chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: U
Vaccine: HEP
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash; Itching; Initial report received on 15-Nov-2023  A pharmacy student reported that a 53-year-old female patient (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and Shingrix on the same day and experienced a rash and itching on both sides of her abdomen three days afterwards.  Medical history and concomitant mediations at the time of vaccination were not reported. The patient had no known drug allergies.  On 30-Aug-2023, the patient received a dose of HEPLISAV-B (Lot # 943008, expiration date 30-Sep-2025, an NDC # 435280003-01) intramuscularly in the right deltoid. Concomitant vaccination administered included Shingrix (no details reported).  On 02-Sep-2023, three days after having been vaccinated with HEPLISAV-B and Shingrix, the patient experienced a rash and itching on both sides of her abdomen. The rash and itching resolved with Benadryl. There were no current side effects at the time of reporting.  No other information was available.  Company Comment:  The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient Received An Expired Dose Of Heplisav-B; Initial report received on 16-Nov-2023  A medical assistant in the reported that a 74-year-old female patient (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant mediations at the time of vaccination were not reported. The patient had a previous reaction to the flu vaccine with hives on her arms.  On 16-Nov-2023, the patient received the first dose of HEPLISAV-B (Lot # 935849, expiration date 13 Jan-2023, and NDC # 43528-003-05; route not reported) in the left deltoid. The HEPLISAV-B dose was expired. No adverse reactions were reported.  No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Patient Had A Severe Allergic Reaction; Initial report received on 17-Nov-2023  A registered nurse in the reported a patient (age, gender, race, and ethnicity not provided) who received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization had a "severe allergic reaction."  Medical history and concomitant mediations at the time of vaccination were not reported. Allergies were unknown.   On an unknown date, the patient received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route of administration, and injection site were unknown).   On an unknown date, the patient had a "severe allergic reaction" (details not reported).  No additional information was available.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Dose Of Heplisav-B Given To Male Patient; Initial report received on 21-Nov-2023  A licensed practical nurse in the reported that a 38-year-old male patient (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant mediations at the time of vaccination were not reported. The patient is allergic to morphine, vancomycin, and tedizolid.  On 21-Nov-2023, the patient received a dose of HEPLISAV-B (Lot # 937230, expiration date 11-Sep-2023, an NDC # 43528-003-01; route not reported) in the left deltoid. The dose of HEPLISAV-B was expired. No adverse reactions were reported.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pregnant; Initial report received on 21-Nov-2023.  A medical support supervisor in the reported that a 26-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 32 weeks pregnant.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 20-Nov-2023, the patient received the first dose of HEPLISAV-B (Lot # 943187, expiration date 30-Nov-2025, and NDC # 43528-002-01) in the left deltoid.   On 20-Nov-2023, the patient was vaccinated with HEPLISAV-B while 32 weeks pregnant. No adverse reactions were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Heplisav-B given as first dose. Engerix given as second dose.; Initial report received on 30-Nov-2023  A pharmacist in the reported that a 22-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and ENERGIX as the second dose.  No medical history and concomitant medications at the time of vaccination were reported. The patient did not have any allergies.  On 19-Oct-2023, the patient received a dose of HEPLISAV-B (Lot # 943186, expiration date 30-Nov-2025, and NDC # 43528-003-05; route and injection site not reported). No adverse reactions were reported.  On 29-Nov-2023, 42 days after having been vaccinated with HEPLISAV-B, the patient received ENGERIX (no details provided).  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: she inadvertently gave Kinrix to a 4 month old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: she inadvertently gave Kinrix to a 4 month old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JAN-2024 The medical assistant reported that she inadvertently gave Kinrix to a 4-month-old patient, which led to an inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: pregnant patient (32 to 36 weeks) was inadvertently administered Arexvy; inappropriate age/ patient was 30-years-old and inadvertently received Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number HG1755, expiry date 15-NOV-2029) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient (32 to 36 weeks) was inadvertently administered Arexvy) and inappropriate age at vaccine administration (Verbatim: inappropriate age/ patient was 30-years-old and inadvertently received Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 19-JAN-2024 The pharmacist reported a pregnant patient (32 to 36 weeks) was inadvertently administered Arexvy, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: few bubbles just trying to tap them like normal; whole top of the neck of the prefilled syringe broke right off; became unusable; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 18Jan2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM7648, Expiration Date: Mar2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "few bubbles just trying to tap them like normal; whole top of the neck of the prefilled syringe broke right off; became unusable".  Additional information: The pharmacist reported that they were having an issue with a one of the doses of Abrysvo. They were mixing it and it mixed up okay and then when they went to finishing and get it, changed out the needle and then just tried to tap the bubbles. There were few bubbles just trying to tap them like normal, like the whole top of the neck of the prefilled syringe broke right off. So, became unusable.   The reporter considered "few bubbles just trying to tap them like normal; whole top of the neck of the prefilled syringe broke right off; became unusable" not related to rsv vaccine prot.subunit pref 2v. Causality for "few bubbles just trying to tap them like normal; whole top of the neck of the prefilled syringe broke right off; became unusable" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer.  A 70-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Lot number: fk9893), in left leg for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: After 4 days a negative covid test/tested negative on day 4 and day 6; (Jan2024) Negative, notes: tested negative on day 4 and day 6; (Jan2024) Positive, notes: tested + covid day 8. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid from 03Jan2024 to 07Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 as dose 6 (booster), single (Lot number: g76742) at the age of 47 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single), as dose 4 (booster), single) and as dose 5 (booster), single) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 10Jan2024 to 15Jan2024.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An elderly patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30May2023 as dose 5 (booster), single (Lot number: GM1767), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: NEBIVOLOL, start date: 15Apr2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID from 13Jan2024 to 17Jan2024 for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. which includes Paxlovid from 11Jan2024 to 16Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer from product quality group. An adult female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Nov2023 at 12:30 as dose 1, single (Lot number: HF9299), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: (17Jan2024) Negative; (18Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID from 10Jan2024 to 15Jan2024 with lot number: 00069108530.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Heart rate, Hypoaesthesia, Palpitations
Clinical narrative: face got numb; heart beats started racing; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rimegepant (NURTEC ODT), from 21Dec2023 to 22Dec2023 at early morning for migraine; influenza vaccine (FLU VACCINE), on 20Dec2023 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "headache", start date: 12Dec2023 (ongoing), notes: lasting for 8 days prior to the vaccine administration. The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (medically significant) with onset 21Dec2023, outcome "recovered" (21Dec2023), described as "face got numb"; PALPITATIONS (medically significant) with onset 21Dec2023, outcome "recovered" (21Dec2023), described as "heart beats started racing". The events "face got numb" and "heart beats started racing" required emergency room visit. Clinical course: The patient has taken Comirnaty and the flu vaccine on 20Dec2023. She've had a headache lasting for 8 days prior to the vaccine administration according to what the patient reported. She took Nurtec ODT on 21Dec2023 early morning. Following Nurtec administration, her face got numb and her heart beats started racing. She ended up in the ER. The patient underwent the following laboratory tests and procedures: Heart rate: (21Dec2023) racing. The action taken for rimegepant was temporarily withdrawn on 22Dec2023. It was unknown if therapeutic measures were taken as a result of hypoaesthesia, palpitations.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment  ; COVID 19 Treatment  ; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2024 at 15:00 as dose 7 (booster), single (Lot number: GK0928) at the age of 70 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single), as dose 4 (booster), single), as dose 5 (booster), single) and as dose 6 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "hypercholesterolemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: GEMFIBROZIL, start date: Jan1998; METFORMIN, start date: Jan2004; LOSARTAN, start date: Jan2022; DUTASTERIDE, start date: Jan2004. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment  ". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (Jan2024) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: after starting paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.The patient took Paxlovid on 10Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2 , MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had COVID vaccine administration on 02Oct2023 (vaccine dose number:6). Thereafter, he had received PAXLOVID as COVID-19 treatment from 10Jan2024 to 14Jan2024. After completion of Paxlovid, patient had two negative tests.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a consumer (patient herself).  A 54-year-old female patient (not pregnant) received BNT162B2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Nov2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "allergies: sulfa" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "car accident" (unspecified if ongoing); "surgeries from car accident" (unspecified if ongoing), notes: +. Concomitant medications included: ACETAMINOPHEN, start date: 01Sep2023; IBUPROFEN, start date: 01Sep2023; MONTELUKAST, start date: 01Jan2023; METHOCARBAMOL, start date: 01Sep2023, stop date: 23Jan2024; PREGABALIN, start date: 18Dec2023; VITAMIN D [VITAMIN D NOS], start date: 01Dec2022; CALCIUM, start date: 01Jan2023; VITAMIN B NOS, start date: 01Jan2023; VITAMIN C [ASCORBIC ACID], start date: 01Oct2023. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, COVID-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID) starting from 12Jan2024.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: yes, but too long to list" (unspecified if ongoing), notes: known allergies: yes, but too long to list. 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". 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 14Jan2024 to 19Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: covid; covid; This is a spontaneous report received from a Consumer or other non HCP  A 72-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, 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 (Primary Immunization series complete), for Covid-19 Immunization. The patient received all Pfizer vaccines. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". The patient reported that the last booster was in Nov2023 and she got COVID since. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as treatment.  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Wrong technique in product usage process
Clinical narrative: not administered at the rate that would be proper of the medical procedure/person did it very forcefully/got it really near the shoulder bone/introduced with great force and high speed; I had pain immediately/very painful; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Lot number: HD9876) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Oct2023, outcome "unknown", described as "I had pain immediately/very painful"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 17Oct2023, outcome "unknown", described as "not administered at the rate that would be proper of the medical procedure/person did it very forcefully/got it really near the shoulder bone/introduced with great force and high speed". Additional information: The patient had two concerns. She was reportedly, not administered with the vaccine correctly. Secondly, the vaccine was refrigerated and she was not given the dosage for two and half to three hours later, after it was removed from the refrigerator. She inquired if the vaccine was still good if it has been removed from the refrigerator and she waited two and a half to three hours before she was inoculated. The patient further clarified that she was wrongly administered with the vaccine because the person did it very forcefully. Reportedly, the vaccine was pushed into the muscle up to the shoulder bone, very fast. The patient described, "I got it really near the shoulder bone, right near the very bone, near the very close. Somebody said to me there is actually come the bone, the very shoulder bone itself, very top." She further stated, "I had pain immediately when it was misadministered. It is very painful when it was introduced with great force and high speed and sudden though. It was not administered at the rate that would be proper of the medical procedure."
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive covid; tested positive covid; This is a spontaneous report received from a Consumer or other non HCP.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0161), in left arm and on 07Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 11Jan2024, outcome "unknown" and all described as "tested positive covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jan2024) positive; (12Jan2024) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure as patient received Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hbp" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series completed; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); ; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 36-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 as dose 1, single (Lot number: HG2649) at the age of 36 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication included: TRAZODONE, start date: 15Jun2023. Vaccination history included: Moderna (Dose Number: 4, Batch/Lot No: AS7162B, Location of injection: Arm Right), administration date: 17Sep2022, when the patient was 35-year-old, for Covid-19 immunization; pfizer / biontech (Dose Number: 3, Batch/Lot No: 32030BD, Location of injection: Arm Right), administration date: 23Nov2021, when the patient was 34-year-old, for Covid-19 immunization; pfizer / biontech (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Right), administration date: 03Apr2021, when the patient was 33-year-old, for Covid-19 immunization; pfizer / biontech (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Right), administration date: 13Mar2021, when the patient was 33-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19, treated with Paxlovid from 14Jan2024 to 19Jan2024.  Additional information: The patient has no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 18:00 as dose 4 (booster), single at the age of 53 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 at 12:00 as dose 1, single (Lot number: EN6201), in left arm, on 19Feb2021 at 15:00 as dose 2, single (Lot number: BN6201), in right arm and on 22Nov2021 at 15:00 as dose 3 (booster), single (Lot number: 320300P), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2024 at 09:00, outcome "unknown" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jan2024) Positive; (23Jan2024) Positive, notes: re-testing, tested positive day 11. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Tested positive for Covid on 12Jan2024 at 0900am. Confirmed positive result at urgent care.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Heart rate, SARS-CoV-2 test, Tachycardia, Vaccination failure
Clinical narrative: Repeat covid test positive (sore throat and rhinorrhea, but also much worse tachycardia to 110 and chest tightness); Repeat covid test positive (sore throat and rhinorrhea, but also much worse tachycardia to 110 and chest tightness); tachycardia to 110; This is a spontaneous report received from a Physician.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Celery" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jan2024, outcome "not recovered" and all described as "Repeat covid test positive (sore throat and rhinorrhea, but also much worse tachycardia to 110 and chest tightness)"; TACHYCARDIA (non-serious) with onset 23Jan2024, outcome "unknown", described as "tachycardia to 110". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2024) Negative, notes: Covid symptoms resolved by day 5 of Paxlovid and home covid test negative 3 days after that; (23Jan2024) Positive, notes: Repeat covid test positive; Heart rate: (unspecified date) 110. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received PAXLOVID as COVID-19 Treatment from 14Jan2024 to 18Jan2024. Covid symptoms resolved by day 5 of Paxlovid and home covid test negative 3 days after that. 48 hours after that, symptoms returned, including sore throat and rhinorrhea, but also much worse tachycardia to 110 and chest tightness. Repeat covid test positive.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for the event vaccination failure. This case will be reassessed upon receipt of additional information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test, Scan, Vaccination failure
Clinical narrative: contracted COVID; contracted COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 12:15 as dose 1 (toppac), single (Lot number: HG4628) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Unilateral mastectomy", start date: 2017 (unspecified if ongoing), notes: no return of cancer. The patient does not have any diagnosed illnesses or chronic health conditions. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1; lot number ZX0438 or EX0438), administration date: 14Apr2021, when the patient was 75-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2; lot number: EY0583, administered in left arm), administration date: 20Jun2021, when the patient was 75-year-old, for Covid-19 immunization; moderna spikevax (DOSE 3 (BOOSTER); lot number: 016E21A, administered in left arm), administration date: 25Nov2021, when the patient was 76-year-old, for Covid-19 immunization; moderna spikevax (DOSE 4 (BOOSTER); lot number: 056A22A, administered in left arm), administration date: 05May2022, when the patient was 76-year-old, for Covid-19 immunization; moderna spikevax (DOSE 5 (BOOSTER); lot number: 015F22A, administered at 11:45 am in left arm), administration date: 15Sep2022, when the patient was 76-year-old, for Covid-19 immunization; BNT162b2 (DOSE 6 (BOOSTER); lot number: GJ6742, administered in left arm), administration date: 12Dec2022, when the patient was 77-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2024, outcome "recovered" (13Jan2024) and all described as "contracted COVID". The clinical course was reported as follows: The patient reported she still runs/ works out with weights, and she is still working in science. She reported that after avoiding COVID for 4 years, she finally contracted it from her husband on 08Jan2024. However, she only had a 99.7F/37.6C fever and a sore throat. No aches, congestion, cough. She isolated at home. Because of her age (no comorbidities) she decided to take nirmatrelvir, ritonavir (PAXLOVID) from 08Jan2024 to 12Jan2024, although her doctor thought she did not need to take it. Previously, she had no reaction to any of the vaccines, and had no unexpected reaction to nirmatrelvir, ritonavir (just the normal metallic taste & diarrhea). She tested negative for COVID from 13Jan2024 through 15Jan2024. The patient underwent the following laboratory tests and procedures: Scan: (unspecified date) Unknown results, notes: numerous scans for cancer. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400023259 Same patient, different drug and event;
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 30-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 4 (Booster), Single; Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single; Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single; Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, Single; Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies: many foods" (unspecified if ongoing). Concomitant medication(s) included: NYQUIL, start date: 15Jan2024, stop date: 21Jan2024. Past drug history included: Aspirin, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid treatment from 15Jan2024 to 19Jan2024.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "SSHL" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; VITAMIN D3; CALCIUM; MAGNESIUM; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; FLONASE [FLUTICASONE PROPIONATE]; PROBIOTIC [BIFIDOBACTERIUM LACTIS]. Past drug history included: Keflex, reaction(s): "allergies"; Eurythomicin, reaction(s): "allergies"; Bactrim, reaction(s): "allergies"; Levaquin, reaction(s): "allergies"; Clindamycin, reaction(s): "allergies". Vaccination history included: BNT162b2 (Dose 5; brand: Pfizer/BioNTech, at 12:00 AM in left arm), administration date: 07Oct2022, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose 4; brand: Pfizer/BioNTech, at 12:00 AM in left arm), administration date: 19Apr2022, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose 3; brand: Pfizer/BioNTech, at 12:00 AM in left arm), administration date: 22Oct2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Dose 2; brand: Pfizer/BioNTech, at 12:00 AM in left arm), administration date: 20Apr2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Dose 1; brand: Pfizer/BioNTech, at 12:00 AM in left arm), administration date: 30Mar2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was vaccinated at 12:00 AM. The patient received Paxlovid treatment from 12Jan2024 to 17Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: had been vaccinated but still contracted COVID-19; had been vaccinated but still contracted COVID-19; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier: 02536561 (Merck).  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (batch/lot number: EN6200), on 19Mar2021 as dose 2, single (batch/lot number: EN6203) and on 03Dec2021 as dose 3 (booster), single (batch/lot number: 33130BA) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "recovered" and all described as "had been vaccinated but still contracted COVID-19".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400010949 same patient/product, different dose/event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: had been vaccinated but still contracted COVID-19; had been vaccinated but still contracted COVID-19; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier: 02536561 (Merck).  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (batch/lot number: EN6200), on 19Mar2021 as dose 2, single (batch/lot number: EN6203) and on 03Dec2021 as dose 3 (booster), single (batch/lot number: 33130BA) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "recovered" and all described as "had been vaccinated but still contracted COVID-19".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400010949 same patient/product, different dose/event;