chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored 30-MAR-2023 and adminstred on 03-MAY-2023; No adverse event; They had a vial of Moderna that had been unpunctured, but it was used after the BUD date/It was administered within 5 days of the expiration of the beyond-use-date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They had a vial of Moderna that had been unpunctured, but it was used after the BUD date/It was administered within 5 days of the expiration of the beyond-use-date), PRODUCT STORAGE ERROR (The vial was initially stored 30-MAR-2023 and administered on 03-MAY-2023) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis. No Medical History information was reported. On 03-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-May-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (They had a vial of Moderna that had been unpunctured, but it was used after the BUD date/It was administered within 5 days of the expiration of the beyond-use-date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored 30-MAR-2023 and administered on 03-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They had a vial of Moderna that had been unpunctured, but it was used after the BUD date/It was administered within 5 days of the expiration of the beyond-use-date), PRODUCT STORAGE ERROR (The vial was initially stored 30-MAR-2023 and administered on 03-MAY-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (They had a vial of Moderna that had been unpunctured, but it was used after the BUD date/It was administered within 5 days of the expiration of the beyond-use-date) and PRODUCT STORAGE ERROR (The vial was initially stored 30-MAR-2023 and adminstred on 03-MAY-2023).    No concomitant medication was reported.  The vial was initially stored in the refrigerator on 30-MAR-2023. It was administered within 5 days of the expiration of the beyond-use-date, which was 29-Apr-2023. The vial did not undergo any temperature excursions. No treatment information was reported.
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; A pediatric patient less than 5 years old received a 0.2 ml dose of the moderna COVID-19 vaccine with the pink cap and the label with the yellow border; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (A pediatric patient less than 5 years old received a 0.2 ml dose of the moderna COVID-19 vaccine with the pink cap and the label with the yellow border) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PENTACEL on 23-Mar-2023, ROTATEQ on 23-Mar-2023, VAXNEUVANCE on 23-Mar-2023 and FLUZONE [INFLUENZA VACCINE] (second) on 21-Apr-2023. Past adverse reactions to the above products included No adverse event with FLUZONE [INFLUENZA VACCINE], PENTACEL, ROTATEQ and VAXNEUVANCE.    On 27-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 27-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (A pediatric patient less than 5 years old received a 0.2 ml dose of the moderna COVID-19 vaccine with the pink cap and the label with the yellow border). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A pediatric patient less than 5 years old received a 0.2 ml dose of the moderna COVID-19 vaccine with the pink cap and the label with the yellow border) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A pediatric patient less than 5 years old received a 0.2 ml dose of the moderna COVID-19 vaccine with the pink cap and the label with the yellow border).    No concomitant medications were provided. Patient did not experienced any symptoms.  No treatment medication was provided.
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue
Clinical narrative: Caller mentioned she opened a box of Prevnar 20 and she noticed there is a brown small precipitant in the vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team and product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GN1898) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "Caller mentioned she opened a box of Prevnar 20 and she noticed there is a brown small precipitant in the vaccine".  Additional information: Caller mentioned she opened a box of Prevnar 20 and she noticed there is a brown small precipitant in the vaccine. She said it is not a lot, but there is a small brown precipitant. She wants to know if this is common.
Sex: M
Vaccine: PNC20
Symptoms: Immunoglobulins decreased
Clinical narrative: immunoglobulin deficiency; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 33-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNOGLOBULINS DECREASED (non-serious), outcome "unknown", described as "immunoglobulin deficiency". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter mentioned that the patient was diagnosed with "immunoglobulin deficiency" and was asking if there was a test to check his immunity which would determine if he will need to get another dose of Prevnar 20 vaccine.   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: 24.0
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 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 24 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Congenital heart defect" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I was negative for Covid; Positive, notes: showed I was positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid. Clinical course: After completing paxlovid treatment, she immediately felt better. Took a Covid test 3 days after treatment which showed she was negative for Covid. Two days later she began to feel very congested and she took another test which showed she was positive for Covid. Patient took Paxlovid from 29Apr2023 to 03May2023.  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-202300187474 Same patient, different product/event;
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies: Grains" (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 Apr2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from  22Apr2023 to 01May2023  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-202300187446 Same patient, different drug, different event;
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient 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 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "cataracts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 29Apr2023 to 03May2023. Patient did not have known allergies.  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-202300187540 Same patient, different drug/ events;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other Moderna/vaccine brand Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 22Dec2021 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Oct2022, outcome "unknown", described as "Vaccine brand other Moderna/vaccine brand Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of Drug ineffective, Covid-19 which includes Paxlovid treatment from 28Apr2023 to 03May2023. Clinical course: Patient had no known allergies.  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-202300187520 same patient, different drug/AE.;
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment.; COVID 19 Treatment.; 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 77-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 at 08:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Feb2021 at 08:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 26Aug2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11May2022, outcome "unknown"; 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 with Paxlovid. Clinical course: Patient took paxlovid from 01May2023 to 06May2023.  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-202300187649 same patient, different drug/event;
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose: 4 / Pfizer, Dose: 5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 as dose 5 (booster), single (Lot number: FF8006) at the age of 33 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Sep2022 as dose 4 (booster), single (Lot number: AS7144B), 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: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hashimoto" (unspecified if ongoing); "Ehlers Danlos" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Known allergies: Melon" (unspecified if ongoing); "Known allergies: Adhesive" (unspecified if ongoing); "Known allergies: CT IV Contrast" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2022, outcome "recovered", described as "Moderna, Dose: 4 / Pfizer, Dose: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (May2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Negative, notes: Tested negative and felt better after completing full course of Paxlovid. Therapeutic measures were taken as a result of Drug ineffective, Covid-19 which includes Paxlovid treatment from 30Apr2023 to 05May2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300188730 same reporter/patient, different drug/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 38-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: "Asthma" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa allergy" (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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, with paxlovid. Clinical course: Patient took paxlovid from 02May2023 to 07May2023.  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-202300188693 Same patient, different drug/event;
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; Pfizer -Dose Number: 2; Moderna - Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 27Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 01Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "unknown", described as "Pfizer -Dose Number: 2; Moderna - Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
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 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06May2022 at 13:00 as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Type 2 Diabetes" (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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19; Negative, notes: prior negative test result. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; negative, notes: tested negative; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid). Clinical course: The patient started paxlovid on 1st day of onset of symptoms and completed 5 days course. Asymptomatic after 5 days and tested negative. 2 days later, recurrence of symptoms and tested positive again. Symptoms more severe during recurrence (Runny nose, sore throat, headache, mild fever), on path to recovery 5 days later.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: child reported injection site pain approximately 4 hours after receiving his bivalent booster (IM) in the left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11May2023 at 10:30 as dose 4 (orange cap, booster), single (Lot number: GK0876) at the age of 5 years intramuscular, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer/BioNTech, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: FT9142, Prev dose lot unknown: False, Prev dose administrator route: Intramuscular, Prev dose administration date: 25Oct2022, Prev dose dose number: 3, DOSE 3 (MAROON CAP), SINGLE), administration date: 25Oct2022, when the patient was 4-year-old, for COVID-19 immunization; BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer/BioNTech, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: FT9142, Prev dose lot unknown: False, Prev dose administrator route: Intramuscular, Prev dose administration date: 29Aug2022, Prev dose dose number: 2, DOSE 2 (MAROON CAP), SINGLE), administration date: 29Aug2022, when the patient was 4-year-old, for COVID-19 immunization; BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer/BioNTech, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: FT9142, Prev dose lot unknown: False, Prev dose administrator route: Intramuscular, Prev dose administration date: 08Aug2022, Prev dose dose number: 1, DOSE 1 (MAROON CAP), SINGLE), administration date: 08Aug2022, when the patient was 4-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11May2023 at 14:30, outcome "recovered" (12May2023), described as "child reported injection site pain approximately 4 hours after receiving his bivalent booster (IM) in the left leg". Therapeutic measures were taken as a result of vaccination site pain. Additional information: On 11May2023, child reported injection site pain approximately 4 hours after receiving bivalent booster (IM) in the left leg. No medicine was given at the time. Approximately 11 hours after receiving the vaccine, the event had not resolved and was given ibuprofen to help sleep through the night. The patient did not have any adverse events upon waking the next day (ie, the event resolved by 12May2023).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine.; Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-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: BJ3342) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL9261), on 06Feb2021 as dose 2, single (Lot number: EL9264), on 25Sep2021 as dose 3 (booster), single (Lot number: FF2588) and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history included: "heart surgery" (unspecified if ongoing); "quadruple bypass" (unspecified if ongoing), notes: He added that he's been on atorvastatin because he had a heart surgery due to blockages. Concomitant medication(s) included: ATORVASTATIN taken for surgery, start date: May2020, stop date: 11Apr2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid from 03Mar2023 to 09Mar2023.  Clinical course: Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine. Indication: Had tested positive on 02Mar2023 for Covid symptoms, very mild, like a mild cold, runny nose, congestion, coughing, low grade temperature also. Called primary care, did video appointment and doctor thought for caller to try Paxlovid and made the recommendation to stop Atorvastatin while taking the Paxlovid and to lower the Eliquis.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiocardiogram, Colonoscopy, Interchange of vaccine products, Investigation, Pulmonary embolism
Clinical narrative: Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine.; Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-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: BJ3342) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL9261), on 06Feb2021 as dose 2, single (Lot number: EL9264), on 25Sep2021 as dose 3 (booster), single (Lot number: FF2588) and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history included: "heart surgery" (unspecified if ongoing); "quadruple bypass" (unspecified if ongoing), notes: He added that he's been on atorvastatin because he had a heart surgery due to blockages. Concomitant medication(s) included: ATORVASTATIN taken for surgery, start date: May2020, stop date: 11Apr2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid from 03Mar2023 to 09Mar2023.  Clinical course: Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine. Indication: Had tested positive on 02Mar2023 for Covid symptoms, very mild, like a mild cold, runny nose, congestion, coughing, low grade temperature also. Called primary care, did video appointment and doctor thought for caller to try Paxlovid and made the recommendation to stop Atorvastatin while taking the Paxlovid and to lower the Eliquis.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin lesion
Clinical narrative: Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine.; Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-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: BJ3342) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL9261), on 06Feb2021 as dose 2, single (Lot number: EL9264), on 25Sep2021 as dose 3 (booster), single (Lot number: FF2588) and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history included: "heart surgery" (unspecified if ongoing); "quadruple bypass" (unspecified if ongoing), notes: He added that he's been on atorvastatin because he had a heart surgery due to blockages. Concomitant medication(s) included: ATORVASTATIN taken for surgery, start date: May2020, stop date: 11Apr2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid from 03Mar2023 to 09Mar2023.  Clinical course: Had 5 Pfizer injections for Covid, clarified and confirmed had 5 doses of the Pfizer COVID-19 vaccine. Indication: Had tested positive on 02Mar2023 for Covid symptoms, very mild, like a mild cold, runny nose, congestion, coughing, low grade temperature also. Called primary care, did video appointment and doctor thought for caller to try Paxlovid and made the recommendation to stop Atorvastatin while taking the Paxlovid and to lower the Eliquis.
Sex: U
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness at injection site; symptoms of swelling at the injection site and a ring around the injection site; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GM9409, Expiration Date: 31Aug2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness at injection site"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "symptoms of swelling at the injection site and a ring around the injection site".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300185147 same drug and AE, different patient;
Sex: F
Vaccine: PNC13, UNK
Symptoms: COVID-19 pneumonia, Drug ineffective, Pneumonia, Vaccination site erythema, Vaccination site pain
Clinical narrative: COVID pneumonia; I had a sore arm that was red and swollen around the injection site; I had a sore arm that was red and swollen around the injection site; I had a sore arm that was red and swollen around the injection site; It was very raised and warm to the touch for about 3 days; COVID-19; I had pneumonia one other time; I had pneumonia one other time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE POLYSACCH 23V]), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "idiopathic CHF" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant) all with onset 2016, outcome "recovered" and all described as "I had pneumonia one other time"; COVID-19 PNEUMONIA (medically significant), outcome "unknown", described as "COVID pneumonia"; VACCINATION SITE PAIN (non-serious), outcome "unknown", VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered" and all described as "I had a sore arm that was red and swollen around the injection site"; VACCINATION SITE WARMTH (non-serious), outcome "recovered", described as "It was very raised and warm to the touch for about 3 days"; COVID-19 (non-serious), outcome "unknown". It was reported that patient has had pneumonia since being vaccinated initially in 2016. The patient then reported to have pneumonia one other time in Jan2018. The reporter also stated that when I had COVID-19 (on an unspecified date), the patient was also diagnosed with COVID pneumonia. Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema, vaccination site warmth which included Benadryl.  The reporter considered "I had pneumonia one other time" not related to pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein).  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: The association between the event lack of effect (Pneumonia) with PREVNAR 13 can not be fully excluded.
Sex: F
Vaccine: PNC13, UNK
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: COVID pneumonia; I had a sore arm that was red and swollen around the injection site; I had a sore arm that was red and swollen around the injection site; I had a sore arm that was red and swollen around the injection site; It was very raised and warm to the touch for about 3 days; COVID-19; I had pneumonia one other time; I had pneumonia one other time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE POLYSACCH 23V]), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "idiopathic CHF" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant) all with onset 2016, outcome "recovered" and all described as "I had pneumonia one other time"; COVID-19 PNEUMONIA (medically significant), outcome "unknown", described as "COVID pneumonia"; VACCINATION SITE PAIN (non-serious), outcome "unknown", VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered" and all described as "I had a sore arm that was red and swollen around the injection site"; VACCINATION SITE WARMTH (non-serious), outcome "recovered", described as "It was very raised and warm to the touch for about 3 days"; COVID-19 (non-serious), outcome "unknown". It was reported that patient has had pneumonia since being vaccinated initially in 2016. The patient then reported to have pneumonia one other time in Jan2018. The reporter also stated that when I had COVID-19 (on an unspecified date), the patient was also diagnosed with COVID pneumonia. Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema, vaccination site warmth which included Benadryl.  The reporter considered "I had pneumonia one other time" not related to pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein).  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: The association between the event lack of effect (Pneumonia) with PREVNAR 13 can not be fully excluded.
Sex: U
Vaccine: PNC20
Symptoms: Azotaemia
Clinical narrative: Uremia; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 03May2023 as dose number unknown, 0.5ml single (Lot number: GH9842) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AZOTAEMIA (medically significant) with onset May2023, outcome "unknown", described as "Uremia".; Sender's Comments: Uremia is more likely associated with the patient underlying medical condition unlikely to PREVNAR 20 use.  Further information such as complete medical history, concomitant medications, concurrent illness and event term details especially onset data are needed for meaningful evaluation.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Eczema
Clinical narrative: COPD; Eczema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Chantix, reaction(s): "Stomach ache". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (hospitalization), outcome "unknown", described as "COPD"; ECZEMA (hospitalization), outcome "unknown". Clinical course: Patient asking if the Chantix was still available in the market. She was taking Chantix before. She never had a bad side effects, except for stomach ache. She was on the hospital right now and she had COPD and eczema. She mentioned that she really need it and she really help. And said she got booster shot from us.  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-202300187597 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: she's ever been allergic to this; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "she's ever been allergic to this".  Additional information: Patient was trying to schedule an appointment online and she got into the fact sheet and in the bottom it asked to scan to capture. Reporter said they wanted patient to answer some questions that she is ever been allergic to this. Patient chose the Pfizer drug and the website was asking her to scan a QR code and she didnt know that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: I have read that the covid vaccines can bring the onset of PMR. I was diagnosed with it after receiving my vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "not recovered", described as "I have read that the covid vaccines can bring the onset of PMR. I was diagnosed with it after receiving my vaccines". Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical course: She had read that the covid vaccines can bring the onset of Polymyalgia rheumatica. She was diagnosed with it after receiving her vaccines. She was on low dose prednisone for about a year after tapering off. Then maybe 6 months started feeling it again. Tapering off in about 3 months. It was now back.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 2013 (unspecified if ongoing), notes: diagnosis of Asthma [in 2013]. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2021, outcome "recovered" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2021) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death, Illness
Clinical narrative: got sick; he was dead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for COVID-19 Immunization. The following information was reported: DEATH (death, medically significant) with onset 14Jan2023, outcome "fatal", described as "he was dead"; ILLNESS (non-serious), outcome "unknown", described as "got sick". The event "he was dead" required emergency room visit. The patient date of death was 14Jan2023. The reported cause of death was unknown. It was not reported if an autopsy was performed. Details were as follows: Patient received the shot on 02Jan2023, and by the 14Jan2023, he was dead. The reporter noted that when the patient first got sick (not further specified), he stayed over his friend's house, and reporter urged him to go to the emergency room.   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.; Reported Cause(s) of Death: he was dead