chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Right eye hurt like a blood vessel burst/blood burst in my right eye; do have allergies you know like I took the second shot. I had a allergic reaction I did get anaphylactic shock I had that 3 times; Right eye hurt like a blood vessel burst; Heart started racing; 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 66 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, first vaccine she was fine), administration date: Apr2021, for Covid-19 Immunization, reaction(s): "No reaction on previous exposure to Vaccine". The following information was reported: EYE HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "Right eye hurt like a blood vessel burst/blood burst in my right eye"; ANAPHYLACTIC SHOCK (medically significant) with onset 2021, outcome "unknown", described as "do have allergies you know like I took the second shot. I had a allergic reaction I did get anaphylactic shock I had that 3 times"; EYE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Right eye hurt like a blood vessel burst"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "Heart started racing". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Jan2022) went up, notes: high blood pressure; investigation: (Jan2022) unknown result.  Clinical course: Consumer stated, "Yes, I took the two shots, not the booster. I just want to know for how long it could stay in your system for side effects but how long after. Consumer stated, "I have a question. I took your shot, you know the vaccine and the first one was ok but the second one after two days my heart was racing like crazy and I woke up with a blood burst in my right eye. I was 121 and they did all kinds of tests here and nothing has come up. I was just wondering, is it possible that it could be in my system from that, you know because we took 5 days." The patient had allergies you know like she took the second shot.  The Consumer stated, "I had a allergic reaction and did get anaphylactic shock I had that 3 times. I was just wondering because my mouth used to be a little bit to my left side, they thought that might be 'IA' but now they were going towards that with high blood pressure medicine but never had that around in my life".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Blood pressure measurement, Eye haemorrhage, Eye pain, Investigation
Clinical narrative: Right eye hurt like a blood vessel burst/blood burst in my right eye; do have allergies you know like I took the second shot. I had a allergic reaction I did get anaphylactic shock I had that 3 times; Right eye hurt like a blood vessel burst; Heart started racing; 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 66 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, first vaccine she was fine), administration date: Apr2021, for Covid-19 Immunization, reaction(s): "No reaction on previous exposure to Vaccine". The following information was reported: EYE HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "Right eye hurt like a blood vessel burst/blood burst in my right eye"; ANAPHYLACTIC SHOCK (medically significant) with onset 2021, outcome "unknown", described as "do have allergies you know like I took the second shot. I had a allergic reaction I did get anaphylactic shock I had that 3 times"; EYE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Right eye hurt like a blood vessel burst"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "Heart started racing". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Jan2022) went up, notes: high blood pressure; investigation: (Jan2022) unknown result.  Clinical course: Consumer stated, "Yes, I took the two shots, not the booster. I just want to know for how long it could stay in your system for side effects but how long after. Consumer stated, "I have a question. I took your shot, you know the vaccine and the first one was ok but the second one after two days my heart was racing like crazy and I woke up with a blood burst in my right eye. I was 121 and they did all kinds of tests here and nothing has come up. I was just wondering, is it possible that it could be in my system from that, you know because we took 5 days." The patient had allergies you know like she took the second shot.  The Consumer stated, "I had a allergic reaction and did get anaphylactic shock I had that 3 times. I was just wondering because my mouth used to be a little bit to my left side, they thought that might be 'IA' but now they were going towards that with high blood pressure medicine but never had that around in my life".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Right eye hurt like a blood vessel burst/blood burst in my right eye; do have allergies you know like I took the second shot. I had a allergic reaction I did get anaphylactic shock I had that 3 times; Right eye hurt like a blood vessel burst; Heart started racing; 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 66 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, first vaccine she was fine), administration date: Apr2021, for Covid-19 Immunization, reaction(s): "No reaction on previous exposure to Vaccine". The following information was reported: EYE HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "Right eye hurt like a blood vessel burst/blood burst in my right eye"; ANAPHYLACTIC SHOCK (medically significant) with onset 2021, outcome "unknown", described as "do have allergies you know like I took the second shot. I had a allergic reaction I did get anaphylactic shock I had that 3 times"; EYE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Right eye hurt like a blood vessel burst"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "Heart started racing". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Jan2022) went up, notes: high blood pressure; investigation: (Jan2022) unknown result.  Clinical course: Consumer stated, "Yes, I took the two shots, not the booster. I just want to know for how long it could stay in your system for side effects but how long after. Consumer stated, "I have a question. I took your shot, you know the vaccine and the first one was ok but the second one after two days my heart was racing like crazy and I woke up with a blood burst in my right eye. I was 121 and they did all kinds of tests here and nothing has come up. I was just wondering, is it possible that it could be in my system from that, you know because we took 5 days." The patient had allergies you know like she took the second shot.  The Consumer stated, "I had a allergic reaction and did get anaphylactic shock I had that 3 times. I was just wondering because my mouth used to be a little bit to my left side, they thought that might be 'IA' but now they were going towards that with high blood pressure medicine but never had that around in my life".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test; Positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Dec2021 (Lot number: FK5618) as dose 2 (tris), single and administration date 20Nov2021 (Lot number: FK5618) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 31Jan2022, outcome "unknown" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Jan2022) positive.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: swollen painful lymph nodes; swollen painful lymph nodes; Minor pain at injection site; mild headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 06Feb2021 10:30 (Lot number: EM9810) at the age of 55 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Stage 3 Breast cancer-Left", start date: 01Mar2006, stop date: 07Jan2007, notes: 2 Lumpectomies removed all lymph on total thyroidectomy RA 131.; "Tall cell thyroid cancer", start date: 17Mar2014, stop date: 01Sep2014; "total thyroidectomy RA 131" (unspecified if ongoing); "Lumpectomies" (unspecified if ongoing); "Chemo Radiation" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Lot no: EL3249, Anatomical location: Arm right), administration date: 16Jan2021, when the patient was 55 years old, for COVID-19 immunisation, reaction(s): "Minor pain at injection site", "mild headache". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Feb2021, outcome "recovered" (2021), described as "Minor pain at injection site"; HEADACHE (non-serious) with onset 06Feb2021, outcome "recovered" (2021), described as "mild headache"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 07Feb2021 08:00, outcome "recovered" (2021) and all described as "swollen painful lymph nodes". Therapeutic measures were not taken as a result of vaccination site pain, headache, lymphadenopathy, lymph node pain.  Additional information: The vaccine was administered in a Public Health Department. The vaccine administration date was also reported as 02Feb2021. The events did not result to admission to a hospital or a visit to emergency room or physician's office.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Anion gap, Antibody test, Antinuclear antibody, Antinuclear antibody positive
Clinical narrative: midnight ethroid and maxillary sinusitis; Sprain or partial tear of the anterior tibofibular ligament; Tenosynovitis involving the flexor hallucis longus tendon; serum carbon dioxide decreased; alkaline phosphatase decreased; creatinine decreased; ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive; This is a spontaneous report received from contactable reporter (other healthcare professional).  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Feb2021 (Lot number: EL3302) at the age of 41 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Graves disease", start date: 2014 (unspecified if ongoing), notes: s/p RAI, on levothyroxine; "RAI" (unspecified if ongoing); "Celiac disease", start date: 2014 (unspecified if ongoing), notes: gluten free diet; "Expressive language disorder" (unspecified if ongoing); "left ankle pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, start date: 2015, reaction: "Allergy"; Effexor, start date: 2015, reaction: "Allergy". Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: EL1284, Time vaccination was given: 09:30, Route of administration: Intramuscular, Anatomical location: Arm left), administration date: 13Jan2021, for covid-19 immunization, reactions: "left side arm, leg and face tingling", "twitching", "sharp pain", "muscle spasms" and "brain fog"; Tdap, administration date: Dec2019, when the patient was 39 years old, for immunization; Mmr, for measles immunization; Hepc, administration date: 1999, for hepatitis immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "serum carbon dioxide decreased"; BLOOD ALKALINE PHOSPHATASE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "alkaline phosphatase decreased"; BLOOD CREATININE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "creatinine decreased"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 03Feb2021, outcome "unknown", described as "ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive"; LIGAMENT SPRAIN (non-serious) with onset 25Feb2021, outcome "unknown", described as "Sprain or partial tear of the anterior tibofibular ligament"; TENOSYNOVITIS (non-serious) with onset 25Feb2021, outcome "unknown", described as "Tenosynovitis involving the flexor hallucis longus tendon"; SINUSITIS (non-serious) with onset 02Dec2021, outcome "unknown", described as "midnight ethroid and maxillary sinusitis". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.   Follow-Up (04Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase, Blood albumin, Blood alkaline phosphatase, Blood alkaline phosphatase decreased, Blood bilirubin
Clinical narrative: midnight ethroid and maxillary sinusitis; Sprain or partial tear of the anterior tibofibular ligament; Tenosynovitis involving the flexor hallucis longus tendon; serum carbon dioxide decreased; alkaline phosphatase decreased; creatinine decreased; ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive; This is a spontaneous report received from contactable reporter (other healthcare professional).  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Feb2021 (Lot number: EL3302) at the age of 41 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Graves disease", start date: 2014 (unspecified if ongoing), notes: s/p RAI, on levothyroxine; "RAI" (unspecified if ongoing); "Celiac disease", start date: 2014 (unspecified if ongoing), notes: gluten free diet; "Expressive language disorder" (unspecified if ongoing); "left ankle pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, start date: 2015, reaction: "Allergy"; Effexor, start date: 2015, reaction: "Allergy". Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: EL1284, Time vaccination was given: 09:30, Route of administration: Intramuscular, Anatomical location: Arm left), administration date: 13Jan2021, for covid-19 immunization, reactions: "left side arm, leg and face tingling", "twitching", "sharp pain", "muscle spasms" and "brain fog"; Tdap, administration date: Dec2019, when the patient was 39 years old, for immunization; Mmr, for measles immunization; Hepc, administration date: 1999, for hepatitis immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "serum carbon dioxide decreased"; BLOOD ALKALINE PHOSPHATASE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "alkaline phosphatase decreased"; BLOOD CREATININE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "creatinine decreased"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 03Feb2021, outcome "unknown", described as "ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive"; LIGAMENT SPRAIN (non-serious) with onset 25Feb2021, outcome "unknown", described as "Sprain or partial tear of the anterior tibofibular ligament"; TENOSYNOVITIS (non-serious) with onset 25Feb2021, outcome "unknown", described as "Tenosynovitis involving the flexor hallucis longus tendon"; SINUSITIS (non-serious) with onset 02Dec2021, outcome "unknown", described as "midnight ethroid and maxillary sinusitis". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.   Follow-Up (04Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium, Blood chloride, Blood creatinine, Blood creatinine decreased, Blood glucose
Clinical narrative: midnight ethroid and maxillary sinusitis; Sprain or partial tear of the anterior tibofibular ligament; Tenosynovitis involving the flexor hallucis longus tendon; serum carbon dioxide decreased; alkaline phosphatase decreased; creatinine decreased; ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive; This is a spontaneous report received from contactable reporter (other healthcare professional).  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Feb2021 (Lot number: EL3302) at the age of 41 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Graves disease", start date: 2014 (unspecified if ongoing), notes: s/p RAI, on levothyroxine; "RAI" (unspecified if ongoing); "Celiac disease", start date: 2014 (unspecified if ongoing), notes: gluten free diet; "Expressive language disorder" (unspecified if ongoing); "left ankle pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, start date: 2015, reaction: "Allergy"; Effexor, start date: 2015, reaction: "Allergy". Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: EL1284, Time vaccination was given: 09:30, Route of administration: Intramuscular, Anatomical location: Arm left), administration date: 13Jan2021, for covid-19 immunization, reactions: "left side arm, leg and face tingling", "twitching", "sharp pain", "muscle spasms" and "brain fog"; Tdap, administration date: Dec2019, when the patient was 39 years old, for immunization; Mmr, for measles immunization; Hepc, administration date: 1999, for hepatitis immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "serum carbon dioxide decreased"; BLOOD ALKALINE PHOSPHATASE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "alkaline phosphatase decreased"; BLOOD CREATININE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "creatinine decreased"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 03Feb2021, outcome "unknown", described as "ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive"; LIGAMENT SPRAIN (non-serious) with onset 25Feb2021, outcome "unknown", described as "Sprain or partial tear of the anterior tibofibular ligament"; TENOSYNOVITIS (non-serious) with onset 25Feb2021, outcome "unknown", described as "Tenosynovitis involving the flexor hallucis longus tendon"; SINUSITIS (non-serious) with onset 02Dec2021, outcome "unknown", described as "midnight ethroid and maxillary sinusitis". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.   Follow-Up (04Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, Blood urea
Clinical narrative: midnight ethroid and maxillary sinusitis; Sprain or partial tear of the anterior tibofibular ligament; Tenosynovitis involving the flexor hallucis longus tendon; serum carbon dioxide decreased; alkaline phosphatase decreased; creatinine decreased; ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive; This is a spontaneous report received from contactable reporter (other healthcare professional).  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Feb2021 (Lot number: EL3302) at the age of 41 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Graves disease", start date: 2014 (unspecified if ongoing), notes: s/p RAI, on levothyroxine; "RAI" (unspecified if ongoing); "Celiac disease", start date: 2014 (unspecified if ongoing), notes: gluten free diet; "Expressive language disorder" (unspecified if ongoing); "left ankle pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, start date: 2015, reaction: "Allergy"; Effexor, start date: 2015, reaction: "Allergy". Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: EL1284, Time vaccination was given: 09:30, Route of administration: Intramuscular, Anatomical location: Arm left), administration date: 13Jan2021, for covid-19 immunization, reactions: "left side arm, leg and face tingling", "twitching", "sharp pain", "muscle spasms" and "brain fog"; Tdap, administration date: Dec2019, when the patient was 39 years old, for immunization; Mmr, for measles immunization; Hepc, administration date: 1999, for hepatitis immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "serum carbon dioxide decreased"; BLOOD ALKALINE PHOSPHATASE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "alkaline phosphatase decreased"; BLOOD CREATININE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "creatinine decreased"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 03Feb2021, outcome "unknown", described as "ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive"; LIGAMENT SPRAIN (non-serious) with onset 25Feb2021, outcome "unknown", described as "Sprain or partial tear of the anterior tibofibular ligament"; TENOSYNOVITIS (non-serious) with onset 25Feb2021, outcome "unknown", described as "Tenosynovitis involving the flexor hallucis longus tendon"; SINUSITIS (non-serious) with onset 02Dec2021, outcome "unknown", described as "midnight ethroid and maxillary sinusitis". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.   Follow-Up (04Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Carbon dioxide, Carbon dioxide decreased, Double stranded DNA antibody, Ligament sprain
Clinical narrative: midnight ethroid and maxillary sinusitis; Sprain or partial tear of the anterior tibofibular ligament; Tenosynovitis involving the flexor hallucis longus tendon; serum carbon dioxide decreased; alkaline phosphatase decreased; creatinine decreased; ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive; This is a spontaneous report received from contactable reporter (other healthcare professional).  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Feb2021 (Lot number: EL3302) at the age of 41 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Graves disease", start date: 2014 (unspecified if ongoing), notes: s/p RAI, on levothyroxine; "RAI" (unspecified if ongoing); "Celiac disease", start date: 2014 (unspecified if ongoing), notes: gluten free diet; "Expressive language disorder" (unspecified if ongoing); "left ankle pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, start date: 2015, reaction: "Allergy"; Effexor, start date: 2015, reaction: "Allergy". Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: EL1284, Time vaccination was given: 09:30, Route of administration: Intramuscular, Anatomical location: Arm left), administration date: 13Jan2021, for covid-19 immunization, reactions: "left side arm, leg and face tingling", "twitching", "sharp pain", "muscle spasms" and "brain fog"; Tdap, administration date: Dec2019, when the patient was 39 years old, for immunization; Mmr, for measles immunization; Hepc, administration date: 1999, for hepatitis immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "serum carbon dioxide decreased"; BLOOD ALKALINE PHOSPHATASE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "alkaline phosphatase decreased"; BLOOD CREATININE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "creatinine decreased"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 03Feb2021, outcome "unknown", described as "ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive"; LIGAMENT SPRAIN (non-serious) with onset 25Feb2021, outcome "unknown", described as "Sprain or partial tear of the anterior tibofibular ligament"; TENOSYNOVITIS (non-serious) with onset 25Feb2021, outcome "unknown", described as "Tenosynovitis involving the flexor hallucis longus tendon"; SINUSITIS (non-serious) with onset 02Dec2021, outcome "unknown", described as "midnight ethroid and maxillary sinusitis". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.   Follow-Up (04Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Metabolic function test, Protein total, Sinusitis, Tenosynovitis
Clinical narrative: midnight ethroid and maxillary sinusitis; Sprain or partial tear of the anterior tibofibular ligament; Tenosynovitis involving the flexor hallucis longus tendon; serum carbon dioxide decreased; alkaline phosphatase decreased; creatinine decreased; ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive; This is a spontaneous report received from contactable reporter (other healthcare professional).  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Feb2021 (Lot number: EL3302) at the age of 41 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Graves disease", start date: 2014 (unspecified if ongoing), notes: s/p RAI, on levothyroxine; "RAI" (unspecified if ongoing); "Celiac disease", start date: 2014 (unspecified if ongoing), notes: gluten free diet; "Expressive language disorder" (unspecified if ongoing); "left ankle pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, start date: 2015, reaction: "Allergy"; Effexor, start date: 2015, reaction: "Allergy". Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: EL1284, Time vaccination was given: 09:30, Route of administration: Intramuscular, Anatomical location: Arm left), administration date: 13Jan2021, for covid-19 immunization, reactions: "left side arm, leg and face tingling", "twitching", "sharp pain", "muscle spasms" and "brain fog"; Tdap, administration date: Dec2019, when the patient was 39 years old, for immunization; Mmr, for measles immunization; Hepc, administration date: 1999, for hepatitis immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "serum carbon dioxide decreased"; BLOOD ALKALINE PHOSPHATASE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "alkaline phosphatase decreased"; BLOOD CREATININE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "creatinine decreased"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 03Feb2021, outcome "unknown", described as "ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive"; LIGAMENT SPRAIN (non-serious) with onset 25Feb2021, outcome "unknown", described as "Sprain or partial tear of the anterior tibofibular ligament"; TENOSYNOVITIS (non-serious) with onset 25Feb2021, outcome "unknown", described as "Tenosynovitis involving the flexor hallucis longus tendon"; SINUSITIS (non-serious) with onset 02Dec2021, outcome "unknown", described as "midnight ethroid and maxillary sinusitis". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.   Follow-Up (04Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12
Clinical narrative: midnight ethroid and maxillary sinusitis; Sprain or partial tear of the anterior tibofibular ligament; Tenosynovitis involving the flexor hallucis longus tendon; serum carbon dioxide decreased; alkaline phosphatase decreased; creatinine decreased; ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive; This is a spontaneous report received from contactable reporter (other healthcare professional).  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Feb2021 (Lot number: EL3302) at the age of 41 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Graves disease", start date: 2014 (unspecified if ongoing), notes: s/p RAI, on levothyroxine; "RAI" (unspecified if ongoing); "Celiac disease", start date: 2014 (unspecified if ongoing), notes: gluten free diet; "Expressive language disorder" (unspecified if ongoing); "left ankle pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, start date: 2015, reaction: "Allergy"; Effexor, start date: 2015, reaction: "Allergy". Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: EL1284, Time vaccination was given: 09:30, Route of administration: Intramuscular, Anatomical location: Arm left), administration date: 13Jan2021, for covid-19 immunization, reactions: "left side arm, leg and face tingling", "twitching", "sharp pain", "muscle spasms" and "brain fog"; Tdap, administration date: Dec2019, when the patient was 39 years old, for immunization; Mmr, for measles immunization; Hepc, administration date: 1999, for hepatitis immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "serum carbon dioxide decreased"; BLOOD ALKALINE PHOSPHATASE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "alkaline phosphatase decreased"; BLOOD CREATININE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "creatinine decreased"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 03Feb2021, outcome "unknown", described as "ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive"; LIGAMENT SPRAIN (non-serious) with onset 25Feb2021, outcome "unknown", described as "Sprain or partial tear of the anterior tibofibular ligament"; TENOSYNOVITIS (non-serious) with onset 25Feb2021, outcome "unknown", described as "Tenosynovitis involving the flexor hallucis longus tendon"; SINUSITIS (non-serious) with onset 02Dec2021, outcome "unknown", described as "midnight ethroid and maxillary sinusitis". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.   Follow-Up (04Feb2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Drug ineffective, Meningitis pneumococcal
Clinical narrative: got the Pneumovax vaccine and Prevnar 13 but sometime after that, she got pneumococcal meningitis; got the Pneumovax vaccine and Prevnar 13 but sometime after that, she got pneumococcal meningitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), MENINGITIS PNEUMOCOCCAL (medically significant), outcome "unknown" and all described as "got the Pneumovax vaccine and Prevnar 13 but sometime after that, she got pneumococcal meningitis". Therapeutic measures were taken as a result of drug ineffective, meningitis pneumococcal; patient was given antibiotics (unspecified). Clinical course: It was reported that they were not sure what strain it was because they had started antibiotics right away but they presumed it was one that was not covered by those vaccines which is why her doctor wants her to get the Prevnar 20, however her doctor and the pharmacies do not have it and one of the pharmacies was not even aware it existed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Pruritus, Skin lesion, Swelling
Clinical narrative: Blacked out; fell to ground; swelling; sores / Right wrist, Right arm underarm back; itching / Itching is intense; outbreaks of hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Dec2021 (Lot number: FH8027) at the age of 81 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anaphylaxis bee sting", start date: 1980 (unspecified if ongoing), notes: Other medical history: Anaphylaxis bee sting 1980 ER. Concomitant medication(s) included: FIORICET; TYLENOL; BENICAR. Vaccination history included: Bnt162b2 (lot number: ER2613, dose number: 2, vaccine location: Right arm), administration date: 26Mar2021, when the patient was 81 years old, for Covid-19 immunization; Bnt162b2 (lot number: EN6199, administration route: Intramuscular, dose number: 1, vaccine location: Right arm), administration date: 05Mar2021, when the patient was 81 years old, for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 08Dec2021, outcome "not recovered", described as "Blacked out"; FALL (medically significant) with onset 08Dec2021, outcome "not recovered", described as "fell to ground"; URTICARIA (non-serious) with onset 08Dec2021, outcome "not recovered", described as "outbreaks of hives"; PRURITUS (non-serious) with onset 08Dec2021, outcome "not recovered", described as "itching / Itching is intense"; SWELLING (non-serious) with onset 08Dec2021, outcome "not recovered", described as "swelling"; SKIN LESION (non-serious) with onset 08Dec2021, outcome "not recovered", described as "sores / Right wrist, Right arm underarm back". The events "blacked out", "fell to ground", "outbreaks of hives", "itching / itching is intense", "swelling" and "sores / right wrist, right arm underarm back" were evaluated at the physician office visit. Therapeutic measures were taken as a result of loss of consciousness, fall, urticaria, pruritus, swelling, skin lesion. Therapeutic measures were taken as a result of loss of consciousness, urticaria, pruritus, swelling, arthralgia, pain in extremity, axillary pain, back pain, fall. Clinical course: The patient had no other vaccine in four weeks and no known allergies. As of the time of report, the patient was still having outbreaks of hives, itching, swelling and sores two months after last dose in the right wrist, right arm, underarm and back. Doctor's prescription of Triamcinolone Acetonide cream .5% was not helping. Blacked out 08Dec2021 briefly and fell to ground. Itching was intense. The patient had no COVID prior vaccination and was not tested post vaccination.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Blacked out; fell to ground; swelling; sores / Right wrist, Right arm underarm back; itching / Itching is intense; outbreaks of hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Dec2021 (Lot number: FH8027) at the age of 81 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anaphylaxis bee sting", start date: 1980 (unspecified if ongoing), notes: Other medical history: Anaphylaxis bee sting 1980 ER. Concomitant medication(s) included: FIORICET; TYLENOL; BENICAR. Vaccination history included: Bnt162b2 (lot number: ER2613, dose number: 2, vaccine location: Right arm), administration date: 26Mar2021, when the patient was 81 years old, for Covid-19 immunization; Bnt162b2 (lot number: EN6199, administration route: Intramuscular, dose number: 1, vaccine location: Right arm), administration date: 05Mar2021, when the patient was 81 years old, for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 08Dec2021, outcome "not recovered", described as "Blacked out"; FALL (medically significant) with onset 08Dec2021, outcome "not recovered", described as "fell to ground"; URTICARIA (non-serious) with onset 08Dec2021, outcome "not recovered", described as "outbreaks of hives"; PRURITUS (non-serious) with onset 08Dec2021, outcome "not recovered", described as "itching / Itching is intense"; SWELLING (non-serious) with onset 08Dec2021, outcome "not recovered", described as "swelling"; SKIN LESION (non-serious) with onset 08Dec2021, outcome "not recovered", described as "sores / Right wrist, Right arm underarm back". The events "blacked out", "fell to ground", "outbreaks of hives", "itching / itching is intense", "swelling" and "sores / right wrist, right arm underarm back" were evaluated at the physician office visit. Therapeutic measures were taken as a result of loss of consciousness, fall, urticaria, pruritus, swelling, skin lesion. Therapeutic measures were taken as a result of loss of consciousness, urticaria, pruritus, swelling, arthralgia, pain in extremity, axillary pain, back pain, fall. Clinical course: The patient had no other vaccine in four weeks and no known allergies. As of the time of report, the patient was still having outbreaks of hives, itching, swelling and sores two months after last dose in the right wrist, right arm, underarm and back. Doctor's prescription of Triamcinolone Acetonide cream .5% was not helping. Blacked out 08Dec2021 briefly and fell to ground. Itching was intense. The patient had no COVID prior vaccination and was not tested post vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vitiligo
Clinical narrative: Vitiligo; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 13Feb2021 (Lot number: unknown) at the age of 51 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing), notes: DMT2; "Depression" (unspecified if ongoing); "Multiple allergies" (unspecified if ongoing), notes: Allergies; "GERD" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Fish allergy" (unspecified if ongoing), notes: Known allergies: Fish and "Fruit allergy" (unspecified if ongoing), notes: Known allergies: bananas, kiwi, star fruit, mangos, coconuts. Concomitant medication(s) included: JANUVIA; GLYBURIDE; SINGULAIR; MONTELUKAST and METFORM. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: unknown; Route of administration: unspecified; Anatomical location: Left arm), administration date: 23Jan2021, when the patient was 51 year(s) old, for COVID-19 immunisation.  The following information was reported: VITILIGO (non-serious) with onset 26Mar2021, outcome "recovering", described as "Vitiligo". The event "Vitiligo" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vitiligo.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19. Treatment included for event Vitiligo was MD visits, topical (unspecified medication).  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Infection, SARS-CoV-2 test
Clinical narrative: covid test result: Positive; covid test result: Positive; breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 31Jan2022 22:00, outcome "unknown", COVID-19 (medically significant) with onset 31Jan2022 22:00, outcome "not recovered" and all described as "covid test result: Positive"; INFECTION (medically significant) with onset 31Jan2022 22:00, outcome "not recovered", described as "breakthrough infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Jan2022) positive. Therapeutic measures were not taken as a result of covid-19, infection. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Platelet disorder, Pneumonitis, Tremor
Clinical narrative: inflammation in lungs; having problem with the platelets in his blood; started trembling and loose balance; started trembling and loose balance; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown (booster), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PNEUMONITIS (hospitalization, life threatening), outcome "not recovered", described as "inflammation in lungs"; PLATELET DISORDER (non-serious), outcome "unknown", described as "having problem with the platelets in his blood"; TREMOR (non-serious), BALANCE DISORDER (non-serious), outcome "unknown" and all described as "started trembling and loose balance". The event "inflammation in lungs" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pneumonitis, platelet disorder. Clinical course: After he got the booster shot, he started having problem with the platelets in his blood. So, a treatment with steroids was started. He was like 3 or 4 less than a month when he started trembling and loose balance so he was put to 'that' and they said it is like inflammation in lungs and told that it was a pneumonia. Patient never had a COVID but they saw a bacteria or a fungus so, they started treatment. When further clarified, patient was very 'epiploic' pneumonia. He is like pneumonia but the 'oleic' sounds no pneumonia it is like the inflammation of the lungs and they said like they have no idea how to treat it because it's something new from the latest information for COVID. They have been treating it with antibiotics but they suspended antibiotics today because they found with the 'latest thing' they have been doing that it's not a bacteria that it's not a fungus now they said it's no pneumonia but he is on a ventilator. So, the doctor told them that it was an inflammation of the lungs but this is very new for them. The patient's condition worsened and is now in the ICU on a ventilator.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Developed mild to moderate COVID; Developed mild to moderate COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (age reported as 50 with no units provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Developed mild to moderate COVID". The event "developed mild to moderate covid" and "developed mild to moderate covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: mild to moderate covid. Therapeutic measures were taken as a result of covid-19. The reporter provided the following information: Family of 5 who were all vaccinated with Comirnaty ranging in ages of 50 (received primary series and booster) with other family members receiving primary series (ages 50, 20, 17, 13) all developed mild to moderate COVID. No family member was hospitalized.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200131953 Same reporter/RA, Different patient/AE;US-PFIZER INC-202200204042 Same reporter/RA, Different patient/AE;US-PFIZER INC-202200204043 Same reporter/RA, Different patient/AE;US-PFIZER INC-202200204041 Same reporter/RA, Different patient/AE