chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Vaccine brand other=Moderna/ vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 37 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208) and on 02Apr2021 as dose 2, single (Lot number: EW0151) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Dec2021 as dose 3 (booster), single (Lot number: 024C21A) 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 04Dec2021, outcome "unknown", described as "Vaccine brand other=Moderna/ vaccine brand=Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included COVID-19 Treatment form 24Feb2023 to 01Mar2023.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
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 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfate" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "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: Linked Report(s) : US-PFIZER INC-202300098063 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Deathly sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient 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 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: ILLNESS (medically significant), outcome "unknown", described as "Deathly sick". Clinical course: She was not sure what product she was calling about. Was asking if manufacturer Paxlovid? Reported her last booster the Pfizer bivalent COVID vaccine made her deathly sick. She did not know what to do, she did not know if she had to get another booster shot because her choice would be not to do it. Advised to consult with HCP and offered to transfer to alternate source for inquiry. Stated she had a doctor calling on the other line and she would need to report at a different time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: I originally tested positive using a home test on 14Feb2023; I originally tested positive using a home test on 14Feb2023; Vaccine dose number=1/2: vaccine brand=Pfizer/BioNTech; Vaccine dose number=3/4/5: vaccine brand=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0150), in left arm and on 01May2021 as dose 2, single (Lot number: EW0171) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Dec2021 as dose 3, single (Lot number: 013F21A), in left arm, on 11May2022 as dose 4, single (Lot number: 056A22A), in left arm and on 21Nov2022 as dose 5, single (Lot number: 017H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic sinusitis" (ongoing); "high cholesterol" (unspecified if ongoing); "stroke" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "known allergies: NSAIDs" (unspecified if ongoing), notes: known allergies: NSAIDs; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin; Septra, reaction(s): "known allergies: Septra", notes: known allergies: Septra; Relafen, reaction(s): "known allergies: Relafen", notes: known allergies: Relafen. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Dec2021, outcome "unknown", described as "Vaccine dose number=1/2: vaccine brand=Pfizer/BioNTech; Vaccine dose number=3/4/5: vaccine brand=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Feb2023, outcome "unknown" and all described as "I originally tested positive using a home test on 14Feb2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Feb2023) positive, notes: using a home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia, Nausea, Overdose
Clinical narrative: make me sick; muscle and body ache; muscle and body ache; some nausea; headache; overdose (4 doses in one shot); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-713740 (Moderna).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Lot Number: Unknown, Route of administration: Unknown), administration date: 06Feb2021, when the patient was 69-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE , Lot Number: Unknown, Route of administration: Unknown), administration date: 27Feb2021, when the patient was 69-year-old, for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious) with onset 08Oct2021, outcome "unknown", described as "overdose (4 doses in one shot)"; HEADACHE (non-serious) with onset 09Oct2021, outcome "unknown", described as "headache "; ILLNESS (non-serious) with onset 09Oct2021, outcome "unknown", described as "make me sick"; MYALGIA (non-serious), PAIN (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "muscle and body ache"; NAUSEA (non-serious) with onset 09Oct2021, outcome "unknown", described as "some nausea".  Additional Information: Reporter stated that All vaccines made her sick, muscle and body aches, some nausea, headache the next day after the vaccine.  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-202300099348 same patient/ same reporter/ different dose/ different events; US-PFIZER INC-202300099349 same patient/ same reporter/ different dose/ different events;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: make me sick; muscle and body ache; muscle and body ache; some nausea; headache; overdose (4 doses in one shot); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-713740 (Moderna).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Lot Number: Unknown, Route of administration: Unknown), administration date: 06Feb2021, when the patient was 69-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE , Lot Number: Unknown, Route of administration: Unknown), administration date: 27Feb2021, when the patient was 69-year-old, for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious) with onset 08Oct2021, outcome "unknown", described as "overdose (4 doses in one shot)"; HEADACHE (non-serious) with onset 09Oct2021, outcome "unknown", described as "headache "; ILLNESS (non-serious) with onset 09Oct2021, outcome "unknown", described as "make me sick"; MYALGIA (non-serious), PAIN (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "muscle and body ache"; NAUSEA (non-serious) with onset 09Oct2021, outcome "unknown", described as "some nausea".  Additional Information: Reporter stated that All vaccines made her sick, muscle and body aches, some nausea, headache the next day after the vaccine.  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-202300099348 same patient/ same reporter/ different dose/ different events; US-PFIZER INC-202300099349 same patient/ same reporter/ different dose/ different events;
Age: 59.0
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 a contactable reporter(s) (Consumer or other non 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), on 24Nov2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: FENOFIBRATE; TRIAMTERENE; LOSARTAN. The following information was reported: COVID-19 (medically significant) with onset 01Mar2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 01Mar2023, outcome "not recovered". The events "drug ineffective" and "covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Mar2023) Positive. 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: Linked Report(s) : US-PFIZER INC-202300097422 same patient, different drug/event;
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder, Malaise
Clinical narrative: He was at the hospital; He has been in four times for lung problem; He has been in the hospital for two month; He is very very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2 NOS), on 07Dec2022 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: LUNG DISORDER (hospitalization) with onset Dec2022, outcome "not recovered", described as "He was at the hospital; He has been in four times for lung problem; He has been in the hospital for two month"; MALAISE (non-serious), outcome "unknown", described as "He is very very ill". The patient was hospitalized for lung disorder (start date: Dec2022, discharge date: 2023). Clinical course: Well, reporter had a question about Pfizer medication. Her son had it the injection (Clarified as Pfizer COVID-19 Vaccine) 07Dec2022 and by the end of the month he was at the hospital, he had been in four times for lung problem and reporter did not knew if this was a reaction from the injection or what the problem was, but he had been in the hospital for two month and he never really had any big problem with lungs or anything. Yes, he kept down with the virus and from then on he had lungs problems and he was having lung problems yesterday. Reporter was informed about the Role of Pfizer Drug Safety and also informed about Pfizer Medical Information Department. Okay, Reporter did not see if there was any compensation up for that or not but he was very very ill.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
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) (Physician).  A 50-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "vit d deficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: plus antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 44 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Nov2021 as dose 3 (booster), single (Lot number: 034f21a) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; OMEPRAZOLE; AMLODIPINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Negative; (27Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Treatment of COVID-19 from 21Dec2022 to 26Dec2022. After course of Paxlovid, patient stated he felt well and tested negative with at home antigen test on 26Dec2022, 27Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300097300 same patient, different drug/event;
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 NOS), on 03Sep2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroid disease" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Acetaminophen, reaction(s): "known allergies: Acetaminophen", notes: known allergies: Acetaminophen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from  25Feb2023 to 01Mar2023.  Clinical course: Covid Rebound after taking Paxlovid five days after the last day of taking the medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia, Nausea, SARS-CoV-2 test
Clinical narrative: Sick; Muscle and body aches; Nausea; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-713740 (Moderna).  A 69-year-old female patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Feb2021, 1 day after the suspect product(s) administration, outcome "unknown"; MYALGIA (non-serious) with onset Feb2021, 1 day after the suspect product(s) administration, outcome "unknown", described as "Muscle and body aches"; NAUSEA (non-serious) with onset Feb2021, 1 day after the suspect product(s) administration, outcome "unknown"; ILLNESS (non-serious) with onset Feb2021, 1 day after the suspect product(s) administration, outcome "unknown", described as "Sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported all vaccines made her sick, muscle and body aches, some nausea, headache the next day after the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia, Nausea, Pain
Clinical narrative: Make me sick; Muscle and body aches; Muscle and body aches; Nausea; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-713740 (Moderna).  A 69-year-old female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 06Feb2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "sick", "muscle and body aches", "muscle and body aches", "nausea", "headache". The following information was reported: HEADACHE (non-serious) with onset 28Feb2021, outcome "unknown"; ILLNESS (non-serious) with onset 28Feb2021, outcome "unknown", described as "Make me sick"; MYALGIA (non-serious), PAIN (non-serious) all with onset 28Feb2021, outcome "unknown" and all described as "Muscle and body aches"; NAUSEA (non-serious) with onset 28Feb2021, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that all vaccines make her sick, muscle and body aches, some nausea, headache the next day after the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Make me sick; Muscle and body aches; Muscle and body aches; Nausea; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-713740 (Moderna).  A 69-year-old female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 06Feb2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "sick", "muscle and body aches", "muscle and body aches", "nausea", "headache". The following information was reported: HEADACHE (non-serious) with onset 28Feb2021, outcome "unknown"; ILLNESS (non-serious) with onset 28Feb2021, outcome "unknown", described as "Make me sick"; MYALGIA (non-serious), PAIN (non-serious) all with onset 28Feb2021, outcome "unknown" and all described as "Muscle and body aches"; NAUSEA (non-serious) with onset 28Feb2021, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that all vaccines make her sick, muscle and body aches, some nausea, headache the next day after the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; Treatment of 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.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Lot number: CT3175) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: EN6201), in left arm, on 17Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 29Jun2022 as dose 4 (booster), single (Lot number: FP7139), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient received Paxlovid as Treatment of COVID-19 from 21Feb2023 to 27Feb2023. Patient took no other medication in 2 weeks. Patient had no known allergies and had other medical histories.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300098568 Same reporter and patient, different product and event;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: after the first shot I got COVID shortly thereafter; after the first shot I got COVID shortly thereafter; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 58-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "after the first shot I got COVID shortly thereafter". Therapeutic measures were taken as a result of drug ineffective and suspected COVID-19. Clinical information: It was reported that the patient was currently being treated in mental health department for major depression. He also had post-traumatic stress disorder (PTSD) prior to the shot he had. It was also mentioned that he had normal (no increased blood pressure, high cholesterol and triglyceride). It was stated that the after the first shot, he got COVID immediately. He received an unspecified treatment for the event.   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-202300100040 same product, patient, different AEs and  dose number;
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 62 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had no known allergies. Patient received treatment with paxlovid from 24Feb2023 till 01Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300099645 Same patient, different product, different event;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: EI9267), in left arm, on 04Mar2021 as dose 2, single (Lot number: EN6202), in left arm, on 18Aug2021 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "Allergy to Eggplant" (unspecified if ongoing); "Allergy to Kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient did not receive any other medication in 2 weeks. The patient received anti-viral treatment with Paxlovid from 24Feb2023 to 01Mar2023. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300099732 Same patient, different product, different event;
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Moderna, Dose Number: 3 / Pfizer, Dose Number: 1, 2, 4; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 4 (booster), single (Lot number: gj3277) at the age of 35 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: ER2613), in left arm and on 06Apr2021 as dose 2, single (Lot number: EW0158), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Dec2021 as dose 3 (booster), single (Lot number: 077h21a), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna, Dose Number: 3 / Pfizer, Dose Number: 1, 2, 4". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid which was given on 06Mar2023.; Sender's Comments: Based on available information, a lack of efficacy (VACCINATION FAILURE and COVID-19) under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: Other medical history: HBP obesity; "obesity" (unspecified if ongoing), notes: Other medical history: HBP obesity; "Cymbalta and cephalexin allergy" (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Treatment of COVID-19 from 24Feb2023 to 01Mar2023.  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-202300099886 Same patient, different product, different event;
Sex: U
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: a drastic change in my health/experienced health related issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jul2021 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: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "a drastic change in my health/experienced health related issues". Additional information: Since Jul2021, the patient noticed a drastic change in health. The patient experienced health related issues that the patient knew were directly connected to the 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-PV202300045087 Same patient, Same reporter, Same product, Different dose, Same event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown), in right 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: "High blood pressure" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "5 major joint replacements" (unspecified if ongoing); "numerous surgeries for various reasons" (unspecified if ongoing); "cervical cancer" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 03Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID-19". The patient tested SARS-CoV-2 positive  in Feb2023. The patient started paxlovid on 23Feb2023 and took for 5 days. She tested on day six and was still positive. After 11 days she retested and was still positive but the line was barely visible. At this time she had no symptoms. She then waited and retested on 08Mar2023 when symptoms returned and was positive right away. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies Yes" (unspecified if ongoing), notes: known allergies Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient received treatment with Paxlovid from 22Feb2023 to 27Feb2023, and the patient experienced fever and hoarseness returned plus more Nasal congestion. Paxlovid rebound.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Illness, Polymyalgia rheumatica
Clinical narrative: Polymyalgia rheumatica; decline in health; sick more or less; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER2613) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Apr2021, outcome "not recovered", described as "sick more or less"; POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "decline in health". Therapeutic measures were taken as a result of polymyalgia rheumatica, illness. Clinical course: The patient needed to get into a vaccine study. She had been sick more or less since Apr2021. She had been on prednisone since Apr2022. She was diagnosed with polymyalgia rheumatica. She was still sick. She sees a relationship between the vaccine and her decline in health. She had never been diagnosed with Covid19.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site reaction
Clinical narrative: injection site reactions after receiving flu and pneumonia vaccines while on Ibrance; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 60-year-old female patient received palbociclib (IBRANCE); pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE REACTION (non-serious), outcome "unknown", described as "injection site reactions after receiving flu and pneumonia vaccines while on Ibrance". The action taken for palbociclib was unknown.  Additional information: patient reported injection site reactions after receiving flu and pneumonia vaccines while on Ibrance. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got a mild case of COVID/got tested positive; got a mild case of COVID/got tested positive; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (batch/lot number: unknown) for covid-19 immunization; BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (batch/lot number: unknown) for covid-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (batch/lot number: unknown) and as dose 2, single (batch/lot number: unknown) for covid-19 immunization. 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 a mild case of COVID/got tested positive". The patient underwent the following laboratory tests and procedures: COVID-19 test: positive.  Additional information: The reporter informed that she got the four doses of Pfizer COVID-19 vaccine. She was interested of getting the fifth shot. The reporter was asking about the time frame of when she will be going to get the fifth shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC20
Symptoms: Death, Hypervolaemia
Clinical narrative: fluid overloaded; passed away; This is a spontaneous report received from contactable reporter (Nurse) from a sales representative.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Feb2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 24Feb2023, outcome "fatal", described as "passed away"; HYPERVOLAEMIA (hospitalization, medically significant), outcome "unknown", described as "fluid overloaded". The patient date of death was 24Feb2023. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Additional information: Nurse administered PCV20 on 16Feb2023 to patient. On 17Feb2023, patient went to the hospital and on 24Feb2023 the patient passed away. They didn't report because based on doctor it didn't feel it was related to Prevnar 20 and instead on fluid overloaded however the nurse felt suspicion that it was due to her giving PCV20 which is why she asked me what the mortality rate of PCV20 is.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: The limited information in this report precludes a full assessment of the case.  The patient's death on fluid overloaded which occurred one day after the vaccination more likely is associated with underlying medical condition.  However, follow-up information such medical history, concurrent diseases, concomitant medications and event term details especially death cause and autopsy results are needed for meaningful evaluation.   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; Reported Cause(s) of Death: passed away
Sex: U
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: a drastic change in my health/experienced health related issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jul2021, for COVID-19 Immunization, reaction(s): "a drastic change in my health/experienced health related issues". The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset Aug2021, outcome "unknown", described as "a drastic change in my health/experienced health related issues".  Additional Information: It was reported that the patient noticed a drastic change in health in Aug2021 when 2nd dose COVID vaccine was received. The patient also experienced health related issues and knew that they were directly connected to the 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-202300101458 Same patient, Same reporter, Same product, Different dose, Same event;
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Eczema
Clinical narrative: autoimmune reaction; Eczema; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023SA040901.  A 92-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), (Batch/Lot number: unknown) at first dose. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number unknown, manufacturer unknown), administration date: 2022, for Covid-19 immunisation. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune reaction"; ECZEMA (medically significant), outcome "unknown". It was reported that "he believes his eczema is due to an autoimmune reaction from receiving the Pfizer Covid Vaccine regimen. He received two doses of the vaccine back in early 2022. No lab data was reported." The action taken for dupilumab was unknown. Case was assessed as not serious and Company agent (Private) casual was Yes.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  No further information is expected.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incomplete course of vaccination, Medication error, No adverse event
Clinical narrative: patient having received only one Menactra vaccine prior to the age of 18 with no reported adverse event; Initial information received on 03-Mar-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 18 years old male patient who had patient having received only one menactra vaccine prior to the age of 18 with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 1 of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection (lot number, strength, frequency, dosage, expiration date not reported via unknown route in unknown administration site for immunisation.  On an unknown date the patient developed a non-serious event patient having received only one menactra vaccine prior to the age of 18 with no reported adverse event (incomplete course of vaccination) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient having received only one menactra vaccine prior to the age of 18 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 guidelines. 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.