chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Gave an adult a pediatric dose of Engerix-B; Gave an adult a pediatric dose of Engerix-B; patient received the 1st dose in 2002 and 2nd dose on 21-11-23; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 35-year-old male patient who received HBV (Engerix B pediatric) (batch number 32M5G, expiry date 14-SEP-2025) for prophylaxis.   Previously administered products included Engerix B pediatric (1st dose received on 2002 when he was 14 years old).   On 21-NOV-2023, the patient received the 2nd dose of Engerix B pediatric. On 21-NOV-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Gave an adult a pediatric dose of Engerix-B), underdose (Verbatim: Gave an adult a pediatric dose of Engerix-B) and drug dose administration interval too long (Verbatim: patient received the 1st dose in 2002 and 2nd dose on 21-11-23). The outcome of the adult use of a child product, underdose and drug dose administration interval too long were unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 21-Nov-2023 The reporter reported that an adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The patient received 2nd dose of Engerix-B late than recommended time frame, which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via postal.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: CAME DOWN WITH COVID; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced came down with covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of came down with covid was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In June 2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient wanted to know what was recommended time was on getting another vaccine after they had COVID-19. She had the 5th number of the Moderna vaccines. She was supposed to get 6th dose but did not get it as she had the COVID-19. She stated she remember when the first vaccine came out. There were sign that told if you had a reaction with trimethamine you should not get the moderna vaccine. Her husband had allergic reaction a year ago to tromethamine. She was wondering since she does not see the sign anymore if that had changed. She reported that tromethamine was used as contrast dye. Concomitant medications were not reported.  No treatment information was provided by the reporter.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site reaction/ large, raised red and warm area on arm where she got her booster; Injection site reaction/ large, raised red and warm area on arm where she got her booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE WARMTH (Injection site reaction/ large, raised red and warm area on arm where she got her booster) and INJECTION SITE ERYTHEMA (Injection site reaction/ large, raised red and warm area on arm where she got her booster) in an 11-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On 24-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 25-Nov-2023, the patient experienced INJECTION SITE WARMTH (Injection site reaction/ large, raised red and warm area on arm where she got her booster) and INJECTION SITE ERYTHEMA (Injection site reaction/ large, raised red and warm area on arm where she got her booster). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE (BENADRYL DR) for Injection site reaction, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Injection site reaction/ large, raised red and warm area on arm where she got her booster) and INJECTION SITE ERYTHEMA (Injection site reaction/ large, raised red and warm area on arm where she got her booster) outcome was unknown.            Concomitant product use was not provided by the reporter.  One day after the booster vaccine, patient had an injection site reaction. She had a large, raised red and warm area on her arm where she got her booster It was unknown if the patient experienced any additional symptoms/events. She took a dose of child's Benadryl Saturday night and the raised injection site reaction on her arm was gone on Sunday. There were no lab data/results available.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Currently I have a headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Currently I have a headache) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 22-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced HEADACHE (Currently I have a headache). At the time of the report, HEADACHE (Currently I have a headache) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient brain felt like it was swooshing in her head, and she felt off balance and currently had a headache. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Lethargic after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic after 2nd booster) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (patient mentioned previous ones were Pfizer). Past adverse reactions to the above products included No adverse reaction with Pfizer.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargic after 2nd booster). At the time of the report, LETHARGY (Lethargic after 2nd booster) had resolved.            Concomitant and treatment medications were not reported.  Patient was lethargic after 2nd booster. It was the first one with Moderna (Reporter think patient mentioned previous ones were Pfizer) It was unknown if the patient experienced any additional symptoms/events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 53.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 16:15 as dose 1, single (Batch/Lot number: unknown) at the age of 53 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 (Dose1 , unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose2 , unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose3 , unknown manufacturer), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, vaccination failure. Patient received paxlovid from 08Nov2023 to 12Nov2023 for COVID-19 treatment.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Biopsy
Clinical narrative: Anaphlaxic after first 2 Pfizer vaccines; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing), notes: Celiac; "EDS (Ehlers-Danlos syndromes)" (unspecified if ongoing); "Mast cell activation positive biopsy" (unspecified if ongoing), notes: Mast cell activation positive biopsy. The patient's concomitant medications were not reported. Past drug history included: Phenergan, reaction(s): "known allergies: phenergan"; Benadryl, reaction(s): "known allergies: Benadryl". Vaccination history included: Hpv vaccines, reaction(s): "known allergies: HPV vaccines"; Bnt162b2 (Dose 1, Anaphlaxic after first 2 Pfizer vaccines), for COVID-19 immunization, reaction(s): "Anaphlaxic". The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphlaxic after first 2 Pfizer vaccines". The patient underwent the following laboratory tests and procedures: Biopsy: Mast cell activation positive. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have COVID; I have COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 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. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunization; Moderna (DOSE 2, SINGLE), for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The reporter stated that it was like 3 and a half years but now he/she has COVID. The patient has been given Paxlovid. The patient took the first two initial vaccines (reported as Moderna). First booster was Moderna and the latest one was Pfizer.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
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) (Physician). The reporter is the patient.  A 75-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; 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). 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 "recovering" 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.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: After completing full dose of paxlovid, patient's symptoms began to worsen and we are actively considering hospitalization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: A daybreak two after completing the Paclovid treatment I began to feel symptoms again overnight.  I took a home test and it was positive again.; A daybreak two after completing the Paclovid treatment I began to feel symptoms again overnight.  I took a home test and it was positive again.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-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 left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "arthritis in knees" (unspecified if ongoing); "sciatica" (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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Nov2023 at 02:00, outcome "unknown" and all described as "A daybreak two after completing the Paclovid treatment I began to feel symptoms again overnight.  I took a home test and it was positive again.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Nov2023) Positive, notes: took a home test and it was positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: A daybreak two after completing the Paxlovid treatment patient began to feel symptoms again overnight. Patient took a home test and it was positive again.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; Moderna booster: 04Apr2023; Pfizer / BioNTech: 04Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) and on 04Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 16Oct2023 at 15:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2023 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Iron deficient anemia" (unspecified if ongoing); "large hiatal hernia" (unspecified if ongoing), notes: large; "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2023, outcome "unknown", described as "Moderna booster: 04Apr2023; Pfizer / BioNTech: 04Oct2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162B2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Prediabetic" (unspecified if ongoing), notes: prediabetic; "Seasonal allergies" (unspecified if ongoing); "Environmental allergies" (unspecified if ongoing); "Reflux" (unspecified if ongoing); "Allergies to sulf" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, 2, 3, and 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered with sequelae" (Nov2023) and all described as "COVID-19". When the patient initially had symptoms, very definitively, positive test (SARS-CoV-2 test in Nov2023) line is dark pink and showed up within a few seconds of starting the test. The patient underwent treatment for the events with nirmatrelvir/ritonavir (PAXLOVID) from 13Nov2023 to 17Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-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 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: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure. The patient's concomitant medications were not reported. Past drug history included: Ketoprofen, reaction(s): "known allergies: Ketoprofen", notes: known allergies: Ketoprofen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 for which included nirmatrelvir, ritonavir (PAXLOVID) from 15Nov2023 to 20Nov2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Rebound; Rebound; 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 male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Nov2023 at 12:00, outcome "unknown" and all described as "Rebound". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 06Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing), notes: elevated cholesterol. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 04, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 05, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Event details reported as follow: Started Paxlovid on 16Nov2023 - second day of symptoms when tested positive. 5 days later tested negative. 5 days later, got sicker and tested positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2023) Positive; (21Nov2023) Negative, notes: 5 days later tested negative; (26Nov2023) Positive, notes: 5 days later, got sicker and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, single, manufacturer unknown), for COVID-19 immunization. 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: Positive, notes: COVID 19 Treatment, brand=Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid on 14Nov2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-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 included: "celiac disease" (unspecified if ongoing); "CFS (Chronic fatigue syndrome)" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "Mast cell issue" (unspecified if ongoing); "autism" (unspecified if ongoing); "bipolar disorder" (unspecified if ongoing); "ADHD (attention deficit hyperactivity disorder)" (unspecified if ongoing); "known allergies: contrast media" (unspecified if ongoing); "known allergies: Mold" (unspecified if ongoing); "known allergies: dogs" (unspecified if ongoing); "known allergies: dust mites" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known allergies: compazine". Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment was from 16Nov2023 to 20Nov2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 77.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa based drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 4, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 5, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 6, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 7, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 8, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 9, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as which include Paxlovid. . The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Epstein-Barr virus infection, Laboratory test, Scan
Clinical narrative: Shot caused EBV (Epstein-Barr virus); This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (COMIRNATY ORIGINAL, OMICRON BA.4-5), on 08Aug2023 at 09:00 as dose 1, single (Lot number: GJ3268), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizure" (not ongoing), notes: seizure disorder over 30 years ago seizure free.; "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: LEVOTHYROXINE; TEGRETOL; VENLAFAXINE. The following information was reported: EPSTEIN-BARR VIRUS INFECTION (disability, life threatening) with onset 15Aug2023 at 01:00, outcome "not recovered", described as "Shot caused EBV (Epstein-Barr virus)". The patient experinced shot caused EBV (Epstein-Barr virus), disability and loss of job.  The event "shot caused ebv (epstein-barr virus)" required physician office visit. The patient underwent the following laboratory tests and procedures: Labs: (2023) Unknown results; Scan: (2023) Unknown results. Therapeutic measures were taken as a result of epstein-barr virus infection included labs, scans, and dietary changes as a result of epstein-barr virus infection.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between suspect drug and event EBV infection cannot be excluded. 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, COVID19-2
Symptoms: Antinuclear antibody positive, Brain fog, Cytomegalovirus test, Epstein-Barr virus test positive, Fall
Clinical narrative: Shot caused EBV (Epstein-Barr virus); This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (COMIRNATY ORIGINAL, OMICRON BA.4-5), on 08Aug2023 at 09:00 as dose 1, single (Lot number: GJ3268), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizure" (not ongoing), notes: seizure disorder over 30 years ago seizure free.; "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: LEVOTHYROXINE; TEGRETOL; VENLAFAXINE. The following information was reported: EPSTEIN-BARR VIRUS INFECTION (disability, life threatening) with onset 15Aug2023 at 01:00, outcome "not recovered", described as "Shot caused EBV (Epstein-Barr virus)". The patient experinced shot caused EBV (Epstein-Barr virus), disability and loss of job.  The event "shot caused ebv (epstein-barr virus)" required physician office visit. The patient underwent the following laboratory tests and procedures: Labs: (2023) Unknown results; Scan: (2023) Unknown results. Therapeutic measures were taken as a result of epstein-barr virus infection included labs, scans, and dietary changes as a result of epstein-barr virus infection.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between suspect drug and event EBV infection cannot be excluded. 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, COVID19-2
Symptoms: Hypotension, Loss of employment, Muscle twitching, Pain, Palpitations
Clinical narrative: Shot caused EBV (Epstein-Barr virus); This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (COMIRNATY ORIGINAL, OMICRON BA.4-5), on 08Aug2023 at 09:00 as dose 1, single (Lot number: GJ3268), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizure" (not ongoing), notes: seizure disorder over 30 years ago seizure free.; "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: LEVOTHYROXINE; TEGRETOL; VENLAFAXINE. The following information was reported: EPSTEIN-BARR VIRUS INFECTION (disability, life threatening) with onset 15Aug2023 at 01:00, outcome "not recovered", described as "Shot caused EBV (Epstein-Barr virus)". The patient experinced shot caused EBV (Epstein-Barr virus), disability and loss of job.  The event "shot caused ebv (epstein-barr virus)" required physician office visit. The patient underwent the following laboratory tests and procedures: Labs: (2023) Unknown results; Scan: (2023) Unknown results. Therapeutic measures were taken as a result of epstein-barr virus infection included labs, scans, and dietary changes as a result of epstein-barr virus infection.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between suspect drug and event EBV infection cannot be excluded. 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, COVID19-2
Symptoms: Pyrexia, Syncope
Clinical narrative: Shot caused EBV (Epstein-Barr virus); This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (COMIRNATY ORIGINAL, OMICRON BA.4-5), on 08Aug2023 at 09:00 as dose 1, single (Lot number: GJ3268), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizure" (not ongoing), notes: seizure disorder over 30 years ago seizure free.; "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: LEVOTHYROXINE; TEGRETOL; VENLAFAXINE. The following information was reported: EPSTEIN-BARR VIRUS INFECTION (disability, life threatening) with onset 15Aug2023 at 01:00, outcome "not recovered", described as "Shot caused EBV (Epstein-Barr virus)". The patient experinced shot caused EBV (Epstein-Barr virus), disability and loss of job.  The event "shot caused ebv (epstein-barr virus)" required physician office visit. The patient underwent the following laboratory tests and procedures: Labs: (2023) Unknown results; Scan: (2023) Unknown results. Therapeutic measures were taken as a result of epstein-barr virus infection included labs, scans, and dietary changes as a result of epstein-barr virus infection.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between suspect drug and event EBV infection cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 72.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left 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) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective and covid-19, which including Paxlovid from 14Nov2023 to 18Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose1, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 IMMUNIZATION; Covid-19 vaccine (Dose 2), for COVID-19 IMMUNIZATION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID-19 treatment from 15Nov2023 to 19Nov2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, 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 Nov2023, outcome "recovered" (25Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2023) Negative; (26Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 11Nov2023 to 15Nov2023. Clinical course: Patient had no known allergies. No significant health issues.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300410759 Same patient, different drug, different event;
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Ophthalmological examination, Visual impairment
Clinical narrative: severe headache; vision problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Mixed connective tissue disorder" (ongoing); "Auto immune disease", start date: 01Jan2006 (ongoing); "Sjogren's syndrome" (unspecified if ongoing); "Raynaud's syndrome" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE oral taken for mixed connective tissue disease (ongoing); FOLIC ACID oral (ongoing). Vaccination history included: bnt162b2 (At 08:00, DOSE 1, SINGLE, Batch/Lot number: EL1283, Anatomical Site of injection: Arm, Route of administration: Intramuscular), administration date: 22Jan2021, when the patient was 53-year-old, for COVID-19 immunization; bnt162b2 (At 15:00, DOSE 2, SINGLE, Batch/Lot number: EL3246, Anatomical Site of injection: Arm, Route of administration: Intramuscular), administration date: 12Feb2021, when the patient was 53-year-old, for COVID-19 immunization; bnt162b2 (At 16:00, DOSE 3 (BOOSTER), SINGLE, Anatomical Site of injection: Arm, Route of administration: Intramuscular), administration date: 12Dec2021, when the patient was 54-year-old, for COVID-19 immunization; Flu shot (DOSE NUMBER UNKNOWN, SINGLE), for flu vaccination. The following information was reported: HEADACHE (non-serious) with onset 13Nov2023, outcome "not recovered", described as "severe headache"; VISUAL IMPAIRMENT (non-serious) with onset 13Nov2023, outcome "not recovered", described as "vision problems". Relevant laboratory tests and procedures are available in the appropriate section.  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-PV202300193763 same patient, different drug and event;US-PFIZER INC-202300413922 same patient, different drug and event;US-PFIZER INC-202200086905 same patient, different drug and event;
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: severe headache; vision problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Mixed connective tissue disorder" (ongoing); "Auto immune disease", start date: 01Jan2006 (ongoing); "Sjogren's syndrome" (unspecified if ongoing); "Raynaud's syndrome" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE oral taken for mixed connective tissue disease (ongoing); FOLIC ACID oral (ongoing). Vaccination history included: bnt162b2 (At 08:00, DOSE 1, SINGLE, Batch/Lot number: EL1283, Anatomical Site of injection: Arm, Route of administration: Intramuscular), administration date: 22Jan2021, when the patient was 53-year-old, for COVID-19 immunization; bnt162b2 (At 15:00, DOSE 2, SINGLE, Batch/Lot number: EL3246, Anatomical Site of injection: Arm, Route of administration: Intramuscular), administration date: 12Feb2021, when the patient was 53-year-old, for COVID-19 immunization; bnt162b2 (At 16:00, DOSE 3 (BOOSTER), SINGLE, Anatomical Site of injection: Arm, Route of administration: Intramuscular), administration date: 12Dec2021, when the patient was 54-year-old, for COVID-19 immunization; Flu shot (DOSE NUMBER UNKNOWN, SINGLE), for flu vaccination. The following information was reported: HEADACHE (non-serious) with onset 13Nov2023, outcome "not recovered", described as "severe headache"; VISUAL IMPAIRMENT (non-serious) with onset 13Nov2023, outcome "not recovered", described as "vision problems". Relevant laboratory tests and procedures are available in the appropriate section.  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-PV202300193763 same patient, different drug and event;US-PFIZER INC-202300413922 same patient, different drug and event;US-PFIZER INC-202200086905 same patient, different drug and event;