chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Device leakage
Clinical narrative: Three of them has it Luer lock unsecured so it popped off; Some of the vaccines got wasted and leaked; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 23Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group, Program ID. A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HH1819, Expiration Date: Feb2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "Three of them has it Luer lock unsecured so it popped off; Some of the vaccines got wasted and leaked".  The reporter considered "three of them has it luer lock unsecured so it popped off; some of the vaccines got wasted and leaked" associated to device constituent of rsv vaccine prot.subunit pref 2v. Causality for "three of them has it luer lock unsecured so it popped off; some of the vaccines got wasted and leaked" was determined associated to device constituent of rsv vaccine prot. subunit pref 2v.  A brief summary of noted that this is a medical device related. Reportability Determination: This complaint for a Pharmacist on the other line and he mentioned that he was dispensing bunch of Abrysvo and three of them has it Luer lock unsecured so it popped off and we sent some of the vaccine. So, he did not try or he did not administer this vaccines to patient but he is requesting if this can be replaced. That is right. So, it popped off, and some of the vaccines got wasted and leaked" for ABRYSVO INJECTABLE (VACCINE) is a reportable malfunction. If it were to recur, could likely cause or contribute to death or serious injury. This event is NOT a reportable malfunction for ROW since the deficiency of the device was found prior to use on the patient and the deficiency would always be detected. Product used for treatment. This is 30-day reportable. Forward to Clinician Peer Reviewer 25Oct2023.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Metal taste in mouth; A practice administrator was calling about the Pfizer Covid Vaccine 2023-2024 formula; they gave a 5-11 years dose to 20-year-old patient; A practice administrator was calling about the Pfizer Covid Vaccine 2023-2024 formula; they gave a 5-11 years dose to 20-year-old patient; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 20-year-old female patient received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), on 05Oct2023 as dose 1, 0.3 ml single (Lot number: HE2391, Expiration Date: 30Apr2024) at the age of 20 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), UNDERDOSE (non-serious) all with onset 05Oct2023, outcome "unknown" and all described as "A practice administrator was calling about the Pfizer Covid Vaccine 2023-2024 formula; they gave a 5-11 years dose to 20-year-old patient"; DYSGEUSIA (non-serious) with onset 05Oct2023, outcome "unknown", described as "Metal taste in mouth". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: A practice administrator was calling about the Pfizer Covid Vaccine 2023-2024 formula; they gave a 5-11 years dose to 20-year-old patient and wanted to see what was recommended. Caller stated that she called about the Covid vaccine 5-11, a Pfizer product. They had determined doing a vaccine inventory that they gave a 5-11 dose to a 20 year old. Knew they got a weaker dose. Wanted to know was it recommended to do second one or leave with the dose they got. Clarified name of the product as it appeared on the label as the Pfizer Biontech Covid 19 vaccine 2023-2024 formula (for ages 5 years to less than 12). Was a few weeks that determined that this happened. They do need to notify the patient if they had to come back in.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.  Follow-up (27Oct2023): This is a spontaneous follow-up report received from a contactable Nurse. Updated information Included: Reporter information added and new reporter in sliders 2 and 3 added. Updated Slider 1 as an HCP. Patient (Date of birth, Height and weight) added. For suspect dose date, Dose, Unit, Lot, Expiration date and Dose description updated. New event of Dysgeusia and additional information updated.
Sex: U
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: experienced anterior non-blanching rash hours after on lower extremity; This is a spontaneous report received from contactable reporter (Other HCP) from medical information team.  A 2-month-old patient received pneumococcal 20- valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "experienced anterior non-blanching rash hours after on lower extremity". Additional information: a 2-month-old patient received the first dose of pneumococcal 20- valent conjugate vaccine (diphtheria crm197 protein) and experienced anterior non-blanching rash hours after on lower extremity.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site erythema, Vaccination site macule, Vaccination site pain
Clinical narrative: She has a red circle on her right arm; She has a red circle on her right arm, it hurts and it's painful.; right arm is red and hurts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Lot number: HF9300) at the age of 71 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 24Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset Oct2023, outcome "unknown", described as "right arm is red and hurts"; VACCINATION SITE PAIN (non-serious) with onset 25Oct2023, outcome "unknown", described as "She has a red circle on her right arm, it hurts and it's painful."; VACCINATION SITE MACULE (non-serious) with onset 26Oct2023, outcome "unknown", described as "She has a red circle on her right arm". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pain, vaccination site macule.  Additional information: The patient got a flu shot in her left arm and the COMIRNATY shot in the right arm on 24Oct2023 at the doctor's office. Her right arm was red and hurts. She had a red circle on her right arm, it hurts and was painful. After she got the COMIRNATY shot, after a day or so it started being really painful. Today is when she noticed the red circle on her arm. With the flu shot, she did not have any reaction. She did not know if it was a side effect or not. Just wanted to know if she needed to call her doctor about it.
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Headache, Influenza like illness, Lethargy, Pain
Clinical narrative: body aches; severe headache; low grade temperature; lethargy; general feeling of having the flu; This is a spontaneous report received from a non-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 (BNT162B2 OMI XBB.1.5), on 25Oct2023 at 16:00 as dose 1, single (Lot number: HB4589), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: artificial sweeteners" (unspecified if ongoing); "Crohns Disease" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Degenerative disc disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Imuran, reaction(s): "known allergies"; Tetanus, reaction(s): "known allergies". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Only prior event occurred after 1st dose in 2021 and symptoms lasted 12 hrs.), administration date: 2021, for COVID-19 immunization, reaction(s): "body aches"; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), administration date: 2021, for COVID-19 immunization, reaction(s): "low grade temperature", "severe headache", "general feeling of having the flu", "lethargy"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 26Oct2023 at 03:00, outcome "not recovered", described as "body aches"; INFLUENZA LIKE ILLNESS (non-serious) with onset 26Oct2023 at 03:00, outcome "not recovered", described as "general feeling of having the flu"; LETHARGY (non-serious) with onset 26Oct2023 at 03:00, outcome "not recovered"; BODY TEMPERATURE DECREASED (non-serious) with onset 26Oct2023 at 03:00, outcome "not recovered", described as "low grade temperature"; HEADACHE (non-serious) with onset 26Oct2023 at 03:00, outcome "not recovered", described as "severe headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, headache, body temperature decreased, lethargy, influenza like illness.  Additional Information: The patient did not receive any other vaccine in four weeks. Approx 10 hours post vaccination, had onset of body aches, severe headache, low grade temperature, lethargy, and a general feeling of having the flu. At time of report symptoms have lasted 34.5 hrs. Only prior event occurred after 1st dose in 2021 and symptoms lasted 12 hrs. Patient did not have covid prior to vaccination and was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 19Nov2022, outcome "unknown", described as "Hives". The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Thimerosol, reaction(s): "Known allergies: thimerosol". The following information was reported: HEADACHE (non-serious) with onset 27Oct2023 at 19:30, outcome "not recovered"; NAUSEA (non-serious) with onset 27Oct2023 at 19:30, outcome "not recovered". Therapeutic measures were not taken as a result of headache, nausea.  Additional information: Patient have not received any other vaccine in four weeks or any medications in two weeks, no covid prior to vaccination and was not tested for covid post vaccination.  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: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: VERTIGO (non-serious), outcome "unknown". Additional information: I also know of another person who had vertigo of towards, but it wasn't as serious as mine. The shots seem to do as much damage as covid, so I think it is a toss up.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukemia (CLL)" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Augmentin, reaction(s): "Drug Allergies: Augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Jun2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative on days 3-5 of treatment with Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid, start date as 02Jun2023 and stop date as 07Jun2023. Clinical course: Patient received COMIRNATY (2023-2024 Formula) as dose 1, single on 19Sep2023 for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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.,Linked Report(s) : US-PFIZER INC-202300351144 same reporter/patient, different product/events;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: overall body aches; Chills; 100.4 fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 17:15 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "lung cancer" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 21Oct2023 at 07:00, outcome "recovered", described as "100.4 fever"; CHILLS (non-serious) with onset 21Oct2023 at 07:00, outcome "recovered"; PAIN (non-serious) with onset 21Oct2023 at 07:00, outcome "recovered", described as "overall body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, chills, pyrexia.  Additional information: Patient had no known allergies, no covid prior to vaccination and was not tested for covid post vaccination.  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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: Jan2003, stop date: 29Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (26Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 19Oct2023 to 24Oct2023. Clinical course: The patient had no known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202300350861 Same patient, different drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Joint pain; Nausea; Feeling unwell; Dizziness; Muscle pain; Woke up with feeling of pressure in her chest that she normally doesn't have; Diarrhea; Decreased appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 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: Covid-19 vaccine (Primary Immunization series completed, Manufacturer Unknown.), for COVID-19 Immunization. The following information was reported: DECREASED APPETITE (non-serious) with onset Oct2023, outcome "unknown"; DIARRHOEA (non-serious) with onset Oct2023, outcome "unknown", described as "Diarrhea"; DIZZINESS (non-serious) with onset Oct2023, outcome "unknown"; MALAISE (non-serious) with onset Oct2023, outcome "unknown", described as "Feeling unwell"; ARTHRALGIA (non-serious) with onset Oct2023, outcome "unknown", described as "Joint pain"; MYALGIA (non-serious) with onset Oct2023, outcome "unknown", described as "Muscle pain"; NAUSEA (non-serious) with onset Oct2023, outcome "unknown"; CHEST DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "Woke up with feeling of pressure in her chest that she normally doesn't have".  Additional information: The caller got her booster dose of Comirnaty last Tuesday, 24Oct2023, and was having all of the symptoms on the paper they gave her to include muscle pain, joint point, feeling unwell, and dizziness. Agent stated that caller reported at first she thought it was her arthritis, but when the feeling unwell, nausea, and dizziness started caller thought it was from the vaccine. Today caller woke up with feeling of pressure in her chest that she normally doesn't have. It doesn't feel like a heart attack but caller was concerned with things that have to do with the heart muscle that can happen with the vaccine. She had experienced diarrhea and decreased appetite, but no fever or headache. Transfer agent provided caller had just disconnected the line. Caller had asked Medical Information agent for side effect information for an 85-year-old. Referred caller to either go to the ER or to contact her physician to be evaluated today due to the chest pressure.  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: Malaise, Myalgia, Nausea
Clinical narrative: Joint pain; Nausea; Feeling unwell; Dizziness; Muscle pain; Woke up with feeling of pressure in her chest that she normally doesn't have; Diarrhea; Decreased appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 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: Covid-19 vaccine (Primary Immunization series completed, Manufacturer Unknown.), for COVID-19 Immunization. The following information was reported: DECREASED APPETITE (non-serious) with onset Oct2023, outcome "unknown"; DIARRHOEA (non-serious) with onset Oct2023, outcome "unknown", described as "Diarrhea"; DIZZINESS (non-serious) with onset Oct2023, outcome "unknown"; MALAISE (non-serious) with onset Oct2023, outcome "unknown", described as "Feeling unwell"; ARTHRALGIA (non-serious) with onset Oct2023, outcome "unknown", described as "Joint pain"; MYALGIA (non-serious) with onset Oct2023, outcome "unknown", described as "Muscle pain"; NAUSEA (non-serious) with onset Oct2023, outcome "unknown"; CHEST DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "Woke up with feeling of pressure in her chest that she normally doesn't have".  Additional information: The caller got her booster dose of Comirnaty last Tuesday, 24Oct2023, and was having all of the symptoms on the paper they gave her to include muscle pain, joint point, feeling unwell, and dizziness. Agent stated that caller reported at first she thought it was her arthritis, but when the feeling unwell, nausea, and dizziness started caller thought it was from the vaccine. Today caller woke up with feeling of pressure in her chest that she normally doesn't have. It doesn't feel like a heart attack but caller was concerned with things that have to do with the heart muscle that can happen with the vaccine. She had experienced diarrhea and decreased appetite, but no fever or headache. Transfer agent provided caller had just disconnected the line. Caller had asked Medical Information agent for side effect information for an 85-year-old. Referred caller to either go to the ER or to contact her physician to be evaluated today due to the chest pressure.  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: Platelet count, Platelet count decreased
Clinical narrative: dropping platelets; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization. The following information was reported: PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "dropping platelets". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of platelet count decreased. Additional information: The caller said she had experienced problems with all three shots; however, the first two shots were severe. She further added, with every shot with every vaccine, she have had a dropping platelets. In both cases, being on 20 mg of Prednisone has reversed the incident.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300179280 Same patient/vaccine/event, different dose;US-PFIZER INC-202300352576 Same patient/vaccine/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Platelet count decreased
Clinical narrative: third one was crayola bleeding; low platelets; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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; Bnt162b2 (DOSE 2), for Covid-19 Immunization. The following information was reported: HAEMORRHAGE (medically significant), outcome "unknown", described as "third one was crayola bleeding"; PLATELET COUNT DECREASED (medically significant), outcome "unknown", described as "low platelets". The patient underwent the following laboratory tests and procedures: Platelet count decreased: low, notes: low platelets. Therapeutic measures were taken as a result of haemorrhage, platelet count decreased. Additional information: The caller said she had experienced problems with all three shots; however, the first two shots were severe, and the third one was crayola bleeding, low platelets, protectia, and ten months of medications to finally clear the problem.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300179280 Same patient/vaccine, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got fully vaccinated with Pfizer Covid Vaccine but got Covid 19 so they gave Paxlovid at the beginning of the year; got fully vaccinated with Pfizer Covid Vaccine but got Covid 19 so they gave Paxlovid at the beginning of the year; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID.  A patient (no qualifiers 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got fully vaccinated with Pfizer Covid Vaccine but got Covid 19 so they gave Paxlovid at the beginning of the year". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: Reporter (Nurse Practioner) would like to know if they could gave Paxlovid multiple times to a patient in a year. They had a patient who got fully vaccinated with Pfizer Covid Vaccine but got Covid 19 so they gave Paxlovid at the beginning of the year.  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: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 (BNT162B2 NOS to the reported Drug ineffective ,COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-PV202300179412 same patient, different drug/AE.;
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Pfizer/biontech, Vaccine dose number=2/ brand other=Moderna, Vaccine dose number=3; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 12Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), on 25Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 06Oct2023 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "arrythmia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "obstructive sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Sulfa, reaction(s): "Known allergies: sulfa". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Nov2021, outcome "recovering", described as "Vaccine brand=Pfizer/biontech, Vaccine dose number=2/ brand other=Moderna, Vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Oct2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2023) Positive, notes: Tested positive for COVID in urgent care clinic 19Oct2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid from 19Oct2023 to 23Oct2023. Initial onset of symptoms: 18Oct2023. Tested positive for COVID in urgent care clinic 19Oct2023. Started Paxlovid: 19Oct2023, felt much better, almost completely well for 3-4 days.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering interchange of vaccine, the contributory role of company suspect drug BNT162b2 to all the reported events DRUG INEFFECTIVE and COVID-19  cannot be excluded completely.,Linked Report(s) : US-PFIZER INC-202300352919 Same patient, different drug, different event;
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleepiness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: SOMNOLENCE (non-serious) with onset 2023, outcome "unknown", described as "sleepiness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: She developed hives.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to anything gel based such as the gel cap vitamins" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "hives". Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 Immunization; Bnt162b2 (Dose 2, single), for Covid-19 Immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "She developed hives.".  Additional Information: Patient was instructed by the pharmacist to call Pfizer medical information contact number to ask about one of the ingredients in the COVID-19 vaccine that's currently out, whether this vaccine contains anything gel-based or whether the glycoprotein is gel-based. Patient that she is allergic to anything gel based such as the gel cap vitamins, Tylenol liquid gel which causes her to develop hives. Patient confirmed that she previously received 3 Pfizer COVID vaccines and opt not to receive the fourth because of what happened to her. Patient confirmed that after the third shot of the COVID vaccine, she developed hives. Upon providing response, patient mentioned that the pharmacist told her that Glycoproteins are gel-based.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site movement impairment
Clinical narrative: low fever; felt pain in his arm; cannot lift arm without difficulty/had some concerns with how the vaccine was administered; This is a spontaneous report received from a contactable reporter (physician). The reporter is the patient. A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (lot number unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "cannot lift arm without difficulty/had some concerns with how the vaccine was administered"; PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "not recovered", described as "felt pain in his arm"; PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "low fever". It was unknown if therapeutic measures were taken as a result of pyrexia, pain in extremity, vaccination site movement impairment.  Additional Information: The patient received the vaccine on 16Oct2023. For 24 hours he had no symptoms. On an unknown date in Oct2023, he then developed a mild reaction to vaccine such as low fever, but then felt pain in his arm which has not gone away. He now cannot lift arm without difficulty. He had some concerns with how the vaccine was administered but in his opinion as a physician, he thinks this is separate from the symptoms he communicated today. It is unknown if the patient had covid-19 prior to the vaccination and unknown if covid tested post-vaccination.  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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 57-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 56 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 Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid (start date: 21Oct2023, stop date: 26Oct2023).  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-202300353007 same patient, different drug, different event;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 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 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment during unspecified dates in Oct2023. Patient had no known allergies.  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-202300352989 Same patient, different product, different event (Paxlovid case);
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Echocardiogram, Magnetic resonance imaging
Clinical narrative: stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 01:00 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAVIX; CRESTOR. Patient has no known allergies. Vaccination history included: Bnt162b2 (approximately 4 weeks after taking the Pfizer COVID vaccine in 2022), administration date: 2022, for COVID 19 immunization, reaction(s): "stroke". Patient have no covid prior vaccination and post vaccination. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, life threatening) with onset 27Oct2023 at 07:00, outcome "not recovered", described as "stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results; Echocardiogram: Unknown results; Magnetic resonance imaging: Unknown results. Therapeutic measures were taken as a result of cerebrovascular accident and included treatment with blood thinners and meds.  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-202300353195 same patient/AE, different vaccine dose number;
Age: 68.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Feb2023 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 29Jan2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 19Feb2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 05Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 03Jun2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: mold" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: 15Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 13Oct2023 to 18Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353185 Same patient, different product, different event;
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 contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" 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 which included Paxlovid from 30Oct2023. Clinical Course: Caller prescribed the Paxlovid yesterday evening. She also mentioned that she was up to date with the Pfizer COVID vaccines.  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-202300353163 Same patient, different drug, different event;
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Cerebrovascular accident, Computerised tomogram, Condition aggravated, Echocardiogram, Magnetic resonance imaging
Clinical narrative: Had a stroke approximately 4 weeks after taking the Pfizer COVID vaccine in 2022 and again in 2023. Both times almost exactly 4 weeks after vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 29Sep2023 at 01:00 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAVIX; CRESTOR. Vaccination history included: Bnt162b2 (Had a stroke approximately 4 weeks after taking the Pfizer COVID vaccine in 2022), administration date: 2022, for COVID-19 immunization, reaction(s): "stroke". The following information was reported: CEREBROVASCULAR ACCIDENT (caused and prolonged hospitalization, disability, life threatening) with onset 27Oct2023 at 07:00, outcome "not recovered", described as "Had a stroke approximately 4 weeks after taking the Pfizer COVID vaccine in 2022 and again in 2023. Both times almost exactly 4 weeks after vaccine.". The patient was hospitalized and prolonged hospitalization for cerebrovascular accident (hospitalization duration: 4 day(s)). The events "had a stroke approximately 4 weeks after taking the pfizer covid vaccine in 2022 and again in 2023. both times almost exactly 4 weeks after vaccine." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown Results; Echocardiogram: Unknown Results; Magnetic resonance imaging: Unknown Results. Therapeutic measures were taken as a result of cerebrovascular accident which includes: Blood thinners, MRI, CT, Echo cardio grams, meds (unspecified).   Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19 since the vaccination.   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-202300353169 same patient/AE, different vaccine dose number;
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: had the vaccine yesterday and then in that, in a way that felt like; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 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: FEELING ABNORMAL (non-serious) with onset Oct2023, outcome "unknown", described as "had the vaccine yesterday and then in that, in a way that felt like".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.