chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: really bad side effects after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really bad side effects after the second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 VACCINATION COMPLICATION (really bad side effects after the second dose). In 2021, VACCINATION COMPLICATION (really bad side effects after the second dose) had resolved.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-358977, MOD-2021-359049 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received dose from a punctured vials in the refrigerator for days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received dose from a punctured vials in the refrigerator for days) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received dose from a punctured vials in the refrigerator for days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received dose from a punctured vials in the refrigerator for days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported.  It was reported that patients were vaccinated with vaccine which was punctured for more than 6 hours and placed back into the refrigerator for multiple days. It was not confirmed whether it was first or second dose of vaccine.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered an expired vaccine.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Oct-2021 and was forwarded to Moderna on 20-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Oct-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. On 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine.). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications are provide by the reporter.  On 15-oct-2021 vaccine moved to refrigeration, used by on 13-oct-2021.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Non significant follow up received
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Gastroenteritis viral, Paraesthesia, Product dose omission issue
Clinical narrative: Received the first dose of the Moderna COVID 19 Vaccine and later had COVID symptoms and missed the second dose; Fatigue; Sneezing; Tingle; Kind of dizzy spell when had the vaccine; Had an stomach flu or something like that and tested negative; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), PARAESTHESIA (Tingle), DIZZINESS (Kind of dizzy spell when had the vaccine), GASTROENTERITIS VIRAL (Had an stomach flu or something like that and tested negative) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PARAESTHESIA (Tingle) and DIZZINESS (Kind of dizzy spell when had the vaccine). In April 2021, the patient experienced GASTROENTERITIS VIRAL (Had an stomach flu or something like that and tested negative). On 18-Aug-2021, the patient experienced SNEEZING (Sneezing) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID 19 Vaccine and later had COVID symptoms and missed the second dose). At the time of the report, SNEEZING (Sneezing), PARAESTHESIA (Tingle), DIZZINESS (Kind of dizzy spell when had the vaccine) and FATIGUE (Fatigue) outcome was unknown and GASTROENTERITIS VIRAL (Had an stomach flu or something like that and tested negative) and PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID 19 Vaccine and later had COVID symptoms and missed the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: negative (Negative) Negative. On 18-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.  The patient reported that she was sure that had COVID since she had all the symptoms.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sneezing
Clinical narrative: Received the first dose of the Moderna COVID 19 Vaccine and later had COVID symptoms and missed the second dose; Fatigue; Sneezing; Tingle; Kind of dizzy spell when had the vaccine; Had an stomach flu or something like that and tested negative; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), PARAESTHESIA (Tingle), DIZZINESS (Kind of dizzy spell when had the vaccine), GASTROENTERITIS VIRAL (Had an stomach flu or something like that and tested negative) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PARAESTHESIA (Tingle) and DIZZINESS (Kind of dizzy spell when had the vaccine). In April 2021, the patient experienced GASTROENTERITIS VIRAL (Had an stomach flu or something like that and tested negative). On 18-Aug-2021, the patient experienced SNEEZING (Sneezing) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID 19 Vaccine and later had COVID symptoms and missed the second dose). At the time of the report, SNEEZING (Sneezing), PARAESTHESIA (Tingle), DIZZINESS (Kind of dizzy spell when had the vaccine) and FATIGUE (Fatigue) outcome was unknown and GASTROENTERITIS VIRAL (Had an stomach flu or something like that and tested negative) and PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID 19 Vaccine and later had COVID symptoms and missed the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: negative (Negative) Negative. On 18-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.  The patient reported that she was sure that had COVID since she had all the symptoms.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction starting the day after my 2 nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction starting the day after my 2 nd dose) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00721A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-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. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction starting the day after my 2 nd dose). At the time of the report, VACCINATION COMPLICATION (Reaction starting the day after my 2nd dose) outcome was unknown. Not Provided.          No concomitant medication was provided.  No treatment medication was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, Body temperature: 97.9 normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Pain; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Pain) and HEADACHE (Headache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain) and HEADACHE (Headache). At the time of the report, PAIN (Pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Chest X-ray, Chest pain, Discomfort, Echocardiogram
Clinical narrative: exhausted; tingling in my lungs; freezing cold metal sensation in my throat; tachycardia; discomfort / uncomfortable; aching in my chest; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable) and CHEST PAIN (aching in my chest) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL 8 HOUR) and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021 at 11:00 PM, the patient experienced PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable) and CHEST PAIN (aching in my chest). On 05-Jan-2021, the patient experienced FATIGUE (exhausted). In January 2021, PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable), CHEST PAIN (aching in my chest) and FATIGUE (exhausted) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Heart rate: increased (High) heart rate was in the 120s, 130s. On 05-Jan-2021, Chest X-ray: negative (Negative) Negative. On 05-Jan-2021, Electrocardiogram: abnormal (abnormal) tachycardia of 120 and some PVCs. On 11-Mar-2021, Serology test: abnormal (abnormal) had great titers. In 2021, Blood immunoglobulin G: positive (Positive) strongly positive. In 2021, Heart rate: high (High) remained elevated whether walking her dog, up and down the stairs, laying down and getting up, lasted for 5 days. In September 2021, Echocardiogram: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Feeling cold, Heart rate, Paraesthesia
Clinical narrative: exhausted; tingling in my lungs; freezing cold metal sensation in my throat; tachycardia; discomfort / uncomfortable; aching in my chest; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable) and CHEST PAIN (aching in my chest) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL 8 HOUR) and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021 at 11:00 PM, the patient experienced PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable) and CHEST PAIN (aching in my chest). On 05-Jan-2021, the patient experienced FATIGUE (exhausted). In January 2021, PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable), CHEST PAIN (aching in my chest) and FATIGUE (exhausted) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Heart rate: increased (High) heart rate was in the 120s, 130s. On 05-Jan-2021, Chest X-ray: negative (Negative) Negative. On 05-Jan-2021, Electrocardiogram: abnormal (abnormal) tachycardia of 120 and some PVCs. On 11-Mar-2021, Serology test: abnormal (abnormal) had great titers. In 2021, Blood immunoglobulin G: positive (Positive) strongly positive. In 2021, Heart rate: high (High) remained elevated whether walking her dog, up and down the stairs, laying down and getting up, lasted for 5 days. In September 2021, Echocardiogram: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Serology test, Tachycardia
Clinical narrative: exhausted; tingling in my lungs; freezing cold metal sensation in my throat; tachycardia; discomfort / uncomfortable; aching in my chest; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable) and CHEST PAIN (aching in my chest) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL 8 HOUR) and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021 at 11:00 PM, the patient experienced PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable) and CHEST PAIN (aching in my chest). On 05-Jan-2021, the patient experienced FATIGUE (exhausted). In January 2021, PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable), CHEST PAIN (aching in my chest) and FATIGUE (exhausted) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Heart rate: increased (High) heart rate was in the 120s, 130s. On 05-Jan-2021, Chest X-ray: negative (Negative) Negative. On 05-Jan-2021, Electrocardiogram: abnormal (abnormal) tachycardia of 120 and some PVCs. On 11-Mar-2021, Serology test: abnormal (abnormal) had great titers. In 2021, Blood immunoglobulin G: positive (Positive) strongly positive. In 2021, Heart rate: high (High) remained elevated whether walking her dog, up and down the stairs, laying down and getting up, lasted for 5 days. In September 2021, Echocardiogram: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; fatigue; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 01Oct2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 40 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 and dose 2 on unspecified date(s), batch/lot and expiries unknown, both as a single dose for COVID 19 immunization. Medical history and concomitant products were not reported. The patient had received his first dose as of 05Jan2021. The patient reported he experienced chills and fatigue with the first 2 doses. The outcome of the events was unknown. He subsequently received the 3rd dose/ booster of BNT162B2 on 28Sep2021.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101301634 same patient, similar events with dose 3
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Ultrasound scan
Clinical narrative: a lump in that arm/Second dose: lump stayed about the same; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8732), via an unspecified route of administration in left arm on 29Mar2021 at 9:00AM or 10:00AM (at the age of 68 years old) as dose 2, single for covid-19 immunisation. Medical history included thyroid disorder, paroxysmal nocturnal hemoglobinuria. Concomitant medications included ravulizumab cwvz (ULTOMIRIS [RAVULIZUMAB CWVZ]) infusion every 8 weeks taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (Lot number: EN6206), via an unspecified route of administration in left arm on 08Mar2021 at 10:00 AM (at the age of 68 years old) for covid-19 immunisation and patient experienced swelling in her left arm, her left arm hurt, lump in her left arm at the injection site, arm was hurting at the injection site, benign lump on that left side, lump in left arm is like a mass or oval, swelled a little, not a lot but it was swollen for about 2 weeks, having pain in her left arm off and on, sometimes the lump in her left arm feels larger than other times. The patient previously received flu vaccine, pneumonia vaccine, meningitis vaccine and has never gotten a lump or anything like that. She received her second dose at the end of Mar2021 and she didn't have any side effects. no pain or anything. After the second Covid 19 vaccine the a lump in that arm/lump stayed about the same, it didn't get worse. She has had the second dose of the vaccine in the left arm as well but in a slightly different area, no date was provided by caller of the second dose. Sometimes the lump in her left arm feels larger than other times. She doesn't know. She reports she received both doses in her left arm but the second dose the site was a little upper, a different part in her left arm. She had the ultrasound of the injection site in her left arm on 17Jun2021 and it came back that the lump was benign but she did not get any other information. The doctor told her if it gets worse than to call back. The nurse at the health department mentioned that there have been side effects with lymph nodes but the caller has never had a lump in her arm before. The patient underwent lab tests and procedures which included ultrasound scan: unknown on 17Jun2021. The outcome of event was not recovered.  Follow-Up (02Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: he developed a lump on his neck; This is a spontaneous report from a contactable consumer reporting for a patient. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA6780), via an unspecified route of administration on 13Jul2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date as single dose for covid-19 immunisation. On an unspecified date in Jul2021, the patient experienced 2 days after the second dose of the Pfizer vaccine, slowly he developed a lump on his neck. After 3 days, It's much reduced. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Malaise, Pyrexia, Thirst
Clinical narrative: injection site pain; feeling unwell; lost weight; joint pain; fever; very thirsty after 2 hr; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318) via intramuscular route of administration, administered in left deltoid (at age of vaccination 74) on 28Jan2021 as dose 1, single for COVID-19 immunization (School/ Student Health clinic). The patient medical history included baker cyst bunion and simple renal cyst from 01Jun2010, osteoarthritis and nocturia from 04May2012, hypertensive disorder and hyperlipidemia from 11Jun2010, chronic prostatitis and interstitial cystitis from 23Nov2013, degenerative arthritis of knee from 05May2012. The patient concomitant medications included acetylsalicylic acid (ASPIRIN 81), Atorvastatin, Cholecalciferol, Hydrochlorothiazide, Losartan and Tamsulosin taken for unspecified indication and start date and stop date was not reported. On an unspecified date, the patient experienced injection site pain, feeling unwell, lost weight, joint pain, fever and very thirsty after 2 hr. The patient underwent lab tests and procedures which included body temperature 99.7F (29Jan2021, 11:45), 98.3F (30Jan2021, 7:15), 99.4F (30Jan2021, 01:45), 98.8F (30Jan2021, 4:30), 98.4F (30Jan2021, 9:30), 98.5F (31Jan2021, 04:15), 95.7F (31Jan2021, 06:30), 99.8F (01Feb2021, 13:15), 98.7 (01Feb2021,06:00), 98F (02Feb2021, 04:00). The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Weight decreased
Clinical narrative: injection site pain; feeling unwell; lost weight; joint pain; fever; very thirsty after 2 hr; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318) via intramuscular route of administration, administered in left deltoid (at age of vaccination 74) on 28Jan2021 as dose 1, single for COVID-19 immunization (School/ Student Health clinic). The patient medical history included baker cyst bunion and simple renal cyst from 01Jun2010, osteoarthritis and nocturia from 04May2012, hypertensive disorder and hyperlipidemia from 11Jun2010, chronic prostatitis and interstitial cystitis from 23Nov2013, degenerative arthritis of knee from 05May2012. The patient concomitant medications included acetylsalicylic acid (ASPIRIN 81), Atorvastatin, Cholecalciferol, Hydrochlorothiazide, Losartan and Tamsulosin taken for unspecified indication and start date and stop date was not reported. On an unspecified date, the patient experienced injection site pain, feeling unwell, lost weight, joint pain, fever and very thirsty after 2 hr. The patient underwent lab tests and procedures which included body temperature 99.7F (29Jan2021, 11:45), 98.3F (30Jan2021, 7:15), 99.4F (30Jan2021, 01:45), 98.8F (30Jan2021, 4:30), 98.4F (30Jan2021, 9:30), 98.5F (31Jan2021, 04:15), 95.7F (31Jan2021, 06:30), 99.8F (01Feb2021, 13:15), 98.7 (01Feb2021,06:00), 98F (02Feb2021, 04:00). The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dermatitis, Eating disorder, Pain of skin, Pruritus, Sleep disorder due to a general medical condition
Clinical narrative: itching has gotten worse; broke out in hives and welps; My skin is still inflamed and painful; My skin is still inflamed and painful; I cant eat or sleep well due to the pain and itching; I cant eat or sleep well due to the pain and itching; This is a spontaneous report from a contactable consumer. This consumer reported for a patient in response to non-HCP letter send in cross reference case that included: A 54 years-old female patient received bnt162b2 (COMIRNATY; Lot Number; EW0178) Intramuscular administered in Arm Left on 18May2021 at 09:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient received second dose of bnt162b2 (COMIRNATY; Lot Number; EW0181) Intramuscular administered on 19Jun2021 at 16:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history was none reported. Concomitant medications were none reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date the patient experienced that the week before I received my first vaccine dose, I was working in my garden and bitten by Chiggers. Once I got the vaccine, the itching become more intense, burning and painful. After about 10days on 29May. I went to the E.R. The doctor said he couldn't give me anything because i'd taken the vaccine for Covid. He also said that I should take the 2nd dose because it's better than dying from Covid. On his advice, I took the second dose/vaccine, and the itching has gotten worse. I broke out in Hives and welps. My skin is still inflamed of painful after (3) weeks since getting my second dose. I can't eat or sleep over due to the pain of itching. The patient visited emergency room due to events. The patient did not receive treatment for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: itching has gotten worse; broke out in hives and welps; My skin is still inflamed and painful; My skin is still inflamed and painful; I cant eat or sleep well due to the pain and itching; I cant eat or sleep well due to the pain and itching; This is a spontaneous report from a contactable consumer. This consumer reported for a patient in response to non-HCP letter send in cross reference case that included: A 54 years-old female patient received bnt162b2 (COMIRNATY; Lot Number; EW0178) Intramuscular administered in Arm Left on 18May2021 at 09:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient received second dose of bnt162b2 (COMIRNATY; Lot Number; EW0181) Intramuscular administered on 19Jun2021 at 16:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history was none reported. Concomitant medications were none reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date the patient experienced that the week before I received my first vaccine dose, I was working in my garden and bitten by Chiggers. Once I got the vaccine, the itching become more intense, burning and painful. After about 10days on 29May. I went to the E.R. The doctor said he couldn't give me anything because i'd taken the vaccine for Covid. He also said that I should take the 2nd dose because it's better than dying from Covid. On his advice, I took the second dose/vaccine, and the itching has gotten worse. I broke out in Hives and welps. My skin is still inflamed of painful after (3) weeks since getting my second dose. I can't eat or sleep over due to the pain of itching. The patient visited emergency room due to events. The patient did not receive treatment for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Have occasional chest pains when sitting up breathing normal.; when take a deeper breath it would be more uncomfortable.; This is a spontaneous report from a contactable healthcare professional. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 12:15 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, heart problems as a premature baby and premature baby. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took azithromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 03Aug2021 at 13:30, the patient had occasional chest pains when sat up breathing normal and when taking a deeper breath, it would be more uncomfortable. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events had occasional chest pains when sat up breathing normal and when taking a deeper breath, it would be more uncomfortable was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Feeling hot, Mass, Vaccination site swelling
Clinical narrative: Swelling at the injection site; There is a lump and it is slightly warm to the touch; Swelling underneath the arm of the injection site and at the breast area near the armpit; There is a lump and it is slightly warm to the touch; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration on 04Aug2021 at 13:30 (on Wednesday, at the age of 52-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included High Blood pressure. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for hypertension, start and stop date were not reported; naproxen (NAPROXEN) taken for pain, start and stop date were not reported. On 07Aug2021 (more towards to the noon), the patient experienced swelling at the injection site, there is a lump and it is slightly warm to the touch, swelling underneath the arm of the injection site and at the breast area near the armpit, there is a lump and it is slightly warm to the touch. No treatment was received for events. The outcomes of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Pyrexia, Vomiting
Clinical narrative: Severe body pain; migraine; fever; vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. On 06Aug2021, the patient experienced severe body pain, migraine, fever and vomiting. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe body pain, migraine, fever and vomiting were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular
Clinical narrative: Severe menstrual cramps few hours after the shot; Period started 4 days earlier; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Aug2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 07Aug2021 at 14:00, few hours after the shot, the patient experienced severe menstrual cramps and the patient's period started 4 days earlier. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe menstrual cramps and period started 4 days earlier were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in shoulders/ Pain continue to migrate to elbow's, hands, wrists and feet; This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: not provided), via unspecified route as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. On an unknown date, the patient experienced pain continued to migrate from shoulders to elbows, hands, wrist and feet not as severe. The outcome of the events were unknown.  No follow up attempts were possible. Information about lot/batch number cannot be requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast pain, Swelling
Clinical narrative: Lump under left arm, left breast pain.; left breast pain.; neck also got swollen; This is a spontaneous report from a contactable consumer (patient).   A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0198) via an unspecified route of administration, administered in arm left on 30Jul2021 at 09: 15 (at the age of 39-years-old) as dose 1, single for covid-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had not received any other vaccine in four weeks. Concomitant medications included famotidine and ketoconazole (in two weeks). Patient's past drug included Percocet and she had Known allergy with Percocet. On 31Jul2021, the patient experienced lump under left arm and left breast pain and neck also got swollen. The patient visited doctor or other healthcare professional office/clinic visit and emergency room as result in the events. The patient reported that the day after 1st dose my armpit got swollen and painful. The patient reported that the day after 1st dose her armpit got swollen and painful. This lasted for weeks, her neck also got swollen, she also experienced breast pain, visited doctor the day before 2nd dose on 19Aug2021. The outcome of the events lump under left arm, left breast pain was not recovered. The outcome of the event neck also got swollen was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast mass, Breast pain
Clinical narrative: Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: FC3180) via an unspecified route of administration, administered in arm left on 12Aug2021 18:30 (at the age of 61-year-old) at dose 1, single for covid-19 immunisation. Medical history included lichen planus. Patient had no known allergies. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for covid post vaccination. Concomitant medication included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) received in two weeks. On 15Aug2021 16:00 the patient experienced adverse event: Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness. Patient had no treatment for the adverse events. Outcome of the events was unknown.  Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Menstrual cycle irregular; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to gluten(celiac). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced menstrual cycle irregular. The event did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the event. On an unknown date, the patient underwent COVID-19 virus test and the result was unknown. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event menstrual cycle irregular was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Dysmenorrhoea, Feeling abnormal
Clinical narrative: Dizzy; Brain fog; Diarrhea; stomach cramping; Menstrual spotting; Cramps 2 weeks early; Body aches muscles and joints; This is a spontaneous report from a non-contactable nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 14Aug2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Aug2021 at 19:00, the patient experienced dizzy, brain fog, diarrhea, stomach cramping, menstrual spotting, cramps 2 weeks early, body aches muscles and joints. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, brain fog, diarrhea, stomach cramping, menstrual spotting, cramps 2 weeks early, body aches muscles and joints was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Pain
Clinical narrative: Dizzy; Brain fog; Diarrhea; stomach cramping; Menstrual spotting; Cramps 2 weeks early; Body aches muscles and joints; This is a spontaneous report from a non-contactable nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 14Aug2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Aug2021 at 19:00, the patient experienced dizzy, brain fog, diarrhea, stomach cramping, menstrual spotting, cramps 2 weeks early, body aches muscles and joints. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, brain fog, diarrhea, stomach cramping, menstrual spotting, cramps 2 weeks early, body aches muscles and joints was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash; Itching; Hives (On legs, arms, chest and side); This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 17Aug2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in Aug2021, the patient experienced rash, itching, and hives on legs, arms, chest, and side. The clinical outcome of the events rash, itching, and hives on legs, arms, chest, and side was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Philadelphia chromosome positive
Clinical narrative: Fatigue; Sick with headaches; very sick with headaches, fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: unknown) via an unspecified route of administration on an unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included chronic myeloid leukaemia from an unknown date and unknown if ongoing. Concomitant medications included bosutinib (BOSULIF), loperamide hydrochloride (IMODIUM A-D), verapamil hcl (VERAPAMIL HCL ER), buspirone hcl and famotidine (PEPCID) taken for an unspecified indication, start and stop date were not reported. The patient previously took bcr-abl tyrosine kinase inhibitors. It was reported that the patient and wife were both had the covid vaccine recently and were very sick with headaches and fatigue on an unspecified date in 2021. The patient underwent lab tests and procedures which included chromosome positive (BCR/ABL-positive, not having achieved remission) on an unspecified date. Outcome of the events was unknown.   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-202101078366 same reporter/SD/AE, different patient