chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild fever (100.4 to 101.2 °F); Joint pain and no interference with activity; Mild muscle pain and no interference with activity; Mild fatigue and no interference with activity; Mild injection site redness; Mild injection site swelling; Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and FATIGUE (Mild fatigue and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2024, Body temperature: 100.4 to 101.2 °F.         AutoCruitment Subject ID was reported.  RTI-HS Subject ID was reported.  Concomitant medication was not provided.  Patient experienced reported events anytime during the 2 days after COVID-19 vaccination, which occurred on Jan 13, 2024 and Jan 14, 2024. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-757659 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757659:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19/cold; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid 19/cold) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In January 2024, the patient experienced COVID-19 (covid 19/cold). At the time of the report, COVID-19 (covid 19/cold) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Patient stated her symptoms were extremely mild. Patient had very mild cold symptoms. Patient did not know she was exposed. She felt fine. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, X-ray
Clinical narrative: Patient started to have pain; Patient started to have tingling in arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Patient started to have pain) and PARAESTHESIA (Patient started to have tingling in arm) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine.    On 15-Dec-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced PAIN IN EXTREMITY (Patient started to have pain) and PARAESTHESIA (Patient started to have tingling in arm). At the time of the report, PAIN IN EXTREMITY (Patient started to have pain) and PARAESTHESIA (Patient started to have tingling in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: had a cracked tendon.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Age: 77.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue
Clinical narrative: The patient did receive a flu shot on the same day as his Covid-19 shot and felt a little tired.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (The patient did receive a flu shot on the same day as his Covid-19 shot and felt a little tired.) in a 77-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1, lot number was not known.) in January 2021, Moderna covid-19 vaccine (Dose 2, lot number was not known.) on 16-Feb-2021, Moderna covid-19 vaccine (Dose 3, lot number was not known.) on 01-Nov-2021, Moderna covid-19 vaccine (Dose 4, Lot number- 049L21A) on 06-Jun-2022, MODERNA COVID-19 VACCINE (Dose 5 and lot number- A37147B) on 18-Oct-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.   On 10-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 10-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced FATIGUE (The patient did receive a flu shot on the same day as his Covid-19 shot and felt a little tired.). At the time of the report, FATIGUE (The patient did receive a flu shot on the same day as his Covid-19 shot and felt a little tired.) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that the patient did receive a flu shot on the same day as his Covid-19 shot and felt a little tired.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu; 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 Consumer or other non HCP from medical information team.  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "COVID-19"; Bnt162b2 (Dose 2), for Covid-19 Immunization, reaction(s): "COVID-19"; Bnt162b2 (dose 3), for Covid-19 Immunization, reaction(s): "COVID-19". The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201110773 same patient, different vaccine dose/AE.;
Sex: M
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: Every time he gets a shot, the phlegm gets worse; This is a spontaneous report received from a Consumer or other non HCP.  A 76-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 included: "Other Conditions: No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PRODUCTIVE COUGH (non-serious), outcome "not recovered", described as "Every time he gets a shot, the phlegm gets worse". The event "every time he gets a shot, the phlegm gets worse" required physician office visit. Therapeutic measures were taken as a result of productive cough.  Additional information: The patient had no information regarding his vaccines at time of call. The vaccine card was at home. He was currently on a bus. He has received between 4-6 vaccines, it's been a lot. Patient reported that every time he gets a shot, the phlegm gets worse. He wants to get rid of the phlegm. His doctor doesn't know how to take care of it. Referred caller to his HCP for medical advice. No treatment yet, he uses honey and lemon to get the phlegm to come up. Caller was difficult to hear as he sounded distant and muffled throughout call.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Took Paxlovid for treatment of COVID-19; Took Paxlovid for treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hernia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer/biontech vaccine (DOSE 6 (BOOSTER), SINGLE (Vaccine administration time at 12:00 PM,, Vaccine lot unknown reason- Misplaced/discarded, Vaccine location- Right arm)), administration date: 17Apr2023, when the patient was 73-year-old, for Covid-19 immunization; Covid-19 vaccine (DOSE 9 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 8 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Took Paxlovid for treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment from 28Dec2023 to 01Jan2024).  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, FLUX
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain
Clinical narrative: Horrible stiffness in my neck on the left side; Neck pain and going into my shoulder as well; Neck pain and going into my shoulder as well; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Lot number: Unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (primary series), for covid-19 immunisation; Comirnaty (booster), for covid-19 immunisation. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Horrible stiffness in my neck on the left side"; NECK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Neck pain and going into my shoulder as well". The action taken for influenza vaccine was unknown. Additional information:Patient went back to the same pharmacy to get my Booster and I got the Pfizer Comirnaty and then I also got a Flu Vaccine (Hence, suspect product captured as Unspecified Flu Vaccine) which I've already had both of those done in the past. So, patient didn't really have any real side effects but like a week later, a few days later, patient have been having like this some horrible stiffness in my neck on the left side and  cannot connected to anything that  can think of, other than the vaccine was the only foreign thing that pateint had done and to have this, to have this type of neck pain and going into the shoulder as well.  Batch/lot number is not provided, and it cannot be obtained.
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. A 68-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 and concomitant medications were not reported. 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 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), 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". 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 which included Paxlovid from 10Jan2024 to 15Jan2024 (lot number: GJ3344).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jan2024 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Type two diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (dose 2, single, unknown manufacturer), 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 Treatment". 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.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 32.0
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 32-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Dec2023 at 10:15 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asplenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: 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 Immunization. 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 covid-19, which included nirmatrelvir, ritonavir (PAXLOVID) from 06Jan2024 to 10Jan2024. Clinical course: The patient had no known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got a positive Covid 19 test; got a positive Covid 19 test; This is a spontaneous report received from a Physician from medical information team. An adult male patient received BNT162b2 (BNT162B2), 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 was not reported. Concomitant medications included: VITAMIN A [RETINOL]; VITAMIN C [ASCORBIC ACID]; VITAMIN B COMPLEX;ZINC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jan2024, outcome "unknown" and all described as "got a positive Covid 19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jan2024) Positive, notes: he got a positive Covid 19 test today. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Additional information: the patient reported that he got tested positive for COVID this morning. He also added that he had allergic reaction to the Pfizer vaccine 1 and 2 and could not boost because of the reaction.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the given information and known safety profile , the possible contributory role of the suspect for the event Drug ineffective and covid-19 cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202400018502 same reporter/patient/drug, different events/dose;US-PFIZER INC-202100951894 same reporter/patient/drug, different events/dose;
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report received from a Physician from medical information team.  An elderly male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single at 14:30, intramuscular, administered in Left arm (Left deltoid)), administration date: 16Jul2021, for COVID-19 Immunisation, reaction(s): "hives are basically in the buttocks, upper thighs, lower and side of the abdomen, lower back, upper back, mostly on lower trunk area/extremely erythematous/large as the palm of his hands", "They are very red and are very itchy/Generalized pruritus with skin rash", "They are very red and are very itchy/Generalized pruritus with skin rash", "allergic reaction". The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction". Additional information: Caller is a retired physician that reported that he tested positive for Covid this morning and had a script called in for Paxlovid. He had adverse allergic reaction to the Pfizer vaccine 1 and 2 and could not boost because of the reaction. Caller clarified that it was the Pfizer Covid-19 vaccine dose 1 and 2.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400018387 same patient/drug and different dose/events;US-PFIZER INC-202100951894 same patient/drug and different dose/events;US-PFIZER INC-202100951894 same patient/drug and different dose/AEs;
Age: 63.0
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jun2022 at 17:00 as dose 1, single (batch/lot number: unknown) at the age of 62 years, in left arm and on 17Jul2023 at 17:00 as dose 2, single (batch/lot number: unknown) at the age of 63 years, in right arm for COVID-19 immunization. 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 which included Paxlovid from 17Jan2024 to 18Jan2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400018556 same patient/product, different dose/events;
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune - Rheumatoid Arthritis" (unspecified if ongoing), notes: Autoimmune; "Immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: ENBREL, stop date: 28Dec2023. 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. 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jan2024) Negative; (15Jan2024) Negative; (18Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which include Paxlovid.
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 62-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 patient has no known allergies. 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; Covid-19 vaccine (DOSE 4 (BOOSTER); single, Manufacturer: Unknown), 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  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, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 15:30 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jan2024 at 10:00, outcome "unknown" and all described as "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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; is pregnant: Pregnant; This is a spontaneous report received from a Consumer or other non HCP. A 41-year-old female patient (pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Date of last menstrual period: 01Oct2023. The patient was 4 weeks pregnant at the time of exposure to BNT162b2 omi xbb.1.5. The patient was 4 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05Jul2024. The patient's concomitant medications were not reported. Vaccination history included: 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: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 03Nov2023, outcome "unknown", described as "is pregnant: Pregnant"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2024, outcome "recovered" (08Jan2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2024) Negative, notes: I tested negative on 08Jan2024; (11Jan2024) Negative, notes: I tested negative on 08Jan2024 and 11Jan2024; (17Jan2024) Positive, notes: I then tested positive on 17Jan2024. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 02Jan2024 to 07Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from an Other HCP. A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (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 Jan2024, outcome "not recovered" and all described as "COVID". The patient took Paxlovid starting day 2 of Covid. Took it as directed for full course, 5 days,  start date: 07Jan2024 and stop date: 12Jan2024. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) 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 will be requested and submitted if and when received.; Sender's Comments: Based on the given information and known safety profile , the possible contributory role of the suspect for the event vaccination failure and covid-19 cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: lose hair; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female 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's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "lose hair".  Additional information: Reporter's sister, the patient, had received the Pfizer COVID vaccine and reporter's sister was 8 years younger than reporter and the patient had started to lose hair near the front in little patches near the front.   Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Stated caller got really sick with 5th dose.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 71-year-old female 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's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (dose 4, lot number:GH9693   , shot in the arm), administration date: 06Oct2022, when the patient was 70-year-old, for covid-19 immunisation, reaction(s): "severe hair breakage", "Hair loss"; comirnaty (dose 1, lot number: EM9810), administration date: 03Feb2021, when the patient was 69-year-old, for covid-19 immunisation; comirnaty (dose 2, lot number: EM9804, Shot in the arm, ), administration date: 26Feb2021, when the patient was 69-year-old, for covid-19 immunisation; comirnaty (dose 3, lot number: FM9992, anatomical location: In arm, ), administration date: 29Apr2022, when the patient was 70-year-old, for covid-19 immunisation; pneumonia shot, administration date: 06Oct2022, when the patient was 70-year-old, for immunisation, reaction(s): "sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Stated caller got really sick with 5th dose.". Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400018411 same patient, drug/ different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, Somnolence
Clinical narrative: Couldn't stay awake; Muscle spasms all over her body; She didn't make one antibody from the Pfizer COVID vaccine, it was as if she never had the shot; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Immune disease / Autoimmune disease" (unspecified if ongoing); "Severe gastrophoresis" (unspecified if ongoing); "Sensitive to drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "Couldn't stay awake"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Muscle spasms all over her body"; SARS-COV-2 ANTIBODY TEST NEGATIVE (non-serious), outcome "unknown", described as "She didn't make one antibody from the Pfizer COVID vaccine, it was as if she never had the shot". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient reported that she received the Pfizer COVID vaccine a couple of years prior to the time of the report. At that time, she there was no information on use in patients with her condition (she has a primary immune disease/common variable immune disease and an autoimmune disease, severe gastrophoresis and is sensitive to drugs). She reported that 6 months after the shot, she experienced "awful" and "horrendous" side effects. She couldn't stay awake and she muscle spasms all over her body. When she got tested for antibodies, she didn't make one antibody from the Pfizer COVID vaccine, it was as if she never had the shot. The patient confirms that she is at least 18 years of age and older.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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 a Consumer or other non HCP.  A 53-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's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Penicillin allergy" (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: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid treatment via oral on 19Jan2024.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Feb2021 as dose 1, single (Lot number: 012A21A), in left arm, on 25Mar2021 as dose 2, single (Lot number: 031A21A), in right arm, on 08Nov2021 as dose 3 (booster), single (Lot number: 939906), in right arm and on 12Oct2023 as dose 5 (booster), single (Lot number: 3031281), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 62.0
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 a Consumer or other non HCP.  A 63-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Keflex, reaction(s): "allergies". Vaccination history included: Covid-19 vaccine (Dose 1, single; Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, single; Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (booster), single; Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 (booster), single; Unknown manufacturer), 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: (18Jan2024) Positive; (20Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid from 11Jan2024 to 16Jan2024.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: FATIGUE (non-serious), outcome "unknown", described as "Tired". Additional information: the patient had the three-shot last year.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: tremors; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 21-year-old male patient received BNT162b2 (BNT162B2), in 2021 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: TREMOR (non-serious), outcome "unknown", described as "tremors". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. Additional information: It was reported that the patient got Pizer vaccine in 2021 because in order for him to get the job he had to. Months later the patient has tremors that no one could not explain but the only unknown thing that went into his body was Pfizer vaccine. The reporter further stated that the patient is 21-years old male and could not live is best life because of this vaccine.
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: the hub on the syringe was broken/hub of the syringe came off of the syringe; This is a spontaneous report and received from Consumer or other non HCPs from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GY1932, Expiration Date: Dec2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the hub on the syringe was broken/hub of the syringe came off of the syringe".  The reporter considered "the hub on the syringe was broken/hub of the syringe came off of the syringe" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "the hub on the syringe was broken/hub of the syringe came off of the syringe" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: Prevnar 20 was received and the hub on the syringe was broken. The hub of the syringe came off of the syringe. They have a box of 10 and unsure if the other 9 are compromised as well. The site sent her pictures if they are needed. They had a little damage to the outside of the box. Nothing major, just a little dent on the box. It was suggested to reach out to Pfizer as it was considered concealed damage. The return container has been mailed to the site.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she acquired covid in November; she acquired covid in November; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A female 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'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 Nov2023, outcome "unknown" and all described as "she acquired covid in November".  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: IPV, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was in the office for a TB test and was given IPOL instead with no reported adverse event; Initial information received on 11-Jan-2024 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves Adult and unknown gender patient who was in the office for a Tuberculin Test [Tubersol] and was given IPV (VERO) [IPOL] instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Jan-2024, the patient who was in the office for tuberculin test Solution for injection was given IPV (VERO) Suspension for injection (dosage, route, batch number, expiry date- unknown) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation) instead with no reported adverse event (wrong product administered) (latency- same day). Information on the batch number was requested.  Reporter stated, Not sure if medication was given IM (intramuscular)or Subcutaneous.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: staff members mixed ACTHIB with sterile water instead of the diluent in the box with no reported adverse event; Initial information received on 11-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient and reporter reported that one of their staff members mixed HIB (PRP/T) VACCINE [ACT-HIB] with sterile water instead of the diluent in the box with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination (Immunization).  On 11-Jan-2024, the patient received 0.5 mL dose of mixed HIB (PRP/T) VACCINE with sterile water instead of the diluent in the box with no reported adverse event (product preparation error) (latency: same day) (Powder and solvent for solution for injection), (Frequency: once), (Strength: standard) (lot UJ863AA and expiry date: 25-Mar-2024) via intramuscular route in the left thigh for Immunization.  It was reported that "Coordinator called to report that one of their staff members mixed ACTHIB with sterile water instead of the diluent in the box. She asked for recommendations. She asked if this is an invalid dose and should they repeat it again. According to vaccine coordinator, she was told that the diluent was not in the box, but she is not there during the administration so she isn't sure what happened. This situation is pre-assessed as a medication error/an inappropriate use due to incorrect diluent that was used for the administration of ACTHIB."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered an expired FLUZONE to two patients today due to a mix-up with the vaccines with no reported Adverse event; Initial information received on 11-Jan-2024 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 48 years old female patient who was inadvertently administered an expired Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] to two patients today due to a mix-up with the vaccines with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Jan-2024, the patient received a 0.5 ml expired dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (strength: standard, frequency: once, lot UT7759MA and expiry date: unknown) via unknown route in unknown administration site as Immunization (expired product administered) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.