chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 (Lot number: FF2590) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Not Known allergies. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3246, Location of injection: Arm Left), administration date: 08Jan2021, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left), administration date: 15Dec2020, for COVID-19 immunisation. The following information was reported: TINNITUS (disability) with onset 28Oct2021, outcome "not recovered", described as "Tinnitus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Feb2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of tinnitus.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine BNT162B2 to reported event of  Tinnitus cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: hair loss; Lichen Planopilaris; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Feb2021 (Lot number: EN6200, Expiration Date: 30Jun2021) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, start date: 09Feb2021, stop date: 09Feb2021. Vaccination history included: Bnt162b2 (Dose 1, Route of administration: Intramuscular, Batch/Lot no: EN5318, Anatomical site of injection: Right arm), administration date: 01Feb2021, for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset May2021, outcome "unknown", described as "hair loss"; LICHEN PLANOPILARIS (non-serious) with onset 2021, outcome "unknown", described as "Lichen Planopilaris". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: In May2021 I noticed some hair loss but blamed it on getting older until the fall of 2021 when I noticed more than usual was falling out. Since I already had a 6 Mo follow-up appt with my dermatologist on 01Dec2021, I waited to be checked until then. She could see some disease was going on, on my scalp so did a biopsy of the scalp. Diagnosis was Lichen Planopilaris. In my research I found cases of hair loss after vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Biopsy, Lichen planopilaris
Clinical narrative: hair loss; Lichen Planopilaris; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Feb2021 (Lot number: EN6200, Expiration Date: 30Jun2021) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, start date: 09Feb2021, stop date: 09Feb2021. Vaccination history included: Bnt162b2 (Dose 1, Route of administration: Intramuscular, Batch/Lot no: EN5318, Anatomical site of injection: Right arm), administration date: 01Feb2021, for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset May2021, outcome "unknown", described as "hair loss"; LICHEN PLANOPILARIS (non-serious) with onset 2021, outcome "unknown", described as "Lichen Planopilaris". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: In May2021 I noticed some hair loss but blamed it on getting older until the fall of 2021 when I noticed more than usual was falling out. Since I already had a 6 Mo follow-up appt with my dermatologist on 01Dec2021, I waited to be checked until then. She could see some disease was going on, on my scalp so did a biopsy of the scalp. Diagnosis was Lichen Planopilaris. In my research I found cases of hair loss after vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I started getting extremely sweaty hands; dizziness; rapid heart rate; felt like I could not breath; First dose: 14May2021/ Second dose: 28May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28May2021 12:00 (Batch/Lot number: unknown) at the age of 33-year as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 14May2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: HYPERHIDROSIS (disability) with onset 28May2021 13:00, outcome "not recovered", described as "I started getting extremely sweaty hands"; DIZZINESS (disability) with onset 28May2021 13:00, outcome "not recovered", described as "dizziness"; HEART RATE INCREASED (disability) with onset 28May2021 13:00, outcome "not recovered", described as "rapid heart rate"; DYSPNOEA (disability) with onset 28May2021 13:00, outcome "not recovered", described as "felt like I could not breath"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28May2021 12:00, outcome "unknown", described as "First dose: 14May2021/ Second dose: 28May2021". The events "i started getting extremely sweaty hands", "dizziness", "rapid heart rate" and "felt like i could not breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) unknown result; heart rate: (28May2021) rapid; sars-cov-2 test: (10Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of hyperhidrosis, dizziness, heart rate increased, dyspnoea. Clinical course: Patient had no known allergies. Patient had no other medications in two weeks and no other vaccine in four weeks. 15 minutes after receiving the vaccine, patient started getting extremely sweaty hands, dizziness, rapid heart rate and felt like she could not breath - this only happened after the 2nd dose of the vaccine. Patient continue to have these episodes after receiving the vaccination, and she was currently seeking care from a psychologist and physician to resolve the issue. Therapy for assumed panic attacks. Patient had no covid prior vaccination and covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: I started getting extremely sweaty hands; dizziness; rapid heart rate; felt like I could not breath; First dose: 14May2021/ Second dose: 28May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28May2021 12:00 (Batch/Lot number: unknown) at the age of 33-year as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 14May2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: HYPERHIDROSIS (disability) with onset 28May2021 13:00, outcome "not recovered", described as "I started getting extremely sweaty hands"; DIZZINESS (disability) with onset 28May2021 13:00, outcome "not recovered", described as "dizziness"; HEART RATE INCREASED (disability) with onset 28May2021 13:00, outcome "not recovered", described as "rapid heart rate"; DYSPNOEA (disability) with onset 28May2021 13:00, outcome "not recovered", described as "felt like I could not breath"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28May2021 12:00, outcome "unknown", described as "First dose: 14May2021/ Second dose: 28May2021". The events "i started getting extremely sweaty hands", "dizziness", "rapid heart rate" and "felt like i could not breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) unknown result; heart rate: (28May2021) rapid; sars-cov-2 test: (10Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of hyperhidrosis, dizziness, heart rate increased, dyspnoea. Clinical course: Patient had no known allergies. Patient had no other medications in two weeks and no other vaccine in four weeks. 15 minutes after receiving the vaccine, patient started getting extremely sweaty hands, dizziness, rapid heart rate and felt like she could not breath - this only happened after the 2nd dose of the vaccine. Patient continue to have these episodes after receiving the vaccination, and she was currently seeking care from a psychologist and physician to resolve the issue. Therapy for assumed panic attacks. Patient had no covid prior vaccination and covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: I started getting extremely sweaty hands; dizziness; rapid heart rate; felt like I could not breath; First dose: 14May2021/ Second dose: 28May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28May2021 12:00 (Batch/Lot number: unknown) at the age of 33-year as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 14May2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: HYPERHIDROSIS (disability) with onset 28May2021 13:00, outcome "not recovered", described as "I started getting extremely sweaty hands"; DIZZINESS (disability) with onset 28May2021 13:00, outcome "not recovered", described as "dizziness"; HEART RATE INCREASED (disability) with onset 28May2021 13:00, outcome "not recovered", described as "rapid heart rate"; DYSPNOEA (disability) with onset 28May2021 13:00, outcome "not recovered", described as "felt like I could not breath"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28May2021 12:00, outcome "unknown", described as "First dose: 14May2021/ Second dose: 28May2021". The events "i started getting extremely sweaty hands", "dizziness", "rapid heart rate" and "felt like i could not breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) unknown result; heart rate: (28May2021) rapid; sars-cov-2 test: (10Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of hyperhidrosis, dizziness, heart rate increased, dyspnoea. Clinical course: Patient had no known allergies. Patient had no other medications in two weeks and no other vaccine in four weeks. 15 minutes after receiving the vaccine, patient started getting extremely sweaty hands, dizziness, rapid heart rate and felt like she could not breath - this only happened after the 2nd dose of the vaccine. Patient continue to have these episodes after receiving the vaccination, and she was currently seeking care from a psychologist and physician to resolve the issue. Therapy for assumed panic attacks. Patient had no covid prior vaccination and covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Eczema, Rash
Clinical narrative: Spongiotic dermatitis/Broke out in a rash/Looked like eczema all over torso, scalp, legs, back/Started to get really extremely itchy/Uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Spongiotic dermatitis/Broke out in a rash/Looked like eczema all over torso, scalp, legs, back/Started to get really extremely itchy/Uncomfortable) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 006M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested positive for COVID-19) in August 2021. Concurrent medical conditions included Eczema (The patient had gotten eczema patches in the past but nothing terrible).   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced ECZEMA (Spongiotic dermatitis/Broke out in a rash/Looked like eczema all over torso, scalp, legs, back/Started to get really extremely itchy/Uncomfortable). The patient was treated with PREDNISONE (oral) in January 2022 for Spongiotic dermatitis, at an unspecified dose and frequency and CLOBETASOL (topical) in January 2022 for Spongiotic dermatitis, at an unspecified dose and frequency. At the time of the report, ECZEMA (Spongiotic dermatitis/Broke out in a rash/Looked like eczema all over torso, scalp, legs, back/Started to get really extremely itchy/Uncomfortable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 antibody test: positive (Positive) Tested positive for COVID-19. In January 2022, Biopsy: spongiotic dermatitis The patient had a biopsy to see what was causing the rash and it was called spongiotic dermatitis.         In August 2021, patient  had COVID-19 where she took Advil and Tylenol for pain and fever that lasted about 5 days.  Patient had no health issues.  Concomitant medication taken by the patient included birth control pill.  It was reported that a few days after the booster  patient broke out in a rash,looked like eczema all over torso, scalp, legs, back started to get real itchy, worse and worse. Patient  visited dermatologist and they prescribed her oral steroids (Prednisone) and then when that was done, she flared up again and then they put her on a stronger topical steroid Clobetasol.It was extremely itchy and uncomfortable and had another terrible flare last Tuesday.   This case was linked to MOD-2022-515549, MOD-2022-515565 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Eczema, SARS-CoV-2 antibody test
Clinical narrative: Spongiotic dermatitis/Broke out in a rash/Looked like eczema all over torso, scalp, legs, back/Started to get really extremely itchy/Uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Spongiotic dermatitis/Broke out in a rash/Looked like eczema all over torso, scalp, legs, back/Started to get really extremely itchy/Uncomfortable) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 006M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested positive for COVID-19) in August 2021. Concurrent medical conditions included Eczema (The patient had gotten eczema patches in the past but nothing terrible).   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced ECZEMA (Spongiotic dermatitis/Broke out in a rash/Looked like eczema all over torso, scalp, legs, back/Started to get really extremely itchy/Uncomfortable). The patient was treated with PREDNISONE (oral) in January 2022 for Spongiotic dermatitis, at an unspecified dose and frequency and CLOBETASOL (topical) in January 2022 for Spongiotic dermatitis, at an unspecified dose and frequency. At the time of the report, ECZEMA (Spongiotic dermatitis/Broke out in a rash/Looked like eczema all over torso, scalp, legs, back/Started to get really extremely itchy/Uncomfortable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 antibody test: positive (Positive) Tested positive for COVID-19. In January 2022, Biopsy: spongiotic dermatitis The patient had a biopsy to see what was causing the rash and it was called spongiotic dermatitis.         In August 2021, patient  had COVID-19 where she took Advil and Tylenol for pain and fever that lasted about 5 days.  Patient had no health issues.  Concomitant medication taken by the patient included birth control pill.  It was reported that a few days after the booster  patient broke out in a rash,looked like eczema all over torso, scalp, legs, back started to get real itchy, worse and worse. Patient  visited dermatologist and they prescribed her oral steroids (Prednisone) and then when that was done, she flared up again and then they put her on a stronger topical steroid Clobetasol.It was extremely itchy and uncomfortable and had another terrible flare last Tuesday.   This case was linked to MOD-2022-515549, MOD-2022-515565 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased, Neck pain, Teething, Vaccination site pain
Clinical narrative: Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (Tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Vitamin D).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Tired). In 2021, FATIGUE (Tired) had resolved. At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         The patient was right-handed and not had other vaccines within 1 month prior to Moderna COVID-19 vaccine.  No concomitant medications were reported. Patient  also tested positive some more times but doesn´t remember the dates. The patient had received the second dose on her left arm one month after the first one and was tired for about two or three days. No treatment medications were reported.   This case was linked to MOD-2022-511800, MOD-2022-511849, MOD-2022-511849 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (Tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Vitamin D).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Tired). In 2021, FATIGUE (Tired) had resolved. At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         The patient was right-handed and not had other vaccines within 1 month prior to Moderna COVID-19 vaccine.  No concomitant medications were reported. Patient  also tested positive some more times but doesn´t remember the dates. The patient had received the second dose on her left arm one month after the first one and was tired for about two or three days. No treatment medications were reported.   This case was linked to MOD-2022-511800, MOD-2022-511849, MOD-2022-511849 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Dyspnoea, Erythema
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 55 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 31Mar2021 (Lot number: ER8727) at the age of 55 years as dose number unknown, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: fluticasone propionate, salmeterol xinafoate (ADVAIR); esomeprazole magnesium (NEXIUM); amlodipine. Past drug history included: sulfacetamide sodium (SULFA), reaction(s): "Allergy". The following information was reported: ANAPHYLACTIC REACTION (hospitalization, life threatening) with onset 31Mar2021 16:30, outcome "recovered with sequelae" (31Mar2021), described as "Anaphylactic Reaction". The event "anaphylactic reaction" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic reaction. Clinical course: emergency need for an epinephrine shot, ambulance taken to emergency room, spent several hours under observation, ultimate diagnosis of Anaphylactic Reaction: allergen Pfizer Covid-19 Vaccine. No other medication in 2weeks. No other vaccine in four weeks.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema nodosum, Flushing, General physical health deterioration, Hypersensitivity, Immunisation reaction
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 55 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 31Mar2021 (Lot number: ER8727) at the age of 55 years as dose number unknown, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: fluticasone propionate, salmeterol xinafoate (ADVAIR); esomeprazole magnesium (NEXIUM); amlodipine. Past drug history included: sulfacetamide sodium (SULFA), reaction(s): "Allergy". The following information was reported: ANAPHYLACTIC REACTION (hospitalization, life threatening) with onset 31Mar2021 16:30, outcome "recovered with sequelae" (31Mar2021), described as "Anaphylactic Reaction". The event "anaphylactic reaction" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic reaction. Clinical course: emergency need for an epinephrine shot, ambulance taken to emergency room, spent several hours under observation, ultimate diagnosis of Anaphylactic Reaction: allergen Pfizer Covid-19 Vaccine. No other medication in 2weeks. No other vaccine in four weeks.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Panniculitis, Pharyngeal swelling, Pruritus, Swollen tongue
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 55 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 31Mar2021 (Lot number: ER8727) at the age of 55 years as dose number unknown, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: fluticasone propionate, salmeterol xinafoate (ADVAIR); esomeprazole magnesium (NEXIUM); amlodipine. Past drug history included: sulfacetamide sodium (SULFA), reaction(s): "Allergy". The following information was reported: ANAPHYLACTIC REACTION (hospitalization, life threatening) with onset 31Mar2021 16:30, outcome "recovered with sequelae" (31Mar2021), described as "Anaphylactic Reaction". The event "anaphylactic reaction" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic reaction. Clinical course: emergency need for an epinephrine shot, ambulance taken to emergency room, spent several hours under observation, ultimate diagnosis of Anaphylactic Reaction: allergen Pfizer Covid-19 Vaccine. No other medication in 2weeks. No other vaccine in four weeks.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 55 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 31Mar2021 (Lot number: ER8727) at the age of 55 years as dose number unknown, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: fluticasone propionate, salmeterol xinafoate (ADVAIR); esomeprazole magnesium (NEXIUM); amlodipine. Past drug history included: sulfacetamide sodium (SULFA), reaction(s): "Allergy". The following information was reported: ANAPHYLACTIC REACTION (hospitalization, life threatening) with onset 31Mar2021 16:30, outcome "recovered with sequelae" (31Mar2021), described as "Anaphylactic Reaction". The event "anaphylactic reaction" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic reaction. Clinical course: emergency need for an epinephrine shot, ambulance taken to emergency room, spent several hours under observation, ultimate diagnosis of Anaphylactic Reaction: allergen Pfizer Covid-19 Vaccine. No other medication in 2weeks. No other vaccine in four weeks.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site swelling, Insomnia, Myalgia, Pyrexia
Clinical narrative: Headache, fever/chills, insomnia, muscle aches, swelling at injection site. Most symptoms dissipated after 2 days.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood electrolytes normal, Diarrhoea, Fatigue, Feeling hot
Clinical narrative: 2 days after the vaccine, patient developed N/V x6 episodes, and had a couple of loose stools. Then developed a slight sense of throat constriction, left jaw area swelling/warmth, bilateral periorbital edema, followed by perioral edema and lips swelling/tenderness. The facial swelling resolved, but it was followed by migratory large joint pains/warmth: knees, hips, shoulders and neck. Also, she had a headache, fatigue and tactile fever. Entire syndrome lasted about 3-4 days.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Headache, Joint warmth, Leukocytosis, Lip pain
Clinical narrative: 2 days after the vaccine, patient developed N/V x6 episodes, and had a couple of loose stools. Then developed a slight sense of throat constriction, left jaw area swelling/warmth, bilateral periorbital edema, followed by perioral edema and lips swelling/tenderness. The facial swelling resolved, but it was followed by migratory large joint pains/warmth: knees, hips, shoulders and neck. Also, she had a headache, fatigue and tactile fever. Entire syndrome lasted about 3-4 days.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Liver function test normal, Periorbital oedema, Pyrexia, Renal function test normal
Clinical narrative: 2 days after the vaccine, patient developed N/V x6 episodes, and had a couple of loose stools. Then developed a slight sense of throat constriction, left jaw area swelling/warmth, bilateral periorbital edema, followed by perioral edema and lips swelling/tenderness. The facial swelling resolved, but it was followed by migratory large joint pains/warmth: knees, hips, shoulders and neck. Also, she had a headache, fatigue and tactile fever. Entire syndrome lasted about 3-4 days.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Throat tightness, Urine analysis normal, White blood cell count increased
Clinical narrative: 2 days after the vaccine, patient developed N/V x6 episodes, and had a couple of loose stools. Then developed a slight sense of throat constriction, left jaw area swelling/warmth, bilateral periorbital edema, followed by perioral edema and lips swelling/tenderness. The facial swelling resolved, but it was followed by migratory large joint pains/warmth: knees, hips, shoulders and neck. Also, she had a headache, fatigue and tactile fever. Entire syndrome lasted about 3-4 days.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID on Jan 24, 2022, developed bronchitis on Jan 27,2022
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Joint swelling, Nausea, Pain
Clinical narrative: Nausea, fever, headache, body aches, ringing in ears, severe chills. Not sure if related but I had my right ankle swell a month later and developed painful red bumps on both legs and then feet. Two rounds of antibiotics and it cleared up, except some lingering discoloration for several months.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Skin discolouration, Tinnitus
Clinical narrative: Nausea, fever, headache, body aches, ringing in ears, severe chills. Not sure if related but I had my right ankle swell a month later and developed painful red bumps on both legs and then feet. Two rounds of antibiotics and it cleared up, except some lingering discoloration for several months.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Diarrhoea, Headache
Clinical narrative: Nausea, diarrhea, chills, fever, headache, extreme weakness, ringing in ears for 24 hours, lower back pain, mild weakness for a couple days after.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tinnitus
Clinical narrative: Nausea, diarrhea, chills, fever, headache, extreme weakness, ringing in ears for 24 hours, lower back pain, mild weakness for a couple days after.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dry skin, Erythema, Hypersensitivity, Pruritus
Clinical narrative: Allergic reaction with itching on the body for two days.; Allergic reaction with itching on the body for two days.; But at the moment I have a big red spot with crusting on the edge; But at the moment I have a big red spot with crusting on the edge; and it keeps getting bigger; has a different texture, rough, red and not itchy.; has a different texture, rough, red and not itchy.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2022 11:00 (Lot number: FK9729) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EW0175, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 28Apr2021, when the patient was 52 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 07Apr2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), PRURITUS (non-serious) all with onset 05Feb2022 22:00, outcome "not recovered" and all described as "Allergic reaction with itching on the body for two days."; ERYTHEMA (non-serious), SCAB (non-serious) all with onset 05Feb2022 22:00, outcome "not recovered" and all described as "But at the moment I have a big red spot with crusting on the edge"; CONDITION AGGRAVATED (non-serious) with onset 05Feb2022 22:00, outcome "not recovered", described as "and it keeps getting bigger"; DRY SKIN (non-serious), ERYTHEMA (non-serious) all with onset 05Feb2022 22:00, outcome "not recovered" and all described as "has a different texture, rough, red and not itchy.". Therapeutic measures were not taken as a result of hypersensitivity, pruritus, erythema, scab, condition aggravated, dry skin, erythema.  Additional information: Patient did not receive any other vaccines within 4 weeks. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Scab
Clinical narrative: Allergic reaction with itching on the body for two days.; Allergic reaction with itching on the body for two days.; But at the moment I have a big red spot with crusting on the edge; But at the moment I have a big red spot with crusting on the edge; and it keeps getting bigger; has a different texture, rough, red and not itchy.; has a different texture, rough, red and not itchy.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2022 11:00 (Lot number: FK9729) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EW0175, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 28Apr2021, when the patient was 52 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 07Apr2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), PRURITUS (non-serious) all with onset 05Feb2022 22:00, outcome "not recovered" and all described as "Allergic reaction with itching on the body for two days."; ERYTHEMA (non-serious), SCAB (non-serious) all with onset 05Feb2022 22:00, outcome "not recovered" and all described as "But at the moment I have a big red spot with crusting on the edge"; CONDITION AGGRAVATED (non-serious) with onset 05Feb2022 22:00, outcome "not recovered", described as "and it keeps getting bigger"; DRY SKIN (non-serious), ERYTHEMA (non-serious) all with onset 05Feb2022 22:00, outcome "not recovered" and all described as "has a different texture, rough, red and not itchy.". Therapeutic measures were not taken as a result of hypersensitivity, pruritus, erythema, scab, condition aggravated, dry skin, erythema.  Additional information: Patient did not receive any other vaccines within 4 weeks. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Drainage, Vaccination site mass, Wrong technique in product usage process
Clinical narrative: vaccine was administered "incorrectly" and the the lump "needed to be drained."; "lump on her deltoid."; This spontaneous report as received from a company representative and refers to a 24 year old female patient.The patient medical history, concurrent condition and concomitant medication were not reported. On 24-JAN-2022, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # U032636, expiration date 26-OCT-2023, intramuscularly (strength and dose were not reported), as HPV prevention. On an unknown date in 2022, the patient experienced lump on her deltoid (vaccination site mass). The patient went to family practice doctor, who informed her that the vaccine was administered incorrectly (product administration error) and the lump needed to be drained. The treatment was given for the event. The outcome of the event "lump on deltoid" was reported as not recovered. The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: An improperly stored dose of VARIVAX was administered to the patient on 19 FEB 2022; This spontaneous report has been received from a medical assistant referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions or allergies and concurrent conditions were not reported.   On 19-FEB-2022, the patient was vaccinated with an improperly store dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliters (ml) (route of administration, anatomical site of vaccination, and vaccine scheme were not reported; lot number U008181 has been verified to be valid, expiration date reported and established as 08-FEB-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of 9 degrees Fahrenheit (F) during a time frame of 293 hours and 14 minutes (product storage error). No previous temperature excursion was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA008282: US-009507513-2202USA007938: US-009507513-2202USA008270:
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The immediate area around the patient's right arm injection site was "fine"/ patient experienced redness and swelling of the upper half of the right arm above the elbow; The immediate area around the patient's right arm injection site was "fine"/ patient experienced redness and swelling of the upper half of the right arm above the elbow; This spontaneous report has been received from a pharmacist referring to a 77-year-old female patient. The patient's medical history included breast cancer. The reporter stated that she believed the patient underwent a lumpectomy on the right breast. The patient had allergy to latex, sulfonamide (reported as "sulfa"), sulfamethoxazole (+) trimethoprim (BACTRIM) and penicillin. Her concomitant medications included levothyroxine sodium (SYNTHROID) and anastrozole. Historical vaccines included pneumococcal vaccine conj 7v (crm197) (PREVNAR).   On 24-FEB-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) 0.5 ml one time administration, intramuscularly (IM) in her right arm (lot number U010534 has been verified to be valid, expiration date reported and established as 31-OCT-2022) for pneumonia prevention.   On 24-FEB-2022, the patient experienced redness (erythema) and swelling of the upper half of the right arm above the elbow (peripheral swelling). The reporter stated that the immediate area around the patient's right arm injection site was "fine".   On 26-FEB-2022, the patient told the reporter that the redness and swelling was better. On 28-FEB-2022, the patient told the reporter that the redness and swelling was almost gone. It was reported that the patient did not seek medical attention, and no treatment was given for the events.   Additionally, it was reported that the patient did not have reactions to any other vaccines.   At the time of reporting, the patient was recovering from erythema and peripheral swelling. The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and the events was not provided.
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional AE; Aphysician reported a patient (teenager) inadvertently received GARDASIL 9 instead of the flu vaccine. The four dose was administered on 03-MAR-2022; Aphysician reported a patient (teenager) inadvertently received GARDASIL 9 instead of the flu vaccine. The four dose was administered on 03-MAR-2022; 1st dose 03-DEC-2018, 2ND DOSE 05-FEB-2019, 3RD DOSE 07-JAN-2020, 4TH DOSE 03-MAR-2022; This spontaneous report has been received from a physician, concerning to a female patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-DEC-2018, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number validated as R008164, expiration date reported and stablished as 12-NOV-2020), the second dose on 05-FEB-2019 (lot number validated as R011630, expiration date reported and stablished as 12-DEC-2020), and the third dose on 07-JAN-2020 (lot number validated as R030453, expiration date reported and stablished as 23-JUL-2021) (inappropriate schedule of product administration) all three doses as prophylaxis (strength, dose, route of administration and anatomical location were not provided). Moreover, on 03-MAR-2022 inadvertently the patient was administered a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliters (mL) (lot number validated as U007667, expiration date reported and stablished as 23-MAY-2023) instead of a flu vaccine (wrong product administered, extra dose administered) (strength, route of administration and anatomical location were not provided). No additional adverse events (AE) reported (no adverse event).
Age: 0.17
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: CALLER REPORTS PROQUAD WAS ADMINISTERED TO A 2 MONTH OLD. NO ADDITIONAL AE REPORTED.; CALLER REPORTS PROQUAD WAS ADMINISTERED TO A 2 MONTH OLD. NO ADDITIONAL AE REPORTED.; This spontaneous report was received from a medical assistant and refers to a 2-month-old patient of unspecified gender. The patient's pertinent medical history, current conditions, concomitant medications, past drug reactions or allergies were not reported.  On 16-FEB-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter (mL) (vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number U022728 that was verified to be a valid lot number with an expiration date reported and established as 16-JAN-2023) for prophylaxis (product administered to patient of inappropriate age).  No additional adverse event (AE) was reported (no adverse event).
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Gardasil 9 that had undergone temperature excursion on 12/10/2021 was administered to a patient on 1/10/2022; This spontaneous report was received from a medical assistant and refers to a 17-year-old male patient. His pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.   On 12-DEC-2021, the product HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) (lot number 1687291 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 11-SEP-2022) experienced a temperature excursion reported as: 23 degrees Fahrenheit (F) during a time frame of 2 and a half (reported as "2 and 1/2") seconds. No previous temperature excursion reported.  On 10-JAN-2022, the patient was vaccinated with an improperly store dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) (vaccination scheme frequency, route of administration and anatomical site of application were not reported) (product storage error) as prophylaxis.  No additional adverse event (AE) was reported (no adverse event).
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; GARDASIL 9 that had undergone temperature excursion on 12/10/2021 was administered to a patient on 1/18/2022; This spontaneous report was received from a certified medical assistant and refers to 13-year-old female patient. There was no information regarding patient's medical history, concurrent conditions and concomitant medications provided.  On 18-JAN-2022, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in dose 0.5 milliliter (lot# 1687293 verified as valid with expiration date: 30-APR-2023) (dose number, frequency, route of administration and anatomical location were not provided) for prophylaxis. The aforementioned vaccine underwent a temperature excursion of 23 degrees Fahrenheit for 2.5 seconds (product storage error temperature too low) on 10-DEC-2021, before administration. There was no previous temperature excursion. It was unknown if digital data logger was involved. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA004292:
Sex: F
Vaccine: HPV9
Symptoms: Product prescribing issue
Clinical narrative: Caller's physician is recommending GARDASIL 9 to treat her warts.; This spontaneous report was received from a consumer referring to herself, a female patient with unknown age. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patient's physician was recommending hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, route, lot# and expiration date were unknown) for her warts (product prescribing issue).   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA005480: