chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: BODY ACHES; SWEATING; PAIN IN RIGHT SIDE OF LOWER ABDOMEN THAT STARTED AROUND 11PM LAST NIGHT; CHILLS; HEADACHES; VOMITING; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: smoker, and other pre-existing medical conditions included: Patient was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 30-OCT-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 30-OCT-2021, the patient experienced body aches. On 30-OCT-2021, the patient experienced sweating. On 30-OCT-2021, the patient experienced pain in right side of lower abdomen that started around 11pm last night. On 30-OCT-2021, the patient experienced chills. On 30-OCT-2021, the patient experienced headaches. On 30-OCT-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headaches, vomiting, body aches, sweating, and pain in right side of lower abdomen that started around 11pm last night. This report was non-serious. This case, from the same reporter is linked to 20211100672.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Influenza like illness, Migraine
Clinical narrative: FLU-LIKE SYMPTOMS; MIGRAINES; PAIN IN LOWER LEFT ABDOMEN; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: 20-MAR-2022) dose was not reported, administered on 30-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-OCT-2021, the patient experienced flu-like symptoms. On 30-OCT-2021, the patient experienced migraines. On 30-OCT-2021, the patient experienced pain in lower left abdomen. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, migraines, and pain in lower left abdomen. This report was non-serious. This case, from the same reporter is linked to 20211100454.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient got a dose of an expired vaccine; 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 (Patient got a dose of an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got a dose of an expired vaccine). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient got a dose of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored in the refrigerator 1 or 2 days before 20-Oct-2021 and the vial did not undergone any temperature excursions. The vial was expired on 11-Oct-2021. No concomitant medications were reported No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Non Significant follow-up received reporter fax number added.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: third full shot of Moderna vaccine after having two shots of Pfizer vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third full shot of Moderna vaccine after having two shots of Pfizer vaccine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third full shot of Moderna vaccine after having two shots of Pfizer vaccine). On 01-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third full shot of Moderna vaccine after having two shots of Pfizer vaccine) 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 information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered  past the expiration date; 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 EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) had resolved.        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 medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-359738 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow up received with No new information as  event as reported by primary source  includes Updated additional contact information . Start date and expiry date added from initial document which was missed earlier
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Feeling abnormal, Incorrect dose administered, Pain
Clinical narrative: patient received full 3rd dose despite no pre-existing conditions; slight upset stomach; I'm feeling kind of blah; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received full 3rd dose despite no pre-existing conditions), PAIN (body aches), FEELING ABNORMAL (I'm feeling kind of blah), ABDOMINAL DISCOMFORT (slight upset stomach) and CHILLS (chills) in a 68-year-old male patient 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 20-Oct-2021, the patient experienced PAIN (body aches) and CHILLS (chills). On 21-Oct-2021, the patient experienced FEELING ABNORMAL (I'm feeling kind of blah). On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (patient received full 3rd dose despite no pre-existing conditions) and ABDOMINAL DISCOMFORT (slight upset stomach). On 20-Oct-2021, CHILLS (chills) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (patient received full 3rd dose despite no pre-existing conditions) had resolved, PAIN (body aches) had not resolved and FEELING ABNORMAL (I'm feeling kind of blah) and ABDOMINAL DISCOMFORT (slight upset stomach) outcome was unknown.            No concomitant medication was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow-up received contains NNI
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Administration error, 2 doses 0.25mL instead of one fully dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Administration error, 2 doses 0.25mL instead of one fully dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Administration error, 2 doses 0.25mL instead of one fully dose). On 22-Oct-2021, PRODUCT ADMINISTRATION ERROR (Administration error, 2 doses 0.25mL instead of one fully dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was administered with a 0.25 ml booster dose instead of second dose and after 30 minutes, received another 0.25 ml to complete the full dose.  No concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow-up received contain patient details (patient initial, date of birth, gender), start date of drug and added reporter details.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: body ache; felt tired/body ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and FATIGUE (felt tired/body ache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F3H1) for COVID-19 vaccination.     Concurrent medical conditions included Diuretic effect and Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, HYDROCHLOROTHIAZIDE for Diuretic effect.   On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced MYALGIA (body ache) and FATIGUE (felt tired/body ache). At the time of the report, MYALGIA (body ache) and FATIGUE (felt tired/body ache) had resolved.      No treatment medications were provided. Patient stated that symptoms have resolved since I called.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received contains events Outcome updated and email address of reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Herpes zoster
Clinical narrative: My hair is thinning, just two weeks after my second dose and is continuing to thin until now; shingles up until now.; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (My hair is thinning, just two weeks after my second dose and is continuing to thin until now) and HERPES ZOSTER (shingles up until now.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Corneal transplant. Concurrent medical conditions included Shingles and Blurred vision.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced ALOPECIA (My hair is thinning, just two weeks after my second dose and is continuing to thin until now) and HERPES ZOSTER (shingles up until now.). At the time of the report, ALOPECIA (My hair is thinning, just two weeks after my second dose and is continuing to thin until now) and HERPES ZOSTER (shingles up until now.) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications were reported. No treatment information was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site reaction, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: some reactions; 98-99 range by 6 o'clock; woke up Saturday morning not feeling so good; body aches most of the day; 102 degrees; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (woke up Saturday morning not feeling so good), INJECTION SITE REACTION (some reactions), PYREXIA (98-99 range by 6 o'clock), PYREXIA (102 degrees) and MYALGIA (body aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced PYREXIA (102 degrees) and MYALGIA (body aches). On 23-Oct-2021, the patient experienced FEELING ABNORMAL (woke up Saturday morning not feeling so good), PYREXIA (98-99 range by 6 o'clock) and MYALGIA (body aches most of the day). On an unknown date, the patient experienced INJECTION SITE REACTION (some reactions). On 26-Oct-2021, FEELING ABNORMAL (woke up Saturday morning not feeling so good), PYREXIA (98-99 range by 6 o'clock) and MYALGIA (body aches most of the day) had resolved. At the time of the report, INJECTION SITE REACTION (some reactions) outcome was unknown and PYREXIA (102 degrees) and MYALGIA (body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 102 (High) 102 degree celsius.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Followup received on 26-oct-2021 and contains significant information includes dose details,events were added. On 27-Oct-2021: The Follow up document was received and contains Non significant information: Updated Contact Information
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine from expired vial; 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 EXPIRED PRODUCT ADMINISTERED (Received vaccine from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine from expired vial). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Non significant follow up appended On 27-Oct-2021: Follow up received contains No New Information
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination complication
Clinical narrative: Feeling bad; Was the 2nd moderna shot mad at me; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad) and VACCINATION COMPLICATION (Was the 2nd moderna shot mad at me) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad) and VACCINATION COMPLICATION (Was the 2nd moderna shot mad at me). At the time of the report, FEELING ABNORMAL (Feeling bad) and VACCINATION COMPLICATION (Was the 2nd moderna shot mad at me) outcome was unknown. Not Provided          No Concomitant medications were provided  No treatment medications were provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Contusion, Eczema, Mass, Morphoea
Clinical narrative: bruise on my abdomen; widespread chronic itching and some hives; widespread chronic itching and some hives; developed a mass in the same location; eczema; Morphea; This is a spontaneous report from a contactable nurse (patient). A 41 years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration in arm right on 15Jan2021 (at the age of 41 years-old) as dose 2, single for COVID-19 immunization at hospital. The patient's medical history included HTN and Hyperlipidaemia since an unknown date. Patient had no known allergies. Concomitant medications were not reported. Historical vaccine included the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration in right arm on an 22dec2020(Batch/Lot number unknown) (at the age of 41 years-old) as dose 1, single for covid-19 immunisation. 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 has been tested for COVID-19. On 20Jan2021 12:00 AM, 2-3 days after his second vaccine the patient developed a bruise on his abdomen. He also started to develop widespread chronic itching and some hives. The bruise went away and he developed a mass in the same location. The itching was getting worse followed by eczema. After an ultrasound showed no mass. He went to see a dermatologists about the itching and eczema and asked about the mass which had now turned to a white patch. They biopsied the mass and was diagnosed with Morphea and eczema. Which he had no predispositions to any auto-immune disorder or had ever had eczema. It was concluded that he may be having a systemic reaction to the vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. On 20Jan2021, the patient underwent lab tests and procedures which included Biopsy: diagnosed with Morphea, ultrasound: no mass. The patient received multiple treatments for adverse event. The outcome of events was recovering.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  Information regarding lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Ultrasound scan, Urticaria
Clinical narrative: bruise on my abdomen; widespread chronic itching and some hives; widespread chronic itching and some hives; developed a mass in the same location; eczema; Morphea; This is a spontaneous report from a contactable nurse (patient). A 41 years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration in arm right on 15Jan2021 (at the age of 41 years-old) as dose 2, single for COVID-19 immunization at hospital. The patient's medical history included HTN and Hyperlipidaemia since an unknown date. Patient had no known allergies. Concomitant medications were not reported. Historical vaccine included the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration in right arm on an 22dec2020(Batch/Lot number unknown) (at the age of 41 years-old) as dose 1, single for covid-19 immunisation. 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 has been tested for COVID-19. On 20Jan2021 12:00 AM, 2-3 days after his second vaccine the patient developed a bruise on his abdomen. He also started to develop widespread chronic itching and some hives. The bruise went away and he developed a mass in the same location. The itching was getting worse followed by eczema. After an ultrasound showed no mass. He went to see a dermatologists about the itching and eczema and asked about the mass which had now turned to a white patch. They biopsied the mass and was diagnosed with Morphea and eczema. Which he had no predispositions to any auto-immune disorder or had ever had eczema. It was concluded that he may be having a systemic reaction to the vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. On 20Jan2021, the patient underwent lab tests and procedures which included Biopsy: diagnosed with Morphea, ultrasound: no mass. The patient received multiple treatments for adverse event. The outcome of events was recovering.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  Information regarding lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in the fingertips of my left arm; Numbness and tingling in the fingertips of my left arm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant 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 04Sep2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and 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. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 04Sep2021, the patient experienced numbness and tingling in the fingertips of her left arm. The shot was administered into left arm. She had never had that side effect or anything like that before. 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 numbness and tingling in the fingertips of her left arm was not resolved at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral swelling, Skin discolouration
Clinical narrative: Numbing; Tingling/ pricking swollenblue hands; pricking swollenblue hands; pricking swollenblue hands; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unspecified age 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 31Aug2021 at 12:15 as a single dose for COVID-19 immunisation. Medical history included Hasimoto's disease. The patient had no known allergies to medications, food or other products. 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 included levothyroxine sodium (SYNTHROID) from an unknown date for unspecified indication and unknown if ongoing. On 01Sep2021 at 18:45, the patient experienced numbing, tingling and pricking swollen blue hands. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbing, tingling, pricking swollen and blue hands was not recovered 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: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Musculoskeletal stiffness
Clinical narrative: Sudden stiffness and pain in rightlower armpit approx. 50 hours after injection in left arm muscle.; Sudden stiffness and pain in rightlower armpit approx. 50 hours after injection in left arm muscle.; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 03Sep2021 at 10:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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. On 05Sep2021 at 12:00, 50 hours after the injection in left arm muscle, the patient experienced sudden stiffness and pain in right lower armpit which lasted for several hours. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sudden stiffness and pain in right lower armpit approx. 50 hours after injection in left arm muscle was resolving at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations, Respiration abnormal
Clinical narrative: I felt like my heart was racing; My breathing was off; I was feeling a pain in the left side of my chest under my breast and under my ribs that would come and go; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on an unknown date (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to possibly sulfa drugs. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously took tetracycline (MANUFACTURER UNKNOWN) and doxycycline (MANUFACTURER UNKNOWN); both taken for unknown indications and experienced drug allergy. On an unknown date, the patient felt like her heart was racing, her breathing was off, and she was feeling a pain in the left side of her chest under her breast and under her ribs that would come and go on the first night and into the second day. 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. The clinical outcome of the events she felt like her heart was racing, her breathing was off, and she was feeling a pain in the left side of her chest under her breast and under her ribs that would come and go was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspepsia, Headache, Insomnia, Nausea
Clinical narrative: Sore injection site; Burning in throat; Severe headache; Nausea; Insomnia; Indigestion; Stomach pain; Heart palpitations; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Aug2021 at 16:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's, asthma and known allergies to gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 29Aug2021 at 16:15, the patient experienced sore injection site, burning in throat, severe headache with nausea, insomnia, indigestion, stomach pain and heart palpitations. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event sore injection site, burning in throat, severe headache with nausea, insomnia, indigestion, stomach pain and heart palpitations was 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Throat irritation, Vaccination site pain
Clinical narrative: Sore injection site; Burning in throat; Severe headache; Nausea; Insomnia; Indigestion; Stomach pain; Heart palpitations; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Aug2021 at 16:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's, asthma and known allergies to gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 29Aug2021 at 16:15, the patient experienced sore injection site, burning in throat, severe headache with nausea, insomnia, indigestion, stomach pain and heart palpitations. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event sore injection site, burning in throat, severe headache with nausea, insomnia, indigestion, stomach pain and heart palpitations was 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: Terrible headache all day; Fever; Chills; Vomiting; diarrhea; Tummy aches; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (BNT162b2; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 18:00(at the age of 31-year-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (BNT162b2; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Aug2021 at 16:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Sep2021 at 08:00 the patient experienced terrible headache all day, fever, chills, vomiting, diarrhea and tummy aches. The patient did not receive any treatment for the events. No therapeutic measures were taken as a result of the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events terrible headache all day, fever, chills, vomiting, diarrhea and tummy aches was not recovered 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Terrible headache all day; Fever; Chills; Vomiting; diarrhea; Tummy aches; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (BNT162b2; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 18:00(at the age of 31-year-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (BNT162b2; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Aug2021 at 16:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Sep2021 at 08:00 the patient experienced terrible headache all day, fever, chills, vomiting, diarrhea and tummy aches. The patient did not receive any treatment for the events. No therapeutic measures were taken as a result of the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events terrible headache all day, fever, chills, vomiting, diarrhea and tummy aches was not recovered 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: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Headache everyday; Nauseated; Sore throat; Tired; Dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 09Sep2021 at 12:15 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. 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 medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Sep2021 at 19:00, the patient experienced headache everyday, nauseated, sore throat, tired and dizzy. 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 headache everyday, nauseated, sore throat, tired and dizzy were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Felt like I had severe case of flu with high fever; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Sep2021 at 17:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Sep2021 at 13:00, the patient felt like she had severe case of flu with high fever. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event felt like had severe case of flu with high fever was 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: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose started bleeding big fat drops of blood very, very quickly.; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old male patient 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 12Sep2021 at 00:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Sep2021 at 20:15, the patient had experienced a small bloody nose the previous day to the day of report (day of vaccination), but it stopped in 5 minutes. On the day of the report, the patient's nose started bleeding big fat drops of blood very, very quickly. It was reported that the patient did not have a bloody nose in a year and his nose continued to gush for 30-40 minutes. During this time, it got under control. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event nose started bleeding big fat drops of blood very, very quickly was resolving 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia for 1 week; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient 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 07Sep2021 at 14:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any vaccines within four weeks prior to vaccination. Concomitant medications were not reported. The patient previously took terbinafine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 08Sep2021 at 01:30, the patient experienced insomnia for 1 week. 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 event insomnia for 1 week was resolved on 15Sep2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Renal impairment
Clinical narrative: after 2nd dose and showed kidney function had decreased; This is a spontaneous report from a non-contactable consumer (patient) via Regulatory Authority. This 36-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 on an unknown date (at 36-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported she experienced lower kidney function on an unspecified date. The patient reported blood work was done prior to both doses and after the second dose showed kidney function had decreased. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: sars-Cov-2 nasal swab on 01Sep2021 with result of positive; sars-Cov-2 nasal swab on 01Sep2021 with result of positive; This is a spontaneous report from a non-contactable consumer (patient). This 46-year-old female patient received dose 1 of BNT162B2 (lot number EP6955) via an unspecified route of administration on 07Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunization and dose 2 of BNT162B2 (lot number EP6955) via an unspecified route of administration on 28Apr2021 (at the age of 46-years-old)  as a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not have any known allergies. On 25Aug2021 the patient experienced muscle aches, fatigue, and headache. The events were reported as non-serious. The patient was not hospitalized for the events. The patient underwent lab tests and procedures which included sars-Cov-2 nasal swab on 01Sep2021 with result of positive. The patient did not receive any treatment for the events. The outcomes of muscle aches, fatigue, headache, and sars-Cov-2 were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Nodule, Ultrasound scan
Clinical narrative: she has one nodule; Intramammary lymph node enlargement; This is a spontaneous report received from a contactable nurse (patient) via a Pfizer.   A 58-year-old female patient received second dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 14Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history included osteoporosis, autoimmune disorder and osteopenia (she will be getting her Reclast infusion for her osteoporosis and osteopenia). The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced one nodule and intramammary lymph node enlargement. It was reported that she specified that she had one nodule and breast nodule. Patient stated that she received the last dose of Pfizer Covid-19 vaccine on 14Apr2021 and will get the booster dose in December. She had autoimmune disease, Osteoporosis and will be having treatment/taking medication for her Osteoporosis on 27Oct2021. She asked that taking the medication will affect the booster dose and does she need to take the booster dose before or after the treatment. She waited to get her mammogram on 27Jul2021, and it was normal. The sonogram she had the same day was abnormal and showed 2 nodules in her breast. She waited for two months and repeated the sonogram on 27Sep2021, and the 2 nodules were still there. The doctor stated it was Intramammary lymph node enlargement. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numb finger tips on left hand.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient 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 in Aug2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Sep2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 16Sep2021 at 14:00, the patient experienced numb finger tips on left hand. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event numb finger tips on left hand was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.