26, 2023. Medication for esophageal spasms. I continue to have constant stomach and abdominal pain and cramping, causing difficulty sleeping and ruining normal life. I had never had GI problems of any kind my entire life until September, 2022. The two heart stents seem to have been effective, though test show it is likely that I had irreversible heart damage between October and April.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac disorder, Chest pain, Choking sensation, Computerised tomogram, Computerised tomogram abdomen
Clinical narrative: Chest pain, difficulty swallowing, choking sensation, stomach and abdominal pain.  Heart stent Oct 5, 2022. Heart stent April 26, 2023. Medication for esophageal spasms. I continue to have constant stomach and abdominal pain and cramping, causing difficulty sleeping and ruining normal life. I had never had GI problems of any kind my entire life until September, 2022. The two heart stents seem to have been effective, though test show it is likely that I had irreversible heart damage between October and April.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dysphagia, Echocardiogram, Insomnia, Laboratory test abnormal, Oesophageal spasm
Clinical narrative: Chest pain, difficulty swallowing, choking sensation, stomach and abdominal pain.  Heart stent Oct 5, 2022. Heart stent April 26, 2023. Medication for esophageal spasms. I continue to have constant stomach and abdominal pain and cramping, causing difficulty sleeping and ruining normal life. I had never had GI problems of any kind my entire life until September, 2022. The two heart stents seem to have been effective, though test show it is likely that I had irreversible heart damage between October and April.