chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Significant arthralgia; Fatigue; Left arm soreness; Feverish; Feeling overall unwell; 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 received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering"; MALAISE (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering", described as "Feeling overall unwell"; PYREXIA (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering", described as "Feverish"; PAIN IN EXTREMITY (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering", described as "Left arm soreness"; ARTHRALGIA (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering", described as "Significant arthralgia". Relevant laboratory tests and procedures are available in the appropriate section.  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: SARS-CoV-2 test
Clinical narrative: Significant arthralgia; Fatigue; Left arm soreness; Feverish; Feeling overall unwell; 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 received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering"; MALAISE (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering", described as "Feeling overall unwell"; PYREXIA (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering", described as "Feverish"; PAIN IN EXTREMITY (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering", described as "Left arm soreness"; ARTHRALGIA (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering", described as "Significant arthralgia". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; off label use; Interchange of vaccine products; 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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: El9265), in left arm, on 20Feb2021 as dose 2, single (Lot number: En6200), in right arm and on 26Sep2021 as dose 3 (booster), single (Lot number: En6200) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Apr2022 as dose 4 (booster), single (Lot number: 066k21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing). There was no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Apr2022, outcome "recovering"; OFF LABEL USE (medically significant) with onset 03Apr2022, outcome "recovering"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) positive, notes: Rebound symptoms and positive test 9 days after negative tests and no symptoms; (Sep2022) negative, notes: Rebound symptoms and positive test 9 days after negative tests and no symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19; tested positive for covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 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; Manufacture unknown), for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Sep2022, outcome "not recovered" and all described as "tested positive for covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Sep2022) Negative; (16Sep2022) Negative; (17Sep2022) Positive. Clinical course: On 08Sep2022, the patient got the updated Covid vaccine. On 14Sep2022 was the beginning of some symptoms. At that day it was like just little cough seems like an allergic cough but by 15Sep2022 morning, it was obvious that something was going on. So, the patient tested negative on 15Sep2022, tested negative on 16Sep2022, tested positive on the 17Sep2022. Seriousness reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergic sinusitis, Hypersensitivity, Illness, SARS-CoV-2 test, Weight
Clinical narrative: lost a lot of weight; sick; dry conditions and had a very bad fire with smoke in the air that caused allergy problems; Sinus problem in Aug2022, allergies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Lot number: GL9694), in left arm for covid-19 immunisation. The patient's relevant medical history included: "sensitive skin" (unspecified if ongoing), notes: has had sensitive skin for years and years and years and doing everything no dyes no perfumes; "sinus", start date: Aug2022 (unspecified if ongoing), notes: has had sensitive skin for years and years and years and doing everything no dyes no perfumes; "allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Pfizer Covid vaccine #1 on 05Jun2021, lot EW0180. Does not have NDC or expiry to provide.), administration date: 05Jun2021, for COVID-19 immunization; BNT162b2 (Pfizer Covid vaccine #2 26Jun2021, lot EW0198. Does not have NDC or expiry to provide.), administration date: 26Jun2021, for COVID-19 immunization; BNT162b2 (Pfizer Covid vaccine booster on 23Dec2021 , lot 330258D. Does not have NDC or expiry to provide.), administration date: 23Dec2021, for COVID-19 immunization; Flu (She had the regular Covid shot and gets a flu shot every year and has never had a reaction in her life). The following information was reported: ALLERGIC SINUSITIS (non-serious) with onset Aug2022, outcome "unknown", described as "Sinus problem in Aug2022, allergies"; HYPERSENSITIVITY (non-serious) with onset 20Sep2022, 8 days after the suspect product(s) administration, outcome "not recovered", described as "dry conditions and had a very bad fire with smoke in the air that caused allergy problems"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost a lot of weight"; ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had a sinus problem in Aug2022, allergies. They have dry conditions and had a very bad fire with smoke in the air that caused allergy problems. Had the Covid outbreak at the facility and tested negative she was out a couple days for safety as she takes care of her mother.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: lost a lot of weight; sick; dry conditions and had a very bad fire with smoke in the air that caused allergy problems; Sinus problem in Aug2022, allergies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Lot number: GL9694), in left arm for covid-19 immunisation. The patient's relevant medical history included: "sensitive skin" (unspecified if ongoing), notes: has had sensitive skin for years and years and years and doing everything no dyes no perfumes; "sinus", start date: Aug2022 (unspecified if ongoing), notes: has had sensitive skin for years and years and years and doing everything no dyes no perfumes; "allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Pfizer Covid vaccine #1 on 05Jun2021, lot EW0180. Does not have NDC or expiry to provide.), administration date: 05Jun2021, for COVID-19 immunization; BNT162b2 (Pfizer Covid vaccine #2 26Jun2021, lot EW0198. Does not have NDC or expiry to provide.), administration date: 26Jun2021, for COVID-19 immunization; BNT162b2 (Pfizer Covid vaccine booster on 23Dec2021 , lot 330258D. Does not have NDC or expiry to provide.), administration date: 23Dec2021, for COVID-19 immunization; Flu (She had the regular Covid shot and gets a flu shot every year and has never had a reaction in her life). The following information was reported: ALLERGIC SINUSITIS (non-serious) with onset Aug2022, outcome "unknown", described as "Sinus problem in Aug2022, allergies"; HYPERSENSITIVITY (non-serious) with onset 20Sep2022, 8 days after the suspect product(s) administration, outcome "not recovered", described as "dry conditions and had a very bad fire with smoke in the air that caused allergy problems"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost a lot of weight"; ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had a sinus problem in Aug2022, allergies. They have dry conditions and had a very bad fire with smoke in the air that caused allergy problems. Had the Covid outbreak at the facility and tested negative she was out a couple days for safety as she takes care of her mother.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: ER8732), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8732), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hx Hbp" (unspecified if ongoing); "bariatric Gatric RNY recently" (unspecified if ongoing); "asthma" (unspecified if ongoing); "chronic intestinal issues" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOL [PANTOPRAZOLE], start date: 29Jul2021, stop date: 12Sep2022; ADDERALL, start date: 11Nov2020; VITAMIN A [RETINOL], start date: 30Jul2022, stop date: 15Sep2022; CALCIUM, start date: 31Jul2021; VITAMIN B12 [CYANOCOBALAMIN], start date: 30Jul2022. Past drug history included: Tegretol, reaction(s): "Known allergies: Tegretol", notes: Known allergies: Tegretol. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: Patient revived Covid-19 treatment with Paxlovid  from 13Sep2022, to 18Sep2022.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: 210122-137), in left arm, on 15Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: Other medical history: hypothyroid. There was no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (21Sep2022) Positive, notes: Return of positive home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 for which included Paxlovid from 13Sep2022 to 17Sep2022.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She thinks she had Covid a couple of weeks.; She thinks she had Covid a couple of weeks.; 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 received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0168), in arm and on 01Jul2021 as dose 2, single (Lot number: WM5350) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Stress" (unspecified if ongoing), notes: is a stressor and is horrible.; "She is old and has to get her glasses" (unspecified if ongoing), notes: She is old and has to get her glasses; "Surgery" (unspecified if ongoing), notes: she had surgery. There were no concomitant medications. Vaccination history included: Flu shots (Caller said did not hurt and did not feel like anything and the flu shots hurt worse and she won't get the flu shot anymore.), for Immunization, reaction(s): "hurt". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "She thinks she had Covid a couple of weeks.". Clinical course: He has a caller on the line and she mentioned she got her first and second Pfizer Covid-19 vaccine and got really sick and she was so upset about it and wanted to get the legal department because she lost her job and wants to be paid the month for medical bills and sick for a year and 2 months and now and she can barely move and her whole body was falling apart. She mentioned she could barely walk and wanted to speak to someone to address this concern right away and wanted to speak to someone that was not going to hang up. The caller confirmed the details provided by the transfer agent. Caller said she has never been right and Pfizer saved a lot of lives and she was telling coworker that she does not have HIV and no diabetes and no heart disease and she got sick after the second shot and go to work from her desk to the program in (place name withheld) in the and she has not been right since then on 01Jul2021. She said she thought she had Covid a couple of weeks ago and no friends to give her a home test.; Sender's Comments: Based on the available information in the case, the causal association between the events 'Drug ineffective', 'Suspected COVID-19' and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201182036 similar report from same reporter.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: She thinks she had Covid a couple of weeks.; She thinks she had Covid a couple of weeks.; 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 received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0168), in arm and on 01Jul2021 as dose 2, single (Lot number: WM5350) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Stress" (unspecified if ongoing), notes: is a stressor and is horrible.; "She is old and has to get her glasses" (unspecified if ongoing), notes: She is old and has to get her glasses; "Surgery" (unspecified if ongoing), notes: she had surgery. There were no concomitant medications. Vaccination history included: Flu shots (Caller said did not hurt and did not feel like anything and the flu shots hurt worse and she won't get the flu shot anymore.), for Immunization, reaction(s): "hurt". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "She thinks she had Covid a couple of weeks.". Clinical course: He has a caller on the line and she mentioned she got her first and second Pfizer Covid-19 vaccine and got really sick and she was so upset about it and wanted to get the legal department because she lost her job and wants to be paid the month for medical bills and sick for a year and 2 months and now and she can barely move and her whole body was falling apart. She mentioned she could barely walk and wanted to speak to someone to address this concern right away and wanted to speak to someone that was not going to hang up. The caller confirmed the details provided by the transfer agent. Caller said she has never been right and Pfizer saved a lot of lives and she was telling coworker that she does not have HIV and no diabetes and no heart disease and she got sick after the second shot and go to work from her desk to the program in (place name withheld) in the and she has not been right since then on 01Jul2021. She said she thought she had Covid a couple of weeks ago and no friends to give her a home test.; Sender's Comments: Based on the available information in the case, the causal association between the events 'Drug ineffective', 'Suspected COVID-19' and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201182036 similar report from same reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Vaccine brand other=Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 28Jan2021 at 08:30 as dose 2, single (Lot number: EL1283) at the age of 59 years, in left arm; elasomeran (MODERNA COVID-19 VACCINE), on 07Jan2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Jan2022 at 14:00, outcome "unknown", described as "Vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events Covid 19 and vaccination failure and suspect product bnt162b2 cannot be ruled out.
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory distress
Clinical narrative: Respiratory Distress; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 90-years-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose number unknown (booster), 0.3 ml single (Batch/Lot number: GJ5342, Expiration Date: 18Nov2022) intramuscular for covid-19 immunization. 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.  The following information was reported: RESPIRATORY DISTRESS (death, medically significant) with onset 21Sep2022 at 16:00, outcome "fatal". The patient date of death was 21Sep2022. Reported cause of death: "Respiratory Distress". No autopsy was performed.  Clinical information: About Respiratory Distress: Clarified first patient, 90-years-old old female, passed away at 4pm on 21Sep2022. She went into respiratory distress hours after receiving the vaccine so it was not anaphylaxis related.; Sender's Comments: 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-202201182355 same reporter/product/AE, different patient; Report 2 of 2;; Reported Cause(s) of Death: Respiratory Distress.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid treatment; Covid treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 at 11:00 as dose 1, single (Lot number: EL9269), in left arm, on 01Mar2021 at 11:00 as dose 2, single (Lot number: EN6205), in left arm, on 28Sep2021 at 11:00 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 06May2022 at 11:00 as dose 4 (booster), single (Lot number: F54989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (06Sep2022) Positive, notes: positive antigen test on day 7. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received vaccine but not received any other medication in 2weeks. The patient took Anti-viral medication from 30Aug2022 to 04Sep2022 for treatment of COVID-19. The patient had no other adverse effects from 4 vaccinations.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of 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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Patient had no other medication in 2weeks. Past drug history included: Zithromax, reaction(s): "Known allergies: Zithromax", notes: Known allergies: Zithromax; Gabapentin, reaction(s): "Known allergies: gabapentin", notes: Known allergies: gabepentin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11Sep2022 to 16Sep2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, COVID-19, Drug ineffective, Drug level, SARS-CoV-2 test
Clinical narrative: His 2-dose COVID-19 vaccination series, plus two booster doses, were completed two months prior to infection.; His 2-dose COVID-19 vaccination series, plus two booster doses, were completed two months prior to infection.; The initial case was missing the following minimum criteria: [No Adverse event]. Upon receipt of follow-up information on [21-SEP-2022], this case now contains all required information to be considered valid.   This is a literature report for the following literature source(s).   A 76-year-old male patient received BNT162b2 (BNT162B2), 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: "heart transplant", start date: 2014 (ongoing), notes: He received his heart transplant in 2014. Concomitant medication(s) included: TACROLIMUS taken for heart transplant; MYCOPHENOLATE MOFETIL taken for heart transplant. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 2 months after the suspect product(s) administration, outcome "recovered" and all described as "His 2-dose COVID-19 vaccination series, plus two booster doses, were completed two months prior to infection.". The patient underwent the following laboratory tests and procedures: Blood creatinine (1.8-2.0): 2.6 mg/dl; Drug level (4-6): 49 ng/ml, notes: supratherapeutic; 5.5 ng/ml, notes: the month prior; 54.6 ng/ml; 10.5 ng/ml, notes: acceptable range; SARS-CoV-2 test: mild COVID-19 infection. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Interchange of vaccine products; contracted COVID-19; contracted COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02245892.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "contracted COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Unknown results, notes: Contracted COVID-19. The reporter reported that the patient who received two of the elasomeran and bnt162b2 booster shots contracted COVID-19 around May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: stopped my Shingles; 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), 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), for COVID-19 Immunization, reaction(s): "stopped my Shingles". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "stopped my Shingles".  Additional information: The patient shared that all COVID 19 shorts and the two booster also stopped the shingles.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200068023 same patient/drug/event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Disease recurrence, Herpes zoster
Clinical narrative: all COVID 19 "shorts" and the two booster also stopped their shingles/ this third booster did not, they broke back out a week after 3rd booster; all COVID 19 "shorts" and the two booster also stopped their shingles/ this third booster did not, they broke back out a week after 3rd booster; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunization, reaction(s): "stopped their shingles"; Bnt162b2 (dose 2, Batch/Lot number: unknown), for Covid-19 immunization, reaction(s): "stopped their shingles"; Shingrix shots (dose number unknown, Batch/Lot number: unknown), for immunisation, reaction(s): "shingles were still coming monthly". The following information was reported: HERPES ZOSTER (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "all COVID 19 "shorts" and the two booster also stopped their shingles/ this third booster did not, they broke back out a week after 3rd booster".  Additional information: The reporter shared that all COVID 19 "shorts" and the two booster also stopped their shingles. This third booster did not, they broke back out a week after 3rd booster. The reporter knew the Pfizer shots for COVID were not for shingles but it was an added benefit. Even after they got varicella zoster vaccine rge (cho) (SHINGRIX) shots, their shingles were still coming monthly. So reporter was guessing the 3rd booster was not as strong. Maybe Pfizer could increase it.  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-PV202200068023 same patient/drug, different dose number/event;
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: sore throat; congestion; fatigue; headache; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 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; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 08Sep2022, outcome "unknown", described as "congestion"; FATIGUE (non-serious) with onset 08Sep2022, outcome "unknown"; HEADACHE (non-serious) with onset 08Sep2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 08Sep2022, outcome "unknown", described as "sore throat". Additional information: The patient received the Covid-19 booster 06Sep2022. Two days later I had sore throat, congestion, fatigue, headache. Did not have these symptoms with first vaccines. Took the vaccine so patient could safely travel to see daughter. Trip was ruined along with expenses changing flight. Patient feel Pfizer didn't explain the severity of the vaccine.  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.
Sex: U
Vaccine: COVID19
Symptoms: Aplastic anaemia, Bone marrow failure, Cough, Immune system disorder
Clinical narrative: Aplastic Anemia; bone marrow failure; chronic ongoing cough; immune system is now attacking my bone marrow stem cells and Erythroid cells; 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), 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), for COVID-19 immunization. The following information was reported: APLASTIC ANAEMIA (medically significant), outcome "unknown", described as "Aplastic Anemia"; BONE MARROW FAILURE (medically significant), outcome "unknown"; COUGH (non-serious), outcome "not recovered", described as "chronic ongoing cough"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune system is now attacking my bone marrow stem cells and Erythroid cells". The event "chronic ongoing cough" required physician office visit. Therapeutic measures were taken as a result of cough.  Clinical course: After patient second Pfizer COVID vaccine, patient started having a chronic ongoing cough. Patient did go to the family doctor and got a inhaler and cough medicine. The cough never fully went away. Patient had Aplastic Anemia. Over the past year, the Aplastic Anemia, bone marrow failure had gotten worse and now requires Cyclosporine treatment. Patient immune system was now attacking bone marrow stem cells and Erythroid cells. Patient had not felt well ever since the second COVID vaccine.  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: Bedridden, Gait disturbance, Illness
Clinical narrative: Can't get out of bed; Can barely walk her dog; Sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  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, SINGLE), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 01Jul2021, outcome "not recovered", described as "Sick"; BEDRIDDEN (non-serious), outcome "unknown", described as "Can't get out of bed"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Can barely walk her dog".  Additional information: It was reported as, the patient wanted to speak with the legal department because she got a lawyer and they're going to start something because she said that we saved thousands and millions of lives but we also infected people. She doesn't have diabetes, heart disease, or HIV and she is a normal person and very healthy. She mentioned that we ruined her life and that she was a medical reporter. Afterwards, she wanted to speak to the president of Pfizer to settle these things out.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Headache, Off label use, Pain, Product use issue
Clinical narrative: she received Shingrix at the same time; she received Shingrix at the same time; in bed all day feeling achy and with a headache; in bed all day feeling achy and with a headache; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for 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. The following information was reported: PAIN (non-serious), HEADACHE (non-serious) all with onset 2022, outcome "not recovered" and all described as "in bed all day feeling achy and with a headache"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 2022, outcome "not recovered" and all described as "she received Shingrix at the same time". Additional information: Nurse stated that she received Pfizer Bivalent booster recently and was in bed all day feeling achy and with a headache. She also stated that she received Shingrix at the same time. 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The vaccine doesn't work is useless.; Caller is calling regarding Paxlovid. She would also like to know if she stops taking Paxlovid, would the Covid return and get 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 65-year-old female patient received BNT162b2 (BNT162B2), 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: "Type 2 diabetic" (unspecified if ongoing), notes: She said she is a Type 2 diabetic. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "The vaccine doesn't work is useless."; COVID-19 (medically significant), outcome "unknown", described as "Caller is calling regarding Paxlovid. She would also like to know if she stops taking Paxlovid, would the Covid return and get worse". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: would the Covid return and get worse. 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.
Age: 1.5
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administered FLUZONE QIV NP after the expiration date with no reported adverse event; Initial information received fon 16-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves 18 months old female patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine (hepatitis A) for Prophylactic vaccination.  On 15-Sep-2022, the patient received suspect influenza quadrival A-B vaccine at a dose of 0.5 ml total (lot UT7407MA, expiry date: 30-Jun-2022) via intramuscular route in the left thigh for immunisation.  On 15-Sep-2022 the patient was administered fluzone qiv np after the expiration date with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: Not applicable.  Outcome: 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: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Seizure, Syncope
Clinical narrative: seizure; fainted; Initial information received on 19-Sep-2022 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 17 years old male patient who had seizure and fainted after receiving vaccines BEXSERO and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 15-Aug-2022, the patient received an unknown booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength was unknown, lot U7294AC and expiry date was unknown) via intramuscular route in unknown administration site for Prophylactic vaccination. On an unknown date, the patient received an unknown booster dose of suspect BEXSERO not produced by Sanofi Pasteur (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 15-Aug-2022 the patient developed a serious event of seizure and fainted (syncope) (Latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and (unknown latency) following the administration of BEXSERO.   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events  Outcome: Recovered / Resolved on 15-Aug-2022 for both events.  Seriousness criteria: Medically significant for both events.; Sender's Comments: Sanofi company comment dated 23-Sep-2022: This case involves a 17 years old male patient who had seizure and fainted after receiving vaccines BEXSERO and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. The time to onset is compatible with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Product preparation error, Single component of a two-component product administered
Clinical narrative: patient the liquid portion only of PENTACEL and did not give the lyophilized portion containing the Acthib with no reported adverse event; patient the liquid portion only of PENTACEL and did not give the lyophilized portion containing the Acthib with no reported adverse event; Initial information received on 14-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient to whom the liquid portion only of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and did not give the lyophilized portion containing the acthib with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 29-Aug-2022, the patient received 0.5ml (Dose 3) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot UU668AAA and expiry date: 13-May-2023) via intramuscular route in vastus lateralis for Immunization. Patient was not using it for the first time.  On 29-AUG-2022 the patient developed a non-serious event of patient the liquid portion only of pentacel and did not give the lyophilized portion containing the acthib with no reported adverse event (single component of a two-component product administered and product preparation error) (unknown latency). The reporter was inquiring how to proceed with this patient. This situation was reported as a medication error due to incorrectly not mixing both of the portions with this vaccine as directed.   Action taken: not applicable.  Outcome: 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 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.