chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: throwing up/Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 immunisation. The following information was reported: VOMITING (non-serious) with onset 21Mar2021, outcome "unknown", described as "throwing up/Vomiting". It was reported that the patient received the 2nd shot on 19Mar2021 (Friday) and had all the symptoms (as provided by the reporter, pending clarification). On 21Mar2021 and 22Mar2021 (Sunday and then on Monday), the patient has been throwing up and it has been at least 6 to 7 times. And on 24Mar2021, the patient was again vomiting and only had liquid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: She woke up having a blister in the part after where she got administered the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (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 VESICLES (non-serious) with onset Mar2021, outcome "unknown", described as "She woke up having a blister in the part after where she got administered the vaccine". Additional information: Reporter's mother who is having side effects after first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Condition aggravated, Peripheral swelling
Clinical narrative: after her first dose of the Covid-19 vaccine, given in her right arm, that her arm was swollen and the swelling went down some/was more swollen after the first dose; after her first dose of the Covid-19 vaccine, given in her right arm, that her arm was swollen and the swelling went down some/was more swollen after the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 22Feb2021 (Lot number: ENG200, Expiration Date: 30Jun2021) at the age of 83 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: she has been having high blood pressure almost her entire life; "right arm was swollen", start date: Dec2020 (ongoing), notes: prior to the first dose of the Pfizer Covid-19 vaccine due to a  car accident 7 years ago.; "arm was broken in the car accident" (unspecified if ongoing); "arm was broken in the car accident" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: COZAAR taken for blood pressure abnormal, stop date: 13Mar2021. The following information was reported: PERIPHERAL SWELLING (non-serious), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "after her first dose of the Covid-19 vaccine, given in her right arm, that her arm was swollen and the swelling went down some/was more swollen after the first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no prior vaccinations (within 4 weeks). Clinical course: Patient reported that after her first dose of the COVID-19 vaccine, given in her right arm, that her arm was swollen and the swelling went down some. Patient stated that her right arm was swollen prior to the first dose of the Pfizer COVID-19 vaccine due to a  car accident 7 years ago. Patient reported that her arm was broken in the car accident and that a cast was placed on her arm versus surgical intervention. Patient reported that beginning in Dec2020 her right arm was a little swollen and that it was more swollen after the first dose of the Pfizer COVID-19 vaccine. Patient reported that her right arm is still a little swollen. The event did not require an emergency room or Physician office visit. The patient did not undergo any relevant tests. The patient also take a concomitant medication olmesartan medoxomil (BENICAR) started on 14Mar2021 and ongoing for blood pressure.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lhermitte's sign, Magnetic resonance imaging, Multiple sclerosis, Myelitis transverse
Clinical narrative: Transverse Myelitis or MS; Transverse Myelitis or MS; diagonosed with Lhermitte's sign; The initial case was missing the following minimum criteria: [unspecified suspect product]. Upon receipt of follow-up information on [12Jan2022], this case now contains all required information to be considered valid.     This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 02Apr2021 10:00 (Lot number: EP7533) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: EN6955), administration date: 12Mar2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "mild back pain", "nerve pain". The following information was reported: MYELITIS TRANSVERSE (medically significant), MULTIPLE SCLEROSIS (medically significant), outcome "unknown" and all described as "Transverse Myelitis or MS"; LHERMITTE'S SIGN (non-serious) with onset 03Apr2021, outcome "unknown", described as "diagonosed with Lhermitte's sign". The events "transverse myelitis or ms", "transverse myelitis or ms" and "diagonosed with lhermitte's sign" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: MRI: (10Jan2022) showing either transverse myelitis or MS, notes: Further testing is needed. Therapeutic measures were taken as a result of back pain. Clinical course: After the 2nd shot on 02Apr2021 patient had severe back pain and was put on dexamethasone on 05Apr2021 and more on 19Apr2021. Since then he has been having issues with pain, tingling and numbness in his face, hands, fingers, legs and feet. He was diagnosed with Lhermitte's sign in Nov2021 and just had a MRI on 10Jan2022 showing either Transverse Myelitis or MS. Further testing is needed and his doctor wanted to know if he had any issue with his covid vaccines and he said yes.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Pain in extremity
Clinical narrative: Slept all day; Painful right arm; Upset stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm right, administration date 06Mar2021 13:45 (Lot number: EN6205) at the age of 70 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Time: 13:45, Site and route of injection: Anatomical site of injection: Right arm, Route of administration: Intramuscular, Batch/Lot number: EM9809), administration date: 13Feb2021, when the patient was 70 years old, for Covid-19 immunisation, reaction(s): "right arm was slightly uncomfortable/slight discomfort"; Bnt162b2 (Dose 1, Time: 13:45, Site and route of injection: Anatomical site of injection: Right arm, Route of administration: Intramuscular, Batch/Lot number: EM9809), administration date: 13Feb2021, when the patient was 70 years old, for COVID-19 immunisation, reaction(s): "pain continued all night/painful at right arm".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Mar2021 17:00, outcome "recovered" (07Mar2021), described as "Painful right arm"; ABDOMINAL DISCOMFORT (non-serious) with onset 06Mar2021 07:00, outcome "recovered" (08Mar2021), described as "Upset stomach"; FATIGUE (non-serious) with onset 07Mar2021, outcome "unknown", described as "Slept all day". Therapeutic measures were not taken as a result of pain in extremity, abdominal discomfort.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Arm soreness; 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 (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 16Feb2021 (Lot number: EL1283) at the age of 26 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Chronic migraines" (unspecified if ongoing). Concomitant medication(s) included: BOTOX taken for migraine, start date: 11Feb2021, stop date: 11Feb2021.The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Arm soreness". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature decreased, Disorientation, Feeling of body temperature change
Clinical narrative: he became somewhat like disorientated; Restless; He did not feel well; Nauseous; he was hot, he was cold and really disorientated; temperature was low; blood pressure was a little low; urinating quite frequently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid 19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: DISORIENTATION (non-serious) with onset 01Jan2022, outcome "unknown", described as "he became somewhat like disorientated"; RESTLESSNESS (non-serious) with onset 01Jan2022, outcome "unknown", described as "Restless"; MALAISE (non-serious) with onset 01Jan2022, outcome "unknown", described as "He did not feel well"; NAUSEA (non-serious) with onset 01Jan2022, outcome "unknown", described as "Nauseous"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 01Jan2022, outcome "unknown", described as "he was hot, he was cold and really disorientated"; BODY TEMPERATURE DECREASED (non-serious) with onset 01Jan2022, outcome "unknown", described as "temperature was low"; HYPOTENSION (non-serious) with onset 01Jan2022, outcome "unknown", described as "blood pressure was a little low"; POLLAKIURIA (non-serious) with onset 01Jan2022, outcome "unknown", described as "urinating quite frequently". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information; Concern: Reporter stated, "My husband received the booster yesterday afternoon around 2 O' clock at the, last night it was about 1 O'clock The patient became somewhat like disorientated, restless, he did not feel well, nauseous. The patient called EMS because the patient was hot, cold and really disorientated. The patient came to the house and his vital signs, his temperature was low and his blood pressure was a little low but they said, the patient did not need to go to the hospital. The patient had more water. The patient uses the bathroom not diarrhea but urinating quite frequently. Further probing could not be initiated as reporter hung up abruptly. Hence, product details (LOT, expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Malaise, Nausea, Pollakiuria, Restlessness
Clinical narrative: he became somewhat like disorientated; Restless; He did not feel well; Nauseous; he was hot, he was cold and really disorientated; temperature was low; blood pressure was a little low; urinating quite frequently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid 19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: DISORIENTATION (non-serious) with onset 01Jan2022, outcome "unknown", described as "he became somewhat like disorientated"; RESTLESSNESS (non-serious) with onset 01Jan2022, outcome "unknown", described as "Restless"; MALAISE (non-serious) with onset 01Jan2022, outcome "unknown", described as "He did not feel well"; NAUSEA (non-serious) with onset 01Jan2022, outcome "unknown", described as "Nauseous"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 01Jan2022, outcome "unknown", described as "he was hot, he was cold and really disorientated"; BODY TEMPERATURE DECREASED (non-serious) with onset 01Jan2022, outcome "unknown", described as "temperature was low"; HYPOTENSION (non-serious) with onset 01Jan2022, outcome "unknown", described as "blood pressure was a little low"; POLLAKIURIA (non-serious) with onset 01Jan2022, outcome "unknown", described as "urinating quite frequently". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information; Concern: Reporter stated, "My husband received the booster yesterday afternoon around 2 O' clock at the, last night it was about 1 O'clock The patient became somewhat like disorientated, restless, he did not feel well, nauseous. The patient called EMS because the patient was hot, cold and really disorientated. The patient came to the house and his vital signs, his temperature was low and his blood pressure was a little low but they said, the patient did not need to go to the hospital. The patient had more water. The patient uses the bathroom not diarrhea but urinating quite frequently. Further probing could not be initiated as reporter hung up abruptly. Hence, product details (LOT, expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Lymphadenopathy, Pain
Clinical narrative: 101 fever for 36 hours after injection.; Tired; achy; chills; Injection site reaction with swollen and tender arm.; Injection site reaction with swollen and tender arm./Swollen area tender to touch. Significant swollen lymph node on left side between shoulder and neck.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer ,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not, available/provided to reporter at the, time of report completion,, prev dose dose number=1), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Jan2022, outcome "not recovered", described as "significant swollen lymph node on left side between shoulder and neck."; PYREXIA (non-serious) with onset 02Jan2022, outcome "not recovered", described as "101 fever for 36 hours after injection."; FATIGUE (non-serious) with onset 02Jan2022, outcome "not recovered", described as "Tired"; PAIN (non-serious) with onset 02Jan2022, outcome "not recovered", described as "achy"; CHILLS (non-serious) with onset 02Jan2022, outcome "not recovered", described as "chills"; PERIPHERAL SWELLING (non-serious) with onset 02Jan2022, outcome "not recovered", described as "Injection site reaction with swollen and tender arm."; TENDERNESS (non-serious) with onset 01Jan2022, outcome "not recovered", described as "Injection site reaction with swollen and tender arm./Swollen area tender to touch.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, pyrexia, fatigue, pain, chills, peripheral swelling, tenderness.  Additional information: Patient did not receive other vaccine in four weeks. AE treatment: Ibuprofen. If Covid prior vaccination: Yes. If Covid tested post vaccination: No. known allergies: NA. other medical history: NA  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: 101 fever for 36 hours after injection.; Tired; achy; chills; Injection site reaction with swollen and tender arm.; Injection site reaction with swollen and tender arm./Swollen area tender to touch. Significant swollen lymph node on left side between shoulder and neck.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer ,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not, available/provided to reporter at the, time of report completion,, prev dose dose number=1), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Jan2022, outcome "not recovered", described as "significant swollen lymph node on left side between shoulder and neck."; PYREXIA (non-serious) with onset 02Jan2022, outcome "not recovered", described as "101 fever for 36 hours after injection."; FATIGUE (non-serious) with onset 02Jan2022, outcome "not recovered", described as "Tired"; PAIN (non-serious) with onset 02Jan2022, outcome "not recovered", described as "achy"; CHILLS (non-serious) with onset 02Jan2022, outcome "not recovered", described as "chills"; PERIPHERAL SWELLING (non-serious) with onset 02Jan2022, outcome "not recovered", described as "Injection site reaction with swollen and tender arm."; TENDERNESS (non-serious) with onset 01Jan2022, outcome "not recovered", described as "Injection site reaction with swollen and tender arm./Swollen area tender to touch.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, pyrexia, fatigue, pain, chills, peripheral swelling, tenderness.  Additional information: Patient did not receive other vaccine in four weeks. AE treatment: Ibuprofen. If Covid prior vaccination: Yes. If Covid tested post vaccination: No. known allergies: NA. other medical history: NA  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Condition aggravated, Immunisation
Clinical narrative: Booster; Hair loss; Hair loss was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 (Lot number: FF2589) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, First Covid vaccine: 15Feb2021, Lot Number / Expiry Date: EN5319 , Route, Anatomical Location: left arm, No. of Previous Doses: NA), administration date: 15Feb2021, when the patient was 69 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2, Second Covid vaccine: 08Mar2021, Lot Number/Expiration Date: EN6203, Anatomical Location: left arm, No. of Previous Doses: one), administration date: 08Mar2021, when the patient was 69 years old, for Covid-19 immunization, reaction(s): "hair loss". The following information was reported: IMMUNISATION (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Booster"; ALOPECIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Hair loss"; CONDITION AGGRAVATED (non-serious) with onset Oct2021, outcome "not recovered", described as "Hair loss was reported as worsened".  Additional information: No additional vaccines administered on same date of the Pfizer suspect. The patient doesn't have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. No emergency room and physician office visit. No relevant tests. The patient stated that the hair loss started after the second dose, and the booster dose.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Inflammation, Product administration error
Clinical narrative: just really want to know if the reaction I had to my first dose was an allergy; inflammation response; I don''t know if it was the vaccine or if it was the way the doctor injected the vaccine; not injected in the middle of my deltoid; injected on the outer side of my deltoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Aug2021 (Lot number: EW0185) 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: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 11Aug2021, outcome "unknown", described as "I don''t know if it was the vaccine or if it was the way the doctor injected the vaccine; not injected in the middle of my deltoid; injected on the outer side of my deltoid"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "just really want to know if the reaction I had to my first dose was an allergy"; INFLAMMATION (non-serious), outcome "unknown", described as "inflammation response".  Additional information: Consumer stated, having a hard time, patient just really want to know if the reaction  had to the first dose was an allergy, because patient have not gotten the second dose because afraid of the response from the first and doctor did not report it to VAERS and patient not getting any help around on the topic and I don't know if it was the vaccine or if it was the way the doctor injected the vaccine because it was not injected in the middle of deltoid in fact it was injected on the outer side of deltoid (further clarifications unknown hence event captured as per verbatim).
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Illness, Influenza like illness, Malaise
Clinical narrative: got sick; felt really bad like she had the flu; felt really bad like she had the flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: She already had COVID a year ago and she has the antibodies but here is the problem; "injured" (unspecified if ongoing), notes: she was out of work because of injured. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "got sick"; MALAISE (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset Dec2021, outcome "unknown" and all described as "felt really bad like she had the flu". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter stated that the concern is my wife. she had one shot on couple weeks ago I guess, she went back to work, she was out of work because of injured (Further clarification unknown) and she has to get a shot to get back in and she got a shot somewhere prior to 16Dec at withheld (Further clarification unknown). So, she made the appointment, she got the shot, she got sick for two days, felt really bad like she had the flu and sometimes it does suppose me give you that. She already had COVID a year ago and she has the antibodies but here is the problem. Not clarified about Lot#.  If follow-up activities cannot be or are not conducted: No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: menstrual cycle every month and was supposed to start on 27Dec and still has not had her menstrual cycle as of 01Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (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: MENSTRUAL DISORDER (non-serious) with onset Dec2021, outcome "not recovered", described as "menstrual cycle every month and was supposed to start on 27Dec and still has not had her menstrual cycle as of 01Jan2022".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Still now sometimes I get my, in my left arm slight pain; After 8 to 9 months I still get the slight pain; I get pain in my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EL9265) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Still now sometimes I get my, in my left arm slight pain; After 8 to 9 months I still get the slight pain; I get pain in my left arm".  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jul2021 09:00 (Lot number: ER8733) at the age of 53 years as dose 1, single and administered in arm right, administration date 31Aug2021 09:00 (Lot number: EWO170) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If Covid prior vaccination. There were no concomitant medications. Past drug history included: None, reaction(s): "allergy". The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovering", described as "Really bad for another 10 hours or so". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling abnormal.No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling
Clinical narrative: Swelling and soreness in the left armpit; Swelling and soreness in the left armpit; booster dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 18:30 (Lot number: FL3209) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 12May2021, when the patient was 29 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0164, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 19Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Jan2022 18:30, outcome "unknown", described as "booster dose"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 06Jan2022 08:00, outcome "recovering" and all described as "Swelling and soreness in the left armpit". Therapeutic measures were not taken as a result of swelling, axillary pain.  Additional information: There was no other vaccine in four weeks. No treatments for adverse events. Patient did not test covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Immunisation
Clinical narrative: Booster vaccine; He is coughing a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 84 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster vaccine"; COUGH (non-serious), outcome "unknown", described as "He is coughing a little bit".  Additional information: Caller received both doses of the Pfizer Covid-19 vaccine as well as the booster vaccine. Caller stated that he is coughing a little bit, which isn't normal for him. Caller is asking where he can go to get tested for the Covid-19 virus? Response: Confirmed that caller had received Pfizer Covid-19 vaccine. Spoke from VR-consumer inquiry management. Referred to HCP, local pharmacy, and health department. Offered warm transfer to DSU, caller accepted and then remotely disconnected while on hold for transfer.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, SARS-CoV-2 test, Seizure
Clinical narrative: seizure with a fever spike of 102; seizure with a fever spike of 102; very tired; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 9 year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 05Jan2022 16:00 (Lot number: FKS189) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Febrile seizures almost 5yrs ago" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: berries" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021 at 21:00 and 07Jan2021, the patient complained of being very tired. On 07Jan2021 at 21:00, he had a seizure with a fever spike of 102, and then a hospital visit. The events "seizure with a fever spike of 102" and "very tired" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (07Jan2022) 102; sars-cov-2 test: (07Jan2022) pending. It was unknown if therapeutic measures were taken as a result of seizure, fatigue, pyrexia. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Chest pain, Hyperglycaemia, Immunisation
Clinical narrative: neuropathy in arms, legs & face; Booster dose; Chest pain; fluctuation in BP; hyperglycemia; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 19 year old male patient received BNT162B2 (Batch/Lot number: unknown) at the age of 19 years as dose 3 (booster), single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for Covid-19 Immunization; Bnt162b2 (Dose Number: 2), for Covid-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "neuropathy in arms, legs & face"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; CHEST PAIN (non-serious), outcome "not recovered", described as "Chest pain"; BLOOD PRESSURE FLUCTUATION (non-serious), outcome "not recovered", described as "fluctuation in BP"; HYPERGLYCAEMIA (non-serious), outcome "not recovered", described as "hyperglycemia". The events "neuropathy in arms, legs & face", "chest pain", "fluctuation in bp" and "hyperglycemia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: fluctuation. It was unknown if therapeutic measures were taken as a result of neuropathy peripheral, chest pain, blood pressure fluctuation, hyperglycaemia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy in arms, legs & face; Booster dose; Chest pain; fluctuation in BP; hyperglycemia; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 19 year old male patient received BNT162B2 (Batch/Lot number: unknown) at the age of 19 years as dose 3 (booster), single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for Covid-19 Immunization; Bnt162b2 (Dose Number: 2), for Covid-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "neuropathy in arms, legs & face"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; CHEST PAIN (non-serious), outcome "not recovered", described as "Chest pain"; BLOOD PRESSURE FLUCTUATION (non-serious), outcome "not recovered", described as "fluctuation in BP"; HYPERGLYCAEMIA (non-serious), outcome "not recovered", described as "hyperglycemia". The events "neuropathy in arms, legs & face", "chest pain", "fluctuation in bp" and "hyperglycemia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: fluctuation. It was unknown if therapeutic measures were taken as a result of neuropathy peripheral, chest pain, blood pressure fluctuation, hyperglycaemia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper
Clinical narrative: He is not able to use the bathroom, he is feeling really  bloated and cramps in the stomach; he says he feels full; He is not able to use the bathroom, he is feeling really  bloated and cramps in the stomach; he says he feels full; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A male patient received BNT162b2 (BNT162B2), administration date 06Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISTENSION (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 07Jan2022, outcome "unknown" and all described as "He is not able to use the bathroom, he is feeling really  bloated and cramps in the stomach; he says he feels full". Additional information: The patient took the Pfizer vaccine and he was not able to use the bathroom, feeling really  bloated and cramps in the stomach. The patient wanted to go to the bathroom but when he went he couldn't do anything and the stomach was cramping like he said he felt full. He got it yesterday and he got the vaccine a day before.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: COVID booster vaccine; pain and swelling in her fingers, wrists and legs; pain and swelling in her fingers, wrists and legs; pain and swelling in her fingers, wrists and legs; pain and swelling in her fingers, wrists and legs; pain and swelling in her fingers, wrists and legs; pain and swelling in her fingers, wrists and legs; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (AE00540121).  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID booster vaccine"; PERIPHERAL SWELLING (non-serious), PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "pain and swelling in her fingers, wrists and legs".  Additional information: Patient missed 5 days of her dose 04Dec2021-08Dec2021. Recommendation of missing her dose of Xeljanz was made by her physician because patient received COVID booster vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: I have gotten an overdose of the Pfizer vaccine 3/2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (medically significant), described as "I have gotten an overdose of the Pfizer vaccine 3/2".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Immunisation, Nasopharyngitis, Paranasal sinus discomfort
Clinical narrative: Sinus/head cold present and the exhaustion is gone; Saturday and Sunday (08Jan2022 and 09Jan2022) felt as though I had a head cold and was very exhausted; Saturday and Sunday (08Jan2022 and 09Jan2022) felt as though I had a head cold and was very exhausted; I tested positive for COVID-19 (10Jan2022); I tested positive for COVID-19 (10Jan2022); booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 12:30 (Lot number: FF2593) at the age of 65 years as dose 3 (booster), single, administered in arm right, administration date 24Mar2021 09:30 (Lot number: EP6955) as dose 2, single and administered in arm right, administration date 04Mar2021 09:30 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jan2022 04:00, outcome "recovering" and all described as "I tested positive for COVID-19 (10Jan2022)"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 10Jan2022 04:00, outcome "recovering", described as "Sinus/head cold present and the exhaustion is gone"; NASOPHARYNGITIS (non-serious) with onset 07Jan2022 04:00, outcome "recovering", FATIGUE (non-serious) with onset 07Jan2022 04:00, outcome "recovered" (Jan2022) and all described as "Saturday and Sunday (08Jan2022 and 09Jan2022) felt as though I had a head cold and was very exhausted". The patient underwent the following laboratory tests and procedures: BinaxNOW COVID-19 Antigen Self Test: (07Jan2022) negative, notes: Nasal Swab; (10Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, paranasal sinus discomfort, nasopharyngitis, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Sinus/head cold present and the exhaustion is gone; Saturday and Sunday (08Jan2022 and 09Jan2022) felt as though I had a head cold and was very exhausted; Saturday and Sunday (08Jan2022 and 09Jan2022) felt as though I had a head cold and was very exhausted; I tested positive for COVID-19 (10Jan2022); I tested positive for COVID-19 (10Jan2022); booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 12:30 (Lot number: FF2593) at the age of 65 years as dose 3 (booster), single, administered in arm right, administration date 24Mar2021 09:30 (Lot number: EP6955) as dose 2, single and administered in arm right, administration date 04Mar2021 09:30 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jan2022 04:00, outcome "recovering" and all described as "I tested positive for COVID-19 (10Jan2022)"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 10Jan2022 04:00, outcome "recovering", described as "Sinus/head cold present and the exhaustion is gone"; NASOPHARYNGITIS (non-serious) with onset 07Jan2022 04:00, outcome "recovering", FATIGUE (non-serious) with onset 07Jan2022 04:00, outcome "recovered" (Jan2022) and all described as "Saturday and Sunday (08Jan2022 and 09Jan2022) felt as though I had a head cold and was very exhausted". The patient underwent the following laboratory tests and procedures: BinaxNOW COVID-19 Antigen Self Test: (07Jan2022) negative, notes: Nasal Swab; (10Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, paranasal sinus discomfort, nasopharyngitis, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: The patient got COVID; The patient got COVID; Dose Number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single, administration date 16May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 25Apr2021 (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: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Dose Number 3"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovered" (Jan2022) and all described as "The patient got COVID". The event "the patient got COVID" was evaluated at the physician office visit. Therapeutic measures were taken as a result of drug ineffective, suspected COVID-19. These events did not result in hospitalization prolonged. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.