chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Nurse also reported that two patients received expired vaccine for their booster shots, past 30; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse also reported that two patients received expired vaccine for their booster shots, past 30) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse also reported that two patients received expired vaccine for their booster shots, past 30). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Nurse also reported that two patients received expired vaccine for their booster shots, past 30) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: mixed series as primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mixed series as primary series) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mixed series as primary series). On 27-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mixed series as primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue on the day of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue on the day of vaccination) in a 49-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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FATIGUE (fatigue on the day of vaccination). At the time of the report, FATIGUE (fatigue on the day of vaccination) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported No treatment drugs were reported.   This case was linked to MOD-2022-445612, MOD-2022-445629 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue on the day of 2nd dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A, 036A21A and 034F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced FATIGUE (Fatigue on the day of 2nd dose). At the time of the report, FATIGUE (Fatigue on the day of 2nd dose) outcome was unknown.            This case was linked to MOD-2022-445612, MOD-2022-445628, MOD-2022-445612 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nucleated red cells, Red blood cell count abnormal
Clinical narrative: NRBCs came back abnormal / It is a low count but it should be a cero; This spontaneous case was reported by a consumer and describes the occurrence of RED BLOOD CELL COUNT ABNORMAL (NRBCs came back abnormal / It is a low count but it should be a cero) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 026L20A and 026120A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RED BLOOD CELL COUNT ABNORMAL (NRBCs came back abnormal / It is a low count but it should be a cero). At the time of the report, RED BLOOD CELL COUNT ABNORMAL (NRBCs came back abnormal / It is a low count but it should be a cero) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Nucleated red cells: abnormal (abnormal) NRBCs came back abnormal.         No concomitant medication were provided. No treatment details were provided.  Event onset date for RED BLOOD CELL COUNT ABNORMAL will be in JAN 2022.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of covid vaccine, Expired vaccine dose administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of covid vaccine, Expired vaccine dose administered to a 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of covid vaccine, Expired vaccine dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of covid vaccine, Expired vaccine dose administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Angioedema, Chronic spontaneous urticaria, Feeling abnormal, Oesophageal spasm, Vaccination complication
Clinical narrative: angioedema report it in the throat area; chronic spontaneous urticaria; esophagus spasm; pattern is eerie, it happens 7-10 days after the booster; having similar symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (angioedema report it in the throat area) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ANGIOEDEMA (angioedema report it in the throat area) (seriousness criterion medically significant), CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria), OESOPHAGEAL SPASM (esophagus spasm), FEELING ABNORMAL (pattern is eerie, it happens 7-10 days after the booster) and VACCINATION COMPLICATION (having similar symptoms). At the time of the report, ANGIOEDEMA (angioedema report it in the throat area), CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria), OESOPHAGEAL SPASM (esophagus spasm), FEELING ABNORMAL (pattern is eerie, it happens 7-10 days after the booster) and VACCINATION COMPLICATION (having similar symptoms) outcome was unknown.            Other medications not provided by the reporter. The support group (called Chronic Spontaneous Urticaria with COVID19 Vaccine Support Group) with 600-700 people who took different COVID19 vaccines, like Pfizer and Moderna.  The reporter encouraged the safety team to take a look at the group because people were reporting a variety of treatments. and mixed different antihistamines.   This case was linked to MOD-2022-440894, MOD-2022-440948 (Patient Link).
Sex: F
Vaccine: MENB
Symptoms: Burning sensation, Headache, Vomiting
Clinical narrative: This is a spontaneous report received from contactable consumer from a sales representative. A 18 year-old female patient received meningococcal group b rlp2086 (TRUMENBA) (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "head is on fire with pain"; VOMITING (non-serious), outcome "unknown", described as "Throwing up". The events "head is on fire with pain" and "throwing up" were evaluated at the emergency room visit. Additional information: It was reported that the patient experienced "head is on fire with pain" approximately 12 -18 hours after the first TRUMENBA shot. The patient was also throwing up and was taken to the ER. The events took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Swelling face
Clinical narrative: Facial swelling on left side of face; Severe headaches; feeling tired; sick; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 17:30 (Lot number: FC3180) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious) with onset 10Aug2021 06:00, outcome "unknown", described as "Facial swelling on left side of face"; HEADACHE (non-serious) with onset 10Aug2021 06:00, outcome "unknown", described as "Severe headaches"; FATIGUE (non-serious) with onset 10Aug2021 06:00, outcome "unknown", described as "feeling tired"; ILLNESS (non-serious) with onset 10Aug2021 06:00, outcome "unknown", described as "sick".  Additional information: No relevant past drug history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Since the vaccination, the patient had not been tested for COVID-19. Facial swelling on left side of face. Severe headaches, feeling tired and sick. Not sure if he should get the 2nd dose due to swelling of his face. Device Date: 10Aug2021.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site pain, Vaccination site swelling
Clinical narrative: Spot where they gave me that injection it's still a little, it's just a little swollen but it's still swollen; it's still very sour; it's pink; Arm pit on the same arm is very sour; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 30Jul2021 (Lot number: FA7485) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension.  The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 30Jul2021, outcome "not recovered", described as "Spot where they gave me that injection it's still a little, it's just a little swollen but it's still swollen"; VACCINATION SITE PAIN (non-serious) with onset 30Jul2021, outcome "not recovered", described as "it's still very sour"; ERYTHEMA (non-serious) with onset 30Jul2021, outcome "not recovered", described as "it's pink"; PAIN IN EXTREMITY (non-serious) with onset 30Jul2021, outcome "not recovered", described as "Arm pit on the same arm is very sour". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain, erythema, pain in extremity.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Following her first Pfizer Covid shot her period came early, and was extremely heavy with severe cramping/Same experience w two subsequent periods; Following her first Pfizer Covid shot her period came early, and was extremely heavy with severe cramping/Same experience w two subsequent periods; Following her first Pfizer Covid shot her period came early, and was extremely heavy with severe cramping/Same experience w two subsequent periods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 13:00 (Lot number: EWO179) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: POLYMENORRHOEA (non-serious), DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 18May2021, outcome "not recovered" and all described as "Following her first Pfizer Covid shot her period came early, and was extremely heavy with severe cramping/Same experience w two subsequent periods". Therapeutic measures were taken as a result of polymenorrhoea, dysmenorrhoea, heavy menstrual bleeding.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 since vaccination. Patient did not receive any other medication within two weeks. The patient had no known allergies. The patient's medical history was none. It was reported that usually, the patient menstruation was mild flow without cramps. Following her first Pfizer Covid shot her period came early and was extremely heavy with severe cramping. Same experience with two subsequent periods. The patient had taken Ibuprofen as a treatment.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Vaccination sites (both) still bleed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 13:15 (Lot number: ew0170) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies Mold" (unspecified if ongoing), notes: Known allergies: mold; "abdominal Planar damage from hernia" (unspecified if ongoing); "hypertansion" (unspecified if ongoing); "permanent plastic implant effects immune system in unusual ways" (unspecified if ongoing); "permanent plastic implant effects immune system in unusual ways" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing), notes: Known allergies: Sulfur. Concomitant medication(s) included: CARVEDILOL. Past drug history included: Erythromycin, reaction(s): "Known allergies", notes: Known allergies: Erythromycin. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious) with onset 02May2021 14:00, outcome "recovered with sequelae", described as "Vaccination sites (both) still bleed". The event "vaccination sites (both) still bleed" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site hemorrhage.  Additional information includes Other medications in two weeks included Coreg. No treatment received for AE. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dysgeusia, Fatigue, Polymerase chain reaction, Pyrexia
Clinical narrative: fatigue, metallic taste in my mouth, fever of up to 104.7 every 2 weeks, loss of appetite; fatigue, metallic taste in my mouth, fever of up to 104.7 every 2 weeks, loss of appetite; fatigue, metallic taste in my mouth, fever of up to 104.7 every 2 weeks, loss of appetite; fatigue, metallic taste in my mouth, fever of up to 104.7 every 2 weeks, loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 14:30 (Lot number: ER8732) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOXYL; BYSTOLIC; DYAZIDE. Past drug history included: Penicillin, reaction(s): "Allergy"; Avalide, reaction(s): "Allergy". The following information was reported: FATIGUE (non-serious), DYSGEUSIA (non-serious), PYREXIA (non-serious), DECREASED APPETITE (non-serious) all with onset 18Jun2021, outcome "not recovered" and all described as "fatigue, metallic taste in my mouth, fever of up to 104.7 every 2 weeks, loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, dysgeusia, pyrexia, decreased appetite.  Additional Information: Patient had not taken other vaccines in four weeks. Patient did not had Covid prior vaccination. Patient tasted Covid post vaccination. patient had allergy to shrimp.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: Caller states the site bled a little after she removed the bandage and the bruise appeared on Friday or Saturday.; Caller states the site bled a little after she removed the bandage and the bruise appeared on Friday or Saturday.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE HAEMORRHAGE (non-serious) all with onset Aug2021, outcome "unknown" and all described as "Caller states the site bled a little after she removed the bandage and the bruise appeared on Friday or Saturday".  Additional Information: AE. E-transmitting. Caller declines transfer to call center and will not provide age, name, phone number or address. Caller is a female. Caller states she thinks it's okay she was pressing on it and then it became a bruise and just wanted to make sure it was okay  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Pain in extremity, Periarthritis, Swelling
Clinical narrative: I have frozen shoulder; Swollen lymph nodes in neck and under arm.; Stiffness on whole left upper shoulder, side of breast; arm pain; It took two months for swelling to go away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 10:00 (Lot number: ER8734) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Graves' disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ENALAPRIL. Vaccination history included: Bnt162b2 (dose 1, single, lot number=EN6206,, administration time=09:00 AM, vaccine location=Left arm), administration date: 11Mar2021, when the patient was 61 years old, for Covid-19 Immunization, reaction(s): "First shot had very sore arm for few days.".The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Mar2021 13:00, outcome "unknown", described as "Swollen lymph nodes in neck and under arm."; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 31Mar2021 13:00, outcome "unknown", described as "Stiffness on whole left upper shoulder, side of breast"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021 13:00, outcome "unknown", described as "arm pain"; SWELLING (non-serious) with onset 31Mar2021 13:00, outcome "recovered" (2021), described as "It took two months for swelling to go away"; PERIARTHRITIS (non-serious) with onset Jun2021, outcome "unknown", described as "I have frozen shoulder". Therapeutic measures were not taken as a result of lymphadenopathy, musculoskeletal stiffness, pain in extremity, swelling, periarthritis.  Additional information :patient did not receive any treatment for AE,Patient not receive any other vaccine in four weeks ,patient receive other medications Levothyroxine, enalapril in two weeks .patient not tested covid positive prior vaccination. patient not tested covid positive post vaccination. No known allergies  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acne pustular, Mass, Rash
Clinical narrative: developed a rash on the right side of his head going to the back of his head, and there's also a pus on the back side of his right ear and now developing on the right side of his face; there is a little lump; also a pus on the back side of his right ear and now developing on the right side of his face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 (Lot number: EW0178) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: RASH (non-serious) with onset 10Aug2021, outcome "not recovered", described as "developed a rash on the right side of his head going to the back of his head, and there's also a pus on the back side of his right ear and now developing on the right side of his face"; MASS (non-serious) with onset Aug2021, outcome "unknown", described as "there is a little lump"; ACNE PUSTULAR (non-serious) with onset Aug2021, outcome "unknown", described as "also a pus on the back side of his right ear and now developing on the right side of his face".  Additional information: Consumer reported that he took about 4 or 5 different medications but he had been taking those for years. The Vaccine was given in the morning. Patients went through VA clinic. Patient did not receive any other vaccine on the same day of Pfizer vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Flushing, Heart rate, Heart rate increased
Clinical narrative: Dizzy; shortness of breath; flushed; elevated heart rate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13May2021 13:00 (Lot number: ER8736) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Preemie" (unspecified if ongoing), notes: (10 weeks early); "VCFS" (unspecified if ongoing); "clubfeet" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, lot number=ER8736, lot unknown=False, dose number=1), when the patient was 16 years old, for Covid-19 Immunisation. The following information was reported: DIZZINESS (non-serious) with onset 07Jun2021 14:30, outcome "not recovered", described as "Dizzy"; DYSPNOEA (non-serious) with onset 07Jun2021 14:30, outcome "not recovered", described as "shortness of breath"; FLUSHING (non-serious) with onset 07Jun2021 14:30, outcome "not recovered", described as "flushed"; HEART RATE INCREASED (non-serious) with onset 07Jun2021 14:30, outcome "not recovered", described as "elevated heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy; On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy; On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy; her arm was hurting bad yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 09:30 (Lot number: FC318) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: FA7484, Anatomical Location: right arm), administration date: 20Jul2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "Her arm hurt". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 12Aug2021, outcome "not recovered" and all described as "On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy"; VACCINATION SITE PRURITUS (non-serious) with onset 12Aug2021, outcome "unknown", described as "On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy"; VACCINATION SITE PAIN (non-serious) with onset 11Aug2021, outcome "not recovered", described as "her arm was hurting bad yesterday".  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect: No. Additional Vaccines Administered on Same Date of the Pfizer Suspect: No. Prior Vaccinations (within 4 weeks): No. Any AE(s) require a visit to: Emergency Room: No, Physician Office: No. Investigation Assessment: No. Relevant Tests: No.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy; On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy; On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy; her arm was hurting bad yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 09:30 (Lot number: FC318) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: FA7484, Anatomical Location: right arm), administration date: 20Jul2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "Her arm hurt". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 12Aug2021, outcome "not recovered" and all described as "On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy"; VACCINATION SITE PRURITUS (non-serious) with onset 12Aug2021, outcome "unknown", described as "On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy"; VACCINATION SITE PAIN (non-serious) with onset 11Aug2021, outcome "not recovered", described as "her arm was hurting bad yesterday".  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect: No. Additional Vaccines Administered on Same Date of the Pfizer Suspect: No. Prior Vaccinations (within 4 weeks): No. Any AE(s) require a visit to: Emergency Room: No, Physician Office: No. Investigation Assessment: No. Relevant Tests: No.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Vaccination site rash
Clinical narrative: Around 2am of 12Aug I woke up with a rash all over my face,where I got injected , my legs,  and breast.; Around 2am of 12Aug I woke up with a rash all over my face,where I got injected , my legs,  and breast.; itchy; my face was red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 11:30 (Lot number: EW0173) at the age of 26 years 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: RASH (non-serious), VACCINATION SITE RASH (non-serious) all with onset 12Aug2021 02:30, outcome "recovering" and all described as "Around 2am of 12Aug I woke up with a rash all over my face,where I got injected , my legs, and breast."; PRURITUS (non-serious) with onset 12Aug2021 02:30, outcome "recovering", described as "itchy"; ERYTHEMA (non-serious) with onset 12Aug2021 02:30, outcome "recovering", described as "my face was red". Therapeutic measures were not taken as a result of rash, vaccination site rash, pruritus, erythema.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19. Since the vaccination, she has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Overdose, Pain, Pyrexia
Clinical narrative: Dose 1 09Mar2021/Dose 2 09Mar2021; Dose 1 09Mar2021/Dose 2 09Mar2021; Headache; body pay elevated fever; body pay elevated fever; Pain on site of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 17:00 (Lot number: EN6207) as dose 1, single and administered in arm left, administration date 09Mar2021 (Lot number: EW0150) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic Maigrain" (unspecified if ongoing), notes: other medical history : Chronic Maigrain. The patient's concomitant medications were not reported. Past drug history included: Augmented antibiotics sulfur, reaction(s): "Drug allergy"; Augmented antibiotics sulfur, reaction(s): "Drug allergy". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; PYREXIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "body pay elevated fever"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain on site of injection"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), OVERDOSE (non-serious) all with onset 09Mar2021, outcome "unknown" and all described as "Dose 1 09Mar2021/Dose 2 09Mar2021".  Additional information: Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient had 3 days of Headache, body pay elevated fever. Pain on site of injection.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Dose 1 09Mar2021/Dose 2 09Mar2021; Dose 1 09Mar2021/Dose 2 09Mar2021; Headache; body pay elevated fever; body pay elevated fever; Pain on site of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 17:00 (Lot number: EN6207) as dose 1, single and administered in arm left, administration date 09Mar2021 (Lot number: EW0150) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic Maigrain" (unspecified if ongoing), notes: other medical history : Chronic Maigrain. The patient's concomitant medications were not reported. Past drug history included: Augmented antibiotics sulfur, reaction(s): "Drug allergy"; Augmented antibiotics sulfur, reaction(s): "Drug allergy". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; PYREXIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "body pay elevated fever"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain on site of injection"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), OVERDOSE (non-serious) all with onset 09Mar2021, outcome "unknown" and all described as "Dose 1 09Mar2021/Dose 2 09Mar2021".  Additional information: Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient had 3 days of Headache, body pay elevated fever. Pain on site of injection.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Severe (excruciating) continuous headache with dizziness; Severe (excruciating) continuous headache with dizziness; extreme joint pain (even my ankles); nausea; vomiting; extreme fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 14:15 (Lot number: FC3180) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroid that is well-managed" (unspecified if ongoing). Concomitant medication(s) included: NP THYROID taken for thyroid disorder; MULTIVITAMIN [VITAMINS NOS]. Past drug history included: Codeine, reaction(s): "rash"; Codeine, reaction(s): "itching"; Morphine, reaction(s): "vomiting"; Tramadol, reaction(s): "vomiting". Vaccination history included: Bnt162b2 (dose number: 1,, lot number: FA7484,, lot unknown: False,, administration date: 20Jul2021,, administration time: 03:30 PM, vaccine location: Left arm), administration date: 20Jul2021, when the patient was 60 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), DIZZINESS (non-serious) all with onset 12Aug2021 05:00, outcome "not recovered" and all described as "Severe (excruciating) continuous headache with dizziness"; ARTHRALGIA (non-serious) with onset 12Aug2021 05:00, outcome "not recovered", described as "extreme joint pain (even my ankles)"; NAUSEA (non-serious) with onset 12Aug2021 05:00, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 12Aug2021 05:00, outcome "not recovered", described as "vomiting"; FATIGUE (non-serious) with onset 12Aug2021 05:00, outcome "not recovered", described as "extreme fatigue". Therapeutic measures were not taken as a result of headache, dizziness, arthralgia, nausea, vomiting, fatigue.  Additional information: Facility where the most recent COVID-19 vaccine was administered  reported as Pharmacy or Drug Store, The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination reported as NP Thyroid 90mg/daily; multivitamin. No Prolonged Hospitalization as result of events. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe (excruciating) continuous headache with dizziness; Severe (excruciating) continuous headache with dizziness; extreme joint pain (even my ankles); nausea; vomiting; extreme fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 14:15 (Lot number: FC3180) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroid that is well-managed" (unspecified if ongoing). Concomitant medication(s) included: NP THYROID taken for thyroid disorder; MULTIVITAMIN [VITAMINS NOS]. Past drug history included: Codeine, reaction(s): "rash"; Codeine, reaction(s): "itching"; Morphine, reaction(s): "vomiting"; Tramadol, reaction(s): "vomiting". Vaccination history included: Bnt162b2 (dose number: 1,, lot number: FA7484,, lot unknown: False,, administration date: 20Jul2021,, administration time: 03:30 PM, vaccine location: Left arm), administration date: 20Jul2021, when the patient was 60 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), DIZZINESS (non-serious) all with onset 12Aug2021 05:00, outcome "not recovered" and all described as "Severe (excruciating) continuous headache with dizziness"; ARTHRALGIA (non-serious) with onset 12Aug2021 05:00, outcome "not recovered", described as "extreme joint pain (even my ankles)"; NAUSEA (non-serious) with onset 12Aug2021 05:00, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 12Aug2021 05:00, outcome "not recovered", described as "vomiting"; FATIGUE (non-serious) with onset 12Aug2021 05:00, outcome "not recovered", described as "extreme fatigue". Therapeutic measures were not taken as a result of headache, dizziness, arthralgia, nausea, vomiting, fatigue.  Additional information: Facility where the most recent COVID-19 vaccine was administered  reported as Pharmacy or Drug Store, The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination reported as NP Thyroid 90mg/daily; multivitamin. No Prolonged Hospitalization as result of events. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Pruritus, SARS-CoV-2 test
Clinical narrative: itchiness; Hair loss; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jul2021 10:30 (Lot number: EW0186) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no known allergies and other medical history. There were no concomitant medications.  The following information was reported: PRURITUS (non-serious) with onset 23Jul2021 22:00, outcome "not recovered", described as "itchiness"; ALOPECIA (non-serious) with onset 23Jul2021 22:00, outcome "not recovered", described as "Hair loss". The events "itchiness" and "hair loss" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus, alopecia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Breast pain, Burning sensation, Chest pain, Chills
Clinical narrative: Aches in bones all over body but worse on the bones in the left arm including shoulder, elbow, Wrist; Burning and tingling on left side of of face, jaw; tingling on left side of of face, jaw; burning in breast; burning in arm and leg of left side of body; Chills; "flu" like feeling; Burning in chest and down left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 12:00 (Lot number: Ew1075) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: 9 months ago. The patient's concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "Aches in bones all over body but worse on the bones in the left arm including shoulder, elbow, Wrist"; BURNING SENSATION (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "Burning and tingling on left side of of face, jaw"; PARAESTHESIA (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "tingling on left side of of face, jaw"; BREAST PAIN (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "burning in breast"; BURNING SENSATION (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "burning in arm and leg of left side of body"; CHILLS (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "Chills"; INFLUENZA LIKE ILLNESS (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as ""flu" like feeling"; CHEST PAIN (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "Burning in chest and down left arm". Therapeutic measures were not taken as a result of bone pain, burning sensation, paraesthesia, breast pain, burning sensation, chills, influenza like illness, chest pain.  Additional information: Aches in bones all over body but worse on the bones in the left arm including shoulder, elbow, Wrist. Burning and tingling on left side of face, jaw and burning in breast, arm and leg of left side of the body. Chills and "flu" like feeling. Burning in chest and down left arm two days after the same as when I had Covid 9 months ago. No other vaccine in four weeks. Other medications were received in two weeks. Had covid prior vaccination. No covid test post vaccination.No known allergies and none other medical history.  Follow-up attempts are completed. No further information is expected.