chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Laboratory test, Physical examination, Tuberculosis
Clinical narrative: diagnosis of dermatomyositis, occurring in association with the COVID-19 vaccine; This is a literature report.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATOMYOSITIS (medically significant), 5 days after the suspect product(s) administration, outcome "recovered", described as "diagnosis of dermatomyositis, occurring in association with the COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (0-55): 154 IU/l, notes: elevated; Antibody test: remarkably elevated; Antinuclear antibody: No antibodies detected; Antinuclear antibody negative: No antibodies detected, notes: Jo-1; Aspartate aminotransferase (5-34): 256 IU/l, notes: elevated; Biopsy: revealed features of interface dermatitis with, notes: superficial perivascular mononuclear inflammation and dermal edema; revealed overexpression of major, notes: histocompatibility complex class I, inflammatory cells, necrotic fibers, and atrophic fibers organized in a perimysial pattern, suggesting an immune-mediated myopathy of a dermatomyositis type; Blood creatine phosphokinase (29-168): 2804 IU/l, notes: first day of presentation; 4476 IU/l, notes: 3 days; 1135 IU/l, notes: decreased significantly; Normalized, notes: 12 weeks after initial presentation; Computerised tomogram abdomen: No internal malignancy; Computerised tomogram pelvis: No internal malignancy; Computerised tomogram thorax: No internal malignancy; Enzyme level test: Normalized, notes: liver enzymes normalized twelve weeks after initial presentation; Flow cytometry: lymphoma disorder unremarkable; Hepatitis B: negative; Hepatitis C: negative; Additional cutaneous findings: included multiple vesicles and erythematous, notes: papules on the right upper extremity and reticulated, erythematous patches on both of her thigh; remarkably elevated; unknown results; showed basal vacuolar alteration with foci of, notes: necrotic keratinocytes; Mi2-a: No antibodies detected, notes: Mi2-alpha; No antibodies were detected, notes: Mi2-beta; No antibodies were detected, notes: PL-12; No antibodies were detected, notes: PL-7; physical examination: violaceous, poikilodermatous scaly plaques were, notes: observed on the anterior aspect of the neck and chest; Tuberculosis: negative. Therapeutic measures were taken as a result of dermatomyositis. She had received an initial dose of the COVID-19 vaccine 5 days before the onset of the symptoms.  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 available reported information, the causal association between the event dermatomyositis and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injury, Nervous system disorder
Clinical narrative: I know 4 other women with injuries ER8731 all neurological Bad Batch; I know 4 other women with injuries ER8731 all neurological Bad Batch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: ER8731) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), INJURY (non-serious), outcome "unknown" and all described as "I know 4 other women with injuries ER8731 all neurological Bad Batch".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200642436 same vaccine/reporter/AE, different patient;US-PFIZER INC-202200642437 same vaccine/reporter/AE, different patient;US-PFIZER INC-202200642438 same vaccine/reporter/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Injury, Nervous system disorder
Clinical narrative: I know 4 other women with injuries ER8731 all neurological Bad Batch; I know 4 other women with injuries ER8731 all neurological Bad Batch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: ER8731) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), INJURY (non-serious), outcome "unknown" and all described as "I know 4 other women with injuries ER8731 all neurological Bad Batch".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200642426 same vaccine/reporter/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Injury, Nervous system disorder
Clinical narrative: I know 4 other women with injuries ER8731 all neurological Bad Batch; I know 4 other women with injuries ER8731 all neurological Bad Batch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: ER8731) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), INJURY (non-serious), outcome "unknown" and all described as "I know 4 other women with injuries ER8731 all neurological Bad Batch".  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200642426 same vaccine/reporter/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: has been suffering from migraines all his life. Since being vaccinated and boosted his migraines have stopped; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the parent.  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "suffering from migraines all his life" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "has been suffering from migraines all his life. Since being vaccinated and boosted his migraines have stopped".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pain, Pyrexia, Vertigo
Clinical narrative: Vertigo symptoms for 5 days; Body and joint aches; Body and joint aches; Temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2022 as dose 4 (booster), single (Lot number: Fk9893) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Manufacturer unknown), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 23Apr2022, outcome "recovered with sequelae" (Apr2022) and all described as "Body and joint aches"; PYREXIA (non-serious) with onset 23Apr2022, outcome "recovered with sequelae" (Apr2022), described as "Temperature"; VERTIGO (non-serious) with onset 23Apr2022, outcome "recovered with sequelae" (28Apr2022), described as "Vertigo symptoms for 5 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, arthralgia, pain, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Dizziness, Headache, Pain
Clinical narrative: Dizzy; Headache; Bodyaches; Temperature of 100; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FL9893) at the age of 62 years, in left arm 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; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization.  The following information was reported: PAIN (non-serious) with onset 23Apr2022 at 18:00, outcome "unknown", described as "Bodyaches"; DIZZINESS (non-serious) with onset 23Apr2022 at 18:00, outcome "unknown", described as "Dizzy"; HEADACHE (non-serious) with onset 23Apr2022 at 18:00, outcome "unknown"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 23Apr2022 at 18:00, outcome "unknown", described as "Temperature of 100". The patient underwent the following laboratory tests and procedures: Body temperature: (23Apr2022) 100. Therapeutic measures were not taken as a result of dizziness, headache, pain, body temperature abnormal.  Additional Information:  the patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,  the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Lack of Effect; had the Pfizer Covid 19 Doses already; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis Treatment" (unspecified if ongoing), notes: Arthritis Treatment. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Lack of Effect; had the Pfizer Covid 19 Doses already"; COVID-19 (medically significant), outcome "unknown".  Clinical course:  Reporter had a caller on the line that was treated for arthritis when she started using Paxlovid. The caller mentioned she had the Pfizer Covid 19 Doses already. The caller states she had some reactions medical but she did not say it was from the Covid 19 Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: break-through COVID-19 infection; break-through COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP6955), on 09Apr2021 as dose 2, single (Lot number: EP6955) and on 28Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 54 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "allergy: Gluten" (unspecified if ongoing), notes: known allergies: Gluten. Concomitant medication(s) included: FLUOXETINE. Past drug history included: Codeine, reaction(s): "Allergy", notes: known allergies: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "not recovered" and all described as "break-through COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive. Therapeutic measures were not taken as a result of covid-19. Additional information: Facility where the most recent COVID-19 vaccine administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was fluoxetine. Reported event was break-through COVID-19 infection. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: break-through COVID-19 infection; break-through COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP6955), on 09Apr2021 as dose 2, single (Lot number: EP6955) and on 28Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 54 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "allergy: Gluten" (unspecified if ongoing), notes: known allergies: Gluten. Concomitant medication(s) included: FLUOXETINE. Past drug history included: Codeine, reaction(s): "Allergy", notes: known allergies: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "not recovered" and all described as "break-through COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive. Therapeutic measures were not taken as a result of covid-19. Additional information: Facility where the most recent COVID-19 vaccine administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was fluoxetine. Reported event was break-through COVID-19 infection. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: i got exposed to COVID around end of 2021; i got exposed to COVID around end of 2021; 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 01May2021 as dose 1, single (Lot number: EW0176), in left arm and on 22May2021 at 12:00 as dose 2, single (Lot number: EW0179) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 17Dec2021, outcome "not recovered" and all described as "i got exposed to COVID around end of 2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. patient did not receive any other medications within 2 weeks of COVID vaccine.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200650035 similar report from same reporter
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Dysmenorrhoea, SARS-CoV-2 test, Upper respiratory tract infection
Clinical narrative: i got exposed to COVID around end of 2021; i got exposed to COVID around end of 2021; 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 01May2021 as dose 1, single (Lot number: EW0176), in left arm and on 22May2021 at 12:00 as dose 2, single (Lot number: EW0179) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 17Dec2021, outcome "not recovered" and all described as "i got exposed to COVID around end of 2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. patient did not receive any other medications within 2 weeks of COVID vaccine.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200650035 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: her two lymph nodes were swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown Manufacturer, Primary immunization completed), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, Unknown Manufacturer, Primary immunization completed), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (Booster), Unknown Manufacturer, Primary immunization completed), for COVID-19 Immunization.  The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "her two lymph nodes were swollen".  Additional Information: Caller was a consumer. She stated she received her second booster of the COMIRNATY vaccine on 08Apr2022. The next day her two lymph nodes were swollen. She was told this was a common side effect, but this lymph nodes were still swollen. She mentioned the swollen lymph nodes were located in her neck. She asked if this was common since it had been 3 weeks since she got the second booster dose.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Biliary colic, Hot flush, Injection site pain, Malaise
Clinical narrative: yesterday she was not feeling well; severe gall bladder pain; feeling kind of having hot flashes' during that night; abdominal distress; had some pain at the sight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Irritable bowel syndrome" (ongoing), notes: Irritable bowel syndrome manages with diet and supplements, currently her bowel is irritated, diagnosed 7-8 years or so.; "gallbladder issues diagnosed" (unspecified if ongoing), notes: gallbladder issues diagnosed about a year and a half ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot: EP6955), administration date: 17Mar2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Lot: EW0153), administration date: 08Apr2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (1st Booster), Lot: FH8020), administration date: 22Oct2021, when the patient was 58-year-old, for Covid-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 27Apr2022, outcome "unknown", described as "abdominal distress"; HOT FLUSH (non-serious) with onset 27Apr2022, outcome "unknown", described as "feeling kind of having hot flashes' during that night"; INJECTION SITE PAIN (non-serious) with onset 27Apr2022, outcome "unknown", described as "had some pain at the sight"; BILIARY COLIC (non-serious) with onset 27Apr2022, outcome "not recovered", described as "severe gall bladder pain"; MALAISE (non-serious) with onset 28Apr2022, outcome "unknown", described as "yesterday she was not feeling well". The events "severe gall bladder pain", "feeling kind of having hot flashes' during that night", "abdominal distress", "had some pain at the sight" and "yesterday she was not feeling well" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: caller states Patient has already been had this gallbladder ejection frequency issue prior to the vaccines, states has been working with acupuncturist to help in an attempt to avoid having surgery. Patient had gall bladder pain and sometimes it was not there and sometimes its maybe 0-3 pain and then sometimes, like this morning, Patient has surging acute pain. Patient received Covid-19 vaccine within Pharmacy In A Grocery Store facility type. Patient did not received vaccine In military facility. Patient does not require to visit emergency room. Patient had not prior vaccination within 4 weeks of first administration date of the suspect vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment
Clinical narrative: yesterday she was not feeling well; severe gall bladder pain; feeling kind of having hot flashes' during that night; abdominal distress; had some pain at the sight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Irritable bowel syndrome" (ongoing), notes: Irritable bowel syndrome manages with diet and supplements, currently her bowel is irritated, diagnosed 7-8 years or so.; "gallbladder issues diagnosed" (unspecified if ongoing), notes: gallbladder issues diagnosed about a year and a half ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot: EP6955), administration date: 17Mar2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Lot: EW0153), administration date: 08Apr2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (1st Booster), Lot: FH8020), administration date: 22Oct2021, when the patient was 58-year-old, for Covid-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 27Apr2022, outcome "unknown", described as "abdominal distress"; HOT FLUSH (non-serious) with onset 27Apr2022, outcome "unknown", described as "feeling kind of having hot flashes' during that night"; INJECTION SITE PAIN (non-serious) with onset 27Apr2022, outcome "unknown", described as "had some pain at the sight"; BILIARY COLIC (non-serious) with onset 27Apr2022, outcome "not recovered", described as "severe gall bladder pain"; MALAISE (non-serious) with onset 28Apr2022, outcome "unknown", described as "yesterday she was not feeling well". The events "severe gall bladder pain", "feeling kind of having hot flashes' during that night", "abdominal distress", "had some pain at the sight" and "yesterday she was not feeling well" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: caller states Patient has already been had this gallbladder ejection frequency issue prior to the vaccines, states has been working with acupuncturist to help in an attempt to avoid having surgery. Patient had gall bladder pain and sometimes it was not there and sometimes its maybe 0-3 pain and then sometimes, like this morning, Patient has surging acute pain. Patient received Covid-19 vaccine within Pharmacy In A Grocery Store facility type. Patient did not received vaccine In military facility. Patient does not require to visit emergency room. Patient had not prior vaccination within 4 weeks of first administration date of the suspect vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Infectious mononucleosis
Clinical narrative: she got mono; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and 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. The following information was reported: INFECTIOUS MONONUCLEOSIS (non-serious), outcome "unknown", described as "she got mono".  Additional Information: The patient's immune system was weak.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain, Restlessness, SARS-CoV-2 test
Clinical narrative: I felt intermittent throbbing pain on the back of my knees; extremity also felt restless; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2021 as dose 2, single (Lot number: EN8735) at the age of 37 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Primary Reynaud's Syndrome" (unspecified if ongoing), notes: Primary Reynaud's Syndrome. Concomitant medication(s) included: DESVENLAFAXINE SUCCINATE; DEXTROAMPHETAMINE [DEXAMFETAMINE]. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: 28Mar2021, when the patient was 37-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 18Apr2021, outcome "unknown", described as "I felt intermittent throbbing pain on the back of my knees"; RESTLESSNESS (non-serious) with onset 18Apr2021, outcome "unknown", described as "extremity also felt restless". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, restlessness.  Additional information: Beginning on the drive home from getting the vaccine, I felt intermittent throbbing pain on the back of my knees and in the crooks of my arms. Wherever this pain was occurring, the extremity also felt restless. This would occur only in one extremity at a time, for approx. 10 mins or less. This went on for months, though the frequency lessened over time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient was tested for COVID-19.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red raise area around vaccine administration site.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 12:00 as dose 4 (booster), single (Lot number: unknown) at the age of 85 years, 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's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (First booster, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 27Apr2022 at 22:30, outcome "recovering", described as "Red raise area around vaccine administration site.". Therapeutic measures were not taken as a result of vaccination site erythema.  Additional information: Patient did not received any other vaccine in four weeks. Patient did not tested COVID post vaccination. Patient did not had known allergies. Patient did not had any other medical history. Seriousness was reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Emotional disorder, SARS-CoV-2 antibody test
Clinical narrative: they are going crazy and want peace of mind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  A 68-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunization. The patient's relevant medical history included: "Splenectomy", start date: 1998 (unspecified if ongoing), notes: spleen removed; "Immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 3), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization; Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "they are going crazy and want peace of mind". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient's wife stated that her 68 year old husband have already gotten 4 vaccine shots, but when they had an antibody test back in Oct2021 the husband tested negative. Caller now thinks that maybe the vaccine is not working for her husband who also doesn't have a spleen. Caller wanted to know if there is a test that will accurately tell if the vaccine is working for them. She says she doesn't know if the test is reliable, and she has read that there have been a lot of false negatives, so she wanted to know if there was a way to know if the vaccine is working. Antibody test that you get at facility, not one that the doctor orders, one where you make your own appointment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Gallbladder disorder, Inflammation, Vomiting
Clinical narrative: Severe back pain; vomited; gallbladder attack; severe inflammation reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2022 at 11:00 as dose 3 (booster), single (Lot number: FJ1614), in left arm for covid-19 immunisation. The patient's relevant medical history included: "C7 cervical radiculopathy" (unspecified if ongoing), notes: C7 cervical radiculopathy but no current symptoms; "possible gallbladder" (unspecified if ongoing), notes: possible gallbladder; "mid back pain felt across my bra line like someone is squeezing my rib cage very tightly" (unspecified if ongoing), notes: mid back pain felt across my bra line like someone is squeezing my rib cage very tightly. Concomitant medication(s) included: NAPROXEN. Past drug history included: Zyrtec, reaction(s): "Known allergies: Zyrtec", notes: Zyrtec antihistamine only 1/2 pill made me feel drugged. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right, Vaccine Administration Time: 10:30 AM), administration date: 10Jul2021, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 19Jun2021, for COVID-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "Severe back pain"; GALLBLADDER DISORDER (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "gallbladder attack"; INFLAMMATION (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "severe inflammation reaction"; VOMITING (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "vomited". Therapeutic measures were not taken as a result of back pain, vomiting, gallbladder disorder, inflammation.  Additional information: Hours after the COVID booster, i had severe back pain and vomited repeatedly the pain was so bad. The back pain i thought was muscular because i had it before, possibly a gallbladder attack that i am checking into now. I felt like the booster set off a possible severe inflammation reaction. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. facility type vaccine was at Pharmacy or Drug Store. I stopped taking Naproxen 7 days before booster.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Dyspnoea, Muscle contracture, Musculoskeletal chest pain, Pain
Clinical narrative: Severe back pain; vomited; gallbladder attack; severe inflammation reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2022 at 11:00 as dose 3 (booster), single (Lot number: FJ1614), in left arm for covid-19 immunisation. The patient's relevant medical history included: "C7 cervical radiculopathy" (unspecified if ongoing), notes: C7 cervical radiculopathy but no current symptoms; "possible gallbladder" (unspecified if ongoing), notes: possible gallbladder; "mid back pain felt across my bra line like someone is squeezing my rib cage very tightly" (unspecified if ongoing), notes: mid back pain felt across my bra line like someone is squeezing my rib cage very tightly. Concomitant medication(s) included: NAPROXEN. Past drug history included: Zyrtec, reaction(s): "Known allergies: Zyrtec", notes: Zyrtec antihistamine only 1/2 pill made me feel drugged. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right, Vaccine Administration Time: 10:30 AM), administration date: 10Jul2021, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 19Jun2021, for COVID-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "Severe back pain"; GALLBLADDER DISORDER (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "gallbladder attack"; INFLAMMATION (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "severe inflammation reaction"; VOMITING (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "vomited". Therapeutic measures were not taken as a result of back pain, vomiting, gallbladder disorder, inflammation.  Additional information: Hours after the COVID booster, i had severe back pain and vomited repeatedly the pain was so bad. The back pain i thought was muscular because i had it before, possibly a gallbladder attack that i am checking into now. I felt like the booster set off a possible severe inflammation reaction. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. facility type vaccine was at Pharmacy or Drug Store. I stopped taking Naproxen 7 days before booster.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Severe back pain; vomited; gallbladder attack; severe inflammation reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2022 at 11:00 as dose 3 (booster), single (Lot number: FJ1614), in left arm for covid-19 immunisation. The patient's relevant medical history included: "C7 cervical radiculopathy" (unspecified if ongoing), notes: C7 cervical radiculopathy but no current symptoms; "possible gallbladder" (unspecified if ongoing), notes: possible gallbladder; "mid back pain felt across my bra line like someone is squeezing my rib cage very tightly" (unspecified if ongoing), notes: mid back pain felt across my bra line like someone is squeezing my rib cage very tightly. Concomitant medication(s) included: NAPROXEN. Past drug history included: Zyrtec, reaction(s): "Known allergies: Zyrtec", notes: Zyrtec antihistamine only 1/2 pill made me feel drugged. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right, Vaccine Administration Time: 10:30 AM), administration date: 10Jul2021, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 19Jun2021, for COVID-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "Severe back pain"; GALLBLADDER DISORDER (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "gallbladder attack"; INFLAMMATION (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "severe inflammation reaction"; VOMITING (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "vomited". Therapeutic measures were not taken as a result of back pain, vomiting, gallbladder disorder, inflammation.  Additional information: Hours after the COVID booster, i had severe back pain and vomited repeatedly the pain was so bad. The back pain i thought was muscular because i had it before, possibly a gallbladder attack that i am checking into now. I felt like the booster set off a possible severe inflammation reaction. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. facility type vaccine was at Pharmacy or Drug Store. I stopped taking Naproxen 7 days before booster.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 16:00 as dose 1, single (Lot number: EN6201), on 06Mar2021 at 10:00 as dose 2, single (Lot number: EN6198) and on 26Sep2021 as dose 3 (booster), single (Lot number: 30130BA) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENALAPRIL; AMLODIPINE; LEXAPRO; SYNTHROID; SINGULAIR. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: Other medication details other medication in 2weeks product was enalapril, amlodipine, lexapro, synthroid, singulair. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. No adverse event from vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the COVID-19,Drug ineffective cannot be completely excluded.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Bronchitis, Pneumonia, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 16:00 as dose 1, single (Lot number: EN6201), on 06Mar2021 at 10:00 as dose 2, single (Lot number: EN6198) and on 26Sep2021 as dose 3 (booster), single (Lot number: 30130BA) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENALAPRIL; AMLODIPINE; LEXAPRO; SYNTHROID; SINGULAIR. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: Other medication details other medication in 2weeks product was enalapril, amlodipine, lexapro, synthroid, singulair. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. No adverse event from vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the COVID-19,Drug ineffective cannot be completely excluded.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pemphigoid, SARS-CoV-2 test
Clinical narrative: Bollus pemphigoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 82-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: EW0202), administration date: 26Oct2021, when the patient was 81-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: ER2613), administration date: 09Mar2021, when the patient was 81-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200), administration date: 26Feb2021, when the patient was 81-year-old, for Covid-19 Immunization.  The following information was reported: PEMPHIGOID (medically significant) with onset 08Apr2022, outcome "not recovered", described as "Bollus pemphigoid". The event "bollus pemphigoid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of pemphigoid.  The course of the event: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Taking medications, unsure name of which one. What treatment received for the adverse event? Dupixent and some steroid pills. Prior to vaccination, was the patient diagnosed with COVID-19? No. Since the vaccination, has the patient been tested for COVID-19? Yes.  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: Pain in extremity
Clinical narrative: sore arm for a day after dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient (not pregnant) received BNT162b2 (BNT162B2), 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, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm for a day after dose". It was unknown if therapeutic measures were taken as a result of pain in extremity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Postural orthostatic tachycardia" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing); "Known allergies: Mango" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Apr2022) Negative, notes: Tested negative from COVID; (26Apr2022) Negative, notes: Negative on day 3 after Paxlovid; (29Apr2022) Positive, notes: Positive COVID test on day 6 after completion of paxlovid. Therapeutic measures were taken as a result of covid-19. Patient received other medication in 2 weeks was not reported. COVID 19 Treatment was Paxlovid. Treatment start date was 19Ap2022. Treatment stop date was 23Apr2022. Relapsed with COVID five days after treatment with Paxlovid. Tested negative from COVID one day after completion of Paxlovid, and negative on day 3 after Paxlovid, then became symptomatic on day 5 with a positive COVID test on day 6 after completion of Paxlovid.