chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: "If a patient has had the bivalent vaccine back in Oct2022 (so it's been 6 months after the latest dose) and they get the virus - when can they get a second dose of the bivalent vaccine?; "If a patient has had the bivalent vaccine back in Oct2022 (so it's been 6 months after the latest dose) and they get the virus - when can they get a second dose of the bivalent vaccine?; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 ""If a patient has had the bivalent vaccine back in Oct2022 (so it's been 6 months after the latest dose) and they get the virus - when can they get a second dose of the bivalent vaccine?". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: Caller was a provider and asking on behalf of a patient and inquiring  if a patient got the Pfizer covid-19 vaccine bivalent and they acquired covid-19 virus now what is the recommendation regards to it. and added how many months before they use Paxlovid. Les's say that a patient tests positive (PCR), vaccinated, and takes Paxlovid within 5 days. This has happened to many patients.   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 available information, a possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202300176620 same patient, different product/events;
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Biaxin, reaction(s): "Drug Allergy"; Naproxen, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had known allergies: a few others. Treatment start date: 29Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300176519 Same patient, different event/drug;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2023 as dose 5 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 23Apr2023 to 27Apr2023. The patient has no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300176662 same reporter/patient different drug /AE.;US-PFIZER INC-202300177575 same patient/drug, different dose/events (Dose 5).;
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "Hypothyroid" (unspecified if ongoing); "tinnitus" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "supraventricular Arrhythmia" (unspecified if ongoing); "Morphine allergy and Entereg allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN, start date: 01Jun2021; METOPROLOL, start date: 01Sep2022. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events,Linked Report(s) : US-PFIZER INC-202300177712 Same patient, different drug, different event;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 with symptoms; tested positive for COVID-19 with symptoms; Moderna, Dose Number: 1, 2, 3 / Pfizer, Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 44 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Jan2021 as dose 1, single (Lot number: 030L20A), on 28Feb2021 as dose 2, single (Lot number: 011A21A) and on 11Nov2021 as dose 3 (booster), single (Lot number: 039F21A), all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for influenza immunisation, on 07Sep2022 as dose number unknown, single; YASMIN. Patient had no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "recovering", described as "Moderna, Dose Number: 1, 2, 3 / Pfizer, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01May2023, outcome "recovering" and all described as "tested positive for COVID-19 with symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2023) Negative, notes: Nasal Swab; (29Apr2023) Negative, notes: Nasal Swab; (01May2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 1st one she had a little headache; 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), 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: HEADACHE (non-serious), outcome "unknown", described as "1st one she had a little headache".  Additional information: Patient wanted to report that she got 3 Pfizer covid vaccines, the 1st one she had a little headache, the 2nd one it got worse, but the 3rd one was the worst (Lot EN6204). Caller also reported that her nurse at the clinic as well as her brother in law died because of the vaccine. She also mentions that her sister in law first got covid recovered with no problems and got more sick when she got the vaccine and was asking for help because her doctor has tried everything already and that she cannot live like this anymore.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose 5 (booster), single (Lot number: GG044U) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EM9810), in right arm, on 27Jul2021 as dose 2, single (Lot number: EN6205), in right arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 22Jul2022 as dose 4 (booster), single (Lot number: FM7553), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Polio vaccine allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Sep2011. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 20Apr2023 to 24Apr2023 for COVID-19 treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300178172 same patient, different drug/event;US-PFIZER INC-202300178192 same patient/vaccine, different dose/event (Dose 2);
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: the 1st one she had a little headache, the 2nd one it got worse; 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), 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, reaction(s): "Headache".  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "the 1st one she had a little headache, the 2nd one it got worse".  Additional information: Patient wanted to report that she got 3 Pfizer Covid vaccines, the 1st one she had a little headache, the 2nd one it got worse.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Joint swelling
Clinical narrative: the 1st one she had a little headache, the 2nd one it got worse, but the 3rd one was the worst (Lot#: EN6204).; all her joints have gotten swollen; doesn't have energy.; 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), as dose 3 (booster), single (Lot number: EN6204) 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): "1st one she had a little headache"; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "the 1st one she had a little headache, the 2nd one it got worse".  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "the 1st one she had a little headache, the 2nd one it got worse, but the 3rd one was the worst (Lot#: EN6204)."; JOINT SWELLING (non-serious), outcome "unknown", described as "all her joints have gotten swollen"; ASTHENIA (non-serious), outcome "unknown", described as "doesn't have energy.".  Additional Information: Caller was told by her doctor to call us, and wanted to report that she got 3 Pfizer covid vaccines, the 1st one she had a little headache, the 2nd one it got worse, but the 3rd one was the worst (Lot#: EN6204). Caller says that all her joints have gotten swollen even though she doesn't have rheumatoid arhtritis and that she doesn't have energy.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller also reports that her nurse at the clinic died because of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: DEATH (death, medically significant), outcome "fatal", described as "Caller also reports that her nurse at the clinic died because of the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300178092 same reporter, same product, different patient/event;; Reported Cause(s) of Death: Caller also reports that her nurse at the clinic died because of the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller also reports that her nurse at the clinic as well as her brother in law died because of the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Caller also reports that her nurse at the clinic as well as her brother in law died because of the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Caller also reports that her nurse at the clinic as well as her brother in law died because of the vaccine.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; 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 43-year-old male patient received BNT162b2 (BNT162B2 NOS), on 11Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Barrett's esophagus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative 9 days after initial symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300178136 same patient/product, different dose/event;
Sex: M
Vaccine: PNC20
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: had 100 fever; pain and redness at site of injection; pain and redness at site of injection; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 45-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "had 100 fever"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "pain and redness at site of injection". The patient underwent the following laboratory tests and procedures: Body temperature: 100, notes: had 100 fever.  Additional information: Event took place after use of product. 45 yo diabetic male pt received Prevnar20 as directed and had 100 fever, pain and redness at site of injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Toxic encephalopathy, Toxic neuropathy
Clinical narrative: Toxic encephalopathy; Toxic neuropathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000000472.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOXIC ENCEPHALOPATHY (medically significant), outcome "unknown"; TOXIC NEUROPATHY (medically significant), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC13
Symptoms: Device breakage
Clinical narrative: The whole thing where you put needle in came off; Prevnar 13 doses when they went to open the top of it in the lab, the top of it kinda shattered; This is a spontaneous report received from a contactable reporter (Nurse) and from the Product Quality Group.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown" described as "The whole thing where you put needle in came off"; DEVICE BREAKAGE (non-serious), outcome "unknown" described as "Prevnar 13 doses when they went to open the top of it in the lab, the top of it kinda shattered."  Additional information: PQC assessment of event is "Reportable." Associated Complaint(s): 8264117. They usually unscrew from clear part that is attached to prefilled syringe and put the needle in. The whole thing where you put needle in came off. Prevnar 13 doses when they went to open the top of it in the lab, the top of it kinda shattered.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Infection, Maternal exposure during pregnancy, Premature baby
Clinical narrative: Maternal exposure during pregnancy, first trimester; Baby has been hospitalized for recurrent infections; Baby has autoimmune issues too; premature live birth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 11-month-old male patient was exposed to BNT162b2 (BNT162B2), transplacental, administration details for the mother: on 19Nov2021 as dose 3 (booster), single (Lot number: FH8027) for covid-19 immunisation. The mother of the patient was 30 years old at the time of vaccination. The patient's relevant medical history was not reported. The mother's relevant medical history included: "Number of previous pregnancies: 1" (unspecified if ongoing); "Lichen Planus in Vagina", start date: 07Dec2021 (ongoing), notes: Pertinent Details: Extreme pain, autoimmune disease, took many many antibiotics. Date of last menstrual period of the mother: 21Oct2021. The mother was 5 weeks pregnant at the time of exposure to BNT162b2. The mother was 5 weeks pregnant at the event onset. The mother is expected to deliver one baby(s) on 28Jul2022. The mother's concomitant medications were not reported. The mother's vaccination history included: moderna covid-19 vaccine (DOSE 1, SINGLE, Batch/Lot: KS139, Anatomical site: left arm), administration date: 20Sep2021, for COVID-19 immunisation; moderna covid-19 vaccine (DOSE 2, SINGLE, Batch/Lot: KS139, Anatomical site: left arm), administration date: 27Oct2021, for COVID-19 immunisation. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization), outcome "unknown", described as "Maternal exposure during pregnancy, first trimester"; INFECTION (hospitalization), outcome "unknown", described as "Baby has been hospitalized for recurrent infections"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Baby has autoimmune issues too"; PREMATURE BABY (non-serious), outcome "unknown", described as "premature live birth". The baby was delivered premature, delivery date 15Jul2022. Clinical course: Baby was stressed during delivery needed antibiotics.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300014645 same reporter/drug, different patient/AE (Mother case);
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Multiple sclerosis
Clinical narrative: multiple sclerosis; weak immune system; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "weak immune system". Clinical course: She said that she's 63 and her husband was 65 with multiple health issues and just wanted to verify because he got an email that said that individuals aged 65 and over that have had their booster 4 months ago are eligible for a booster and moderately or severely immunocompromised which would be her. She wanted to know what the Bivalent vaccine is.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Incorrect route of product administration, Suspected COVID-19
Clinical narrative: Contracted Covid-19; Contracted Covid-19; Inappropriate route of vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "T2D (Type 2 diabetes)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Contracted Covid-19"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate route of vaccination".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Pneumothorax
Clinical narrative: lungs collapsed; left arm locked up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMOTHORAX (hospitalization, medically significant), outcome "unknown", described as "lungs collapsed"; MUSCULOSKELETAL DISORDER (hospitalization), outcome "unknown", described as "left arm locked up". Therapeutic measures were taken as a result of musculoskeletal disorder. Clinical course: Verbal report: The (withheld) made an outbound call to the patient (name withheld) to do a follow-up call and offer a resource. Upon contacting the patient, the patient reported that recently she changed medicines. She no longer takes Ibrance. Now she is on Xeloda. They took her off of Ibrance because her neutrophils were too low on Ibrance. The patient's lowest score was 300-400. Patient also said that being on Ibrance helped a little with her tumors in her upper chest, but the doctor(s) still want to put her on Xeloda because her neutrofills were consistently too low. Patient also has lymphedema in her left arm. Patient also reports that after taking the Pfizer covid vaccine her left arm locked up and her lungs collapsed. She had to be hospitalized. She also explained that ever since she took the Pfizer covid vaccine, she has had to do physical therapy to improve the movement in her left arm that locked up after taking the Pfizer vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200096606 same patient, different drug and different events.;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Did have following covid vaccine: 01May2021(Moderna); 05Nov2021(Moderna); 19Apr2022(Moderna); 25Oct2022(Pfizer-Bivalent)/reason for taking: positive antigen test and symptoms of COVID; Did have following covid vaccine: 01May2021(Moderna); 05Nov2021(Moderna); 19Apr2022(Moderna); 25Oct2022(Pfizer-Bivalent)/reason for taking: positive antigen test and symptoms of COVID; Did have following covid vaccine: 01May2021(Moderna); 05Nov2021(Moderna); 19Apr2022(Moderna); 25Oct2022(Pfizer-Bivalent); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01May2021 as dose 1, single (Batch/Lot number: unknown), on 05Nov2021 as dose 2, single (Batch/Lot number: unknown) and on 19Apr2022 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. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2022, outcome "not recovered", described as "Did have following covid vaccine: 01May2021(Moderna); 05Nov2021(Moderna); 19Apr2022(Moderna); 25Oct2022(Pfizer-Bivalent)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "Did have following covid vaccine: 01May2021(Moderna); 05Nov2021(Moderna); 19Apr2022(Moderna); 25Oct2022(Pfizer-Bivalent)/reason for taking: positive antigen test and symptoms of COVID". 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 includes Paxlovid treatment from 29Mar2023 to 02Apr2023. Clinical course: The patient had no known previous infections.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148313 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Presyncope, Vertigo
Clinical narrative: the Bivalent booster made her vertigo off the charts like fuel in a fire/has ringing in her ears, vertigo issues; almost passed out at the office when her vertigo got way out of control; fatigue; cough; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient in her 50's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "vertigo" (ongoing), notes: COVID as a disease made her vertigo worse. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization, reaction(s): "got COVID a while later". The following information was reported: VERTIGO (non-serious), 1 week after the suspect product(s) administration, outcome "unknown", described as "the Bivalent booster made her vertigo off the charts like fuel in a fire/has ringing in her ears, vertigo issues"; PRESYNCOPE (non-serious), 1 week after the suspect product(s) administration, outcome "unknown", described as "almost passed out at the office when her vertigo got way out of control"; FATIGUE (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown". Clinical information: She was explaining that she did fine with the original vaccines for COVID 19 but then got COVID a while later. COVID as a disease made her vertigo worse. The following year she received a Bivalent booster (Pfizer BioNTech Bivalent Booster) and about a week later almost passed out at the office when her vertigo got way out of control. She said the disease made her vertigo worse, but the Bivalent booster made her vertigo off the charts like fuel in a fire. She still, today has ringing in her ears, vertigo issues, fatigue and a cough but didn't want to be contacted. She just explained she has vertigo and that was all known. The event took place after the use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: had a cold recently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "had a cold recently".  Additional information: A caller was asking for additional medical information if one should wait before they get the new bivalent vaccine if one had a cold recently for the reason that he can not find it on the fact sheet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: vaccine which may have been reconstituted with 0.7mL sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6mL Sodium Chloride solution provided by sanofi pasteur no reported adverse event; Initial information received on 02-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 20 years old male patient who experienced vaccine which may have been reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution provided by sanofi pasteur no reported adverse event while receiving vaccine Yellow Fever Vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On 07-Mar-2023, the patient received a dose of suspect Yellow Fever Vaccine, solution for injection which may have been reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution provided by sanofi pasteu (lot: UJ782AA) via subcutaneous route in unknown administration site for Prophylactic vaccination with no reported adverse event (product preparation error).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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: 24.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Yellow Fever Vaccine which may have been reconstituted with 0.7mL sterile diluent provided by Merck and meant for Merck live virus reconstitution, rather than 0.6mL Sodium Chloride solution with no reported adverse event; Administered IM in lieu of SQ as directed with no reported adverse event; Initial information received on 02-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 24 years old female patient who experienced Yellow Fever Vaccine - [YF-VAX] which may have been reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution and administered IM in lieu of SQ as directed with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On 28-Feb-2023, the patient received a dose of suspect Yellow Fever Vaccine -solution for injection which may have been reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution (lot: UJ782AA) via intramuscular route in lieu of SQ as directed in unknown administration site for prophylactic vaccination with no reported adverse event (product preparation error) and (incorrect route of product administration) (latency: same day).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired menactra to a patient with no reported adverse event; Initial information received on 28-Apr-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an 18 years old female patient who was administered an expired Meningococcal A-C-Y-W135 (D CONJ) vaccine [MENACTRA]to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection of lot U7273BB and expiry: 24-Apr-2023 via unknown route in unknown administration site for Immunization.  On an unknown date, the patient developed a non-serious event administered an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) Vaccine to a patient with no reported adverse event (expired product administered) (latency: 1 day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired menactra to a patient with no reported adverse event.   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: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy
Clinical narrative: vaccine given to 27 weeks pregnant patient with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 21 years old female patient who was exposed to vaccine influenza usp trival a-b subvirion no preservative vaccine [fluzone] in context of vaccine given to 27 weeks pregnant patient with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported vaccine given to 27 weeks pregnant patient with no reported adverse event occurred at 27 weeks of pregnancy and the patient was exposed to Influenza usp trival a-b subvirion no preservative vaccine at 27 weeks of pregnancy, during third pregnancy trimester for influenza usp trival a-b subvirion no preservative vaccine. The date of last menstrual period was reported as 23-Oct-2022. The estimated due date is 30-Jul-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 28-Apr-2023, the patient received 0.5 ml of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection lot UJ906AA, 30-Jun-2023 via intramuscular route in the left deltoid for Influenza.  On 28-Apr-2023 the patient developed a non-serious vaccine given to 27 weeks pregnant patient with no reported adverse event (exposure during pregnancy) (latency: same day).  Relevant prenatal testing after exposure was unknown  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event vaccine given to 27 weeks pregnant patient with no reported adverse event. Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Off label use
Clinical narrative: prescribing menactra with 2-doses for primary vaccination of a 17-year old male going to college with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves 17 years old male patient for whom meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] was prescribed with 2-doses for primary vaccination going to college with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-May-2023, the patient received a dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection (lot number, dosage, strength, expiry date- not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On 01-MAY-2023 , (latency- same day), the patient developed a non-serious event of prescribing menactra with 2-doses for primary vaccination for a patient going to college with no reported adverse event (off label use).  Reportedly, A Father calling on behalf of his son for whom college is prescribing off-label use to take 2-doses of MENACTRA prior to starting college wanting to know how many doses a 17-year-old should receive who is unvaccinated to Meningococcal (Groups A, C, Y and W-135). The father reported that the consumer just received their initial dose of MENACTRA today   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion, temperature reached negative -40F degrees duration of 8 hours and 25 minutes with no reported adverse event; received vaccine post-temperature excursion where the vaccines were not suitable for use with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 19 month old female patient and reporter reported that temperature reached negative -40f degrees duration of 8 hours and 25 minutes with no reported adverse event and received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] post-temperature excursion where the vaccines were not suitable for use with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Apr-2023, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE for Suspension for injection (lot: C5969AD and expiry date: 17-Feb-2024) via intramuscular route in the left arm for Immunization.   On an unknown date, the temperature reached negative -40f degrees duration of 8 hours and 25 minutes with no reported adverse event (product storage error) (unknown latency).  On 04-APR-2023 the patient received vaccine post-temperature excursion where the vaccines were not suitable for use with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.   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.