chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness/ achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness/ achiness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM, HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Soreness/ achiness). At the time of the report, PAIN (Soreness/ achiness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-418822, MOD-2021-419686, MOD-2021-419760 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: soreness; achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness) and PAIN (achiness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM, HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (soreness) and PAIN (achiness). On 06-Nov-2021, PAIN IN EXTREMITY (soreness) and PAIN (achiness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported.   This case was linked to MOD-2021-419686, MOD-2021-419744 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Pruritus, Rash, Swelling
Clinical narrative: a lot of swelling, itching and rash; a lot of swelling, itching and rash; "now a pimple is coming into the rash"; a lot of swelling, itching and rash; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (a lot of swelling, itching and rash), PRURITUS (a lot of swelling, itching and rash), DERMATITIS ACNEIFORM ("now a pimple is coming into the rash") and RASH (a lot of swelling, itching and rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced SWELLING (a lot of swelling, itching and rash), PRURITUS (a lot of swelling, itching and rash), DERMATITIS ACNEIFORM ("now a pimple is coming into the rash") and RASH (a lot of swelling, itching and rash). At the time of the report, SWELLING (a lot of swelling, itching and rash), PRURITUS (a lot of swelling, itching and rash), DERMATITIS ACNEIFORM ("now a pimple is coming into the rash") and RASH (a lot of swelling, itching and rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 grandkids ages 16 and 17 almost 18, they have their 2 vaccinations; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 grandkids ages 16 and 17 almost 18, they have their 2 vaccinations) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 grandkids ages 16 and 17 almost 18, they have their 2 vaccinations). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 grandkids ages 16 and 17 almost 18, they have their 2 vaccinations) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-419804 (Patient Link).   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension
Clinical narrative: headache in the left temple, headache increasing frequently; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and HEADACHE (headache in the left temple, headache increasing frequently) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 007M20A and 025520A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HYPERTENSION (high blood pressure). In October 2021, the patient experienced HEADACHE (headache in the left temple, headache increasing frequently). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (high blood pressure) outcome was unknown and HEADACHE (headache in the left temple, headache increasing frequently) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) Increased.         Patient reports she has a family history of high blood pressure.   This case was linked to MOD-2021-420137, MOD-2021-420138 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Increased blood pressure after first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Increased blood pressure after first 2 doses) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Blood pressure management.   On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced BLOOD PRESSURE INCREASED (Increased blood pressure after first 2 doses). At the time of the report, BLOOD PRESSURE INCREASED (Increased blood pressure after first 2 doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: increased (High) Increased.         No treatment information was provided.   This case was linked to MOD-2021-420137, MOD-2021-420124 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: had her neck swell up like a balloon; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (had her neck swell up like a balloon) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (had her neck swell up like a balloon). At the time of the report, SWELLING (had her neck swell up like a balloon) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Was unconscious for about 20-30 seconds; Fainted; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was unconscious for about 20-30 seconds) and SYNCOPE (Fainted) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Was unconscious for about 20-30 seconds) (seriousness criterion medically significant) and SYNCOPE (Fainted) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Was unconscious for about 20-30 seconds) and SYNCOPE (Fainted) outcome was unknown.            No concomitant medications were provided. No treatment information was provided. COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old patient with no clinical history who experienced the unexpected event of LOSS OF CONSCIOUSNESS and SYNCOPE  The events occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old patient with no clinical history who experienced the unexpected event of LOSS OF CONSCIOUSNESS and SYNCOPE  The events occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Nausea
Clinical narrative: 104.5 fever; Chills; Nausea; shaking/ trembling; cough (severe); loss of bladder control; joint pains; exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 12:00 PM (Lot number: FC3180) at the age of 71 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergies: codeine", notes: Allergies: codeine; Myocin chain drugs, reaction(s): "Allergies: myocin chain drugs", notes: Allergies: zinc; Zinc, reaction(s): "Allergies: zinc". The following information was reported: PYREXIA (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "104.5 fever"; CHILLS (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "Chills"; NAUSEA (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "Nausea"; TREMOR (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "shaking/ trembling"; COUGH (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "cough (severe)"; URINARY INCONTINENCE (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "loss of bladder control"; ARTHRALGIA (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "joint pains"; FATIGUE (non-serious) with onset 18Aug2021, outcome "unknown", described as "exhaustion". The events "104.5 fever", "chills", "nausea", "shaking/ trembling", "cough (severe)", "loss of bladder control", "joint pains" and "exhaustion" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pyrexia, chills, nausea, tremor, cough, urinary incontinence, arthralgia, fatigue. Additional information: The patient did not receive any other vaccine in four weeks of covid-19 vaccine. The patient did not receive other medications in two weeks of covid-19 vaccine. The patient had Covid prior vaccination and did not get tested for Covid-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Urinary incontinence
Clinical narrative: 104.5 fever; Chills; Nausea; shaking/ trembling; cough (severe); loss of bladder control; joint pains; exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 12:00 PM (Lot number: FC3180) at the age of 71 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergies: codeine", notes: Allergies: codeine; Myocin chain drugs, reaction(s): "Allergies: myocin chain drugs", notes: Allergies: zinc; Zinc, reaction(s): "Allergies: zinc". The following information was reported: PYREXIA (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "104.5 fever"; CHILLS (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "Chills"; NAUSEA (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "Nausea"; TREMOR (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "shaking/ trembling"; COUGH (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "cough (severe)"; URINARY INCONTINENCE (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "loss of bladder control"; ARTHRALGIA (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "joint pains"; FATIGUE (non-serious) with onset 18Aug2021, outcome "unknown", described as "exhaustion". The events "104.5 fever", "chills", "nausea", "shaking/ trembling", "cough (severe)", "loss of bladder control", "joint pains" and "exhaustion" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pyrexia, chills, nausea, tremor, cough, urinary incontinence, arthralgia, fatigue. Additional information: The patient did not receive any other vaccine in four weeks of covid-19 vaccine. The patient did not receive other medications in two weeks of covid-19 vaccine. The patient had Covid prior vaccination and did not get tested for Covid-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Swelling
Clinical narrative: experienced severe swelling of the feet; difficulty walking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "experienced severe swelling of the feet"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "difficulty walking".  Additional information: A non-contactable consumer reported for a patient (reporter's family member). No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. That family member was scared to take 2nd dose and wondering if Pfizer would monitor them or screen them to see why they had reaction in the first place. Were any medical questions addressed by this program forwarded/referred to Medical Information? N/A.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, SARS-CoV-2 test, Vision blurred, Visual impairment
Clinical narrative: Changes to my vision occurred; I started to notice I was having trouble reading again; Blurrines was again very severe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 08:30 (Lot number: ER8735) at the age of 22 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "GAD" (unspecified if ongoing); "depression" (unspecified if ongoing); "borderline personality disorder" (unspecified if ongoing); "alcohol abuse disorder" (unspecified if ongoing); "mangoes" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: MIRENA; VYVANSE; SPIRONOLACTONE.   Vaccination history included: Bnt162b2 (product: COVID 19 , brand: Pfizer, lot number: EW0150, lot unknown: False, administration date: 31Mar2021, administration time: 08:30 AM, dose number: 1, vaccine location: Left arm), administration date: 31Mar2021, when the patient was 22 years old, for covid 19 immunization, reaction(s): "The first shot was administered Mar 31st, on Apr 9th around midday I experience a sudden change in my close-up vision, everything suddenly appeared blurry (my distance vision was normal).". The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "recovered", described as "Changes to my vision occurred"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "recovered", described as "I started to notice I was having trouble reading again"; VISION BLURRED (non-serious) with onset 2021, outcome "recovered", described as "Blurrines was again very severe". The events "changes to my vision occurred" and "i started to notice i was having trouble reading again" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of visual impairment, visual impairment, vision blurred.  No follow-up attempts are possible. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: I am having a severe racing heartbeat rasping; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "I am having a severe racing heartbeat rasping". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Globulin, Globulins decreased, Haematocrit, Haematocrit decreased
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient. A 57 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 15Jul2021 (Lot number: ER8736) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Right back basal cell carcinoma", stop date: 07Jan2016, notes: Illness/AE: Right back basal cell carcinoma, Stop date: 07Jan2016, Pertinent details:excision. Concomitant medication(s) included: IMIQUIMOD taken for precancerous condition, start date: 01Apr2021, stop date: 19May2021. Vaccination history included: Bnt162b2 (Dose:1, Date and Time: 13Mar2021, Anatomical site of Injection: Left deltoid, Route of Administration: Intramuscular, Batch/Lot number: ER6166), administration date: 13Mar2021, when the patient was 56 years old, for COVID-19 immunisation; Bnt162b2 (Dose:2, Date and Time: 01Apr2021 , Anatomical site of Injection: Left deltoid, Route of Administration: Intramuscular, Batch/Lot number: ER0866), administration date: 01Apr2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: VITAMIN D DECREASED (non-serious), outcome "unknown", described as "low vitamin D"; VITAMIN B12 DECREASED (non-serious), outcome "unknown", described as "low vit B12"; GLOBULINS DECREASED (non-serious), outcome "unknown", described as "low globulin"; RED BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "RBC low"; HAEMATOCRIT DECREASED (non-serious), outcome "unknown", described as "HCT low"; MEAN CELL HAEMOGLOBIN CONCENTRATION INCREASED (non-serious), outcome "unknown", described as "MCHC high"; IMMUNISATION (non-serious) with onset 15Jul2021, outcome "unknown", described as "Booster". Relevant laboratory tests and procedures are available in the appropriate section. Additional information- Laboratory results (02Oct2021) abnormal results found Hx of low vit D (25 oh vit D total) at 19.3mg/ml (30-100 mg/ml) 2021 labs check up show low vit B 12 at 157 pg/ml (211-911). Low globulin at 2.13 gm/dl (2.5-3.4) (may used to produce IgG covid-19). CBC: total RBC 4.34 millions/cu.mm (4.5-5.5) (may cause by low vit B 12). HCT (pcv) 39.2 percent (40-50) (may cause by low vit B 12). MCHC 35.5 g/dl (31.5-34.5) (may cause by low vit B 12). No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Mean cell haemoglobin concentration, Mean cell haemoglobin concentration increased, Red blood cell count, Red blood cell count decreased
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient. A 57 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 15Jul2021 (Lot number: ER8736) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Right back basal cell carcinoma", stop date: 07Jan2016, notes: Illness/AE: Right back basal cell carcinoma, Stop date: 07Jan2016, Pertinent details:excision. Concomitant medication(s) included: IMIQUIMOD taken for precancerous condition, start date: 01Apr2021, stop date: 19May2021. Vaccination history included: Bnt162b2 (Dose:1, Date and Time: 13Mar2021, Anatomical site of Injection: Left deltoid, Route of Administration: Intramuscular, Batch/Lot number: ER6166), administration date: 13Mar2021, when the patient was 56 years old, for COVID-19 immunisation; Bnt162b2 (Dose:2, Date and Time: 01Apr2021 , Anatomical site of Injection: Left deltoid, Route of Administration: Intramuscular, Batch/Lot number: ER0866), administration date: 01Apr2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: VITAMIN D DECREASED (non-serious), outcome "unknown", described as "low vitamin D"; VITAMIN B12 DECREASED (non-serious), outcome "unknown", described as "low vit B12"; GLOBULINS DECREASED (non-serious), outcome "unknown", described as "low globulin"; RED BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "RBC low"; HAEMATOCRIT DECREASED (non-serious), outcome "unknown", described as "HCT low"; MEAN CELL HAEMOGLOBIN CONCENTRATION INCREASED (non-serious), outcome "unknown", described as "MCHC high"; IMMUNISATION (non-serious) with onset 15Jul2021, outcome "unknown", described as "Booster". Relevant laboratory tests and procedures are available in the appropriate section. Additional information- Laboratory results (02Oct2021) abnormal results found Hx of low vit D (25 oh vit D total) at 19.3mg/ml (30-100 mg/ml) 2021 labs check up show low vit B 12 at 157 pg/ml (211-911). Low globulin at 2.13 gm/dl (2.5-3.4) (may used to produce IgG covid-19). CBC: total RBC 4.34 millions/cu.mm (4.5-5.5) (may cause by low vit B 12). HCT (pcv) 39.2 percent (40-50) (may cause by low vit B 12). MCHC 35.5 g/dl (31.5-34.5) (may cause by low vit B 12). No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vitamin B12, Vitamin B12 decreased, Vitamin D, Vitamin D decreased
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient. A 57 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 15Jul2021 (Lot number: ER8736) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Right back basal cell carcinoma", stop date: 07Jan2016, notes: Illness/AE: Right back basal cell carcinoma, Stop date: 07Jan2016, Pertinent details:excision. Concomitant medication(s) included: IMIQUIMOD taken for precancerous condition, start date: 01Apr2021, stop date: 19May2021. Vaccination history included: Bnt162b2 (Dose:1, Date and Time: 13Mar2021, Anatomical site of Injection: Left deltoid, Route of Administration: Intramuscular, Batch/Lot number: ER6166), administration date: 13Mar2021, when the patient was 56 years old, for COVID-19 immunisation; Bnt162b2 (Dose:2, Date and Time: 01Apr2021 , Anatomical site of Injection: Left deltoid, Route of Administration: Intramuscular, Batch/Lot number: ER0866), administration date: 01Apr2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: VITAMIN D DECREASED (non-serious), outcome "unknown", described as "low vitamin D"; VITAMIN B12 DECREASED (non-serious), outcome "unknown", described as "low vit B12"; GLOBULINS DECREASED (non-serious), outcome "unknown", described as "low globulin"; RED BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "RBC low"; HAEMATOCRIT DECREASED (non-serious), outcome "unknown", described as "HCT low"; MEAN CELL HAEMOGLOBIN CONCENTRATION INCREASED (non-serious), outcome "unknown", described as "MCHC high"; IMMUNISATION (non-serious) with onset 15Jul2021, outcome "unknown", described as "Booster". Relevant laboratory tests and procedures are available in the appropriate section. Additional information- Laboratory results (02Oct2021) abnormal results found Hx of low vit D (25 oh vit D total) at 19.3mg/ml (30-100 mg/ml) 2021 labs check up show low vit B 12 at 157 pg/ml (211-911). Low globulin at 2.13 gm/dl (2.5-3.4) (may used to produce IgG covid-19). CBC: total RBC 4.34 millions/cu.mm (4.5-5.5) (may cause by low vit B 12). HCT (pcv) 39.2 percent (40-50) (may cause by low vit B 12). MCHC 35.5 g/dl (31.5-34.5) (may cause by low vit B 12). No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Immunisation, Off label use
Clinical narrative: booster; off label use; Been with her granddaughter and just found out granddaughter tested positive for COVID; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included COVID-19 Vaccine (Manufacturer unknown, lot number was not reported) as dose 1 and dose 2 for covid-19 immunisation. The patient experienced reported booster and off label use on an unspecified date. On an unspecified date, she had been with her granddaughter and later found out granddaughter tested positive for COVID. She wanted to know if she needed to be concerned. The outcome of exposure to Covid-19 was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-up (29Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: caller reports 4 weeks before getting the first dose, she had filler injected by her eyes and now one of her eyes looks all messed up and she will need surgery to correct that problem.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Pfizer (159558). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "she got the filler injections", start date: 02Mar2021 (unspecified if ongoing), notes: Caller states she waited from the time she got the filler injections on 02Mar2021, 6 weeks. There were no concomitant medications. The following information was reported: OCULAR DISCOMFORT (medically significant), outcome "unknown", described as "caller reports 4 weeks before getting the first dose, she had filler injected by her eyes and now one of her eyes looks all messed up and she will need surgery to correct that problem.". 4 weeks before getting the first dose, she had filler injected by her eyes and now one of her eyes looks all messed up and she will need surgery to correct that problem. It was reported that filler had to be completely removed. It was reported that she wanted to see out of courtesy what they were wiling to do for her. Caller states now she is stuck having to correct her eye, it is  completely sunk in on the left side.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: Face was swollen/my face is like swollen on that side; Front of my face and neck went numb/the side of my face went numb; 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 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 08Nov2021 09:40 (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 (First Dose), for Covid-19 immunization. The following information was reported: SWELLING FACE (non-serious) with onset 09Nov2021, outcome "unknown", described as "Face was swollen/my face is like swollen on that side"; HYPOAESTHESIA (non-serious) with onset 08Nov2021, outcome "unknown", described as "Front of my face and neck went numb/the side of my face went numb".  Additional information: Patient reported that, she recently got her second dose of the Pfizer Covid 19 vaccine and when she received it the front of her face and neck went numb. They had her sit there a couple of minutes until it felt better and then they said she was okay to leave because, it kinda of went away. She went home and it was still numb but it got better basically. This morning (09Nov2021) she noticed the front of herface was swollen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Vaccination site pain, Vulvovaginal pruritus
Clinical narrative: injection site pain; burning in her arm pit; vaginal itching; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VULVOVAGINAL PRURITUS (non-serious) with onset Nov2021, outcome "unknown", described as "vaginal itching"; BURNING SENSATION (non-serious) with onset 08Nov2021, outcome "recovered" (Nov2021), described as "burning in her arm pit"; VACCINATION SITE PAIN (non-serious) with onset 09Nov2021, outcome "recovered" (2021), described as "injection site pain".  Additional information :It was reported that patient experienced injection site pain, which she realizes is expected and also experienced burning in arm pit (same side as injection) that lasted a couple days and went away, but a week after she started to get vaginal itching. Patient thought she had a yeast or fungal infection. It was reported that patient was uncomfortable receiving the second dose and asks is there something that can be documented so she don't have to receive both doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: she inadvertently gave a 35 year old male the vaccine 1.5 hours after the 6 hours dilution period; she inadvertently gave a 35 year old male the vaccine 1.5 hours after the 6 hours dilution period; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program .  A 35-year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) and all described as "she inadvertently gave a 35 year old male the vaccine 1.5 hours after the 6 hours dilution period".  Additional information: The reporter stated that she diluted the vaccine, drew up 6 syringes and placed the syringes back into the refrigerator. The reporter stated that she inadvertently gave a 35 year old male the vaccine 1.5 hours after the 6 hours dilution period. The reporter confirmed diluted, Pfizer Covid-19 vaccine with a purple cap, stored in a syringe, in the refrigerator. The reporter queried if she would need to give the patient another dose. The reporter was seeking stability information for diluted Pfizer Covid-19 vaccine with a purple cap that was stored in the syringe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Enuresis
Clinical narrative: My son wet the bed 2 nights in a row after vaccine, this has never happened before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 18:45 (Batch/Lot number: unknown) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "premature birth" (unspecified if ongoing); "Lactose intolerance" (unspecified if ongoing), notes: Known allergies: Lactose allergy. The patient's concomitant medications were not reported. The following information was reported: ENURESIS (non-serious) with onset 13Nov2021 22:45, outcome "unknown", described as "My son wet the bed 2 nights in a row after vaccine, this has never happened before". Therapeutic measures were not taken as a result of enuresis.  Additional information: Facility type vaccine was pharmacy or drug store. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no COVID prior vaccination and not tested COVID post vaccination.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: a relative who experienced T along with some other symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).   A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "a relative who experienced T along with some other symptoms".  Follow-up attempts completed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cough, Fatigue
Clinical narrative: Prolonged cough that has lasted 3 days; loss of voice; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Nov2021 (Lot number: Unknown) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 08Oct2021.  The following information was reported: COUGH (non-serious) with onset 13Nov2021 05:00, outcome "recovering", described as "Prolonged cough that has lasted 3 days"; APHONIA (non-serious) with onset 13Nov2021 05:00, outcome "recovering", described as "loss of voice"; FATIGUE (non-serious) with onset 13Nov2021 05:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of cough, aphonia, fatigue.  Additional information: The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient not been tested for COVID-19. The patient had no known allergies. Device timestamp:15Nov2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt horrible; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "recovering", described as "felt horrible".  No follow-up attempts were possible. No further information was expected.  Additional information: While on call with patient stated that the patient had to stop taking Xeljanz for 10days after receiving the COVID vaccine. The patient stated that she felt horrible, and started to feel better now she's been back on Xeljanz for two days.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash". This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash". Additional information: Reporter stated her son 11 years old, received the Pfizer Covid 19 vaccine, several days after it was administered, he started with a rash that progressively got worst. One week later, he has a terrible rash all over his entire body. She was looking for information on what is considered a severe allergic reaction, since she is getting conflicting information from the FDA website and her son's pediatrician.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature baby
Clinical narrative: other is pregnant approximately 30 weeks and delivered the baby early; other is pregnant approximately 30 weeks and delivered the baby early; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transplacental (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE BABY (medically significant), MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown" and all described as "other is pregnant approximately 30 weeks and delivered the baby early".  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (14Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "Premature Baby" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101408376 Same reporter, event, product/ mother, fetus
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: Hot flashes,I just turned 29 and I am having night hotflashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 01:15 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Polycystic ovary syndrome" (unspecified if ongoing); "Mushroom" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious) with onset 10Nov2021 12:00, outcome "not recovered", described as "Hot flashes,I just turned 29 and I am having night hotflashes". Therapeutic measures were not taken as a result of hot flush.  Additional information: The patient did not receive any other vaccine within 4 weeks and did not receive any other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had other vaccine details included Pfizer, on 08Nov2021 administered in arm right.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Laboratory test
Clinical narrative: got sick, did all kinds of tests and narrowed it down to the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 76 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick, did all kinds of tests and narrowed it down to the shot". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash
Clinical narrative: having heart palpitations; weird rashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. This consumer reported different events for different patients. This is 2 of 3 reports.   A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "having heart palpitations"; RASH (non-serious), outcome "unknown", described as "weird rashes". Clinical information: Within the caller's original report the parent (mother) mentioned that her daughter had all kinds of issues after she had the 2nd dose, but that is her daughter's story to tell not hers. Her daughter has not been the same since she had the vaccine, she is 44 years old and she is now on beta blockers and is having heart palpitations and weird rashes and obviously her daughter is blaming everything on the vaccine.   Follow-up attempts are completed. No further information expected.