chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Wheezing
Clinical narrative: My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Acne, Thrombosis
Clinical narrative: blood became a clot; pimple; This is a spontaneous report received from a Pfizer sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2 reported as Pfizer Covid-19 vaccine), dose 1 via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he received Pfizer Covid-19 vaccine first dose on 06Mar2021, and second dose will be on Saturday 27Mar2021. While showering, he broke his pimple on Mar2021 then tried to remove it using the tissue and the blood became a clot. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: he has thrombosis in leg; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient himself) reported that a male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included metastatic cancer in the lungs (he's taking chemotherapy) and heart problems from an unknown date. The patient's concomitant medications were not reported. The patient was due the next day for the 2nd dose of the Pfizer vaccine. He was asking if he can take his pre-scheduled medication, especially he's taking chemotherapy because he has metastatic cancer in the lungs. Due also to the nature of him having heart problems, he had thrombosis in leg and he's taking blood thinner since an unspecified date. He was asking if he should stop the medication or if he can take the blood thinner before the 2nd dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Asthenia, Chills, Pyrexia, Vomiting
Clinical narrative: Un usual Hair loss; Chills; Fever; Vomiting; Lack of Energy; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 01Mar2021 10:50 (Batch/Lot Number: EN6205) as SINGLE DOSE for covid-19 immunisation.  Medical history included mild COPD from 2015 and ongoing, non-smoking, ongoing sinus issues, COVID-19 from Nov2020 to an unknown date. The patient's concomitant medication was none. The patient received dose 1 of vaccine on 08Feb021 11:00AM at Right Arm via Intramuscular (lot number: EM9810) and experienced Fever, Chills, Vomiting, Lack of Energy, Headache. On 02Mar2021 13:00, the patient experienced Fever, Chills, Vomiting, Lack of Energy. The events were assessed as serious, disabling. Treatment Received includes Advil. Also, for approximately two weeks after 2nd shot, the patient had unusual Hair loss. The outcome of the events Fever, Chills, Vomiting, Lack of Energy was recovered on 04Mar2021; outcome oof unusual hair loss was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Fatigue, Headache, Heart rate increased, Myalgia
Clinical narrative: Atrial Fibrillation; increase in heart rate; fatigue; Headache; muscle pain; This is a spontaneous report received from a Pfizer sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2 reported as Pfizer COVID-19 Vaccine), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he was experiencing atrial fibrillation, an increase in heart rate, fatigue, headache, and muscle pain on Mar2021. He mentioned that he is scheduled for the second dose on 26Mar2021 and inquired if he can still continue the 2nd dose of the vaccine. He also inquired if the symptoms would worsen after the second dose of the vaccine. The outcome of the events was unknown.   Information on lot/batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Feeling abnormal, Headache
Clinical narrative: fainted; lightheaded; fever; feeling weak/feels weak; Sunday felt bad; glands felt swollen; body aches; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her second dose of the COVID-19 vaccine on 19Mar2021 and stated that when she woke up Saturday morning, she took acetaminophen (TYLENOL), was experiencing being lightheaded and fainted, she needed help getting back into bed, slept all day had fever 101.0 to 102.0, feeling weak. On Sunday felt bad, that night fever was 99.0. On Monday, glands felt swollen, body aches and headache. And today feels weak, but no fever. The patient underwent lab tests and procedures which included body temperature: 101.0 to 102.0 and 99.0 on an unspecified date. Therapeutic measures were taken as a result of fever and headache. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Syncope
Clinical narrative: fainted; lightheaded; fever; feeling weak/feels weak; Sunday felt bad; glands felt swollen; body aches; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her second dose of the COVID-19 vaccine on 19Mar2021 and stated that when she woke up Saturday morning, she took acetaminophen (TYLENOL), was experiencing being lightheaded and fainted, she needed help getting back into bed, slept all day had fever 101.0 to 102.0, feeling weak. On Sunday felt bad, that night fever was 99.0. On Monday, glands felt swollen, body aches and headache. And today feels weak, but no fever. The patient underwent lab tests and procedures which included body temperature: 101.0 to 102.0 and 99.0 on an unspecified date. Therapeutic measures were taken as a result of fever and headache. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: hearing loss in his right ear; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old male patient received bnt162b2 (BNT162B2), at the age of 33-years at vaccination, dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 15:15 (Batch/Lot Number: EL3248) as SINGLE DOSE, dose 1 via an unspecified route of administration on 02Mar2021 13:00 (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation.  Prior to vaccination, the patient was not diagnosed with COVID 19. The patient's medical history and concomitant medications were not reported.  On 24Mar2021 22:00, patient experienced hearing loss in his right ear with outcome of not recovered.  Since the vaccination, the patient has not been tested for COVID 19.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Fatigue, Pain
Clinical narrative: she is disabled and lives in chronic pain.; Hair is falling out; was too tired; This is a spontaneous report received from contactable consumer, the patient. A 64-year-old adult female received the first dose of BNT162B2 (solution for injection; Lot EN6204 expiry 30Jun2021) as a single dose in the left deltoid (left shoulder) on 22Mar2021 (at 64-years-old), for COVID-19 immunization. Relevant medical history included a failed back surgery. The patient had no family history. Concomitant medications included many [unspecified] medications that the patient has taken for years. The patient denied receiving any prior vaccinations within four weeks of the vaccination, and the patient denied any adverse events (AE) following prior vaccinations. The patient reported that very early in the morning on 24mar20201, she did not know what time as she was too tired to look at the clock, she noticed her hair was failing out. The patient also mentioned that she is disabled and lives in chronic pain from an unspecified date (pending clarification). There was no emergency room visit required and the patient denied any physician office visit though commented she made an appointment with dermatologist for Friday. The outcome of the events too tired, hair is falling out, and disabled and lives in chronic pain was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Arrhythmia, Chest pain, Electrocardiogram
Clinical narrative: arrhythmia; pain in my chest, in my heart; pain in my chest, in my heart; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262) via an unspecified route of administration into the right arm on 11Feb2021 as single dose for COVID-19 immunisation. Medical history included glaucoma, diabetes, hypertension, cholesterol, diuresis, bone disorder, pain, back surgery and replaced right knee. Concomitant medications included atorvastatin (ATORVASTATIN) taken for cholesterol, furosemide (FUROSEMIDE) taken for diuresis, alendronate sodium (ALENDRONIC) taken for bone disorder, latanoprost (LATANOPROST) taken for glaucoma, sitagliptin (JANUVIA) taken for an unspecified indication, potassium (POTASSIUM) taken for an unspecified indication and celecoxib (CELECOXIB) taken for pain. On 11Feb2021, patient felt pain in her chest and in her heart. Patient underwent electrocardiogram (ECG) on 11Feb2021 and was told that she had arrhythmia. Patient was brought to the emergency room and was treated with Aspirin. Outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nephrolithiasis, Pain
Clinical narrative: Kidney stones; extremely sick; pain; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer (patient) of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 22Mar2021, the patient experienced kidney stones which required hospitalization. The patient reported she was extremely sick right now (Mar2021). She reported she was on 5 different medications (unspecified products), that they haven't done anything yet, she was just diagnosed with kidney stones. She also stated she has an appointment to go and do something about it and that the medications were to keep her from not screaming from pain (Mar2021). The patient is scheduled for the second dose of the COVID-19 vaccine tomorrow (25Mar2021). The clinical outcome of kidney stones, extremely sick, and pain was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cardiac arrest 20 hours after receiving BNT162B2 on an unspecified date. The patient passed away due to cardiac arrest. The patient died on an unspecified date. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: cardiac arrest
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: irregular heartbeat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received the first dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 21Mar2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced irregular heartbeat last night (24Mar2021) and he took Dofetilide in order to normalize his heartbeat. He wants to know if this is a side effect of the vaccine and if it is a problem. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Father took covid vaccine. 1 week later, he had a stroke; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient took the covid vaccine and 1 week later (unspecified date), he had a stroke. The event stroke was assessed as serious (medically significant). The outcome of the event was unknown.  Information about lot/batch has been requested.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, SARS-CoV-2 test
Clinical narrative: Brain bleeding; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Right on 19Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 for covid-19 immunization (lot number: EN6198; location: Right arm) The patient experienced brain bleeding on 21Mar2021 19:30. The patient was hospitalized for brain bleeding for 11 days on an unspecified date. The event was also assessed as life-threatening by the reporter.  The patient underwent lab tests and procedures which included nasal swab: unknown on an unspecified date. Treatment for the event was reported as unknown. Outcome of the event was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphagia, Dyspnoea at rest
Clinical narrative: difficulty breathing when laying down; Constant "fluttering" in chest for 2 - 3 hours; difficulty taking medication in large capsules; This is a spontaneous report received from a contactable consumer (patient). This 75-year-old female patient, did not Pregnant at the time of vaccination, received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot EL9269) on 06FEB2021 at single dose on Right arm for COVID-19 immunization. Medical history included ARVD, Breast Cancer, Carcinoid Syndrome, Autoimmune Problems, Asthma. Allergies included Several meds and seasonal respiratory. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. Concomitant medications were not reported. Event started on 06Feb2021 07:45 PM, several hours after vaccination, constant "fluttering" in chest for 2 - 3 hours, difficulty breathing when laying down, difficulty taking medication in large capsules. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was Recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Appendicitis perforated
Clinical narrative: Acute appendicitis; Appendix had small rupture; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm left, on 08Mar2021 at 12:00 (Lot Number: EN6199), as single dose, for COVID-19 immunisation. Medical history included hypothyroidism and COVID-19. The patient had not known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced acute appendicitis (caused hospitalization for 1 day, life threatening) on 12Mar2021 at 10:45 with outcome of recovering and appendix had small rupture (caused hospitalization for 1 day, life threatening) on 12Mar2021 at 10:45 with outcome of recovering. Therapeutic measures were taken as a result of the events. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Fall, Neoplasm malignant, Respiratory arrest
Clinical narrative: died/cancer; collapsed on the floor; eyes rolled back; stopped breathing for a very short.; This is a spontaneous report from a contactable consumer. A 70-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: en6100, expiry date not reported), via an unspecified route of administration, administered in right arm Right on 06Mar2021 11:00 at a single dose for covid-19 immunization.Medical history included stage 4 esophagis cancer and mushroom allergies (known allergies to mushrooms). The patient had no covid prior vaccination; not diagnosed with COVID-19.  The patient had other medications (unspecified) that the patient received within 2 weeks of vaccination. The most COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (lot number: el9267) for covid-19 immunisation in the right arm on 13Feb2021. The patient was not tested for covid post vaccination. Since the vaccination, the patient has not been tested for COVID-19. On the afternoon of 06Mar2021 (16:00), patient collapsed on the floor, eyes rolled back, stopped breathing for a very short. The patient was revived and carried to bed. She died at 4 am on the 13Mar2021. She told the reporter she did not want to go to the hospital and she said she wanted to die at home. The reporter stated that the cause of death was cancer since an unknown date. The events were reported as serious resulting in death. No treatment received for the adverse events reported. The patient died on 13Mar2021. The causes of death were cancer, collapsed on the floor, eyes rolled back, and stopped breathing for a very short.  An autopsy was not performed.; Reported Cause(s) of Death: collapsed on the floor; eyes rolled back; stopped breathing for a very short; died/cancer
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Myalgia, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Achy muscles and joints; Achy muscles and joints; I had no energy; This is a spontaneous report from a contactable consumer reported for self. A 58-year-old female patient (No pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:30 PM (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included lupus. The patient did not have covid prior vaccination, no covid tested post vaccination, and did not have Known allergies. Concomitant drug was reported as too many to list. The patient experienced nausea, vomiting, achy muscles and joints, and she had no energy on 25Mar2021 03:00 AM with outcome of not recovered. All events considered serious due to Disability or permanent damage. No treatment received for the events. This has lasted for 5 days as of this date.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, VIth nerve paralysis
Clinical narrative: 6th cranes nerve palsy; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in upper arm on 24Mar2021 03:45 as single dose for covid-19 immunisation. Medical history included high blood pressure and cardiomegalia. Known allergies was none. None other medications in two weeks. No other vaccine in four weeks. Patient experienced 6th cranes nerve palsy. Unable to look laterally with the right eye two days following vaccine administration on 25Mar2021. Double vision on the day immediately following the covid 19 vaccine on 25Mar2021. CT scan and blood work are normal ruling out possible stroke or brain tumors. AE resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No Covid prior vaccination. No Covid tested post vaccination. Treatment were taken as a result of 6th cranes nerve palsy and double vision including steroid (prednisone). The event outcome for event was not recovered.  Information about lot and batch number was requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest
Clinical narrative: She died 23 hours later on 28Feb/Her cause of death on her death certificate was stated to be cardiac arrest; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 27Feb2021 at a single dose for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient died 23 hours later on 28Feb2021 after first dose on 27Feb2021. She did not show any adverse symptoms after being vaccinated. The questionnaire before the vaccination asked "if you have a chronic health condition such as heart disease". It was stated that she has heart disease; still the vaccination was given. Her cause of death on her death certificate was stated to be cardiac arrest. The patient died on 28Feb2021. It was unknown if an autopsy was performed.  Information about Batch/Lot number has been requested.; Reported Cause(s) of Death: She died 23 hours later on 28Feb/Her cause of death on her death certificate was stated to be cardiac arrest
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: She died 23 hours later on 28Feb/Her cause of death on her death certificate was stated to be cardiac arrest; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 27Feb2021 at a single dose for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient died 23 hours later on 28Feb2021 after first dose on 27Feb2021. She did not show any adverse symptoms after being vaccinated. The questionnaire before the vaccination asked "if you have a chronic health condition such as heart disease". It was stated that she has heart disease; still the vaccination was given. Her cause of death on her death certificate was stated to be cardiac arrest. The patient died on 28Feb2021. It was unknown if an autopsy was performed.  Information about Batch/Lot number has been requested.; Reported Cause(s) of Death: She died 23 hours later on 28Feb/Her cause of death on her death certificate was stated to be cardiac arrest
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: two deaths in her state from vaccine; This is a spontaneous report received from a contactable consumer. This consumer reported similar events for two patients. This the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), on unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter was concerned because there had been two deaths in her state from vaccine and thought Pfizer might be curious in how their product was being handled. The patient died on unspecified date. It was unknown if autopsy was performed. The outcome of the event was fatal.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021371688 same reporter/event, different patient; Reported Cause(s) of Death: two deaths in her state from vaccine
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: high fever; Initial information was received on 26-Mar-2021 regarding an unsolicited valid serious case from a consumer/non-healthcare professional.  This case involves a male patient (age not reported) who had high fever (pyrexia), after he received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date (over 30 years ago), the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (over 30 years ago), the patient developed a serious high fever (pyrexia) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient was hospitalized for this event.  The reporter wanted to know the ingredients of the Pfizer Covid (coronavirus disease) vaccine because the patient had a reaction to the Pertussis vaccine and went to the hospital. He wanted to know if they both vaccines had the same ingredients and that he had checked everywhere to find this information. He was looking if it is safe for him to take it, anyone had a reaction to the product who used Pertussis vaccine.   It was unknown if there were lab data/results available.  An unknown corrective treatment was received at the time of hospitalization.  On an unknown date, the patient recovered from the event.   Information on the batch number was requested.; Sender's Comments: This case concerns a male patient (age not reported) who had pyrexia after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer). Time to onset is compatible with the role of vaccine. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PPV
Symptoms: Expired product administered, Limb discomfort, Medication error, Vomiting
Clinical narrative: left leg has been bothering him since the injection; experienced one episode of vomiting/additional episode of vomiting today; given expired dose of ACTHIB (expiry date-01-Mar-2021); Initial information was received on 16-Mar-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a one-year-old male patient who experienced (limb discomfort) and one episode of vomiting/additional episode of vomiting today (vomiting) after he received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE); HEPATITIS A VACCINE (HEPATITIS A) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  On 05-Mar-2021, the patient received a fourth dose of suspect HIB (PRP/T) VACCINE (lot number unknown, expiry date- 01-Mar-2021) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious left leg has been bothering him since the injection (limb discomfort) and one episode of vomiting/additional episode of vomiting today (vomiting) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  It was reported that, the reporter had a question regarding side effects following administration of expired dose? And also stated that she was contacted by medical practice to return for additional shot. Date: 01Mar2021   It was an actual medication error due to expired vaccine used. (latency: at the time of vaccination)  Details of laboratory data were not reported.  At the time of report, it was unknown if the patient received any corrective treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: A patient received an expired diluent at the time of vaccination, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00525075) and transmitted to Sanofi on 18-Mar-2021.  This case involves an one-year-old female patient who received an expired 0.5 mL dose of  diluent of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ567AA and expiry date: 01-Mar-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 18-Mar-2021 (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of  actual medication error due to expired product administered (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 45.0
Sex: M
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (Reference number- 00525656) and transmitted to company on 18-Mar-2021.  This case involves a 45-year-old male patient who received an expired 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ455AA and expiry date: 17-Mar-2021) via an intramuscular route in the left deltoid for prophylactic vaccination on 18-Mar-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guionne Barre reaction; Initial information received on 29-Mar-2021 regarding an unsolicited valid serious case from a other health professional. This case involves female patient of unknown age who experienced Guionne Barre reaction (Guillain-Barre syndrome), after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s)and family history were not provided.   In 2008, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 15-Oct-2008, the patient developed a serious Guionne Barre reaction (Guillain-Barre syndrome), approximately in the same year (exact latency unknown) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Also reported that patient informed that she was told by her doctor's office that they purchased the vaccine from your company and now she was trying to find out any ingredient that may have caused the reaction so to make an informed decision regarding the COVID-19 (corona virus disease) Vaccine.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the event Guillain-Barre syndrome.  Information on the batch number to e requested for this case.; Sender's Comments: This case involves female patient who had Guillain-Barre syndrome, after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is compatible. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLUC3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: A rash on upper arms that spread to trunk and upper thighs/rash was red and itchy, but without any raised bumps; A rash on upper arms that spread to trunk and upper thighs/rash was red and itchy, but without any raised bumps; This spontaneous case was received on 06-Apr-2021 from other non-health professional (consumer) via Communication (reference number: SEQW21-01134) and concerned a female patient of unknown age.  The patient's medical history and concomitant medications were not reported. The patient's vaccination history included other flu vaccine, but had never had a reaction like this to any.  On 05-Dec-2019, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 261234.  On 07-Dec-2019, within two days after receiving Flucelvax Quadrivalent, the patient developed a rash on upper arms that spread to trunk and upper thighs. The rash was red and itchy, but without any raised bumps.   On an unknown date, the patient saw a doctor who prescribed unspecified steroids for the rash. The first course of steroids did not resolve the rash and the patient was prescribed other unspecified medications, which after completing those, did resolve the rash.  On an unknown date, the patient recovered from the events of 'rash pruritic' and 'rash erythematous'.  The reporter assessed the events as related to Flucelvax Quadrivalent. The patient had never had a reaction like this to any other flu vaccine she had had.  Company comment: The events 'rash pruritic' and 'rash erythematous' are assessed as related to Flucelvax Quadrivalent.; Reporter's Comments: The patient had never had a reaction like this to any other flu vaccine she had had.; Sender's Comments: The events 'rash pruritic' and 'rash erythematous' are assessed as related to Flucelvax Quadrivalent.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Hypertension, Injection site pain, Palpitations
Clinical narrative: Within 30-60 seconds of receiving the vaccine my heart started racing. No other symptoms. I alerted the nurse - she took my blood pressure and it was very high (XXX/110). EMTs were called in case I was having an allergic reaction, but I did not have any other symptoms of allergies, just a very high BP and heart rate. At this point I'm sure anxiety drove my BP higher, on top of the reaction, since I was concerned I was going to go into anaphylaxis, but the original racing heart started within one minute of the injection while I was beginning my 15 minute wait time near the injection station. I worked on regulating my breathing and with the EMTs monitoring, my BP down to a manageable but still elevated rate after about 20 minutes. I did not go to the hospital. Once I was resting at home it took about 4 hours before I felt my heart rate was at a normal level and the feeling of racing was gone.  I did not have any other adverse reactions until 4/7/2021 which is the first day that the injection site (upper L arm) started aching.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient stated she developed Cellulitis in her arm at the injection site.  It became hot with fever, very swollen, and rock hard.  She went to an  clinic and was given a course of antibiotics, which resolved the infection.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Patient reported adverse event when she was due for her second dose. Pressure on chest, trouble breathing, drop in blood pressure, dizziness. Started in the evening of her vaccine and she reports it did resolve on its own a few hours later.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Nausea, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: slight stomach spasm, racing heart, pins and needle pain in bottom of left foot and right foot, sore arm, nausea
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Epigastric discomfort, Gastritis
Clinical narrative: slight stomach spasm, racing heart, pins and needle pain in bottom of left foot and right foot, sore arm, nausea
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pallor, Vomiting
Clinical narrative: At 246pm - Pt alerted the nurse he was felling nauseous. Pt was assisted to wheelchair and to private area.Pt was pale and diaphoretic, pt vomited 3 times. 252 pm     BP 100/80 HR 75 02- 100% Resp 20  Pt states he feels much better after vomiting.  256pm- Pt color and skin returned to WNL after vomiting. BP  110/60 Hr 68 resp 18 02 100%  303pm-  BP 110/72 Hr 58 02 99% Resp 16  Pt states he smoked marijuana and ate food prior to arrival , and that he had similar nausea after first dose but did not vomit the first time because he did not have anything to vomit. Pt states he also has hx of social anxiety.   308pm-  O2 - 99%  resp 16 HR 68  Pt mother in parking lot to transport pt home.  Pt states he feels better and is ready to go home. Pt feels good upon standing and standing VSS -  BP 110/77  HR 68 02 sat 99% resp 18  Reviewed discharge instructions with pt and to call emergency responders or go to nearest ED if symptoms worsen. Pt was provided vsafe flyer. Steady gait exiting clinic.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymph node pain, Myalgia
Clinical narrative: Fatigue, muscle aches, headache, tender lymph nodes (armpits)
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Diarrhoea
Clinical narrative: Diarrhea for 10 days following, took Imodium as needed, repeated... Very painful breast for two+ weeks following. Especially over treatment areas. Took Aleve, Tylenol or like to help some., this was in week 2, 3,4.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient's recieved Pfizer vaccine for first dose and Moderna vaccine for second dose. No notable adverse events reported from shelter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus occurring within days and lingering to-date. Left ear only. I (patient) have a history of left ear infections in my lifetime but none in recent years.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient's recieved Pfizer vaccine for first dose and Moderna vaccine for second dose. No notable adverse events reported from shelter.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Gait disturbance, Tremor
Clinical narrative: On the morning after my second shot, I was extremely week, shaky and exhausted. This lasted for 24 hours. I was so week I could not walk from my room to the bathroom without assistance.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Pallor
Clinical narrative: PER PT, FEELING DIZZY AND AS IF SHE WAS FAINTING - PT WAS RESPONSIVE TO QUESTIONS AND HAD NORMAL BREATHING. PT GIVEN 1 DOSE OF ADULT EPI (LOT 0FM501, EXP 05/22). PER EMT (ARRIVED WITHIN 10 MIN OF CALL), PT HAD NORMAL FAINTING SYMPTOMS OF HYPOTENSION AND LOOKING PALE
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Fatigue, Hyperhidrosis, Injection site pain
Clinical narrative: 9pm - 7 hours after receiving the shot I was extremely itchy all over and took Benadryl  2am- I woke up unable to move my arms, hands, legs, and feet. I wasn?t able to wake my husband and remained as calm as possible. I drifted in and out of sleep. By 4am I was able to wake my husband. He used our elevating bed to sit me up and gave me ibuprofen and water through a straw (not sure why that was his solution and just thankful I?m here today to type this response). By 6am I had terrible shooting pains in my hands, fingers and then Charlie horses in my feet and calves. That is when the ability to move came back. At that point I was extremely fatigued and exhausted and felt like I had a terrible flu. I was in bed for the next 6 hours clammy and  sweaty and in a very achy.  24 hours after the vaccine I was back on my feet.  50 some hours after the vaccine I still have an aching in my hip on my left side and tenderness at the injection site.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle spasms, Pain, Pain in extremity, Pruritus
Clinical narrative: 9pm - 7 hours after receiving the shot I was extremely itchy all over and took Benadryl  2am- I woke up unable to move my arms, hands, legs, and feet. I wasn?t able to wake my husband and remained as calm as possible. I drifted in and out of sleep. By 4am I was able to wake my husband. He used our elevating bed to sit me up and gave me ibuprofen and water through a straw (not sure why that was his solution and just thankful I?m here today to type this response). By 6am I had terrible shooting pains in my hands, fingers and then Charlie horses in my feet and calves. That is when the ability to move came back. At that point I was extremely fatigued and exhausted and felt like I had a terrible flu. I was in bed for the next 6 hours clammy and  sweaty and in a very achy.  24 hours after the vaccine I was back on my feet.  50 some hours after the vaccine I still have an aching in my hip on my left side and tenderness at the injection site.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Symptons:  Sore Arm and Fatigue  Time Course : Occurred day after vaccination, 4/1/2021  One day only