chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Immunisation, Photophobia, Pyrexia, Vomiting
Clinical narrative: Severe headache; Low grade fever; Vomiting; Joint pain; Chills; Sensitivity to light and sound; Sensitivity to light and sound; Dizziness; Shortness of breath; Booster (dose 3); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 13Dec2021 05:00 (Lot number: FH8030) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Postural orthostatic tachycardic syndrome" (unspecified if ongoing); "Peanut allergy" (unspecified if ongoing). Concomitant medication(s) included: AVIANE. Vaccination history included: BNT162B2 (dose 2, single; lot: EW0171; site: right arm; time: 10:00), administration date: 04May2021, when the patient was 29 years old, for COVID-19 immunization; BNT162B2 (dose 1, single; lot: ER8729; site: right arm; time: 10:00), administration date: 19Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 05:00, outcome "unknown", described as "Booster (dose 3)"; HEADACHE (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Severe headache"; PYREXIA (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Low grade fever"; VOMITING (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Vomiting"; ARTHRALGIA (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Joint pain"; CHILLS (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Chills"; PHOTOPHOBIA (non-serious), HYPERACUSIS (non-serious) all with onset 14Dec2021 13:00, outcome "recovering" and all described as "Sensitivity to light and sound"; DIZZINESS (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Dizziness"; DYSPNOEA (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Shortness of breath". Therapeutic measures were not taken as a result of headache, pyrexia, vomiting, arthralgia, chills, photophobia, hyperacusis, dizziness, dyspnoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had no history of COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Erythema, Immunisation, Rash
Clinical narrative: Today I got it all over my back and I keep getting it every day; covid test result Positive; covid test result Positive; got rashes; hives; redness in different areas of my body; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 19:00 (Lot number: FF2590) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's relevant medical history was not reported. The patient did not have covid prior to vaccination and had not known allergies. There were no concomitant medications. Vaccination history included: Moderna (DOSE 2, Lot Number: 005C21A), administration date: 29Apr2021, when the patient was 31 years old, for Covid-19 immunization; Moderna (DOSE 1, Lot Number: 007B21A), administration date: 01Apr2021, when the patient was 31 years old, for Covid-19 immunization. The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021 19:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Dec2021, outcome "unknown" and all described as "covid test result Positive"; RASH (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "got rashes"; URTICARIA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "hives"; ERYTHEMA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "redness in different areas of my body"; CONDITION AGGRAVATED (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Today I got it all over my back and I keep getting it every day". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of rash, urticaria, erythema, condition aggravated.  Clinical course: It was stated that immediately after the Pfizer booster shot had events. This had been going ever since. Today patient got it all over her back and patient keep getting it every day.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Urticaria, Vaccination failure
Clinical narrative: Today I got it all over my back and I keep getting it every day; covid test result Positive; covid test result Positive; got rashes; hives; redness in different areas of my body; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 19:00 (Lot number: FF2590) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's relevant medical history was not reported. The patient did not have covid prior to vaccination and had not known allergies. There were no concomitant medications. Vaccination history included: Moderna (DOSE 2, Lot Number: 005C21A), administration date: 29Apr2021, when the patient was 31 years old, for Covid-19 immunization; Moderna (DOSE 1, Lot Number: 007B21A), administration date: 01Apr2021, when the patient was 31 years old, for Covid-19 immunization. The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021 19:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Dec2021, outcome "unknown" and all described as "covid test result Positive"; RASH (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "got rashes"; URTICARIA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "hives"; ERYTHEMA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "redness in different areas of my body"; CONDITION AGGRAVATED (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Today I got it all over my back and I keep getting it every day". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of rash, urticaria, erythema, condition aggravated.  Clinical course: It was stated that immediately after the Pfizer booster shot had events. This had been going ever since. Today patient got it all over her back and patient keep getting it every day.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Erythema, Interchange of vaccine products, Off label use
Clinical narrative: Today I got it all over my back and I keep getting it every day; covid test result Positive; covid test result Positive; got rashes; hives; redness in different areas of my body; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 19:00 (Lot number: FF2590) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's relevant medical history was not reported. The patient did not have covid prior to vaccination and had not known allergies. There were no concomitant medications. Vaccination history included: Moderna (DOSE 2, Lot Number: 005C21A), administration date: 29Apr2021, when the patient was 31 years old, for Covid-19 immunization; Moderna (DOSE 1, Lot Number: 007B21A), administration date: 01Apr2021, when the patient was 31 years old, for Covid-19 immunization. The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021 19:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Dec2021, outcome "unknown" and all described as "covid test result Positive"; RASH (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "got rashes"; URTICARIA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "hives"; ERYTHEMA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "redness in different areas of my body"; CONDITION AGGRAVATED (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Today I got it all over my back and I keep getting it every day". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of rash, urticaria, erythema, condition aggravated.  Clinical course: It was stated that immediately after the Pfizer booster shot had events. This had been going ever since. Today patient got it all over her back and patient keep getting it every day.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: Today I got it all over my back and I keep getting it every day; covid test result Positive; covid test result Positive; got rashes; hives; redness in different areas of my body; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 19:00 (Lot number: FF2590) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's relevant medical history was not reported. The patient did not have covid prior to vaccination and had not known allergies. There were no concomitant medications. Vaccination history included: Moderna (DOSE 2, Lot Number: 005C21A), administration date: 29Apr2021, when the patient was 31 years old, for Covid-19 immunization; Moderna (DOSE 1, Lot Number: 007B21A), administration date: 01Apr2021, when the patient was 31 years old, for Covid-19 immunization. The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021 19:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Dec2021, outcome "unknown" and all described as "covid test result Positive"; RASH (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "got rashes"; URTICARIA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "hives"; ERYTHEMA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "redness in different areas of my body"; CONDITION AGGRAVATED (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Today I got it all over my back and I keep getting it every day". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of rash, urticaria, erythema, condition aggravated.  Clinical course: It was stated that immediately after the Pfizer booster shot had events. This had been going ever since. Today patient got it all over her back and patient keep getting it every day.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Erythema, Immunisation, Rash
Clinical narrative: covid test result: Positive; covid test result: Positive; rashes in different areas of body; hives in different areas of body; redness in different areas of body; Interchange of vaccine products; off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 19:00 (Lot number: FF2590) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administered in arm left, administration date 01Apr2021 11:15 (Lot number: 007B21A) as dose 1, single and administered in arm left, administration date 29Apr2021 16:15 (Lot number: 005C21A) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 13Dec2021, outcome "unknown" and all described as "covid test result: Positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (medically significant) with onset 01Dec2021, outcome "unknown", described as "off label use"; RASH (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "rashes in different areas of body"; URTICARIA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "hives in different areas of body"; ERYTHEMA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "redness in different areas of body". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2021) positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective, rash, urticaria, erythema.  Patient did not receive any other vaccine in four weeks and any other medications in two weeks. Patient has no reported allergies. Patient did not have covid prior to vaccination and tested for covid post No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Urticaria, Vaccination failure
Clinical narrative: covid test result: Positive; covid test result: Positive; rashes in different areas of body; hives in different areas of body; redness in different areas of body; Interchange of vaccine products; off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 19:00 (Lot number: FF2590) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administered in arm left, administration date 01Apr2021 11:15 (Lot number: 007B21A) as dose 1, single and administered in arm left, administration date 29Apr2021 16:15 (Lot number: 005C21A) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 13Dec2021, outcome "unknown" and all described as "covid test result: Positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (medically significant) with onset 01Dec2021, outcome "unknown", described as "off label use"; RASH (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "rashes in different areas of body"; URTICARIA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "hives in different areas of body"; ERYTHEMA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "redness in different areas of body". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2021) positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective, rash, urticaria, erythema.  Patient did not receive any other vaccine in four weeks and any other medications in two weeks. Patient has no reported allergies. Patient did not have covid prior to vaccination and tested for covid post No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Erythema, Interchange of vaccine products, Off label use
Clinical narrative: covid test result: Positive; covid test result: Positive; rashes in different areas of body; hives in different areas of body; redness in different areas of body; Interchange of vaccine products; off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 19:00 (Lot number: FF2590) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administered in arm left, administration date 01Apr2021 11:15 (Lot number: 007B21A) as dose 1, single and administered in arm left, administration date 29Apr2021 16:15 (Lot number: 005C21A) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 13Dec2021, outcome "unknown" and all described as "covid test result: Positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (medically significant) with onset 01Dec2021, outcome "unknown", described as "off label use"; RASH (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "rashes in different areas of body"; URTICARIA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "hives in different areas of body"; ERYTHEMA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "redness in different areas of body". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2021) positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective, rash, urticaria, erythema.  Patient did not receive any other vaccine in four weeks and any other medications in two weeks. Patient has no reported allergies. Patient did not have covid prior to vaccination and tested for covid post No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: covid test result: Positive; covid test result: Positive; rashes in different areas of body; hives in different areas of body; redness in different areas of body; Interchange of vaccine products; off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 19:00 (Lot number: FF2590) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administered in arm left, administration date 01Apr2021 11:15 (Lot number: 007B21A) as dose 1, single and administered in arm left, administration date 29Apr2021 16:15 (Lot number: 005C21A) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 13Dec2021, outcome "unknown" and all described as "covid test result: Positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (medically significant) with onset 01Dec2021, outcome "unknown", described as "off label use"; RASH (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "rashes in different areas of body"; URTICARIA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "hives in different areas of body"; ERYTHEMA (non-serious) with onset 01Dec2021 20:00, outcome "not recovered", described as "redness in different areas of body". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2021) positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective, rash, urticaria, erythema.  Patient did not receive any other vaccine in four weeks and any other medications in two weeks. Patient has no reported allergies. Patient did not have covid prior to vaccination and tested for covid post No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: Booster; Got COVID; Got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 76 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. , "Primary Immunization series complete but unknown manufacturer"), for COVID-19 immunization; Covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. , "Primary Immunization series complete but unknown manufacturer"), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 14Dec2021, outcome "unknown" and all described as "Got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism
Clinical narrative: diagnosed with hyperthyroidism; This is a spontaneous report received from a contactable reporter(s) (Physician) via Regulatory Authority.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 15Oct2021 (Lot number: FF2589) at the age of 55 years as dose 2, single for covid-19 immunization in Physician office. The patient was not pregnant when administration. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number=1, lot number=FF2589, administrator route=Intramuscular), administration date: 24Sep2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (medically significant) with onset Dec2021, outcome "unknown", described as "diagnosed with hyperthyroidism". The event "diagnosed with hyperthyroidism" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of hyperthyroidism. The patient called and informed the reporter that she was diagnosed with hyperthyroidism approximately a month after the second Pfizer vaccination.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment.  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.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Mass, Vaccination site swelling
Clinical narrative: I have swelling under my left arm; Very large bump, a quarter size of a baseball; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 17:30 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "if Covid prior vaccination: Yes" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, brand=Pfizer Biontech, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 21Apr2021, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, brand=Pfizer Biontech, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 12May2021, when the patient was 49 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 17:30, outcome "unknown", described as "Dose number: 3"; VACCINATION SITE SWELLING (non-serious) with onset 17Dec2021 05:45, outcome "not recovered", described as "I have swelling under my left arm"; MASS (non-serious) with onset 17Dec2021 05:45, outcome "not recovered", described as "Very large bump, a quarter size of a baseball". Therapeutic measures were not taken as a result of vaccination site swelling, mass.  Additional information: it was reported that patient did not took any other vaccine in four weeks nor any medications in two weeks. Patient was not tested covid post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Erythema, Immunisation, Musculoskeletal stiffness
Clinical narrative: Stiffness on left side of neck; swelling of the throat; difficulty breathing and swallowing; difficulty breathing and swallowing; face bright red; received dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Dec2021 02:45 (Lot number: FO7218) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation in Drive thru vaccination clinic. The patient was not pregnant when administration. Relevant medical history included: "known allergies: Tree nuts" (unspecified if ongoing). No other medical history. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL] was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included: Doxycyline, reaction(s): "known allergies: doxycyline". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 23Apr2021, when the patient was 45 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 02Apr2021, when the patient was 45 years old, for COVID-19 Immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The following information was reported: IMMUNISATION (life threatening) with onset 18Dec2021 02:45, outcome "unknown", described as "received dose 3"; MUSCULOSKELETAL STIFFNESS (life threatening) with onset 18Dec2021 15:00, outcome "recovered" (18Dec2021), described as "Stiffness on left side of neck"; PHARYNGEAL SWELLING (life threatening) with onset 18Dec2021 15:00, outcome "recovered" (18Dec2021), described as "swelling of the throat"; DYSPNOEA (life threatening), DYSPHAGIA (life threatening) all with onset 18Dec2021 15:00, outcome "recovered" (18Dec2021) and all described as "difficulty breathing and swallowing"; ERYTHEMA (life threatening) with onset 18Dec2021 15:00, outcome "recovered" (18Dec2021), described as "face bright red". Therapeutic measures (Epi pen, benedryl) were taken as a result of musculoskeletal stiffness, pharyngeal swelling, dyspnoea, dysphagia, erythema. The events resulted in life threatening illness (immediate risk of death from the event). The events were reported as serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: Yes. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.   Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Stiffness on left side of neck; swelling of the throat; difficulty breathing and swallowing; difficulty breathing and swallowing; face bright red; received dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Dec2021 02:45 (Lot number: FO7218) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation in Drive thru vaccination clinic. The patient was not pregnant when administration. Relevant medical history included: "known allergies: Tree nuts" (unspecified if ongoing). No other medical history. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL] was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included: Doxycyline, reaction(s): "known allergies: doxycyline". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 23Apr2021, when the patient was 45 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 02Apr2021, when the patient was 45 years old, for COVID-19 Immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The following information was reported: IMMUNISATION (life threatening) with onset 18Dec2021 02:45, outcome "unknown", described as "received dose 3"; MUSCULOSKELETAL STIFFNESS (life threatening) with onset 18Dec2021 15:00, outcome "recovered" (18Dec2021), described as "Stiffness on left side of neck"; PHARYNGEAL SWELLING (life threatening) with onset 18Dec2021 15:00, outcome "recovered" (18Dec2021), described as "swelling of the throat"; DYSPNOEA (life threatening), DYSPHAGIA (life threatening) all with onset 18Dec2021 15:00, outcome "recovered" (18Dec2021) and all described as "difficulty breathing and swallowing"; ERYTHEMA (life threatening) with onset 18Dec2021 15:00, outcome "recovered" (18Dec2021), described as "face bright red". Therapeutic measures (Epi pen, benedryl) were taken as a result of musculoskeletal stiffness, pharyngeal swelling, dyspnoea, dysphagia, erythema. The events resulted in life threatening illness (immediate risk of death from the event). The events were reported as serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: Yes. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Immunisation, Tinnitus
Clinical narrative: Loss of hearing; tinnitus; received dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 15:00 (Lot number: 3303080) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient was not pregnant when administration. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA. Past drug history included: Zithromax, reaction(s): "Allergy"; Doxycycline, reaction(s): "Allergy"; Tetanus, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, lot number unknown, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 04Jun2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: E100176, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 13May2021, when the patient was 38 years old, for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The following information was reported: IMMUNISATION (medically significant) with onset 17Dec2021 15:00, outcome "unknown", described as "received dose 3"; DEAFNESS (medically significant) with onset 18Dec2021 14:00, outcome "not recovered", described as "Loss of hearing"; TINNITUS (non-serious) with onset 18Dec2021 14:00, outcome "not recovered", described as "tinnitus".  The events "loss of hearing" and "tinnitus" were evaluated at the physician office visit. Prednisone was  taken as a result of deafness, tinnitus.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph nodes; headache; fatigue; body aches; pain at injection site; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 12:00 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High BP" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; VENLAFAXINE HCL; TRAZODONE; BUSPAR. Past drug history included: Codeine, reaction(s): "Known allergies: codeine". Vaccination history included: Bnt162b2 (Dose: 1, dose administration time=03:30 PM, dose vaccine location=Left arm, lot unknown reason=Not available/provided to reporter at the time of report completion), administration date: 09Feb2021, when the patient was 72 years old, for Covid-19 Immunization; Bnt162b2 (Dose: 2, dose administration time=01:00 PM, dose vaccine location=Left arm, lot unknown reason=Not available/provided to reporter at the time of report completion), administration date: 30Mar2021, when the patient was 72 years old, for Covid-19 Immunization, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 12:00, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "Swollen lymph nodes"; HEADACHE (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "body aches"; VACCINATION SITE PAIN (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "pain at injection site". Therapeutic measures were not taken as a result of lymphadenopathy, headache, fatigue, pain, vaccination site pain.  Additional information: Patient did not had Covid prior to vaccination and Covid was not tested post vaccination. other vaccine in four weeks was none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Swollen lymph nodes; headache; fatigue; body aches; pain at injection site; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 12:00 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High BP" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; VENLAFAXINE HCL; TRAZODONE; BUSPAR. Past drug history included: Codeine, reaction(s): "Known allergies: codeine". Vaccination history included: Bnt162b2 (Dose: 1, dose administration time=03:30 PM, dose vaccine location=Left arm, lot unknown reason=Not available/provided to reporter at the time of report completion), administration date: 09Feb2021, when the patient was 72 years old, for Covid-19 Immunization; Bnt162b2 (Dose: 2, dose administration time=01:00 PM, dose vaccine location=Left arm, lot unknown reason=Not available/provided to reporter at the time of report completion), administration date: 30Mar2021, when the patient was 72 years old, for Covid-19 Immunization, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 12:00, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "Swollen lymph nodes"; HEADACHE (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "body aches"; VACCINATION SITE PAIN (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "pain at injection site". Therapeutic measures were not taken as a result of lymphadenopathy, headache, fatigue, pain, vaccination site pain.  Additional information: Patient did not had Covid prior to vaccination and Covid was not tested post vaccination. other vaccine in four weeks was none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Inappropriate schedule of product administration, Meniscus injury, SARS-CoV-2 test, Tenderness
Clinical narrative: lower right side of leg on the shin there is a nodule it's a blood clot; a torn meniscus on her right lower leg; tenderness; Varicose veins; inside the knee in the tissues side of the knee cap I have 3 bruises there; 1st dose on 29Apr2021, 2nd dose on 25Jun2021; 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 68 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jun2021 (Lot number: EW0182) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart disorder" (unspecified if ongoing); "two stents in my heart" (unspecified if ongoing); "pre diabetic" (unspecified if ongoing). Family history included: "Stroke" (unspecified if ongoing), notes: Stroke runs in my family. Concomitant medication(s) included: METFORMIN taken for glucose tolerance impaired and medication for heart (unspecified). Vaccination history included: Bnt162b2 (1st dose, Lot number: EW0176, site of administration: left shoulder), administration date: 29Apr2021, when the patient was 68 years old, for Covid-19 Immunization. The following information was reported: THROMBOSIS (medically significant) with onset 03Aug2021, outcome "not recovered", described as "lower right side of leg on the shin there is a nodule it's a blood clot"; MENISCUS INJURY (non-serious) with onset 03Aug2021, outcome "not recovered", described as "a torn meniscus on her right lower leg"; TENDERNESS (non-serious) with onset 03Aug2021, outcome "not recovered", described as "tenderness"; VARICOSE VEIN (non-serious) with onset 03Aug2021, outcome "not recovered", described as "Varicose veins"; CONTUSION (non-serious) with onset 03Aug2021, outcome "not recovered", described as "inside the knee in the tissues side of the knee cap I have 3 bruises there"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 25Jun2021, outcome "unknown", described as "1st dose on 29Apr2021, 2nd dose on 25Jun2021". The events were evaluated at the physician office visit (seen the doctor twice). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) negative. Therapeutic measures were not taken as a result of thrombosis, meniscus injury, tenderness, varicose vein, contusion. No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Varicose vein
Clinical narrative: lower right side of leg on the shin there is a nodule it's a blood clot; a torn meniscus on her right lower leg; tenderness; Varicose veins; inside the knee in the tissues side of the knee cap I have 3 bruises there; 1st dose on 29Apr2021, 2nd dose on 25Jun2021; 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 68 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jun2021 (Lot number: EW0182) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart disorder" (unspecified if ongoing); "two stents in my heart" (unspecified if ongoing); "pre diabetic" (unspecified if ongoing). Family history included: "Stroke" (unspecified if ongoing), notes: Stroke runs in my family. Concomitant medication(s) included: METFORMIN taken for glucose tolerance impaired and medication for heart (unspecified). Vaccination history included: Bnt162b2 (1st dose, Lot number: EW0176, site of administration: left shoulder), administration date: 29Apr2021, when the patient was 68 years old, for Covid-19 Immunization. The following information was reported: THROMBOSIS (medically significant) with onset 03Aug2021, outcome "not recovered", described as "lower right side of leg on the shin there is a nodule it's a blood clot"; MENISCUS INJURY (non-serious) with onset 03Aug2021, outcome "not recovered", described as "a torn meniscus on her right lower leg"; TENDERNESS (non-serious) with onset 03Aug2021, outcome "not recovered", described as "tenderness"; VARICOSE VEIN (non-serious) with onset 03Aug2021, outcome "not recovered", described as "Varicose veins"; CONTUSION (non-serious) with onset 03Aug2021, outcome "not recovered", described as "inside the knee in the tissues side of the knee cap I have 3 bruises there"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 25Jun2021, outcome "unknown", described as "1st dose on 29Apr2021, 2nd dose on 25Jun2021". The events were evaluated at the physician office visit (seen the doctor twice). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) negative. Therapeutic measures were not taken as a result of thrombosis, meniscus injury, tenderness, varicose vein, contusion. No follow-up attempts are possible. No further information is expected.