chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Hypoaesthesia, Immunisation
Clinical narrative: Pain in armpit, breast, and elbow; Pain in armpit, breast, and elbow; Pain in armpit, breast, and elbow; Numbness in fingers; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 20Dec2021 at 11:45 (Lot number: FH8027) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Patient has taken unspecified concomitant medications. Past drug history included: Augmentin, reaction: "Drug allergy", notes: Known allergies: augmentin; Marcaine, reaction: "Drug allergy", notes: Known allergies: marcaine and Lidocaine, reaction: "Drug allergy", notes: Known allergies: lidocaine. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0176, Route of administration: Intramuscular), administration date: 12May2021, when the patient was 40 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8731, Route of Administration: Intramuscular), administration date: 21Apr2021, when the patient was 40 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 at 11:45, outcome "unknown", described as "Dose number: 3"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious), ARTHRALGIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 21Dec2021, outcome "not recovered", and all described as "Pain in armpit, breast, and elbow". The events "Pain in armpit, breast, and elbow" and "Numbness in fingers" were evaluated at the physician office visit. Therapeutic measures taken as a result of pain in armpit, breast, and elbow, numbness in fingers increased was unknown.  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 prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Therapeutic product effect decreased
Clinical narrative: had my booster they did a test to see the efficacy of the drug and it was down to 37%; had my booster they did a test to see the efficacy of the drug and it was down to 37%; 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 patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), 30 ug single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization; Bnt162b2 (Second dose), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), THERAPEUTIC PRODUCT EFFECT DECREASED (medically significant), outcome "unknown" and all described as "had my booster they did a test to see the efficacy of the drug and it was down to 37%".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Armpit lymph node painful swelling after booster; Armpit lymph node painful swelling after booster; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Dec2021 (Lot number: unknown) at the age of 59 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: unknown), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "Dose number 3"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 17Dec2021, outcome "unknown", and all described as "Armpit lymph node painful swelling after booster". Therapeutic measures were not taken as a result of lymph node pain and lymphadenopathy. 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 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.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: the patient had an episode of pericarditis 10 days after the initial second dose; This is a spontaneous report received from a contactable reporter(s) (Physician) from information team for a sponsored program (159558).  A 41 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), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "the patient had an episode of pericarditis 10 days after the initial second dose".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pericarditis with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction
Clinical narrative: Heart attack; Had three strokes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had three strokes". Clinical Course:Patient already took second shot on 08Apr2021 and he mentioned about the heart problem something (Transferring agent was unsure, hence not captured as event). So, we are not sure if that happened before he took the vaccine or after taking the vaccine. He mentioned, he had a heart attack. He would also like information on how to get the booster shot because they are unable to get it from their doctor (Further clarification was unknown).Patient have had a heart attack and I have had three strokes and I cannot find any place to get shots and neither can my daughter and my daughter calls up on these different places because she 'has a hole in her heart' (Not appropriately clarified over the call, hence split case was not made. LOT# I find on here is and that was 1170828. I can't read this stuff on here it's so small I can't read it.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Clostridium difficile infection, Illness
Clinical narrative: Sickness; Clostridium difficile infection; FACILITATED COLLECT This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4129526-00.  A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Oct2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Lot number: 1154004) at citrate free for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), administration date: 01Sep2021, when the patient was 53 years old, for COVID-19 Vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Sep2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 10Oct2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. No known allergies. The following information was reported: CLOSTRIDIUM DIFFICILE INFECTION (medically significant) with onset 2021, outcome "recovering", described as "Clostridium difficile infection"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "Sickness". The action taken for adalimumab was unknown. Clinical course: Solicited report from the USA by a consumer of a 54-year-old male with events of non-serious C-Diff and Sick with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced C-Diff. In Nov2021, the patient experienced Sick.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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, Ethics Committees, and Investigators, as appropriate
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough COVID Case; Breakthrough COVID Case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adolescent male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer Covid Vaccine, prev dose brand unknown=False, prev dose lot unknown=True, prev dose lot unknown reason=Not, available/provided to reporter at the time of report completion, prev dose administration date=May2021, prev dose dose number=1), administration date: May2021, for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2021, outcome "unknown" and all described as "Breakthrough COVID Case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) positive, notes: Unknown. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Additional information: It was unknown if the patient received any other vaccine in four weeks. Prior to vaccination, patient did not suffer from COVID. Patient was tested for COVID post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Musculoskeletal stiffness, Myalgia, Peripheral swelling
Clinical narrative: Left underarm swelled with mild sensitivity; Left underarm swelled with mild sensitivity; Pain and stiffness from front of left shoulder to bicep; Pain and stiffness from front of left shoulder to bicep; Pain and stiffness from front of left shoulder to bicep; Pain and stiffness from front of left shoulder to bicep; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 09:00 (Lot number: FJ8757) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Bee sting" (unspecified if ongoing), notes: known allergies: Bee sting. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 22Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 03Feb2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "booster"; PERIPHERAL SWELLING (non-serious), SENSITISATION (non-serious) all with onset 16Dec2021 08:00, outcome "recovering" and all described as "Left underarm swelled with mild sensitivity"; ARTHRALGIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), MYALGIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 16Dec2021 08:00, outcome "recovering" and all described as "Pain and stiffness from front of left shoulder to bicep". Therapeutic measures were not taken as a result of peripheral swelling, sensitisation, arthralgia, musculoskeletal stiffness, myalgia, musculoskeletal stiffness.  Additional information: The patient did not covid prior to vaccination and covid was not tested post vaccination. The patient did not take other vaccine in four weeks and other medication in two weeks.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Sensitisation
Clinical narrative: Left underarm swelled with mild sensitivity; Left underarm swelled with mild sensitivity; Pain and stiffness from front of left shoulder to bicep; Pain and stiffness from front of left shoulder to bicep; Pain and stiffness from front of left shoulder to bicep; Pain and stiffness from front of left shoulder to bicep; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 09:00 (Lot number: FJ8757) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Bee sting" (unspecified if ongoing), notes: known allergies: Bee sting. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 22Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 03Feb2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "booster"; PERIPHERAL SWELLING (non-serious), SENSITISATION (non-serious) all with onset 16Dec2021 08:00, outcome "recovering" and all described as "Left underarm swelled with mild sensitivity"; ARTHRALGIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), MYALGIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 16Dec2021 08:00, outcome "recovering" and all described as "Pain and stiffness from front of left shoulder to bicep". Therapeutic measures were not taken as a result of peripheral swelling, sensitisation, arthralgia, musculoskeletal stiffness, myalgia, musculoskeletal stiffness.  Additional information: The patient did not covid prior to vaccination and covid was not tested post vaccination. The patient did not take other vaccine in four weeks and other medication in two weeks.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Paraesthesia
Clinical narrative: Tingling in left arm and left leg; Headache; Dose number 3; This is a spontaneous report from a non-contactable reporter (consumer or non-HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 21Dec2021 at 16:30 (Lot number: FD7218) at the age of 33 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: LEXAPRO; TOPAMAX and AMOXICILLIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Anatomical location: left arm; Lot number: EP7533), administration date: 05Apr2021, when the patient was 32 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Anatomical location: left arm; Lot number: EW0171), administration date: 26Apr2021, when the patient was 32 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 at 16:30, outcome "unknown", described as "Dose number 3"; PARAESTHESIA (non-serious) with onset 21Dec2021 at 17:30, outcome "unknown", described as "Tingling in left arm and left leg"; HEADACHE (non-serious) with onset 21Dec2021 at 17:30, outcome "unknown", described as "Headache". Therapeutic measures were not taken as a result of paraesthesia and headache.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling
Clinical narrative: 2 days after vaccine, my left under arm pit was sore and swollen when I woke up in the morning; 2 days after vaccine, my left under arm pit was sore and swollen when I woke up in the morning; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 20Dec2021 at 12:00 (Lot number: FH8027) at the age of 51 years as dose 3 (booster), single for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included: PROTONIX, ADVIL and unspecified MULTIVITAMINS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP6955, Administration location: left arm, Route of administration: intramuscular), administration date: 16Mar2021, when the patient was 50 years old, for COVID-19 immunisation, reactions: "No adverse reaction" and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP6955 ; Administration location: left arm; Route of administration: intramuscular, administration date: 08Apr2021, when the patient was 50 years old, for COVID-19 immunisation, reactions: "No adverse reaction". The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 at 12:00, outcome "unknown", described as "Dose number: 3"; AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) both with onset 22Dec2021 at 05:00, outcome "recovered" (22Dec2021), and both described as "2 days after vaccine, my left under arm pit was sore and swollen when I woke up in the morning". Therapeutic measures were taken as a result of axillary pain and 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 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 and emergency room/department or urgent care. Treatment for reported events included advil (patient reported to feel okay after approximately 3 hours after taking advil).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Immunisation
Clinical narrative: 100-102 F degree fever; Chills; Tinnitus; Nausea; Minor dizziness; Headache; 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 25-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 21Dec2021 at 13:00 (Lot number: 331308A) at the age of 25 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Prehypertension" (unspecified if ongoing), notes: Pre-hypertension (~127/77) and "Protein S deficiency" (unspecified if ongoing). The patient did not take any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, 0.3 ML SINGLE, Lot Number: ER8734), administration date: 01Apr2021, when the patient was 24 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, 0.3 ML SINGLE, Lot Number: EN6207), administration date: 22Apr2021, when the patient was 24 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 at 13:00, outcome "unknown", described as "Dose received: 3/ Dose number =3"; PYREXIA (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "100-102 F degree fever"; CHILLS (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Chills"; TINNITUS (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Tinnitus"; NAUSEA (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Nausea"; DIZZINESS (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Minor dizziness"; HEADACHE (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, tinnitus, nausea, dizziness and headache. 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-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, emergency room/department or urgent care.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tinnitus
Clinical narrative: 100-102 F degree fever; Chills; Tinnitus; Nausea; Minor dizziness; Headache; 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 25-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 21Dec2021 at 13:00 (Lot number: 331308A) at the age of 25 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Prehypertension" (unspecified if ongoing), notes: Pre-hypertension (~127/77) and "Protein S deficiency" (unspecified if ongoing). The patient did not take any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, 0.3 ML SINGLE, Lot Number: ER8734), administration date: 01Apr2021, when the patient was 24 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, 0.3 ML SINGLE, Lot Number: EN6207), administration date: 22Apr2021, when the patient was 24 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 at 13:00, outcome "unknown", described as "Dose received: 3/ Dose number =3"; PYREXIA (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "100-102 F degree fever"; CHILLS (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Chills"; TINNITUS (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Tinnitus"; NAUSEA (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Nausea"; DIZZINESS (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Minor dizziness"; HEADACHE (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, tinnitus, nausea, dizziness and headache. 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-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, emergency room/department or urgent care.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Pyrexia, Somnolence
Clinical narrative: Dose received: 3; Chills; Fever of 101.9; Vomiting; Can't stay awake; This is a spontaneous report from non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 22Dec2021 at 14:30 (Lot number: FE3594) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0162, Anatomical location: Left arm), administration date: 13Apr2021, when the patient was 31 years old, and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0172, Anatomical location: Left arm), administration date: 04May2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 at 14:30, outcome "unknown", described as "Dose received: 3"; CHILLS (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Fever of 101.9"; VOMITING (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Vomiting"; SOMNOLENCE (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Can't stay awake". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, vomiting and somnolence. Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Dose received: 3; Chills; Fever of 101.9; Vomiting; Can't stay awake; This is a spontaneous report from non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 22Dec2021 at 14:30 (Lot number: FE3594) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0162, Anatomical location: Left arm), administration date: 13Apr2021, when the patient was 31 years old, and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0172, Anatomical location: Left arm), administration date: 04May2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 at 14:30, outcome "unknown", described as "Dose received: 3"; CHILLS (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Fever of 101.9"; VOMITING (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Vomiting"; SOMNOLENCE (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Can't stay awake". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, vomiting and somnolence. Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Child was very afraid while getting vaccinated. Mother asked if lidocaine spray would be allowed before administration. I agreed and used the spray and tehn sterilized his arm with an alcohol wipe. When the child appeared still enough with his mom holding him still, I inserted the needle, before I was able to depress the plunger at all, the child pulled away quickly and I was then forced to reinject the needle to administer the vaccine.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood disorder, Death, Dyspnoea, Resuscitation, Thrombosis
Clinical narrative: Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: Patient ended up with blood clots and died 10/7/21. Had no other side effects from the vaccine. Patient's wife stated he was fine and had no issues until on 10/7 when he was having trouble breathing and then required CPR. He did not survive. Dr's determined it was blood clots caused by the vaccine.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: Patient ended up with blood clots and died 10/7/21. Had no other side effects from the vaccine. Patient's wife stated he was fine and had no issues until on 10/7 when he was having trouble breathing and then required CPR. He did not survive. Dr's determined it was blood clots caused by the vaccine.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Pruritus, Rash, Swelling face
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient has received  booster shot on 12/26/2021. Patient called on 12/29/21 stating that he expereinced severe swelling and itch of his whole body and face on morning of 12/27/2021. Pt stated that he has been using cortisone and eczema creams to help with the itch and swelling since that time and symtoms did get better by 12/29/21, but there still was moderate swelling and onstatnt itch. I did advise patient to see a dr and go to the ER if symtoms get worse. Symptoms are better on 12/30/21.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Sometime last evening (around 9.30pm on 12/30) I became aware of a constant ringing in my right ear. Orienting my head in different ways had no effect. Sometimes it's louder than other times. It still persists this morning as I write this.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Syncope
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Vomiting-Severe
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Systemic: Fever-Severe
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccine breakthrough infection
Clinical narrative: suspect COVID breakthrough
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Somnolence
Clinical narrative: Chills for 10 hours Body aches Sleepiness
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccine breakthrough infection
Clinical narrative: suspect COVID breakthrough
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills , muscles ache,headache
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Movement disorder, Pain
Clinical narrative: The patient called yesterday (12/30/2021) and said she had intense pain at the time (and location) of injection of the vaccine (for her booster). She explained that she's now been dealing with pain for the past three weeks and she will be seeing her doctor next week. She is having difficulty opening her middle finger (when trying to open from a fist). I advised her to definitely go to the doctor next week as soon as she was able to get in, and to let us know if there was anything else we can do to help her.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time normal, Antinuclear antibody positive, Blood fibrinogen normal, Complement factor C4, Contusion
Clinical narrative: Spontaneous bleeding and bruising of individual fingers and toes.  Bruising would appear on a single digit and remain for 24-72 hours.  Not related to any injury or known reason to cause bruise to occur.  The frequecy of bruising increased post vaccine injection.  From 4/9/21 to the present there have been 12 episodes of spontaneous bruising.  Patient did seek medical advice from a hematologist in August 2021. Laboratory testing was done including complete cbc, PT & PTT, ESR, von Willibrand factor screen, serum Cryoglobulin, serum Complement C4, serum Complement C3, Fibrinogen Antigen and ANA Direct.  All test results with the exception of ANA were WNL. The ANA was positive and abnormal.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cryoglobulins, Full blood count normal, Haemorrhage, Prothrombin time normal, Red blood cell sedimentation rate normal
Clinical narrative: Spontaneous bleeding and bruising of individual fingers and toes.  Bruising would appear on a single digit and remain for 24-72 hours.  Not related to any injury or known reason to cause bruise to occur.  The frequecy of bruising increased post vaccine injection.  From 4/9/21 to the present there have been 12 episodes of spontaneous bruising.  Patient did seek medical advice from a hematologist in August 2021. Laboratory testing was done including complete cbc, PT & PTT, ESR, von Willibrand factor screen, serum Cryoglobulin, serum Complement C4, serum Complement C3, Fibrinogen Antigen and ANA Direct.  All test results with the exception of ANA were WNL. The ANA was positive and abnormal.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Von Willebrand's factor antigen normal
Clinical narrative: Spontaneous bleeding and bruising of individual fingers and toes.  Bruising would appear on a single digit and remain for 24-72 hours.  Not related to any injury or known reason to cause bruise to occur.  The frequecy of bruising increased post vaccine injection.  From 4/9/21 to the present there have been 12 episodes of spontaneous bruising.  Patient did seek medical advice from a hematologist in August 2021. Laboratory testing was done including complete cbc, PT & PTT, ESR, von Willibrand factor screen, serum Cryoglobulin, serum Complement C4, serum Complement C3, Fibrinogen Antigen and ANA Direct.  All test results with the exception of ANA were WNL. The ANA was positive and abnormal.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Vomiting
Clinical narrative: Vomiting three times, diarrhea, fatigue, upset stomach.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccine breakthrough infection
Clinical narrative: suspect COVID breakthrough
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: Full body Urticaria, dermatographia with associated priorities. Occurs daily, still occurring at present. Responds partially to Zyrtec 10 mg four times daily.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Limb operation
Clinical narrative: Hand surgery
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received booster dose instead of first dose (0.25mL vs 0.5mL).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient got booster dose vs first dose (0.25mL vs 0.5mL).
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccine breakthrough infection
Clinical narrative: suspect COVID breakthrough
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Biopsy bronchus abnormal, Blood beta-D-glucan normal, Bronchial wall thickening, Bronchiectasis
Clinical narrative: Pt presents to ED with worsening dyspnea. Patient has had persistent dyspnea since COVID infection in February and was placed on home O2 in September due to exertional hypoxemia. Over the past three days, wife states that he has had frequent desaturations into low 80s when getting up to go to bathroom or other activities, which causes patient to become anxious and tachypnic. Patient's wife states his mental status fluctuates when he has desaturations and this has been happening more frequently. He does report of pleuritic chest pain and dry cough however these are not significantly worse over the past month or so. This evening, patient and wife state that he was becoming anxious, short of breath and felt as if he needed to come in. He denies any fevers/chills, night sweats, chest pain, productive cough, nausea/vomiting, abdominal pain, nausea/vomiting or diarrhea   -Tested positive on 11/19. Previously diagnosed 2/2021 and underwent treatment. Received 2 doses of Moderna vaccine. -Has had extensive work up outpatient with pulmonary for chronic hypoxia after initial COVID-19 diagnosis. Recently started on steroid taper for organizing pneumonia. Bronch with biopsy 10/8 with chronic inflammation. -CT PE on admission with interval increase in GGOs throughout lungs with bronchial wall thickening, bronchiectasis, and peribronchial fibrotic changes; no PE. -Other infectious work up negative. Urine histo negative. Beta glucan and autoimmune work up negative -S/p course of Remdesivir until 11/24 and IV cefepime until 11/23 -S/p 14d course of baricitinib until 12/2 -As per rehab facility, patient will benefit from pulmonary rehab but denied by 1st facility and accepted at another facility for rehab -Also OPD referral for pulmonary rehab -Oxygen requirement stable on 4L NC currently (baseline~3-4L PTA at home) -Continue prednisone 40mg until outpatient local clinic follow up in 1mo -Continue PPI and PJP ppx with bactrim while on high dose steroids -Continue mucinex for cough, encourage incentive spirometry and PEP therapy -Discussed with IPAC, isolation removed on 12/11 (21 days from positive date)  Discharge Disposition/Condition Disposition: Rehab facility  Condition: Stable (s/sx potential problems absent or manageable)
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest pain, Computerised tomogram thorax abnormal, Condition aggravated, Cough
Clinical narrative: Pt presents to ED with worsening dyspnea. Patient has had persistent dyspnea since COVID infection in February and was placed on home O2 in September due to exertional hypoxemia. Over the past three days, wife states that he has had frequent desaturations into low 80s when getting up to go to bathroom or other activities, which causes patient to become anxious and tachypnic. Patient's wife states his mental status fluctuates when he has desaturations and this has been happening more frequently. He does report of pleuritic chest pain and dry cough however these are not significantly worse over the past month or so. This evening, patient and wife state that he was becoming anxious, short of breath and felt as if he needed to come in. He denies any fevers/chills, night sweats, chest pain, productive cough, nausea/vomiting, abdominal pain, nausea/vomiting or diarrhea   -Tested positive on 11/19. Previously diagnosed 2/2021 and underwent treatment. Received 2 doses of Moderna vaccine. -Has had extensive work up outpatient with pulmonary for chronic hypoxia after initial COVID-19 diagnosis. Recently started on steroid taper for organizing pneumonia. Bronch with biopsy 10/8 with chronic inflammation. -CT PE on admission with interval increase in GGOs throughout lungs with bronchial wall thickening, bronchiectasis, and peribronchial fibrotic changes; no PE. -Other infectious work up negative. Urine histo negative. Beta glucan and autoimmune work up negative -S/p course of Remdesivir until 11/24 and IV cefepime until 11/23 -S/p 14d course of baricitinib until 12/2 -As per rehab facility, patient will benefit from pulmonary rehab but denied by 1st facility and accepted at another facility for rehab -Also OPD referral for pulmonary rehab -Oxygen requirement stable on 4L NC currently (baseline~3-4L PTA at home) -Continue prednisone 40mg until outpatient local clinic follow up in 1mo -Continue PPI and PJP ppx with bactrim while on high dose steroids -Continue mucinex for cough, encourage incentive spirometry and PEP therapy -Discussed with IPAC, isolation removed on 12/11 (21 days from positive date)  Discharge Disposition/Condition Disposition: Rehab facility  Condition: Stable (s/sx potential problems absent or manageable)
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hypoxia, Immunology test normal, Laboratory test normal, Lung opacity
Clinical narrative: Pt presents to ED with worsening dyspnea. Patient has had persistent dyspnea since COVID infection in February and was placed on home O2 in September due to exertional hypoxemia. Over the past three days, wife states that he has had frequent desaturations into low 80s when getting up to go to bathroom or other activities, which causes patient to become anxious and tachypnic. Patient's wife states his mental status fluctuates when he has desaturations and this has been happening more frequently. He does report of pleuritic chest pain and dry cough however these are not significantly worse over the past month or so. This evening, patient and wife state that he was becoming anxious, short of breath and felt as if he needed to come in. He denies any fevers/chills, night sweats, chest pain, productive cough, nausea/vomiting, abdominal pain, nausea/vomiting or diarrhea   -Tested positive on 11/19. Previously diagnosed 2/2021 and underwent treatment. Received 2 doses of Moderna vaccine. -Has had extensive work up outpatient with pulmonary for chronic hypoxia after initial COVID-19 diagnosis. Recently started on steroid taper for organizing pneumonia. Bronch with biopsy 10/8 with chronic inflammation. -CT PE on admission with interval increase in GGOs throughout lungs with bronchial wall thickening, bronchiectasis, and peribronchial fibrotic changes; no PE. -Other infectious work up negative. Urine histo negative. Beta glucan and autoimmune work up negative -S/p course of Remdesivir until 11/24 and IV cefepime until 11/23 -S/p 14d course of baricitinib until 12/2 -As per rehab facility, patient will benefit from pulmonary rehab but denied by 1st facility and accepted at another facility for rehab -Also OPD referral for pulmonary rehab -Oxygen requirement stable on 4L NC currently (baseline~3-4L PTA at home) -Continue prednisone 40mg until outpatient local clinic follow up in 1mo -Continue PPI and PJP ppx with bactrim while on high dose steroids -Continue mucinex for cough, encourage incentive spirometry and PEP therapy -Discussed with IPAC, isolation removed on 12/11 (21 days from positive date)  Discharge Disposition/Condition Disposition: Rehab facility  Condition: Stable (s/sx potential problems absent or manageable)