chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: accidentally administered half a dose instead of a third full dose (for immunocompromised patient); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (accidentally administered half a dose instead of a third full dose (for immunocompromised patient)) 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 ACCIDENTAL UNDERDOSE (accidentally administered half a dose instead of a third full dose (for immunocompromised patient)). At the time of the report, ACCIDENTAL UNDERDOSE (accidentally administered half a dose instead of a third full dose (for immunocompromised patient)) 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen) and JOINT SWELLING (all the way down to my elbow three inches from the elbow and out to the side) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 020821A and 001A21A) for COVID-19 vaccination. No Medical History information was reported.On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PERIPHERAL SWELLING (arm is swollen) and JOINT SWELLING (all the way down to my elbow three inches from the elbow and out to the side). At the time of the report, PERIPHERAL SWELLING (arm is swollen) and JOINT SWELLING (all the way down to my elbow three inches from the elbow and out to the side) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant medication was reported. No treatment medications were reported. This case was linked to MOD-2021-400108 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling like crap after both of his Moderna Covid-19 vaccinations) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, 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 FEELING ABNORMAL (Feeling like crap after both of his Moderna Covid-19 vaccinations). At the time of the report, FEELING ABNORMAL (Feeling like crap after both of his Moderna Covid-19 vaccinations) outcome was unknown. No concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-400040 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (developed a sore arm) and FEELING ABNORMAL (felt bad for a day after receiving the Moderna COVID-19 vaccine) in a male 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, 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 experienced PAIN IN EXTREMITY (developed a sore arm) and FEELING ABNORMAL (felt bad for a day after receiving the Moderna COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (developed a sore arm) outcome was unknown and FEELING ABNORMAL (felt bad for a day after receiving the Moderna COVID-19 vaccine) had resolved.    No concomitant medications were reported. No treatment information was provided. The patient did not expand on the type of side effects and did not give any further information on this adverse event.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel pretty ill), PYREXIA (I ran a fever of 101) and PYREXIA (Have a fever of 101.5) in a 61-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. In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PYREXIA (I ran a fever of 101). On an unknown date, the patient experienced MALAISE (Feel pretty ill) and PYREXIA (Have a fever of 101.5). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Feel pretty ill), PYREXIA (I ran a fever of 101) and PYREXIA (Have a fever of 101.5) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (High) High. On an unknown date, Body temperature: 101.5 (High) High. No Concomitant medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 3rd dose administered instead of booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (3rd dose administered instead of booster) 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 ACCIDENTAL OVERDOSE (3rd dose administered instead of booster). At the time of the report, ACCIDENTAL OVERDOSE (3rd dose administered instead of booster) 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.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: I haven't had a period since my first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (I haven't had a period since my first vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMENORRHOEA (I haven't had a period since my first vaccine). At the time of the report, AMENORRHOEA (I haven't had a period since my first vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Flu like symptoms after first dose; Fatigue after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms after first dose) and FATIGUE (Fatigue after first dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after first dose) and FATIGUE (Fatigue after first dose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms after first dose) and FATIGUE (Fatigue after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications reported.  Patient received the first dose in her left arm. The patient had fatigue and flu like symptoms.   This case was linked to MOD-2021-401370 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm.) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm.). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications was provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: a lump on the right side of her neck around the clavicle area that was half the size of a tennis ball, her doctor said said that a lymph node possibly became swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (a lump on the right side of her neck around the clavicle area that was half the size of a tennis ball, her doctor said said that a lymph node possibly became swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 012A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (a lump on the right side of her neck around the clavicle area that was half the size of a tennis ball, her doctor said said that a lymph node possibly became swollen). At the time of the report, LYMPHADENOPATHY (a lump on the right side of her neck around the clavicle area that was half the size of a tennis ball, her doctor said said that a lymph node possibly became swollen) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, on 27-Nov-2021, a lymph node possibly became swollen. It had been subsided, but still feel it and see it. It was about a 1/4 the size of a tennis ball. No concomitant and treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: nurse first injected her with air, and then the nurse injected her  subcutaneous tissue; nurse first injected her with air, and then the nurse injected her  subcutaneous tissue; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (nurse first injected her with air, and then the nurse injected her  subcutaneous tissue) and PRODUCT ADMINISTRATION ERROR (nurse first injected her with air, and then the nurse injected her  subcutaneous tissue) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (nurse first injected her with air, and then the nurse injected her  subcutaneous tissue) and PRODUCT ADMINISTRATION ERROR (nurse first injected her with air, and then the nurse injected her  subcutaneous tissue). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (nurse first injected her with air, and then the nurse injected her  subcutaneous tissue) and PRODUCT ADMINISTRATION ERROR (nurse first injected her with air, and then the nurse injected her  subcutaneous tissue) had resolved.     The nurse first injected her with air, and then the nurse injected her subcutaneous tissue. No concomitant and treatment medications were reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives-started from the neck and ear before spreading to the upper body, followed by the rest of the body.; rash-started from the neck and ear before spreading to the upper body, followed by the rest of the body.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives-started from the neck and ear before spreading to the upper body, followed by the rest of the body.) and RASH (rash-started from the neck and ear before spreading to the upper body, followed by the rest of the body.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 007M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced URTICARIA (hives-started from the neck and ear before spreading to the upper body, followed by the rest of the body.) and RASH (rash-started from the neck and ear before spreading to the upper body, followed by the rest of the body.). The patient was treated with PREDNISONE in 2021 for Adverse event, at an unspecified dose and frequency; FAMOTIDINE in 2021 for Adverse event, at an unspecified dose and frequency; HYDROXYZINE in 2021 for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) in 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives-started from the neck and ear before spreading to the upper body, followed by the rest of the body.) and RASH (rash-started from the neck and ear before spreading to the upper body, followed by the rest of the body.) had not resolved.            Prior to the vaccination, patient  was not on any routine medication  Treatment medication provides 3 to 4 hours of relief  Treatment medication Benadryl interchanged with hydroxyzine  Patient went to urgent care twice(25/26 NOV 2021)  and to primary physician once(29 NOV 2021)  Patient  is planning to see an allergist.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hyperhidrosis, Myalgia, Pain
Clinical narrative: Muscle aches; Sweats; Severe fatigue; Sides ache; I can feel every hair on my body throbbing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 18:00 (Lot number: FA7485) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: FA6780, Administration time: 05:15 PM, Vaccine location: Left arm, Dose number: 1), administration date: 22Jul2021, when the patient was 58 years old, for COVID-19 Immunization.The following information was reported: MYALGIA (non-serious) with onset 13Aug2021 08:00, outcome "not recovered", described as "Muscle aches"; HYPERHIDROSIS (non-serious) with onset 13Aug2021 08:00, outcome "not recovered", described as "Sweats"; FATIGUE (non-serious) with onset 13Aug2021 08:00, outcome "not recovered", described as "Severe fatigue"; PAIN (non-serious) with onset 13Aug2021 08:00, outcome "not recovered", described as "Sides ache"; FEELING ABNORMAL (non-serious) with onset 13Aug2021 08:00, outcome "not recovered", described as "I can feel every hair on my body throbbing". Therapeutic measures were not taken as a result of myalgia, hyperhidrosis, fatigue, pain, feeling abnormal.  Additional information: Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Seriousness reported as No.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Injection site sore; Headache; nauseous; very upset stomach; diarrhea; severe fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Aug2021 20:30 (Lot number: FC3180) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "chronic anemia" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Aug2021 22:30, outcome "recovering", described as "Injection site sore"; HEADACHE (non-serious) with onset 09Aug2021 22:30, outcome "recovering", described as "Headache"; NAUSEA (non-serious) with onset 09Aug2021 22:30, outcome "recovering", described as "nauseous"; ABDOMINAL DISCOMFORT (non-serious) with onset 09Aug2021 22:30, outcome "recovering", described as "very upset stomach"; DIARRHOEA (non-serious) with onset 09Aug2021 22:30, outcome "recovering", described as "diarrhea"; FATIGUE (non-serious) with onset 09Aug2021 22:30, outcome "recovering", described as "severe fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, headache, nausea, abdominal discomfort, diarrhoea, fatigue.  Additional information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks. No known allergies. This happened 1 week after receiving the 1st shot, with the exception of the fatigue, which was immediate and lasted throughout. No covid prior vaccination. Covid tested post vaccination. Covid test type post vaccination: Nasal Swab, covid test name post vaccination: Rapid on 13Aug2021 covid test result: Negative. Covid test type post vaccination: Nasal Swab, covid test name post vaccination: Antigen on 13Aug2021, covid test result: Negative onset of latency 7 days 2 hrs.    Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Injection site sore; Headache; nauseous; very upset stomach; diarrhea; severe fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Aug2021 20:30 (Lot number: FC3180) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "chronic anemia" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Aug2021 22:30, outcome "recovering", described as "Injection site sore"; HEADACHE (non-serious) with onset 09Aug2021 22:30, outcome "recovering", described as "Headache"; NAUSEA (non-serious) with onset 09Aug2021 22:30, outcome "recovering", described as "nauseous"; ABDOMINAL DISCOMFORT (non-serious) with onset 09Aug2021 22:30, outcome "recovering", described as "very upset stomach"; DIARRHOEA (non-serious) with onset 09Aug2021 22:30, outcome "recovering", described as "diarrhea"; FATIGUE (non-serious) with onset 09Aug2021 22:30, outcome "recovering", described as "severe fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, headache, nausea, abdominal discomfort, diarrhoea, fatigue.  Additional information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks. No known allergies. This happened 1 week after receiving the 1st shot, with the exception of the fatigue, which was immediate and lasted throughout. No covid prior vaccination. Covid tested post vaccination. Covid test type post vaccination: Nasal Swab, covid test name post vaccination: Rapid on 13Aug2021 covid test result: Negative. Covid test type post vaccination: Nasal Swab, covid test name post vaccination: Antigen on 13Aug2021, covid test result: Negative onset of latency 7 days 2 hrs.    Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Myalgia, Vomiting
Clinical narrative: body temperature 39.5 - 40 degC (103 - 104degF); severe headache; vomiting; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 18:00 (Lot number: FA7484) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number=1,, lot number=EY0584,, administration time=05:00 PM,, vaccine location=Left arm), administration date: 15Jul2021, for Covid-19 immunisation. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 05Aug2021 23:00, outcome "recovered" (Aug2021), described as "body temperature 39.5 - 40 degC (103 - 104degF)"; HEADACHE (non-serious) with onset 05Aug2021 23:00, outcome "recovered" (Aug2021), described as "severe headache"; VOMITING (non-serious) with onset 05Aug2021 23:00, outcome "recovered" (Aug2021), described as "vomiting"; MYALGIA (non-serious) with onset 05Aug2021 23:00, outcome "recovered" (Aug2021), described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased, headache, vomiting, myalgia.  Additional information- Lab data included body temperature 39.5 - 40 degree C (103-104-degree F) on 05Aug2021. Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Migraine
Clinical narrative: swollen lymph nodes; migraine; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 18:45 (Lot number: 59267-1000-01) at the age of 57 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing), notes: Other medical history: Hashimoto's disease, hypertension; "hypertension" (unspecified if ongoing), notes: Other medical history: Hashimoto's disease, hypertension. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 21Aug2021 06:00, outcome "not recovered", described as "swollen lymph nodes"; MIGRAINE (non-serious) with onset 21Aug2021 06:00, outcome "not recovered", described as "migraine"; FATIGUE (non-serious) with onset 21Aug2021 06:00, outcome "not recovered", described as "severe fatigue". Therapeutic measures were not taken as a result of lymphadenopathy, migraine, fatigue.  Additional Information: Patient did not receive other vaccine in four weeks and medications in two weeks. Patient did not tested covid prior vaccination. No any Known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood glucose decreased, Headache, Pain in extremity
Clinical narrative: Severe headache; blood sugar got low; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (Lot number: FC3180) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetic; "Cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol; "Blood pressure measurement" (unspecified if ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: INSULIN. Vaccination history included: Bnt162b2 (Date of First Shot: 03Aug2021, LOT # of First Shot: EW0169), administration date: 03Aug2021, when the patient was 66 years old, for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 26Aug2021, outcome "unknown", described as "Severe headache"; BLOOD GLUCOSE DECREASED (non-serious) with onset 25Aug2021, outcome "unknown", described as "blood sugar got low"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, blood glucose decreased, pain in extremity.   Addition information: The patient took Tylenol, two tablets, every 3 hours for the treatment for Adverse Event. He took a pill for diabetes, blood pressure medicine and cholesterol medicine (Not Clarified).  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Genital ulceration, Headache, Pain, Pyrexia
Clinical narrative: Primary complaint is Acute Genital Ulcers - negative for STD tests, ulcers have never occurred before and onset began 36 hours after injection; Fever; Severe headache; Dizziness; Sensitive and pain in skin on arms; Sensitive and pain in skin on arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the parent.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Aug2021 12:30 (Lot number: FC3181) at the age of 14 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing), notes: Verbatim: Other medical history: IBS. Concomitant medication(s) included: TYLENOL; MOTRIN [IBUPROFEN]; LEXAPRO. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: FA7485, Lot unknown: False, Administration date: 06Aug2021, Administration time: 08:30 PM, Dose number: 1, Vaccine location: Left arm), administration date: 06Aug2021, when the patient was 14 years old, for Covid-19 Immunisation. The following information was reported: GENITAL ULCERATION (non-serious) with onset 30Aug2021 08:00, outcome "not recovered", described as "Primary complaint is Acute Genital Ulcers - negative for STD tests, ulcers have never occurred before and onset began 36 hours after injection"; PYREXIA (non-serious) with onset 30Aug2021 08:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 30Aug2021 08:00, outcome "not recovered", described as "Severe headache"; DIZZINESS (non-serious) with onset 30Aug2021 08:00, outcome "not recovered", described as "Dizziness"; SENSITIVE SKIN (non-serious), PAIN (non-serious) all with onset 30Aug2021 08:00, outcome "not recovered" and all described as "Sensitive and pain in skin on arms". The events "primary complaint is acute genital ulcers - negative for std tests, ulcers have never occurred before and onset began 36 hours after injection", "fever", "severe headache", "dizziness", "sensitive and pain in skin on arms" and "sensitive and pain in skin on arms" 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 taken as a result of genital ulceration, pyrexia, headache, dizziness, sensitive skin, pain. Additional information: The patient did not have other vaccine in four weeks. The patient did not have COVID prior vaccination, COVID test done post vaccination. No known allergies, AE treatment: Pain medication  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sensitive skin, Sexually transmitted disease
Clinical narrative: Primary complaint is Acute Genital Ulcers - negative for STD tests, ulcers have never occurred before and onset began 36 hours after injection; Fever; Severe headache; Dizziness; Sensitive and pain in skin on arms; Sensitive and pain in skin on arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the parent.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Aug2021 12:30 (Lot number: FC3181) at the age of 14 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing), notes: Verbatim: Other medical history: IBS. Concomitant medication(s) included: TYLENOL; MOTRIN [IBUPROFEN]; LEXAPRO. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: FA7485, Lot unknown: False, Administration date: 06Aug2021, Administration time: 08:30 PM, Dose number: 1, Vaccine location: Left arm), administration date: 06Aug2021, when the patient was 14 years old, for Covid-19 Immunisation. The following information was reported: GENITAL ULCERATION (non-serious) with onset 30Aug2021 08:00, outcome "not recovered", described as "Primary complaint is Acute Genital Ulcers - negative for STD tests, ulcers have never occurred before and onset began 36 hours after injection"; PYREXIA (non-serious) with onset 30Aug2021 08:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 30Aug2021 08:00, outcome "not recovered", described as "Severe headache"; DIZZINESS (non-serious) with onset 30Aug2021 08:00, outcome "not recovered", described as "Dizziness"; SENSITIVE SKIN (non-serious), PAIN (non-serious) all with onset 30Aug2021 08:00, outcome "not recovered" and all described as "Sensitive and pain in skin on arms". The events "primary complaint is acute genital ulcers - negative for std tests, ulcers have never occurred before and onset began 36 hours after injection", "fever", "severe headache", "dizziness", "sensitive and pain in skin on arms" and "sensitive and pain in skin on arms" 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 taken as a result of genital ulceration, pyrexia, headache, dizziness, sensitive skin, pain. Additional information: The patient did not have other vaccine in four weeks. The patient did not have COVID prior vaccination, COVID test done post vaccination. No known allergies, AE treatment: Pain medication  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; Severe vomiting; This is a spontaneous report received from a contactable reporter a contactable Pfizer colleague reported for an unknown age female patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: unknown), administration date 30Aug2021 as dose number unknown, single for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. No known allergies. The following information was reported: NAUSEA (non-serious) with onset 31Aug2021 at 01:30, outcome "recovered" (2021), described as "nausea"; VOMITING (non-serious) with onset 31Aug2021 01:30, outcome "recovered" (2021), described as "Severe vomiting". Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of nausea, vomiting.  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.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Headache, Pain in extremity
Clinical narrative: Severe stomach cramps; Diarrhea; Headache; Pain in arm; Weak feeling; Trouble focusing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 12:45 (Lot number: FC3184) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known_allergies: Gluten" (unspecified if ongoing), notes: known_allergies: Gluten; "known_allergies: wheat" (unspecified if ongoing), notes: known_allergies: wheat; "known_allergies: soy" (unspecified if ongoing), notes: known_allergies: soy; "known_allergies: peanuts" (unspecified if ongoing), notes: known_allergies: peanuts; "known_allergies: milk" (unspecified if ongoing), notes: known_allergies: milk. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Severe stomach cramps"; DIARRHOEA (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Diarrhea"; HEADACHE (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Pain in arm"; ASTHENIA (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Weak feeling"; VISION BLURRED (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Trouble focusing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea, headache, pain in extremity, asthenia, vision blurred.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 before vaccination.  Follow-Up (24Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vision blurred
Clinical narrative: Severe stomach cramps; Diarrhea; Headache; Pain in arm; Weak feeling; Trouble focusing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 12:45 (Lot number: FC3184) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known_allergies: Gluten" (unspecified if ongoing), notes: known_allergies: Gluten; "known_allergies: wheat" (unspecified if ongoing), notes: known_allergies: wheat; "known_allergies: soy" (unspecified if ongoing), notes: known_allergies: soy; "known_allergies: peanuts" (unspecified if ongoing), notes: known_allergies: peanuts; "known_allergies: milk" (unspecified if ongoing), notes: known_allergies: milk. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Severe stomach cramps"; DIARRHOEA (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Diarrhea"; HEADACHE (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Pain in arm"; ASTHENIA (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Weak feeling"; VISION BLURRED (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Trouble focusing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea, headache, pain in extremity, asthenia, vision blurred.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 before vaccination.  Follow-Up (24Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Somnolence
Clinical narrative: sleepiness; Woke up during the night with chills; severe arm aching & tenderness at injection site.; severe fatigue; anorexia; Missed work the next day due to HA; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2020 at 09:30 (Lot number: EH9899) at the age of 63 years as dose 1, single for covid-19 immunisation at hospital. Relevant medical history included: "Polycythaemia vera", start date: 2020 (ongoing), notes: other medical history: Polycythaemia vera, Illness/AE: Polycythemia vera, Onset Date: 2020, Stop Date (check box if ongoing): ongoing; "Allergy to penicillin" (unspecified if ongoing), notes: Known allergy: PCN; "Asthma", start date: 2019 (ongoing), notes: Illness/AE: Asthma , Onset Date: 2019, Stop Date (check box if ongoing): ongoing; "allergies" (ongoing); "depression" (ongoing); "rhinorrhea" (ongoing); "Anemia" (ongoing); "bld thinner" (ongoing). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Vaccine was not administered at Military Facility. Concomitant medication(s) included: HYDREA taken for polycythaemia vera, start date: Oct2020 (ongoing); VIT D3; CALCIUM W VIT D; IRON taken for anaemia, start date: 2015 (ongoing); ASA taken for anticoagulant therapy, start date: 2019 (ongoing); EFFEXOR; SINGULAIR taken for asthma, start date: 2020 (ongoing); SIMICORT; AZELASTINE; SYMBICORT taken for asthma, start date: 2019 (ongoing); VENLAFAXINE taken for depression, start date: 2010 (ongoing); AZELASTINE HCL taken for hypersensitivity, start date: 2019 (ongoing); IPRATROPIUM taken for rhinorrhoea, start date: 2019 (ongoing); NASONEX taken for hypersensitivity, start date: 2019. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: Known allergy: Codeine.  The following information was reported: SOMNOLENCE (non-serious) with on-set 29Sep2021, outcome "recovered" (2021), described as "sleepiness"; CHILLS (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "Woke up during the night with chills"; VACCINATION SITE PAIN (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "severe arm aching & tenderness at injection site."; FATIGUE (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "severe fatigue"; DECREASED APPETITE (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "anorexia"; HEADACHE (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "Missed work the next day due to HA".  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sleepiness; Woke up during the night with chills; severe arm aching & tenderness at injection site.; severe fatigue; anorexia; Missed work the next day due to HA; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2020 at 09:30 (Lot number: EH9899) at the age of 63 years as dose 1, single for covid-19 immunisation at hospital. Relevant medical history included: "Polycythaemia vera", start date: 2020 (ongoing), notes: other medical history: Polycythaemia vera, Illness/AE: Polycythemia vera, Onset Date: 2020, Stop Date (check box if ongoing): ongoing; "Allergy to penicillin" (unspecified if ongoing), notes: Known allergy: PCN; "Asthma", start date: 2019 (ongoing), notes: Illness/AE: Asthma , Onset Date: 2019, Stop Date (check box if ongoing): ongoing; "allergies" (ongoing); "depression" (ongoing); "rhinorrhea" (ongoing); "Anemia" (ongoing); "bld thinner" (ongoing). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Vaccine was not administered at Military Facility. Concomitant medication(s) included: HYDREA taken for polycythaemia vera, start date: Oct2020 (ongoing); VIT D3; CALCIUM W VIT D; IRON taken for anaemia, start date: 2015 (ongoing); ASA taken for anticoagulant therapy, start date: 2019 (ongoing); EFFEXOR; SINGULAIR taken for asthma, start date: 2020 (ongoing); SIMICORT; AZELASTINE; SYMBICORT taken for asthma, start date: 2019 (ongoing); VENLAFAXINE taken for depression, start date: 2010 (ongoing); AZELASTINE HCL taken for hypersensitivity, start date: 2019 (ongoing); IPRATROPIUM taken for rhinorrhoea, start date: 2019 (ongoing); NASONEX taken for hypersensitivity, start date: 2019. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: Known allergy: Codeine.  The following information was reported: SOMNOLENCE (non-serious) with on-set 29Sep2021, outcome "recovered" (2021), described as "sleepiness"; CHILLS (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "Woke up during the night with chills"; VACCINATION SITE PAIN (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "severe arm aching & tenderness at injection site."; FATIGUE (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "severe fatigue"; DECREASED APPETITE (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "anorexia"; HEADACHE (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "Missed work the next day due to HA".  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Gait disturbance, Pain, Pain in extremity
Clinical narrative: my right foot and it's so painful to walk on; a lot of pain drop my body especially on my chest my right side and my feet a leading my center back; a lot of pain drop my body especially on my chest my right side and my feet a leading my center back; a lot of pain drop my body especially on my chest my right side and my feet a leading my center back; a lot of pain drop my body especially on my chest my right side and my feet a leading my center back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 07Sep2021 (Lot number: EW0150) 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: PAIN (non-serious), CHEST PAIN (non-serious), PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious) all with onset 09Sep2021, outcome "unknown" and all described as "a lot of pain drop my body especially on my chest my right side and my feet a leading my center back"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "my right foot and it's so painful to walk on".  Additional information: about four days after my initial shot I start getting a lot of pain in my body a mostly raging around my feet my lower back my right side mmm my upper back upper to middle back and my chest mmm as it starts to dull away it still isn't fully completely gone but my feet went to one foot which is my right foot and it's so painful to walk on it feels like there's a nail in my foot a when I take off my shoes at night and even when I'm sleeping it throbs throughout my body the pain on my foot is throbbing like a feels like there's something in my foot or broken bone mmm and i don't know what the issue is I take a Mortrin at night to kind of deal with the pain but I'm about to go to the emergency room or see a doctor for visit to find out what's going on but this all started after I took the first shot   about, a lot of, raging, starts to dull away, in, it throbs, the, throbbing, take a Mortrin at night to kind of deal with the pain but I'm about to go to the emergency room or see a doctor for visit to find out what's going on but this all started after I took the first shot.