chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Tumour marker test, Vomiting, White blood cell count
Clinical narrative: nauseated; vomited; chills; constipation; flu like symptoms; lymph nodes really swollen in armpit and left chest area; muscles tense in armpit; decreased appetite; Tired; Achy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 77-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast Cancer" (unspecified if ongoing). Concomitant medications included: IBRANCE taken for breast cancer female, start date: 17Dec2020 (ongoing); AROMASIN taken for breast cancer female (ongoing). Vaccination history included: COVID-19 vaccine (Dose 1, Manufacturer Unknown (Lot Number: Not Provided)), for COVID-19 Immunisation. The following information was reported: NAUSEA (non-serious), outcome "recovered" (22Mar2021), described as "nauseated"; VOMITING (non-serious), outcome "recovered" (22Mar2021), described as "vomited"; CHILLS (non-serious), outcome "recovered" (22Mar2021), described as "chills"; CONSTIPATION (non-serious), outcome "recovered" (22Mar2021), described as "constipation"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered" (22Mar2021), described as "flu like symptoms"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes really swollen in armpit and left chest area"; MUSCLE TIGHTNESS (non-serious), outcome "unknown", described as "muscles tense in armpit"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; PAIN (non-serious), outcome "unknown", described as "Achy". The events "lymph nodes really swollen in armpit and left chest area" and "muscles tense in armpit" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient  reported that she had issues lately. She got both COVID vaccines and since then she was feeling nauseated, vomited horribly this last weekend, had chills, constipation, and flu like symptoms which seemed like these side effects had resolved since 22Mar2021. Lymph nodes were really swollen in armpit and left chest area 2 weeks after COVID vaccines and she also experienced muscle tense in armpit so she saw her my primary care professional on 12Mar2021 for this. She had decreased appetite, energy level is ok, tired and achy. She would have appointment with primary care professional on 26Mar2021 and next oncologist appointment on 12Apr2021 with shot to strengthen her bones. She would have lab work, computerized tomography and bone scans before oncology visit. Her last scan showed 2 fractured ribs, last lab work showed white blood cell count 2.5 and tumor markers was down from 595 to 262.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allodynia, Asthenia, Chills, Feeling cold, Hyperhidrosis
Clinical narrative: weak; vomiting; freezing; pain all over body/sharp pains behind her ears; allodynia; chills; sweating; feeling okay but not great; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 40's received bnt162b2 (BNT162B2), administration date 23Mar2021 18:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: Mar2020 (unspecified if ongoing); "a-fib" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 24Mar2021, outcome "recovering", described as "feeling okay but not great"; FEELING COLD (non-serious) with onset 24Mar2021 11:00, outcome "recovering", described as "freezing"; PAIN (non-serious) with onset 24Mar2021, outcome "recovering", described as "pain all over body/sharp pains behind her ears"; ALLODYNIA (non-serious) with onset 24Mar2021, outcome "recovering", described as "allodynia"; VOMITING (non-serious) with onset 24Mar2021 19:00, outcome "recovering", described as "vomiting"; CHILLS (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021 01:00), described as "chills"; HYPERHIDROSIS (non-serious) with onset 24Mar2021, outcome "recovering", described as "sweating"; ASTHENIA (non-serious) with onset 25Mar2021, outcome "unknown", described as "weak". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Additional information: Patient received her first dose of the vaccine at 6:30 PM Tuesday, 23Mar2021. She woke up feeling "okay but not great" on Wednesday. By 11:00 AM, she was freezing and had to layer 5 blankets on herself. She had pain all over body and experienced allodynia. She had sharp pains behind her ears. She started vomiting at 7:00 PM, which helped with symptoms. Around 1:00 AM, her chills stopped. She was sweating and her aches aches slowly disappeared. This morning, 25Mar she reported feeling much better but weak.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Vomiting
Clinical narrative: weak; vomiting; freezing; pain all over body/sharp pains behind her ears; allodynia; chills; sweating; feeling okay but not great; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 40's received bnt162b2 (BNT162B2), administration date 23Mar2021 18:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: Mar2020 (unspecified if ongoing); "a-fib" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 24Mar2021, outcome "recovering", described as "feeling okay but not great"; FEELING COLD (non-serious) with onset 24Mar2021 11:00, outcome "recovering", described as "freezing"; PAIN (non-serious) with onset 24Mar2021, outcome "recovering", described as "pain all over body/sharp pains behind her ears"; ALLODYNIA (non-serious) with onset 24Mar2021, outcome "recovering", described as "allodynia"; VOMITING (non-serious) with onset 24Mar2021 19:00, outcome "recovering", described as "vomiting"; CHILLS (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021 01:00), described as "chills"; HYPERHIDROSIS (non-serious) with onset 24Mar2021, outcome "recovering", described as "sweating"; ASTHENIA (non-serious) with onset 25Mar2021, outcome "unknown", described as "weak". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Additional information: Patient received her first dose of the vaccine at 6:30 PM Tuesday, 23Mar2021. She woke up feeling "okay but not great" on Wednesday. By 11:00 AM, she was freezing and had to layer 5 blankets on herself. She had pain all over body and experienced allodynia. She had sharp pains behind her ears. She started vomiting at 7:00 PM, which helped with symptoms. Around 1:00 AM, her chills stopped. She was sweating and her aches aches slowly disappeared. This morning, 25Mar she reported feeling much better but weak.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Discomfort, Fatigue, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: significant stiffness; exhaustion; soreness; uncomfortable; made it impossible to do anything; a bit sore location arm and back; a bit sore location arm and back; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Mar2021 15:00 (Lot number: EN6206) at the age of 45 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Cystic acne" (unspecified if ongoing). Concomitant medication(s) included: ALDACTONE [SPIRONOLACTONE]; PROBIOTICS. Past drug history included: Codeine, reaction(s): "Drug allergy". The following information was reported: BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 20Mar2021, outcome "recovered with sequelae" (Mar2021) and all described as "a bit sore location arm and back"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "significant stiffness"; FATIGUE (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "exhaustion"; PAIN (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "soreness"; DISCOMFORT (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "uncomfortable"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "made it impossible to do anything". Therapeutic measures were not taken as a result of back pain, pain in extremity, musculoskeletal stiffness, fatigue, pain, discomfort, loss of personal independence in daily activities.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The vaccine was administered in Public Health Clinic/Veterans Administration facility.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: significant stiffness; exhaustion; soreness; uncomfortable; made it impossible to do anything; a bit sore location arm and back; a bit sore location arm and back; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Mar2021 15:00 (Lot number: EN6206) at the age of 45 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Cystic acne" (unspecified if ongoing). Concomitant medication(s) included: ALDACTONE [SPIRONOLACTONE]; PROBIOTICS. Past drug history included: Codeine, reaction(s): "Drug allergy". The following information was reported: BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 20Mar2021, outcome "recovered with sequelae" (Mar2021) and all described as "a bit sore location arm and back"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "significant stiffness"; FATIGUE (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "exhaustion"; PAIN (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "soreness"; DISCOMFORT (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "uncomfortable"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "made it impossible to do anything". Therapeutic measures were not taken as a result of back pain, pain in extremity, musculoskeletal stiffness, fatigue, pain, discomfort, loss of personal independence in daily activities.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The vaccine was administered in Public Health Clinic/Veterans Administration facility.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: I am still feeling nauseous prior; some amount of light headedness like dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Apr2021 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "I am still feeling nauseous prior"; DIZZINESS (non-serious), outcome "unknown", described as "some amount of light headedness like dizziness".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Extrasystoles
Clinical narrative: Heartbeat was out of rhythm/ every 5th heart beat was skipping; Heartbeat was out of rhythm/ every 5th heart beat was skipping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient's concomitant medications were none.   The following information was reported: ARRHYTHMIA (medically significant), EXTRASYSTOLES (non-serious) all with onset 24Mar2021, outcome "recovered with sequelae" and all described as "Heartbeat was out of rhythm/ every 5th heart beat was skipping". Therapeutic measures were not taken as a result of arrhythmia, extrasystoles. The patient subsequently received dose 2 of BNT162B2 (Lot# EP6955) on 11Apr2021.  Follow-up (18Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Extrasystoles
Clinical narrative: Heartbeat was out of rhythm/ every 5th heart beat was skipping; Heartbeat was out of rhythm/ every 5th heart beat was skipping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient 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: ARRHYTHMIA (medically significant), EXTRASYSTOLES (non-serious), outcome "unknown" and all described as "Heartbeat was out of rhythm/ every 5th heart beat was skipping". The event was reported as non-serious. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Extrasystoles
Clinical narrative: Heartbeat was out of rhythm/ every 5th heart beat was skipping; Heartbeat was out of rhythm/ every 5th heart beat was skipping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", EXTRASYSTOLES (non-serious) with onset 2021, outcome "unknown" and all described as "Heartbeat was out of rhythm/ every 5th heart beat was skipping". The event was reported as non-serious. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Dyspnoea, Gait disturbance, Immunisation
Clinical narrative: Severe chest pains; Trouble walking and breathing; Trouble walking and breathing; got the booster shot; Running fever; Pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Lot number: FL3197) at the age of 12 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing), notes: ADHD; "Learning disability" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for covid 19 immunization; Bnt162b2 (dose 2), for covid 19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022, outcome "unknown", described as "got the booster shot"; CHEST PAIN (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Severe chest pains"; GAIT DISTURBANCE (non-serious), DYSPNOEA (non-serious) all with onset 08Jan2022, outcome "unknown" and all described as "Trouble walking and breathing"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Running fever"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Pain in arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity. Additional information: the patient just got the booster shot on Friday(07Jan2022) and yesterday(08Jan2022) the reporter (patient's parent) was just watching like around 3 o'clock in the morning, the patient had severe chest pains and had trouble walking and breathing and it was a hard time for him to walk or breathe. The reporter was asking if this a side effect and should he/she take the patient to the emergency room and get this checked up. The reporter asked what was going on because the patient was still having it. It is not severe but he was still having chest pains.  Reporter stated the only thing patient took was Tylenol as he was running fever, reporter did not give him more medication. The only thing was Tylenol that was for the fever and for the pain in the arms. Reporter stated the dosage and frequency of Tylenol as follows: It was 15 ml, the thing was that the patient did not take the form, reporter gave it to patient in liquid. It was a 160 mg and what it was given as 15 ml every 6 hours.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Severe chest pains; Trouble walking and breathing; Trouble walking and breathing; got the booster shot; Running fever; Pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Lot number: FL3197) at the age of 12 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing), notes: ADHD; "Learning disability" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for covid 19 immunization; Bnt162b2 (dose 2), for covid 19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022, outcome "unknown", described as "got the booster shot"; CHEST PAIN (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Severe chest pains"; GAIT DISTURBANCE (non-serious), DYSPNOEA (non-serious) all with onset 08Jan2022, outcome "unknown" and all described as "Trouble walking and breathing"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Running fever"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Pain in arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity. Additional information: the patient just got the booster shot on Friday(07Jan2022) and yesterday(08Jan2022) the reporter (patient's parent) was just watching like around 3 o'clock in the morning, the patient had severe chest pains and had trouble walking and breathing and it was a hard time for him to walk or breathe. The reporter was asking if this a side effect and should he/she take the patient to the emergency room and get this checked up. The reporter asked what was going on because the patient was still having it. It is not severe but he was still having chest pains.  Reporter stated the only thing patient took was Tylenol as he was running fever, reporter did not give him more medication. The only thing was Tylenol that was for the fever and for the pain in the arms. Reporter stated the dosage and frequency of Tylenol as follows: It was 15 ml, the thing was that the patient did not take the form, reporter gave it to patient in liquid. It was a 160 mg and what it was given as 15 ml every 6 hours.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Pericarditis
Clinical narrative: Pericarditis; mild heart attack; 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 23 year-old male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "Pericarditis"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "mild heart attack". Clinical course: Patient received second Pfizer vaccine gave him Pericarditis as well as a mild heart attack. Patient need to get the booster vaccination, but he was unsure how his immune system will react.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Muscle spasms, Muscular weakness, Neurological symptom
Clinical narrative: Neurological side effects; Progressive left arm weakness; Spasms; Symptoms worsen over several months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "Neurological side effects"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "Progressive left arm weakness"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Spasms"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Symptoms worsen over several months". It was unknown if therapeutic measures were taken as a result of neurological symptom, muscular weakness, muscle spasms, condition aggravated.  Clinical course was the following: It was reported about an incidence after the initial 2 doses of Pfizer- BioNTech COVID-19 Vaccine. She noted she had neurological side effects. The symptoms were delayed so she is not sure was it from the vaccine. She had progressive left arm weakness, then spasms, trouble lifting a fork as it will hit the face, and trouble typing. Symptoms worsen over several months and slowly subsided over the summer. She said it is probably not related to the vaccine but these issues only occurred in the vaccinated arm. Symptoms seemed worse in the cold and improved in the warmer temperatures. Symptoms did not return this winter. Then, the patient received the third dose (Moderna vaccine).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: severe headache; chills/chills are getting worse; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP) from medical information team. The reporter is patient's husband.  An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date 10Jan2022 10:00 (Lot number: FE3594) at the age of 89 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Multiple myeloma", start date: 2020 (unspecified if ongoing), notes: Caller says this was diagnosed about two years ago.; "Lung cancer", start date: 2010 (unspecified if ongoing), notes: Caller says this was diagnosed 12 years ago.; "hard of hearing" (ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 10Jan2022 11:00, outcome "not recovered", described as "severe headache"; CHILLS (non-serious) with onset 10Jan2022, outcome "not recovered", described as "chills/chills are getting worse". Therapeutic measures were taken as a result of headache, chills included paracetamol (TYLENOL).   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Speech disorder
Clinical narrative: her tongue and mouth stayed numb for 3 days; her tongue and mouth stayed numb for 3 days; having difficulty speaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "her tongue and mouth stayed numb for 3 days"; SPEECH DISORDER (non-serious) with onset 2021, outcome "unknown", described as "having difficulty speaking".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Illness, Oropharyngeal pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional) from medical information team. The reporter is the patient. A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: FJ8762) at the age of 62 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN CALCIUM 80 mg, one in the evening taken for transient ischaemic attack; ASPIRIN 81, 81 mg once a day taken for blood disorder. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization, reaction(s): "Hardness in the arm, stiff arm that was fine". The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "tested positive for Covid-19 (OMICRON)"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "drug ineffective"; RASH (non-serious) with onset 24Dec2021, outcome "recovered", described as "rash on my arm and between my legs"; OROPHARYNGEAL PAIN (non-serious) with onset 24Dec2021, outcome "unknown", described as "sore throat"; COUGH (non-serious) with onset 31Dec2021, outcome "unknown", described as "Coughing and coughing up phlegm"; ILLNESS (non-serious), outcome "unknown", described as "sick"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "hot 'casing' on where I got my shot"; SEASONAL ALLERGY (non-serious), outcome "unknown", described as "pollen reaction". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: OMICRON. Therapeutic measure Benadryl was taken as a result of rash. Follow-up (10Jan2022): This is a spontaneous follow up report from a contactable consumer. Updated information: Patient information: Additional information: Concomitant drugs added(Atorvastatin Calcium and Aspirin), lot number added, event onset for sore throat added, new events (sick, Vaccination site warmth) added. No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Seasonal allergy, Vaccination site warmth
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional) from medical information team. The reporter is the patient. A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: FJ8762) at the age of 62 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN CALCIUM 80 mg, one in the evening taken for transient ischaemic attack; ASPIRIN 81, 81 mg once a day taken for blood disorder. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization, reaction(s): "Hardness in the arm, stiff arm that was fine". The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "tested positive for Covid-19 (OMICRON)"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "drug ineffective"; RASH (non-serious) with onset 24Dec2021, outcome "recovered", described as "rash on my arm and between my legs"; OROPHARYNGEAL PAIN (non-serious) with onset 24Dec2021, outcome "unknown", described as "sore throat"; COUGH (non-serious) with onset 31Dec2021, outcome "unknown", described as "Coughing and coughing up phlegm"; ILLNESS (non-serious), outcome "unknown", described as "sick"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "hot 'casing' on where I got my shot"; SEASONAL ALLERGY (non-serious), outcome "unknown", described as "pollen reaction". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: OMICRON. Therapeutic measure Benadryl was taken as a result of rash. Follow-up (10Jan2022): This is a spontaneous follow up report from a contactable consumer. Updated information: Patient information: Additional information: Concomitant drugs added(Atorvastatin Calcium and Aspirin), lot number added, event onset for sore throat added, new events (sick, Vaccination site warmth) added. No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tests positive for COVID; tests positive for COVID; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tests positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The reporter was asking when the fully vaccinated patient and tested positive for COVID can received the booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 68.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Fatigue, Skin cancer
Clinical narrative: Skin cancer; Fatigue; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4223419-00 (Abbvie).  A 69 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single and intramuscular, administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN CANCER (medically significant), outcome "recovering", described as "Skin cancer"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". The action taken for upadacitinib was unknown. Clinical course: It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's causality for the event(s) of SKIN CANCER with RINVOQ (UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of fatigue are not provided. Abbvie's opinion is that the events of SKIN CANCER and FATIGUE are not assessable. The reporter's causality for the event(s) of Skin cancer and Fatigue for Pfizer Biontech COVID-19 vaccine (TOZINAMERAN) was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the possible contributory role of suspect product BNT162B2 to the development of events skin cancer, fatigue cannot be totally excluded. The case will be reassessed when additional information 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Crohn's disease aggravated; Booster; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4223921-00.  A 32 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Aug2021 (Batch/Lot number: unknown) at the age of 32 years as dose 3 (booster), single, intramuscular, administration date 07Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for moderate to severe adult crohn's disease. The patient's relevant medical history was not reported. There were no concomitant medications. Patient had no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; IMMUNISATION (medically significant) with onset 31Aug2021, outcome "unknown", described as "Booster"; CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohn's disease aggravated". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the events (Crohn's disease aggravated, COVID-19) with the HUMIRA were not reported.  The reporter's assessment of the causal relationship of the events (Crohn's disease aggravated, COVID-19) with the PFIZER BIONTECH COVID-19 VACCINE were Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and the possible contributory role of suspect product BNT162B2 to the development of events drug ineffective, suspected covid19, Crohn's disease aggravated cannot be totally excluded. The case will be reassessed when additional information 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pain assessment, Spinal pain
Clinical narrative: Mild lower spinal pain the night I received the shot, intense spinal pain the next morning 10/10, I couldn't walk without being in severe pain; I couldn't take a few steps without my legs giving out, I needed objects or other people as support to keep myself up. Has been about an 8/10; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 12:00 (Lot number: FL3198) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: SPINAL PAIN (non-serious) with onset 06Jan2022 21:00, outcome "not recovered", described as "Mild lower spinal pain the night I received the shot, intense spinal pain the next morning 10/10, I couldn't walk without being in severe pain"; GAIT DISTURBANCE (non-serious) with onset 06Jan2022 21:00, outcome "not recovered", described as "I couldn't take a few steps without my legs giving out, I needed objects or other people as support to keep myself up. Has been about an 8/10". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of spinal pain, gait disturbance.  Additional information: no other vaccine in four weeks and no other medications in two weeks. Patient had mild lower spinal pain the night he received the shot, intense spinal pain the next morning 10/10, patient couldn't walk without being in severe pain, he couldn't take a few steps without legs giving out, he needed objects or other people as support to keep up. It had been about an 8/10 as of today (10Jan2021). Patient had no prior health issues.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Rheumatoid arthritis
Clinical narrative: 1st dose on 21Apr2021and 2nd dose on 28Apr2021; Rheumatoid arthritis flare up; Pain in arm; Foot pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4220480-00.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single and intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "Cold symptoms", start date: Mar2021 (not ongoing), notes: In Mar2021, the patient experienced COLD SYMPTOMS. On an unknown date, COLD SYMPTOMS resolved. The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "not recovered", described as "Rheumatoid arthritis flare up"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Apr2021, outcome "unknown", described as "1st dose on 21Apr2021and 2nd dose on 28Apr2021"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Pain in arm"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Foot pain". The action taken for adalimumab was dosage not changed. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter considered "rheumatoid arthritis flare up", "pain in arm" and "foot pain" not related to bnt162b2. The reporter's causality for the event(s) of Rheumatoid arthritis flare up with HUMIRA (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of Left Foot pain was not provided. Causality as per reporter between bnt162b2 (Pfizer Biontech COVID-19 vaccine (TOZINAMERAN)) for event Inappropriate schedule of product administration was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events rheumatoid arthritis flare up, pain in arm, foot pain cannot be totally excluded. The case will be reassessed when additional information 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever; Headache; Injection site pain; COVID-19 virus test positive; COVID-19 virus test positive; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4222730-00.  A 13 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 13 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "not recovered" and all described as "COVID-19 virus test positive"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; INJECTION SITE PAIN (non-serious), outcome "recovered", described as "Injection site pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of covid positive, covid vaccines caused Fever, covid vaccines caused headache and covid vaccines caused sore arm with humira (Adalimumab) was no reasonable possibility.  The reporter's causality for the event(s) of covid positive, covid vaccines caused Fever, covid vaccines caused headache and covid vaccines caused sore arm with Pfizer BioNTech covid-19 vaccine (Tozinameran) Was possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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: SARS-CoV-2 test
Clinical narrative: Fever; Headache; Injection site pain; COVID-19 virus test positive; COVID-19 virus test positive; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4222730-00.  A 13 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 13 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "not recovered" and all described as "COVID-19 virus test positive"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; INJECTION SITE PAIN (non-serious), outcome "recovered", described as "Injection site pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of covid positive, covid vaccines caused Fever, covid vaccines caused headache and covid vaccines caused sore arm with humira (Adalimumab) was no reasonable possibility.  The reporter's causality for the event(s) of covid positive, covid vaccines caused Fever, covid vaccines caused headache and covid vaccines caused sore arm with Pfizer BioNTech covid-19 vaccine (Tozinameran) Was possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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