chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Taking Paxlovid for Covid 19 positive results; Taking Paxlovid for Covid 19 positive results; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2021 at 12:00 as dose 1, single (Lot number: EW0179), in left arm and on 15Jun2021 at 12:00 as dose 2, single (Lot number: EW0178) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stage 3C metastatic melanoma" (unspecified if ongoing), notes: Stage 3C metastatic melanoma. Concomitant medication(s) included: AMLODIPINE, start date: 01Mar2022, stop date: 11Apr2022. Past drug history included: Codeine, reaction(s): "Allergy_Codeine"; Aspirin, reaction(s): "Allergy_Aspirin"; Epinephrine, reaction(s): "Allergy_Epinephrine"; Morphine, reaction(s): "Allergy_Morphine". The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Apr2022 at 01:00, outcome "unknown", COVID-19 (medically significant) with onset 12Apr2022 at 01:00, outcome "not recovered" and all described as "Taking Paxlovid for Covid 19 positive results". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient was taking Paxlovid for Covid 19 positive results. After one dose, Extreme dizziness, lightheaded, dry mouth and metal taste in her mouth. Cannot sleep due to extreme body aches. Patient had allergies with codeine, aspirin, all stimulants, epinephrine, morphine, most pain relievers.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 infection / lack of vaccine efficacy confirmed through testing; COVID-19 infection / lack of vaccine efficacy confirmed through testing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 36-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: FW0158), in left arm, on 19Aug2021 as dose 2, single (Lot number: ER2631), in left arm and on 23Dec2021 as dose 3 (booster), single (Lot number: 3302580) at the age of 36 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "COVID-19 infection / lack of vaccine efficacy confirmed through testing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of covid-19. The patient did not receive other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burns second degree, Burns third degree, Skin injury, Stevens-Johnson syndrome
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US013357 (RA). A 56-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; eltrombopag olamine (PROMACTA), (Batch/Lot number: unknown). 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: STEVENS-JOHNSON SYNDROME (medically significant), outcome "unknown", described as "Stephen-Johnson syndrome"; BURNS THIRD DEGREE (medically significant), BURNS SECOND DEGREE (non-serious), outcome "unknown" and all described as "having 2nd and 3rd degree burns"; SKIN INJURY (non-serious), outcome "unknown", described as "has lost septum due to the skin burns from SJS". The action taken for eltrombopag olamine was unknown. Clinical Course: Product: COVID-19 Vaccine. Relationship to patient: Self. Event: Reports to having Stephen-Johnson syndrome, which happened after getting the Pfizer COVID Booster while on Promacta, reports having 2nd and 3rd degree burns from SJS and has lost septum due to the skin burns from SJS. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I was due for my 2nd booster when I got covid.; I was due for my 2nd booster when I got covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 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 "I was due for my 2nd booster when I got covid.". Therapeutic measures were taken as a result of suspected covid-19.  Clinical information: Please answer a question that my doctor and pharmacist could not. I was due for my 2nd booster when I got covid. I took Paxlovid and cancelled my booster appointment. Is there a waiting period after Paxlovid? All 3 vaccines were Pfizer.  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: COVID-19, Drug ineffective, Multisystem inflammatory syndrome in children
Clinical narrative: 1 patient had evidence of recent SARS-CoV-2 infection; 1 patient had evidence of recent SARS-CoV-2 infection; Multisystem inflammatory syndrome in children;   A child patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "1 patient had evidence of recent SARS-CoV-2 infection"; MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (medically significant), outcome "unknown".  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 current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully excluded. 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-202200580291 Same article/ drug/event and different Patient
Sex: M
Vaccine: COVID19
Symptoms: Autoantibody positive, Autoantibody test, Autoimmune disorder, Monoclonal immunoglobulin present
Clinical narrative: autoimmune disease; M spike protein Elevation/Mag Igm auto antibodies=2350; M spike protein Elevation/Mag Igm auto antibodies=2350; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 80-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (First dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Second dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease"; MONOCLONAL IMMUNOGLOBULIN PRESENT (non-serious), AUTOANTIBODY POSITIVE (non-serious), outcome "unknown" and all described as "head M spike protein Elevation/Mag Igm auto antibodies=2350". The patient underwent the following laboratory tests and procedures: Autoantibody test: 2350; Monoclonal immunoglobulin present: Elevated. The patient was having issues that were not related to vaccine but needed to have a neurology work up and head M Spike protein elevated with mag Igm auto antibodies = 2350. 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 the current available limited information in the case provided, the causal association between the events autoimmune disorder, monoclonal immunoglobulin present, autoantibody positive and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: spouse suffered stroke due to a blood clot one week after receiving her second covid vaccine manufactured by Pfizer; spouse suffered stroke due to a blood clot one week after receiving her second covid vaccine manufactured by Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A 55-year-old female patient received BNT162b2 (BNT162B2), in 2021 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: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), THROMBOSIS (medically significant) all with onset 14May2021, outcome "unknown" and all described as "spouse suffered stroke due to a blood clot one week after receiving her second covid vaccine manufactured by Pfizer". It was reported that patient was perfectly health prior to this. She was still in therapy. We continue to incur substantial medical bills in this matter. What is Pfizer's position on this. Therapeutic measures were taken as a result of cerebrovascular accident, thrombosis. 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: Multisystem inflammatory syndrome
Clinical narrative: Multisystem Inflammatory Syndrome; This is a literature report for the following literature source(s).  An adult patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation, infection. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTISYSTEM INFLAMMATORY SYNDROME (medically significant), outcome "unknown".  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 available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Multisystem Inflammatory syndrome. 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
Sex: U
Vaccine: COVID19
Symptoms: Multisystem inflammatory syndrome in adults
Clinical narrative: Severe Multisystem Inflammatory Syndrome; This is a literature report for the following literature source(s).  An adult patient received BNT162b2 (BNT162B2), 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: MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (medically significant), outcome "unknown", described as "Severe Multisystem Inflammatory Syndrome".  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 available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Severe Multisystem Inflammatory Syndrome. 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-202200572949 Same article/drug/event and different patient.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the waiting period for getting the Pfizer COVID-19 Vaccine second booster after finishing treatment with Paxlovid "a week ago, tomorrow"; the waiting period for getting the Pfizer COVID-19 Vaccine second booster after finishing treatment with Paxlovid "a week ago, tomorrow"; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A female patient received BNT162b2 (BNT162B2), on 01Oct2021 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: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the waiting period for getting the Pfizer COVID-19 Vaccine second booster after finishing treatment with Paxlovid "a week ago, tomorrow"". The patient underwent the following laboratory tests and procedures: COVID-19: positive.  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 the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Computerised tomogram, Malaise, X-ray
Clinical narrative: She didn't feel good, which is not unusual for her when she gets a Covid shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL3248) at the age of 73 years, in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6202), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FC3184) for covid-19 immunisation; rivaroxaban (XARELTO), at 40 mg 1x/day (440 mg, 1x/day (mouth once a day)), oral for anticoagulant therapy. The patient's relevant medical history included: "Blood thinner" (unspecified if ongoing), notes: Manufacturer unknown to Caller. , Therapy start: Caller states about 3 years ago. The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "recovered with sequelae", described as "She didn't feel good, which is not unusual for her when she gets a Covid shot". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for rivaroxaban was dosage not changed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200573621 Same patient and drug, different event separated in time
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Investigation, Pain, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Illness/AE: Cold/about 3 weeks ago; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to penicillin" (ongoing), notes: when she was a baby; "Diabetes" (ongoing), notes: About 15 years ago. The patient's family history included: "arthritis" (unspecified if ongoing), notes: Her mom has arthritis, but never told her it was PMV PMR variety. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: EL0142, Anatomical location: Left arm), administration date: 18Jan2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "Polymyalgia Rheumatica", "She experienced pain", "Sed Rate elevated in the 60s"; BNT162b2 (Dose 2, Single, Lot number: EN6201, Anatomical location: Left arm), administration date: 09Feb2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "Polymyalgia Rheumatica", "She experienced pain", "Sed Rate elevated in the 60s". The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "Illness/AE: Cold/about 3 weeks ago". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received first dose on 18Jan2021. The patient has had symptoms for the past she would say year which she thought were simple arthritic concerns, clarified as pain that she had. It turns out that she has gone to a Rheumatologist and a Neurologist, and they diagnosed her with Polymyalgia rheumatica (PMR). She asked for information on PMR relative to COVID-19 Vaccine. The onset was like boom, she was like what the heck. Bloodwork populated in formal fields was done in late 2021, date otherwise unknown. Other tests were done, lupus was ruled out and whatever else done, but patient did not have any further specific details like test types, and results to provide. The patient received first dose on 09Feb2021. The patient received first dose on 06Oct2021. On an unknown date in 2022, about 3 weeks ago, the patient had Illness/AE: Cold.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Investigation, Nasopharyngitis
Clinical narrative: Illness/AE: Cold/about 3 weeks ago; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to penicillin" (ongoing), notes: when she was a baby; "Diabetes" (ongoing), notes: About 15 years ago. The patient's family history included: "arthritis" (unspecified if ongoing), notes: Her mom has arthritis, but never told her it was PMV PMR variety. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: EL0142, Anatomical location: Left arm), administration date: 18Jan2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "Polymyalgia Rheumatica", "She experienced pain", "Sed Rate elevated in the 60s"; BNT162b2 (Dose 2, Single, Lot number: EN6201, Anatomical location: Left arm), administration date: 09Feb2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "Polymyalgia Rheumatica", "She experienced pain", "Sed Rate elevated in the 60s". The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "Illness/AE: Cold/about 3 weeks ago". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received first dose on 18Jan2021. The patient has had symptoms for the past she would say year which she thought were simple arthritic concerns, clarified as pain that she had. It turns out that she has gone to a Rheumatologist and a Neurologist, and they diagnosed her with Polymyalgia rheumatica (PMR). She asked for information on PMR relative to COVID-19 Vaccine. The onset was like boom, she was like what the heck. Bloodwork populated in formal fields was done in late 2021, date otherwise unknown. Other tests were done, lupus was ruled out and whatever else done, but patient did not have any further specific details like test types, and results to provide. The patient received first dose on 09Feb2021. The patient received first dose on 06Oct2021. On an unknown date in 2022, about 3 weeks ago, the patient had Illness/AE: Cold.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Gastrointestinal disorder, Gastrointestinal inflammation, Pharyngitis streptococcal
Clinical narrative: vomiting; diarrhea; difficulty breathing; gastro intestinal issues like inflammation; gastro intestinal issues like inflammation; testing positive to strep throat without symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: VOMITING (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing"; GASTROINTESTINAL DISORDER (non-serious), GASTROINTESTINAL INFLAMMATION (non-serious), outcome "unknown" and all described as "gastro intestinal issues like inflammation"; PHARYNGITIS STREPTOCOCCAL (non-serious), outcome "unknown", described as "testing positive to strep throat without symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that someone she knows had list of symptoms after getting the Pfizer COVID-19 Vaccine and then said that a nurse in their school told them that those are invalid symptoms and no correlation could be made with the vaccine. The symptoms were vomiting diarrhea, difficulty breathing, gastrointestinal issues like inflammation, testing positive to strep throat without symptoms. Caller wanted to know if this symptoms could be related to the vaccine or not. Asks if it was possible there are other side effects you can get from the vaccines that are not in the listed as side effects?  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: Streptococcus test, Vomiting
Clinical narrative: vomiting; diarrhea; difficulty breathing; gastro intestinal issues like inflammation; gastro intestinal issues like inflammation; testing positive to strep throat without symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: VOMITING (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing"; GASTROINTESTINAL DISORDER (non-serious), GASTROINTESTINAL INFLAMMATION (non-serious), outcome "unknown" and all described as "gastro intestinal issues like inflammation"; PHARYNGITIS STREPTOCOCCAL (non-serious), outcome "unknown", described as "testing positive to strep throat without symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that someone she knows had list of symptoms after getting the Pfizer COVID-19 Vaccine and then said that a nurse in their school told them that those are invalid symptoms and no correlation could be made with the vaccine. The symptoms were vomiting diarrhea, difficulty breathing, gastrointestinal issues like inflammation, testing positive to strep throat without symptoms. Caller wanted to know if this symptoms could be related to the vaccine or not. Asks if it was possible there are other side effects you can get from the vaccines that are not in the listed as side effects?  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: Gastrointestinal disorder
Clinical narrative: gastrointestinal issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 20-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 immunization. The following information was reported: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "gastrointestinal issues".  Additional information: Reporter wanted to verify if gastrointestinal issues are symptoms from getting the Pfizer-BioNTech COVID-19 Vaccine. Reporter confirmed this would be for the 2nd dose of a 20 year old woman.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Fever; chills; dizzy; nausea; no appetite; exhausted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK 9893) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LOSARTAN; SIMVASTATIN. Vaccination history included: Covid-19 vaccine (Dose number: 1 and 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose number: 3 (Booster), dose received: More than 3), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Apr2022 at 12:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 13Apr2022 at 12:00, outcome "recovering"; DIZZINESS (non-serious) with onset 13Apr2022 at 12:00, outcome "recovering", described as "dizzy"; FATIGUE (non-serious) with onset 13Apr2022 at 12:00, outcome "recovering", described as "exhausted"; NAUSEA (non-serious) with onset 13Apr2022 at 12:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 13Apr2022 at 12:00, outcome "recovering", described as "no appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, dizziness, nausea, decreased appetite, fatigue.  Additional Information: If other vaccine in four weeks was reported as no. If covid prior vaccination was reported as no. If covid tested post vaccination was reported as no  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; chills; dizzy; nausea; no appetite; exhausted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK 9893) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LOSARTAN; SIMVASTATIN. Vaccination history included: Covid-19 vaccine (Dose number: 1 and 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose number: 3 (Booster), dose received: More than 3), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Apr2022 at 12:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 13Apr2022 at 12:00, outcome "recovering"; DIZZINESS (non-serious) with onset 13Apr2022 at 12:00, outcome "recovering", described as "dizzy"; FATIGUE (non-serious) with onset 13Apr2022 at 12:00, outcome "recovering", described as "exhausted"; NAUSEA (non-serious) with onset 13Apr2022 at 12:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 13Apr2022 at 12:00, outcome "recovering", described as "no appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, dizziness, nausea, decreased appetite, fatigue.  Additional Information: If other vaccine in four weeks was reported as no. If covid prior vaccination was reported as no. If covid tested post vaccination was reported as no  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aneurysm, Breast cancer, COVID-19, Cardiac disorder, Computerised tomogram
Clinical narrative: tested positive for Covid; tested positive for Covid; now has breast cancer again; malignant parotid tumor; diabetic; She has a dry lung; has an issue with the apex of her heart; aneurysm; had pains in her neck; fever; thyroid operations; she was feeling 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 parent.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing), notes: Note: Thyroid cancer.; "she had breast cancer three times, now has breast cancer again" (unspecified if ongoing); "Breast cancer operations" (unspecified if ongoing); "Thyroid operation" (unspecified if ongoing); "Heart issues" (unspecified if ongoing); "lung issue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed but unknown manufacturer.), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive for Covid"; BREAST CANCER (non-serious), outcome "unknown", described as "now has breast cancer again"; SALIVARY GLAND CANCER (non-serious), outcome "unknown", described as "malignant parotid tumor"; DIABETES MELLITUS (non-serious), outcome "unknown", described as "diabetic"; LUNG DISORDER (non-serious), outcome "unknown", described as "She has a dry lung"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "has an issue with the apex of her heart"; ANEURYSM (non-serious), outcome "unknown"; NECK PAIN (non-serious), outcome "unknown", described as "had pains in her neck"; PYREXIA (non-serious), outcome "unknown", described as "fever"; THYROID OPERATION (non-serious), outcome "unknown", described as "thyroid operations"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she was feeling worse". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) Unknown results; SARS-CoV-2 test: (12Apr2022) Positive. 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: Diabetes mellitus, Drug ineffective, Feeling abnormal, Lung disorder, Neck pain
Clinical narrative: tested positive for Covid; tested positive for Covid; now has breast cancer again; malignant parotid tumor; diabetic; She has a dry lung; has an issue with the apex of her heart; aneurysm; had pains in her neck; fever; thyroid operations; she was feeling 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 parent.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing), notes: Note: Thyroid cancer.; "she had breast cancer three times, now has breast cancer again" (unspecified if ongoing); "Breast cancer operations" (unspecified if ongoing); "Thyroid operation" (unspecified if ongoing); "Heart issues" (unspecified if ongoing); "lung issue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed but unknown manufacturer.), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive for Covid"; BREAST CANCER (non-serious), outcome "unknown", described as "now has breast cancer again"; SALIVARY GLAND CANCER (non-serious), outcome "unknown", described as "malignant parotid tumor"; DIABETES MELLITUS (non-serious), outcome "unknown", described as "diabetic"; LUNG DISORDER (non-serious), outcome "unknown", described as "She has a dry lung"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "has an issue with the apex of her heart"; ANEURYSM (non-serious), outcome "unknown"; NECK PAIN (non-serious), outcome "unknown", described as "had pains in her neck"; PYREXIA (non-serious), outcome "unknown", described as "fever"; THYROID OPERATION (non-serious), outcome "unknown", described as "thyroid operations"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she was feeling worse". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) Unknown results; SARS-CoV-2 test: (12Apr2022) Positive. 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: Pyrexia, SARS-CoV-2 test, Salivary gland cancer, Thyroid operation
Clinical narrative: tested positive for Covid; tested positive for Covid; now has breast cancer again; malignant parotid tumor; diabetic; She has a dry lung; has an issue with the apex of her heart; aneurysm; had pains in her neck; fever; thyroid operations; she was feeling 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 parent.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing), notes: Note: Thyroid cancer.; "she had breast cancer three times, now has breast cancer again" (unspecified if ongoing); "Breast cancer operations" (unspecified if ongoing); "Thyroid operation" (unspecified if ongoing); "Heart issues" (unspecified if ongoing); "lung issue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed but unknown manufacturer.), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive for Covid"; BREAST CANCER (non-serious), outcome "unknown", described as "now has breast cancer again"; SALIVARY GLAND CANCER (non-serious), outcome "unknown", described as "malignant parotid tumor"; DIABETES MELLITUS (non-serious), outcome "unknown", described as "diabetic"; LUNG DISORDER (non-serious), outcome "unknown", described as "She has a dry lung"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "has an issue with the apex of her heart"; ANEURYSM (non-serious), outcome "unknown"; NECK PAIN (non-serious), outcome "unknown", described as "had pains in her neck"; PYREXIA (non-serious), outcome "unknown", described as "fever"; THYROID OPERATION (non-serious), outcome "unknown", described as "thyroid operations"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she was feeling worse". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) Unknown results; SARS-CoV-2 test: (12Apr2022) Positive. 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: Abdominal discomfort
Clinical narrative: severe stomach issues; This is a spontaneous report received from a contactable reporter(s) (Physician).  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS", start date: 1978 (unspecified if ongoing), notes: medical history does include IBS with constipation since 1978; "constipation", start date: 1978 (unspecified if ongoing), notes: medical history does include IBS with constipation since 1978. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot unknown: True, Prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, Prev dose dose number: 1), for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "recovered", described as "severe stomach issues". The event "severe stomach issues" required physician office visit. It was unknown if therapeutic measures were taken as a result of abdominal discomfort.  Additional information: Patient received other vaccine in four weeks was unknown. Patient received other medications in two weeks was unknown. Prior vaccination, patient diagnosed with COVID-19 was unknown. Post vaccination, the patient was tested with COVID-19 was unknown. Patient received the following query from a site research coordinator participating in one of my non-COVID vaccine studies: "Subject 1 shared with the Sub-I that after her second Pfizer Covid-19 vaccine she had "severe stomach issues" that started three days after the shot and resolved by day eight. She did end up having to see her PCP and GI specialist that week for these issues. She denied any other vaccine reactions throughout her life and reports " the first Covid shot caused no issues at all." A diagnosis was never confirmed for this episode per subject. Her medical history does include IBS with constipation since 1978 but she had never had this sort of episode.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure decreased, Dyspnoea, Pharyngeal oedema, SARS-CoV-2 test
Clinical narrative: Anaphylactic reactions immediate; my blood pressure drop suddenly; airways narrow; blocking breathing/ trouble breathing; Constriction of the airways by my swollen tongue and throat; Constriction of the airways by my swollen tongue and throat; Constriction of the airways by my swollen tongue and throat; wheezing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2021 as dose 1, single (Lot number: ER8735) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Gerd" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 18Apr2021, outcome "recovered with sequelae", described as "Anaphylactic reactions immediate"; SWOLLEN TONGUE (non-serious), THROAT TIGHTNESS (non-serious), PHARYNGEAL OEDEMA (non-serious) all with onset 18Apr2021, outcome "recovered with sequelae" and all described as "Constriction of the airways by my swollen tongue and throat"; SMALL AIRWAYS DISEASE (non-serious) with onset 18Apr2021, outcome "recovered with sequelae", described as "airways narrow"; DYSPNOEA (non-serious) with onset 18Apr2021, outcome "recovered with sequelae", described as "blocking breathing/ trouble breathing"; BLOOD PRESSURE DECREASED (non-serious) with onset 18Apr2021, outcome "recovered with sequelae", described as "my blood pressure drop suddenly"; WHEEZING (non-serious) with onset 18Apr2021, outcome "recovered with sequelae". The events "anaphylactic reactions immediate", "my blood pressure drop suddenly", "airways narrow", "blocking breathing/ trouble breathing", "constriction of the airways by my swollen tongue and throat" and "wheezing" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of anaphylactic reaction, blood pressure decreased, small airways disease, dyspnoea, swollen tongue, throat tightness, pharyngeal oedema, wheezing.  Additional information: The patient was administered 2 injections of epinephrine and Benadryl and ambulance to the emergency room. Was in emergency room on monitors for several hours.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Small airways disease, Swollen tongue, Throat tightness, Wheezing
Clinical narrative: Anaphylactic reactions immediate; my blood pressure drop suddenly; airways narrow; blocking breathing/ trouble breathing; Constriction of the airways by my swollen tongue and throat; Constriction of the airways by my swollen tongue and throat; Constriction of the airways by my swollen tongue and throat; wheezing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2021 as dose 1, single (Lot number: ER8735) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Gerd" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 18Apr2021, outcome "recovered with sequelae", described as "Anaphylactic reactions immediate"; SWOLLEN TONGUE (non-serious), THROAT TIGHTNESS (non-serious), PHARYNGEAL OEDEMA (non-serious) all with onset 18Apr2021, outcome "recovered with sequelae" and all described as "Constriction of the airways by my swollen tongue and throat"; SMALL AIRWAYS DISEASE (non-serious) with onset 18Apr2021, outcome "recovered with sequelae", described as "airways narrow"; DYSPNOEA (non-serious) with onset 18Apr2021, outcome "recovered with sequelae", described as "blocking breathing/ trouble breathing"; BLOOD PRESSURE DECREASED (non-serious) with onset 18Apr2021, outcome "recovered with sequelae", described as "my blood pressure drop suddenly"; WHEEZING (non-serious) with onset 18Apr2021, outcome "recovered with sequelae". The events "anaphylactic reactions immediate", "my blood pressure drop suddenly", "airways narrow", "blocking breathing/ trouble breathing", "constriction of the airways by my swollen tongue and throat" and "wheezing" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of anaphylactic reaction, blood pressure decreased, small airways disease, dyspnoea, swollen tongue, throat tightness, pharyngeal oedema, wheezing.  Additional information: The patient was administered 2 injections of epinephrine and Benadryl and ambulance to the emergency room. Was in emergency room on monitors for several hours.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Type of dose gave after expiration date and date 05apr2022; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 72-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Pfizer28Apr2021), administration date: 28Apr2021, when the patient was 71-year-old, for COVID-19 immunization; moderna (Dose 2, second dose Moderna 14Jul2021 lot 044D21A), administration date: 14Jul2021, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 05Apr2022, outcome "unknown", described as "Type of dose gave after expiration date and date 05apr2022".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.