chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; 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 27 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Oct2021 (Lot number: EW0217) at the age of 26 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 26Jan2021 (Lot number: EL3247) as dose 1, single and intramuscular, administered in arm left, administration date 16Feb2021 (Lot number: 3248) as dose 2, 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 IMMUNISATION (medically significant) with onset 07Oct2021, outcome unknown; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Dec2021, outcome unknown. The event tested positive for covid-19 and tested positive for covid-19 was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (17Dec2021) unknown results, Nasal Swab; (17Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Patient had no received other vaccine in four weeks. Patient had no covid prior vaccination. Patient had covid tested post vaccination. Patient had no known allergies. Patient had covid test result pending.  No follow-up attempts needed. No further information expected.
Age: 23.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: potential Covid-19 breakthrough case/covid test date=17Dec2021, covid test result=Positive; potential Covid-19 breakthrough case/covid test date=17Dec2021, covid test result=Positive; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 23 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 09:00 (Lot number: EW0217) at the age of 23 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 21Apr2021 12:00 (Lot number: EW0161) as dose 2, single, and intramuscular, administered in arm left, administration date 31Mar2021 12:00 (Lot number: GR8734) as dose 1, single for covid-19 immunisation; influenza vaccine AFLURIA QUADRIVALENT, administered in arm right, administration date 27Oct2021 (Lot number: P100354282) as dose 1, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported IMMUNISATION (medically significant) with onset 27Oct2021 09:00, outcome unknown; VACCINATION FAILURE (medically significant) with onset 17Dec2021 12:00, outcome unknown, COVID-19 (medically significant) with onset 17Dec2021 12:00, outcome not recovered. The event potential covid-19 breakthrough case/covid test date=17dec2021, covid test result=positive, and potential covid-19 breakthrough case/covid test date=17dec2021, covid test result=positive was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (17Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Course: Patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination. No allergies was reported.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received his first dose of Comirnaty 22Nov2021/had both a positive and negative Covid-19 test on 16Dec2021; had both a positive and negative Covid-19 test on 16Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Lot number: FF2593) at the age of 16 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type II Diabetic" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 16Dec2021, outcome "unknown", described as "Received his first dose of Comirnaty 22Nov2021/had both a positive and negative Covid-19 test on 16Dec2021"; COVID-19 (medically significant) with onset 16Dec2021, outcome "unknown", described as "had both a positive and negative Covid-19 test on 16Dec2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) positive; (16Dec2021) negative. Reporter confirmed both the positive and negative covid-19 test result happened yesterday, 16Dec2021. Someone at school had contracted covid. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks) were reported. Events did not require a visit to Emergency room and Physician office.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Investigation, Thrombosis
Clinical narrative: 3 blood clots in his neck and brain; He is affected on his left hand side, he gets dizzy; 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 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), for COVID-19 Immunization. The following information was reported: THROMBOSIS (medically significant), outcome "recovering", described as "3 blood clots in his neck and brain"; DIZZINESS (non-serious), outcome "recovering", described as "He is affected on his left hand side, he gets dizzy". The patient underwent the following laboratory tests and procedures: investigation: unknown results; it did not, notes: special test to see if blood clots were in his medical and family history. Therapeutic measures were taken as a result of thrombosis by the patients and had him on a blood thinner. The patient doctor advised him that the only thing he can think is that the vaccine caused this to happen to the caller. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A 20 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "recovered", described as "Developed myocarditis after his second COVID vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event myocarditis and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities,  as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Pyrexia, Rash
Clinical narrative: Tired; Low grade fever within 24 hour.; Rash covering torso and face; headache after 24 hours; Dose received 3; This is a spontaneous report from a contactable reporter (consumer or non HCP).   A female patient of unknown age (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 16Dec2021 at 11:30 (Lot number: FL3197) 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, SINGLE, Lot number: ER8734, vaccine location: Left arm, administration time: 09:45 , route of administration: intramuscular), administration date: 27Mar2021, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0162, vaccine location: Left arm, administration time: 09:45, route of administration: intramuscular), administration date: 17Apr2021, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 at 11:30, outcome "unknown", described as "dose received 3"; FATIGUE (non-serious) with onset 17Dec2021 at 08:00, outcome "not recovered", described as "Tired"; PYREXIA (non-serious) with onset 17Dec2021 at 08:00, outcome "not recovered", described as "Low grade fever within 24 hour"; RASH (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Rash covering torso and face"; HEADACHE (non-serious) with onset 17Dec2021, outcome "not recovered", described as "headache after 24 hours". Therapeutic measures were not taken as a result of fatigue, pyrexia, rash and headache.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Hypoacusis, Insomnia, Tinnitus
Clinical narrative: Tinnitus; Affects my ability to hear; Affects my ability to completely sleep; Affects my ability to concentrate some days; This is a spontaneous report from a contactable reporter (consumer or non-HCP). The reporter is the patient.   A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 09Jun2021 at 13:15 (Lot number: EW0183) at the age of 43 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication included: LOESTRIN taken for birth control. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0169, vaccine location: right arm, administration Time: 13:15), administration date: 12May2021, when the patient was 43 years old, for COVID-19 immunisation.  The following information was reported: TINNITUS (non-serious) with onset 09Jun2021, outcome "not recovered", described as "Tinnitus"; HYPOACUSIS (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Affects my ability to hear"; INSOMNIA (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Affects my ability to completely sleep"; DISTURBANCE IN ATTENTION (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Affects my ability to concentrate some days". The event "Tinnitus" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus. Additional information: It was also reported that the tinnitus would not go away. The patient could not remember exact day but it was right after second dose. The patient went to doctor, referred to specialist and was waiting till after holidays to go. The patient thought it would go away if the vaccine only lasted 6 months but it was not going away. It affected ability to hear and completely sleep or concentrate some days. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event tinnitus resulted in doctor or other healthcare professional office/clinic visit.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Immunisation, Pain in extremity
Clinical narrative: chills and sore calves starting midnight; chills and sore calves starting midnight; headache morning of 17- Dec-2021; Felt warm; dose number = 3; This is a spontaneous report from a contactable reporter (consumer or non-HCP).   A 17-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Dec2021 at 10:00 (Lot number: FL3197) at the age of 17 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 2, SINGLE Lot number: EP6955 Route of administration: unspecified), administration date: 12Apr2021, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE Lot number: DP6955 Route of administration: unspecified), administration date: 22Mar2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 at 10:00, outcome "unknown", described as "dose number = 3"; FEELING HOT (non-serious) with onset 16Dec2021 at 22:00, outcome "recovered" (an unknown date in Dec2021), described as "Felt warm"; CHILLS (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 17Dec2021 at 00:00, outcome "recovered" (17Dec2021), and all described as "chills and sore calves starting midnight"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovered" (17Dec2021), described as "headache morning of 17-Dec-2021". Therapeutic measures were not taken as a result of feeling hot, chills, pain in extremity and headache.   Additional Information: On 16Dec2021 at midnight, the patient experienced chills and sore calves and on 17Dec2021 at morning, the patient experienced headache.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Breast tenderness, Immunisation, Lymphadenopathy, Pain
Clinical narrative: Low grade temp and aches resolved after 36 hours.; Aches resolved after 36 hours; Large amount of under arm and axilla lymph node swelling/ Tender, swollen and lymphadenopathy in left axilla; Even some left breast swelling and tenderness that started one day after shot.; Even some left breast swelling; Dose number 3; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 16Dec2021 at 15:00 (Lot number: unknown) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies Penicillin- rash. Concomitant medications included: VYVANSE; DUPIXENT and LEXAPRO. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified, Anatomical site: Left arm), administration date: 30Dec2020, when the patient was 47 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified), administration date: 19Jan2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 at 15:00, outcome "unknown", described as "Dose number 3"; LYMPHADENOPATHY (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Large amount of under arm and axilla lymph node swelling/ Tender, swollen and lymphadenopathy in left axilla"; BREAST TENDERNESS (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Even some left breast swelling and tenderness that started one day after shot"; BREAST SWELLING (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Even some left breast swelling"; PYREXIA (non-serious) with onset 18Dec2021 at 08:00, outcome "recovered" (19Dec2021), described as "Low grade temp and aches resolved after 36 hours"; PAIN (non-serious) with onset 18Dec2021 at 08:00, outcome "recovered" (19Dec2021), described as "Aches resolved after 36 hours". Therapeutic measures were not taken as a result of pyrexia, pain, lymphadenopathy, breast tenderness and breast swelling.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Low grade temp and aches resolved after 36 hours. Large amount of under arm and axilla lymph node swelling. Tender, swollen and lymphadenopathy in left axilla and even some left breast swelling and tenderness that started one day after shot. Presently have this.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade temp and aches resolved after 36 hours.; Aches resolved after 36 hours; Large amount of under arm and axilla lymph node swelling/ Tender, swollen and lymphadenopathy in left axilla; Even some left breast swelling and tenderness that started one day after shot.; Even some left breast swelling; Dose number 3; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 16Dec2021 at 15:00 (Lot number: unknown) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies Penicillin- rash. Concomitant medications included: VYVANSE; DUPIXENT and LEXAPRO. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified, Anatomical site: Left arm), administration date: 30Dec2020, when the patient was 47 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified), administration date: 19Jan2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 at 15:00, outcome "unknown", described as "Dose number 3"; LYMPHADENOPATHY (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Large amount of under arm and axilla lymph node swelling/ Tender, swollen and lymphadenopathy in left axilla"; BREAST TENDERNESS (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Even some left breast swelling and tenderness that started one day after shot"; BREAST SWELLING (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Even some left breast swelling"; PYREXIA (non-serious) with onset 18Dec2021 at 08:00, outcome "recovered" (19Dec2021), described as "Low grade temp and aches resolved after 36 hours"; PAIN (non-serious) with onset 18Dec2021 at 08:00, outcome "recovered" (19Dec2021), described as "Aches resolved after 36 hours". Therapeutic measures were not taken as a result of pyrexia, pain, lymphadenopathy, breast tenderness and breast swelling.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Low grade temp and aches resolved after 36 hours. Large amount of under arm and axilla lymph node swelling. Tender, swollen and lymphadenopathy in left axilla and even some left breast swelling and tenderness that started one day after shot. Presently have this.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Lymph node is left arm swollen four/five days after vaccine; First dose received on 28Jun2021 and second dose on 18Nov2021; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 27-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 18Nov2021 (Lot number: 33826BD) at the age of 27 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There was no concomitant medication. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW8178, Anatomical site: Left arm), administration date: 28Jun2021, when the patient was 27 years old, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "First dose received on 28Jun2021 and second dose on 18Nov2021"; LYMPHADENOPATHY (non-serious) with onset 22Nov2021, outcome "recovering", described as "Lymph node is left arm swollen four/five days after vaccine". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that over the last month it had been swollen on random days, usually in the morning. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash
Clinical narrative: Rash on chest and arms.; Dose received: 3/ Dose number= 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 14Dec2021 at 14:30 (batch number: FD0809) at the age of 57 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8731; Anatomical location: Left Arm), administration date: 14Apr2021, when the patient was 57 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0165; Anatomical location: Left Arm), administration date: 06May2021, when the patient was 57 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 at 14:30, outcome "unknown", described as "Dose received: 3/ Dose number= 3"; RASH (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Rash on chest and arms". Therapeutic measures were taken as a result of rash.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures for RASH included treatment with Benadryl.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Left supraclavicular lymphadenopathy; Dose number: 3; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 (Lot number: 33130807) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing). Concomitant medications included: ADDERALL; LEXAPRO; DAYSEE and VITAMIN D NOS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6207; Route of administration: Unspecified), administration date: 24Mar2021, when the patient was 30 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0150; Route of administration: Unspecified), administration date: 15Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Dose number: 3"; LYMPHADENOPATHY (non-serious) with onset 16Dec2021 at 19:30, outcome "not recovered", described as "Left supraclavicular lymphadenopathy". The event "Left supraclavicular lymphadenopathy" was evaluated at the physician office visit.  Additional information: The patient had no known allergies. It was unknown whether any therapeutic measures were taken as a result of the event. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis
Clinical narrative: Laryngitis.; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP).  An adult female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (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 LARYNGITIS (non-serious), outcome not recovered.  It was reported that the patient believed she had been vaccinated but did not know which one or when.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Left arm is still sore from elbow to shoulder.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  A 35-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in left arm, administration date 27Aug2021 at 16:00 (Lot number: unknown) at the age of 35 years as dose 1, single for COVID-19 immunisation and the patient also received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administration date on an unknown date in Sep2021 (Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medication. The following information was reported PAIN IN EXTREMITY (non-serious) with onset 30Sep2021, outcome not recovered. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity.  Second shot was end of September. Reported to my doctor as well. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Investigation, Pyrexia
Clinical narrative: He is getting very high fevers, like 105, 106. Every 6 hours basically; it's been occurring very high fever consistent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).   A 6-year-old male patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Batch/Lot number: unknown) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Manufacturer unknown), for COVID-19 Immunization. The following information was reported PYREXIA (medically significant) with onset Dec2021, outcome not recovered. Reporter stated, the patient got the Pfizer vaccine second dose, last Friday and right afterwards he was getting very high fever, like 105, 106. Every 6 hours basically, initially, you know of course after vaccine it can happen 48 hours maybe, but it had been occurring, very high fever consistent. So, they wanted to make sure if you guys have been hearing this because they got check for infection and everything is negative. But have you had this long high fevers with the children. The patient underwent the following laboratory tests and procedure: body temperature: (Dec2021) 105; (Dec2021) 106; investigation (got check for infection): (Dec2021) negative.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling
Clinical narrative: My armpit is swollen to the site of a softball causing some pain.; My armpit is swollen to the site of a softball causing some pain.; Dose received 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 45-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 16Dec2021 at 11:15 (Lot number: 33025BD) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: FN6207,Route of Administration: Unspecified, Anatomical Location: Left arm, Time of Administration: 18:30), administration date: 05Apr2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0151,Route of Administration: Unspecified, Anatomical Location: Left arm, Time of Administration: 18:30), administration date: 26Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 at 11:15, outcome "unknown", described as "Dose received 3"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 18Dec2021 at 12:00, outcome "not recovered", and all described as "My armpit is swollen to the site of a softball causing some pain". Therapeutic measures were not taken as a result of swelling and axillary pain.  Additional information: The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac arrest, Cardiovascular symptom, Malaise
Clinical narrative: my heart was like switched up and stopped; I felt bad out all day; I never had a blood clot but I can imagine what blood clot would be like something wasn''t working in my blood system like my heart was stopped and started; 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 08Feb2021 (Lot number: EL3246, Expiration Date: 30Apr2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetic; "Anaemia" (ongoing), notes: Verbatim: Anemic. The patient's concomitant medications were not reported. The following information was reported: CARDIAC ARREST (medically significant), outcome "unknown", described as "my heart was like switched up and stopped"; MALAISE (non-serious), outcome "unknown", described as "I felt bad out all day"; CARDIOVASCULAR SYMPTOM (non-serious), outcome "unknown", described as "I never had a blood clot but I can imagine what blood clot would be like something wasn''t working in my blood system like my heart was stopped and started". Patient took the shot that evening heart was like switched up and stopped it just scared to patient really scared. It done at the couple time while patient was driving pulled out about half an hour later and let her wife drive patient felt bad out all day the next day patient was okay then the following week patient was sitting in his recliner at home it done that again but it was not severe as the first time its almost like patient had a blood clot, patient never had a blood clot, can imagine what blood clot would be like something wasn't working in blood system like heart was stopped and started. It doesn't last long then it cleared up the following week it does the same thing then after that never done it again. So patient question was that, scared to death to take second shot because patient is heart patient, diabetic and anemic. patient not sure whether to try to take the second shot or not, patient spoke with cardiologist and also family doctor they didn't gave the definite answer.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101823379 Same patient, different dose and event
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 22 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 22 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 1), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis".The patient's mother reported that her son suffered a severe case of myocarditis after getting the second dose of our vaccine. Even so, he wants to get our booster as it was required for him to go back to college in January. She asked whether he should still get our booster or switch to another brand like J&J.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pain in extremity
Clinical narrative: Patient received first and second dose of Non-Pfizer vaccine and booster dose of COMIRNATY; Patient received first and second dose of Non-Pfizer vaccine and booster dose of COMIRNATY; Dose received: 3; Complain of pain in the vaccinated arm for several days, it has progress to be worse and having pain and difficulty extending his arm even 7 days after the booster dose.; This is a spontaneous report received from contactable reporter (consumer or other non-HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date an unknown date in 2021 (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: Moderna covid-19 vaccine (DOSE 1, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), both with onset an unknown date in 2021, outcome "unknown", and described as " Patient received first and second dose of Non-Pfizer vaccine and booster dose of COMIRNATY"; IMMUNISATION (non-serious), outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "complain of pain in the vaccinated arm for several days, it has progress to be worse and having pain and difficulty extending his arm even 7 days after the booster dose". It was unknown whether any therapeutic measures were taken as a result of the event pain in extremity.  Additional Information: Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Decreased appetite, Nausea, Pyrexia
Clinical narrative: Nauseous; Did not want to eat; Stomach pains; Vomited; Temp at 99.6; This is a spontaneous report from a contactable reporter (consumer or other non HCP).   A 9-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Dec2021 (Lot number: FK5618) at the age of 9 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications included: ZYRTEC and MOTRIN. Vaccination history included: Comirnaty (DOSE 1 (TRIS), SINGLE, Lot Number: FK5618, Route of Administration: Intramuscular), administration date: an unknown date in Nov2021, when the patient was 9 years old, for COVID-19 immunisation.  The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 18Dec2021 at 07:00, outcome "unknown", described as "Stomach pains"; VOMITING (non-serious) with onset 18Dec2021 at 07:00, outcome "unknown", described as "Vomited"; NAUSEA (non-serious) with onset 18Dec2021 at 11:30, outcome "unknown", described as "Nauseous"; DECREASED APPETITE (non-serious) with onset 18Dec2021 at 11:30, outcome "unknown", described as "Did not want to eat"; PYREXIA (non-serious) with onset 18Dec2021, outcome "unknown", described as "Temp at 99.6". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain upper, vomiting, nausea, decreased appetite and pyrexia.  Additional Information: It was reported that, a 9 year old boy received 2nd dose of COMIRNATY approx. 5:00pm on 12/17. Woke up around 7:00am on 12/18 with stomach pains and vomited. Around 9:00am reported feeling better, but at 11:30 was nauseous and did not want to eat. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nauseous; Did not want to eat; Stomach pains; Vomited; Temp at 99.6; This is a spontaneous report from a contactable reporter (consumer or other non HCP).   A 9-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Dec2021 (Lot number: FK5618) at the age of 9 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications included: ZYRTEC and MOTRIN. Vaccination history included: Comirnaty (DOSE 1 (TRIS), SINGLE, Lot Number: FK5618, Route of Administration: Intramuscular), administration date: an unknown date in Nov2021, when the patient was 9 years old, for COVID-19 immunisation.  The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 18Dec2021 at 07:00, outcome "unknown", described as "Stomach pains"; VOMITING (non-serious) with onset 18Dec2021 at 07:00, outcome "unknown", described as "Vomited"; NAUSEA (non-serious) with onset 18Dec2021 at 11:30, outcome "unknown", described as "Nauseous"; DECREASED APPETITE (non-serious) with onset 18Dec2021 at 11:30, outcome "unknown", described as "Did not want to eat"; PYREXIA (non-serious) with onset 18Dec2021, outcome "unknown", described as "Temp at 99.6". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain upper, vomiting, nausea, decreased appetite and pyrexia.  Additional Information: It was reported that, a 9 year old boy received 2nd dose of COMIRNATY approx. 5:00pm on 12/17. Woke up around 7:00am on 12/18 with stomach pains and vomited. Around 9:00am reported feeling better, but at 11:30 was nauseous and did not want to eat. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Immunisation, Pain, Vaccination site pain
Clinical narrative: Body aches; dizziness; Mild injection sore pain; headache.; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 54-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 18Dec2021 at 12:30 (Lot number: FJ8757) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Heart attack" (unspecified if ongoing), notes: past heart attack and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. Concomitant medications included: ASPIRIN; CARVEDILOL; ATORVASTATIN; CALCIUM; NOVOLOG; VIT D, VIT E and gummy vitamin (as reported). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0169, Route of Administration: intramuscular), administration date: 14Apr2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0167, Route of administration: intramuscular, administration time: 12:00), administration date: 05May2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021 at 12:30, outcome "unknown", described as "Dose received: 3"; PAIN (non-serious) with onset 19Dec2021 at 06:30, outcome "recovering", described as "body aches"; DIZZINESS (non-serious) with onset 19Dec2021 at 06:30, outcome "recovering", described as "dizziness"; VACCINATION SITE PAIN (non-serious) with onset 19Dec2021 at 06:30, outcome "recovering", described as "mild injection sore pain"; HEADACHE (non-serious) with onset 19Dec2021 at 06:30, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of pain, dizziness, vaccination site pain and headache.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Hyperhidrosis
Clinical narrative: Breakthrough case of COVID after 2 doses of vaccine; Breakthrough case of COVID after 2 doses of vaccine; Very tired; woke up for just  one morning sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Breakthrough case of COVID after 2 doses of vaccine"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Very tired"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "woke up for just  one morning sweating".  Clinical information: Patient received a report of a Breakthrough case of COVID after 2 doses of vaccine. Female, approximately 40 years of age. It had been 6 months since their second dose. No booster yet, mild symptoms. Very tired, woke up for just one morning sweating. Only felt symptoms for a few days, other than that was okay.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Individual expressed they get migraines or headaches sometimes believed due to lack of hydration.; Individual expressed they get migraines or headaches sometimes believed due to lack of hydration.; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).  An adult female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Lot number: unknown) as dose 1, single and also received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported MIGRAINE (non-serious), HEADACHE (non-serious) all with outcome unknown.   The reporter did not believe this is AE but was reporting out of caution. The reporter did not know the vaccination date or vaccine and reported that patient was in early 20s.  The lot number for BNT162b2 was not provided and will be requested during follow up.