chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Dysmenorrhoea, Heavy menstrual bleeding, Immunisation, Polymenorrhoea
Clinical narrative: I got my period 2 weeks early - on November 21st, only 11 days after the start of my last period.; My bleeding was much heavier than usual; the cramping was severe.; I was bedridden; Dose received: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: FH5020) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "infertility" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; PROGESTERONE; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Right), administration date: 08Apr2021, when the patient was 41 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Right), administration date: 18Mar2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Dose received: 3"; POLYMENORRHOEA (non-serious) with onset 21Nov2021, outcome "recovering", described as "I got my period 2 weeks early - on November 21st, only 11 days after the start of my last period."; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 21Nov2021, outcome "recovering", described as "My bleeding was much heavier than usual"; DYSMENORRHOEA (non-serious) with onset 21Nov2021, outcome "recovering", described as "the cramping was severe."; BEDRIDDEN (non-serious) with onset 21Nov2021, outcome "recovered" (23Nov2021), described as "I was bedridden". Therapeutic measures were not taken as a result of polymenorrhoea, heavy menstrual bleeding, dysmenorrhoea, bedridden.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. The patient did not received treatment for the events. Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: same affliction in different past of the body/in regards to complaints about the neuropathy; 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 (159558).  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: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "same affliction in different past of the body/in regards to complaints about the neuropathy".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abnormal dreams, Chills, Feeling abnormal, Immunisation
Clinical narrative: I feel sick to my stomach; This booster shot, though, has been awful/I started to feel bad; like pretty extreme flu side effects; chills; aches and pains; slight fever; when I fell asleep, I had the most annoying, weird dreams; This booster shot, though, has been awful; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 09:00 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENADRYL; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 19Jan2021, when the patient was 20 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 10Feb2021, when the patient was 20 years old, for Covid-19 immunization, reaction(s): "I felt a bit worse after the second shot, but still not too bad", "I felt a bit worse after the second shot, but still not too bad". The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 09:00, outcome "unknown", described as "This booster shot, though, has been awful"; FEELING ABNORMAL (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "This booster shot, though, has been awful/I started to feel bad"; INFLUENZA LIKE ILLNESS (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "like pretty extreme flu side effects"; CHILLS (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "aches and pains"; PYREXIA (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "slight fever"; ABNORMAL DREAMS (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "when I fell asleep, I had the most annoying, weird dreams"; ABDOMINAL DISCOMFORT (non-serious) with onset 25Nov2021 05:00, outcome "not recovered", described as "I feel sick to my stomach". Therapeutic measures were not taken as a result of feeling abnormal, influenza like illness, chills, pain, pyrexia, abnormal dreams, abdominal discomfort. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: I feel sick to my stomach; This booster shot, though, has been awful/I started to feel bad; like pretty extreme flu side effects; chills; aches and pains; slight fever; when I fell asleep, I had the most annoying, weird dreams; This booster shot, though, has been awful; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 09:00 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENADRYL; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 19Jan2021, when the patient was 20 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 10Feb2021, when the patient was 20 years old, for Covid-19 immunization, reaction(s): "I felt a bit worse after the second shot, but still not too bad", "I felt a bit worse after the second shot, but still not too bad". The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 09:00, outcome "unknown", described as "This booster shot, though, has been awful"; FEELING ABNORMAL (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "This booster shot, though, has been awful/I started to feel bad"; INFLUENZA LIKE ILLNESS (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "like pretty extreme flu side effects"; CHILLS (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "aches and pains"; PYREXIA (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "slight fever"; ABNORMAL DREAMS (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "when I fell asleep, I had the most annoying, weird dreams"; ABDOMINAL DISCOMFORT (non-serious) with onset 25Nov2021 05:00, outcome "not recovered", described as "I feel sick to my stomach". Therapeutic measures were not taken as a result of feeling abnormal, influenza like illness, chills, pain, pyrexia, abnormal dreams, abdominal discomfort. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fallot's tetralogy
Clinical narrative: tetralogy of fallot; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 18Oct2021 16:40 (Lot number: 30145BA) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Prosthetic valve functioning normally", start date: 24Nov2015 (ongoing), notes: placed 24Nov2015 18Oct2021. There were no concomitant medications. The following information was reported: FALLOT'S TETRALOGY (medically significant) with onset 18Oct2021, outcome "not recovered", described as "tetralogy of fallot". Clinical courses: No prior vaccination within 4 weeks. No family medical history relevant to AE(s).; Sender's Comments: There is no sufficient evidence that the reported tetralogy of fallot, although temporally related, may be related to administration of BNT162B2. Event is likely an intercurrent medical condition. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Immunisation, Pain
Clinical narrative: Severe brain fog; headache; body aches; chills; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 12:15 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: nuts" (unspecified if ongoing); "Known allergies: soy" (unspecified if ongoing). Concomitant medication(s) included: DILANTIN [PHENYTOIN SODIUM]; PHENOBARBITAL. Vaccination history included: Bnt162b2 (Dose 1, Administration time: 10:00, Anatomical location: Left arm), administration date: 05Mar2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Administration time: 10:00, Anatomical location: Left arm), administration date: 26Mar2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Nov2021 12:15, outcome "unknown", described as "dose received: 3"; FEELING ABNORMAL (non-serious) with onset 09Nov2021 14:00, outcome "recovering", described as "Severe brain fog"; HEADACHE (non-serious) with onset 09Nov2021 14:00, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 09Nov2021 14:00, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 09Nov2021 14:00, outcome "recovering", described as "chills". Therapeutic measures were not taken as a result of feeling abnormal, headache, pain, chills.  Additional information: The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with 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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Diarrhoea, Dizziness, Headache, Immunisation
Clinical narrative: Painful knot in arm where injection was given; Painful knot in arm where injection was given; Painful Swelling in underarm and neck near collarbone; Painful Swelling in underarm; swelling in neck near collarbone leaving a painful knot; Flu-like symptoms; headache; dizziness; diarrhea; nausea; 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 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 10:15 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes type 2" (ongoing); "known allergies Seafood" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC. Vaccination history included: Bnt162b2 (Dose 2, lot#:EP7533, Left arm), administration date: 31Mar2021, when the patient was 41 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Lot#:EN6205, Left arm), administration date: 10Mar2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 10:15, outcome "unknown", described as "dose number=3"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Nov2021 09:00, outcome "recovered with sequelae" and all described as "Painful knot in arm where injection was given"; SWELLING (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Painful Swelling in underarm and neck near collarbone"; AXILLARY PAIN (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Painful Swelling in underarm"; NECK MASS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "swelling in neck near collarbone leaving a painful knot"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Flu-like symptoms"; HEADACHE (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "headache"; DIZZINESS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "dizziness"; DIARRHOEA (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "diarrhea"; NAUSEA (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "nausea". Therapeutic measures were not taken as a result of vaccination site mass, vaccination site pain, swelling, axillary pain, neck mass, influenza like illness, headache, dizziness, diarrhoea, nausea.  Additional Information: The patient does not have Covid prior vaccination. The patient covid was not tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Neck mass, Swelling, Vaccination site mass
Clinical narrative: Painful knot in arm where injection was given; Painful knot in arm where injection was given; Painful Swelling in underarm and neck near collarbone; Painful Swelling in underarm; swelling in neck near collarbone leaving a painful knot; Flu-like symptoms; headache; dizziness; diarrhea; nausea; 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 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 10:15 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes type 2" (ongoing); "known allergies Seafood" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC. Vaccination history included: Bnt162b2 (Dose 2, lot#:EP7533, Left arm), administration date: 31Mar2021, when the patient was 41 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Lot#:EN6205, Left arm), administration date: 10Mar2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 10:15, outcome "unknown", described as "dose number=3"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Nov2021 09:00, outcome "recovered with sequelae" and all described as "Painful knot in arm where injection was given"; SWELLING (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Painful Swelling in underarm and neck near collarbone"; AXILLARY PAIN (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Painful Swelling in underarm"; NECK MASS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "swelling in neck near collarbone leaving a painful knot"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Flu-like symptoms"; HEADACHE (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "headache"; DIZZINESS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "dizziness"; DIARRHOEA (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "diarrhea"; NAUSEA (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "nausea". Therapeutic measures were not taken as a result of vaccination site mass, vaccination site pain, swelling, axillary pain, neck mass, influenza like illness, headache, dizziness, diarrhoea, nausea.  Additional Information: The patient does not have Covid prior vaccination. The patient covid was not tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Painful knot in arm where injection was given; Painful knot in arm where injection was given; Painful Swelling in underarm and neck near collarbone; Painful Swelling in underarm; swelling in neck near collarbone leaving a painful knot; Flu-like symptoms; headache; dizziness; diarrhea; nausea; 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 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 10:15 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes type 2" (ongoing); "known allergies Seafood" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC. Vaccination history included: Bnt162b2 (Dose 2, lot#:EP7533, Left arm), administration date: 31Mar2021, when the patient was 41 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Lot#:EN6205, Left arm), administration date: 10Mar2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 10:15, outcome "unknown", described as "dose number=3"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Nov2021 09:00, outcome "recovered with sequelae" and all described as "Painful knot in arm where injection was given"; SWELLING (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Painful Swelling in underarm and neck near collarbone"; AXILLARY PAIN (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Painful Swelling in underarm"; NECK MASS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "swelling in neck near collarbone leaving a painful knot"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Flu-like symptoms"; HEADACHE (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "headache"; DIZZINESS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "dizziness"; DIARRHOEA (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "diarrhea"; NAUSEA (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "nausea". Therapeutic measures were not taken as a result of vaccination site mass, vaccination site pain, swelling, axillary pain, neck mass, influenza like illness, headache, dizziness, diarrhoea, nausea.  Additional Information: The patient does not have Covid prior vaccination. The patient covid was not tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Lymphadenopathy, Pain
Clinical narrative: swollen left arm and lymph node; Fatigue; chills; low fever; sore; swollen left arm and lymph node; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 18:15 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hsv 2" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]; VITAMIN D 2000; PROZAC; IUD NOS. Past drug history included: Diflucan, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: Unknown, Arm Left), administration date: 28Apr2021, when the patient was 34 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: Unknown), administration date: 05Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 18:15, outcome "unknown", described as "booster dose"; LYMPHADENOPATHY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 24Nov2021 06:30, outcome "recovering" and all described as "swollen left arm and lymph node"; FATIGUE (non-serious) with onset 24Nov2021 06:30, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 24Nov2021 06:30, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 24Nov2021 06:30, outcome "recovering", described as "low fever"; PAIN (non-serious) with onset 24Nov2021 06:30, outcome "recovering", described as "sore". Therapeutic measures were not taken as a result of lymphadenopathy, fatigue, chills, pyrexia, pain, peripheral swelling.  Additional Information: The patient did not have Covid prior vaccination. The patent was not tested for Covid post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: swollen left arm and lymph node; Fatigue; chills; low fever; sore; swollen left arm and lymph node; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 18:15 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hsv 2" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]; VITAMIN D 2000; PROZAC; IUD NOS. Past drug history included: Diflucan, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: Unknown, Arm Left), administration date: 28Apr2021, when the patient was 34 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: Unknown), administration date: 05Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 18:15, outcome "unknown", described as "booster dose"; LYMPHADENOPATHY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 24Nov2021 06:30, outcome "recovering" and all described as "swollen left arm and lymph node"; FATIGUE (non-serious) with onset 24Nov2021 06:30, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 24Nov2021 06:30, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 24Nov2021 06:30, outcome "recovering", described as "low fever"; PAIN (non-serious) with onset 24Nov2021 06:30, outcome "recovering", described as "sore". Therapeutic measures were not taken as a result of lymphadenopathy, fatigue, chills, pyrexia, pain, peripheral swelling.  Additional Information: The patient did not have Covid prior vaccination. The patent was not tested for Covid post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fall, Headache, Lethargy
Clinical narrative: Headache; Dizziness; Nausea; Fever 100.6; Fell in shower; Lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Nov2021 17:00 (Batch/Lot number: unknown) at the age of 11 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 06Nov2021, when the patient was 11 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Headache"; DIZZINESS (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Dizziness"; NAUSEA (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Nausea"; PYREXIA (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Fever 100.6"; FALL (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Fell in shower"; LETHARGY (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Lethargic". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, dizziness, nausea, pyrexia, fall, lethargy.  Additional Information: The treatment received for the adverse event was Tylenol. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Headache; Dizziness; Nausea; Fever 100.6; Fell in shower; Lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Nov2021 17:00 (Batch/Lot number: unknown) at the age of 11 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 06Nov2021, when the patient was 11 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Headache"; DIZZINESS (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Dizziness"; NAUSEA (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Nausea"; PYREXIA (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Fever 100.6"; FALL (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Fell in shower"; LETHARGY (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Lethargic". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, dizziness, nausea, pyrexia, fall, lethargy.  Additional Information: The treatment received for the adverse event was Tylenol. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Haemorrhage, Lymphadenopathy
Clinical narrative: Lymph node has bursted and started bleeding; The second vaccine gave me a lot of joint pain; I broke out with swollen lymph node; swollen lymph node that came up under my arm, the same arm where I had the vaccine; Lymph node has bursted and started bleeding/she was told that her lymph nodes were infected; 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. Other Case identifier(s): -PFIZER INC-202101698202 (Pfizer).  A 47-year-old female patient received bnt162b2 (BNT162B2; Formulation: Solution for Injection), administered in arm left, administration date 03Nov2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunization. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure; "numbness" (unspecified if ongoing); "severe Vitamin D and B12 deficiencies" (unspecified if ongoing); "severe Vitamin D and B12 deficiencies" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; VITAMIN D 3 taken for vitamin d deficiency. Vaccination history included: Bnt162b2 (First dose), administration date: Oct2021, for Covid-19 immunization.  The following information was reported: HAEMORRHAGE (medically significant) with onset Nov2021, outcome "not recovered", described as "Lymph node has bursted and started bleeding"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "not recovered", described as "The second vaccine gave me a lot of joint pain"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "not recovered", described as "I broke out with swollen lymph node; swollen lymph node that came up under my arm, the same arm where I had the vaccine"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "not recovered", described as "Lymph node has bursted and started bleeding/she was told that her lymph nodes were infected". The events "lymph node has bursted and started bleeding", "the second vaccine gave me a lot of joint pain", "I broke out with swollen lymph node; swollen lymph node that came up under my arm, the same arm where I had the vaccine" and "lymph node has bursted and started bleeding/she was told that her lymph nodes were infected" were evaluated at the physician office visit. Therapeutic measures were taken as a result of haemorrhage, arthralgia, lymphadenopathy, lymphadenopathy.  Action taken for bnt162b2 (BNT162B2) was not applicable. Therapeutic measures was taken as a result of haemorrhage and lymphadenopathy and included treatment with Neoskin'.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (30Nov2021): This is a spontaneous follow-up report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  Updated information: Treatment for events haemorrhage and lymphadenopathy. Event verbatim for event lymphadenopathy (she was told that her lymph nodes were infected).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: ER8727) as dose 1, single and administered in arm left, administration date 14Apr2021 (Lot number: EP7533) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Environmental allergies" (unspecified if ongoing); "Raynauds bradycardia" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "bradycardia" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; FAMOTIDINE; LORATADINE.  The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 27Nov2021, outcome "recovering" and all described as "Positive COVID-19 test on 27Nov2021."; COUGH (non-serious) with onset 22Nov2021, outcome "recovering", described as "slight cough"; PAIN (non-serious) with onset 22Nov2021, outcome "unknown", described as "body aches"; PYREXIA (non-serious) with onset 22Nov2021, outcome "recovering", described as "mild fever"; SINUS PAIN (non-serious) with onset 22Nov2021, outcome "recovering", described as "sinus pressure/pain,"; SNEEZING (non-serious) with onset 22Nov2021, outcome "recovering", described as "sneezing"; RHINORRHOEA (non-serious) with onset 22Nov2021, outcome "recovering", described as "runny nose"; FATIGUE (non-serious) with onset 22Nov2021, outcome "recovering", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) negative; (27Nov2021) positive, notes: Nasal swab. Therapeutic measures were not taken as a result of covid-19, vaccination failure, cough, pain, pyrexia, sinus pain, sneezing, rhinorrhoea, fatigue.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Sinus pain, Sneezing, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: ER8727) as dose 1, single and administered in arm left, administration date 14Apr2021 (Lot number: EP7533) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Environmental allergies" (unspecified if ongoing); "Raynauds bradycardia" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "bradycardia" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; FAMOTIDINE; LORATADINE.  The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 27Nov2021, outcome "recovering" and all described as "Positive COVID-19 test on 27Nov2021."; COUGH (non-serious) with onset 22Nov2021, outcome "recovering", described as "slight cough"; PAIN (non-serious) with onset 22Nov2021, outcome "unknown", described as "body aches"; PYREXIA (non-serious) with onset 22Nov2021, outcome "recovering", described as "mild fever"; SINUS PAIN (non-serious) with onset 22Nov2021, outcome "recovering", described as "sinus pressure/pain,"; SNEEZING (non-serious) with onset 22Nov2021, outcome "recovering", described as "sneezing"; RHINORRHOEA (non-serious) with onset 22Nov2021, outcome "recovering", described as "runny nose"; FATIGUE (non-serious) with onset 22Nov2021, outcome "recovering", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) negative; (27Nov2021) positive, notes: Nasal swab. Therapeutic measures were not taken as a result of covid-19, vaccination failure, cough, pain, pyrexia, sinus pain, sneezing, rhinorrhoea, fatigue.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Chest pain, Feeling cold, Illness
Clinical narrative: I had 2 doses of Moderna/ I get the Pfizer booster; booster; I had 2 doses of Moderna/ I get the Pfizer booster; heart attack; I have never been so sick in my life; Pain was so intense in my chest; I am so freaking cold; My face is so hot like if it is going to burn up; My whole body just hurts it aches so bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "cholesterol" (unspecified if ongoing); "breast cancer" (unspecified if ongoing). Concomitant medication(s) included: GLIMEPIRIDE taken for diabetes mellitus. Vaccination history included: Moderna vaccine (First Shot: Consumer stated, "031L20'A'.), for COVID-19 immunization; Moderna vaccine (Second Shot: Consumer stated, "001B21A), for COVID-19 immunization, reaction(s): "I ended up with that underarm pits syndrome where your (word not clear) swelled up under the arms". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 2021, outcome "unknown" and all described as "I had 2 doses of Moderna/ I get the Pfizer booster"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "booster"; MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "heart attack"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I have never been so sick in my life"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain was so intense in my chest"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "I am so freaking cold"; BURNING SENSATION (non-serious) with onset 2021, outcome "unknown", described as "My face is so hot like if it is going to burn up"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "My whole body just hurts it aches so bad". The patient underwent the following laboratory tests and procedures: blood test: unknown. Therapeutic measures were not taken as a result of myocardial infarction, illness, chest pain, feeling cold, burning sensation, pain.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Myocardial infarction, Off label use, Pain
Clinical narrative: I had 2 doses of Moderna/ I get the Pfizer booster; booster; I had 2 doses of Moderna/ I get the Pfizer booster; heart attack; I have never been so sick in my life; Pain was so intense in my chest; I am so freaking cold; My face is so hot like if it is going to burn up; My whole body just hurts it aches so bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "cholesterol" (unspecified if ongoing); "breast cancer" (unspecified if ongoing). Concomitant medication(s) included: GLIMEPIRIDE taken for diabetes mellitus. Vaccination history included: Moderna vaccine (First Shot: Consumer stated, "031L20'A'.), for COVID-19 immunization; Moderna vaccine (Second Shot: Consumer stated, "001B21A), for COVID-19 immunization, reaction(s): "I ended up with that underarm pits syndrome where your (word not clear) swelled up under the arms". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 2021, outcome "unknown" and all described as "I had 2 doses of Moderna/ I get the Pfizer booster"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "booster"; MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "heart attack"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I have never been so sick in my life"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain was so intense in my chest"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "I am so freaking cold"; BURNING SENSATION (non-serious) with onset 2021, outcome "unknown", described as "My face is so hot like if it is going to burn up"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "My whole body just hurts it aches so bad". The patient underwent the following laboratory tests and procedures: blood test: unknown. Therapeutic measures were not taken as a result of myocardial infarction, illness, chest pain, feeling cold, burning sensation, pain.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Neck pain, Vomiting
Clinical narrative: Threw up; Neck stiffness; He has this pain in his neck; he cannot move his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 22Nov2021 (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: VOMITING (non-serious) with onset 22Nov2021, outcome "unknown", described as "Threw up"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Nov2021, outcome "unknown", described as "Neck stiffness"; NECK PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "He has this pain in his neck"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "he cannot move his neck".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Emotional disorder, Feeling abnormal, Headache, Hot flush
Clinical narrative: Headache; Chills; Hot flashes; Blurred vision; Tingling in hands; Nausea; Head feels fuzzy at times thinking takes a few moments/ Felt foggy when I woke up; Emotional; Slept alot first 2 days; My lungs seem sore; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 55-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in right arm, administration date 26Nov2021 at 14:00 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient did not receive other medications within two weeks of vaccination. The following information was reported: HEADACHE (non-serious), CHILLS (non-serious), HOT FLUSH (non-serious), VISION BLURRED (non-serious), PARAESTHESIA (non-serious), NAUSEA (non-serious), FEELING ABNORMAL (non-serious), EMOTIONAL DISORDER (non-serious), PULMONARY PAIN (non-serious), all with onset 26Nov2021, outcome "recovering", described as "headache, chills, hot flashes, blurred vision, tingling in hands, nausea, head felt fuzzy at times thinking took a few moments, emotional, felt foggy when she woke up, lungs seemed sore"; HYPERSOMNIA (non-serious) with onset 26Nov2021, outcome "recovered" (28Nov2021), described as "slept a lot first 2 days". The events "headache, chills, hot flashes, blurred vision, tingling in hands, nausea, head felt fuzzy at times thinking took a few moments, emotional, slept a lot first 2 days, felt foggy when she woke up, lungs seemed sore" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache, chills, hot flush, vision blurred, paraesthesia, nausea, feeling abnormal, emotional disorder, hypersomnia and pulmonary pain.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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.