chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: possible thrombosis reaction; Unexpected bruising near injection site.; Bruise was purple and red splotches and has now progressed to mostly yellow/discoloration; Bruise was purple and red splotches and has now progressed to mostly yellow/discoloration; minimal pain/stiffness following the shot; minimal pain/stiffness following the shot; This is a spontaneous report from a contactable consumer (patient).   A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 53-year-old via an unspecified route of administration, administered in Arm Left on 20Apr2021 11:15 (Lot Number: EW0153) at 1st dose, single for covid-19 immunisation.  The patient medical history was not reported. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included famotidine (PEPCID AC).  The patient previously took flu shot in Oct2020, prilosec [omeprazole magnesium] for seasonal allergy and experienced drug hypersensitivity.  The patient experienced unexpected bruising near injection site. Bruise was the size of the bandaid, approximately 1" x 2". Bruising had persisted for more than a week now. The patient had never experienced bruising like this with other vaccines. He would like to rule out possible thrombosis reaction before second shot. He did not have bruising at any other locations other than the injection site.  Bruise was purple and red splotches and has now progressed to mostly yellow. He believed the discoloration was a reaction to the vaccine and not the result of the needle. The shot itself was painful but patient felt minimal pain/stiffness following the shot. The event start date was on 20Apr2021. No treatment was received. The outcome was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Thrombocytopenia
Clinical narrative: hemoglobin had dropped 1.1 grams/now anemic; thrombocytopenia; This is a spontaneous report from a contactable physician. A 63-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Apr2021 (Lot Number: ER8729) as single dose for covid-19 immunization. Medical history included autoimmune thyroiditis, psoriasis. Concomitant medications included levothyroxine. The patient experienced thrombocytopenia on 13Apr2021, one week later, platelets rebounded but his hemoglobin had dropped 1.1 grams, now anemic. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, patient was unknown diagnosed with COVID-19. The outcome was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events thrombocytopenia and hemoglobin decreased and the suspect drug.  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 agency, as appropriate.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Pericarditis, X-ray
Clinical narrative: Extreme heart pain; Pericarditis; very hard to breath; This is a spontaneous report from a contactable consumer (patient). A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 18Apr2021 11:00 (Batch/Lot Number: ER8735) at the age of 23-years-old as single dose for covid-19 immunization. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included known allergies Gluten. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: Er8730) in Right arm on 28Mar2021 11:00 AM at the age of 23-years-old for covid-19 immunization. The patient experienced Pericarditis- Extreme heart pain, very hard to breath, taken to Emergency room (ER) 21Apr2021 19:00. Events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient underwent lab tests and procedures which included blood tests: unknown results,  electrocardiogram (EKG): unknown results, x-ray: unknown results, all on an unknown date. The outcome of the events was recovering.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Ataxia, Headache, Nervous system disorder, Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: neuropathy; ataxia; neurological deficits with headache; Headache; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm left on 16Mar2021 (Lot Number: En6208) (at age of 47-year-old)  as single dose for covid-19 immunization. Medical history included high blood pressure, there was no known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 23Feb2021 (Lot number: En6198) for covid-19 immunization. There was no other vaccine in four weeks. Adverse event: Headache occurred 10-15 mins after second vaccination. Persistent headache after 3 weeks of 2 COVID vaccination. After the 3 weeks (also reported  as on 26Mar2021) started experiencing neurological deficits with headache. Symptoms include: motor sensory weakness, ataxia and neuropathy. Admitted to hospital for neuropathy and ataxia on 21Apr2021. AE results in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative  on 21Apr2021.There was no COVID prior vaccination. The outcome of the events was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 57 years, administered in Arm Left, on 12Mar2021 14:00  (Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included High Blood Pressure. The patient was not pregnant at time of vaccination. Concomitant medications included labetalol; furosemide; spironolactone. The patient previously took naproxen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Bell's Palsy (medically significant) on 16Mar2021 21:00.  The adverse event result in "Emergency room/department or urgent care". The patient received treatment of steroids and antibiotics for event. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. Event outcome was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT in right calf; This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 53-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Left arm on 21Apr2021 14:30 (Lot Number: EWO170) as 1st dose, single for covid-19 immunization. Medical history included hypertonic bladder. The patient's concomitant medication included unspecified medication. The patient experienced DVT in right calf on 26Apr2021. The event resulted in Emergency room/department or urgent care. The patient received the Xarelto 15mg as treatment. The patient was not pregnant at time of vaccination. The outcome of the event was recovering.; Sender's Comments: The event DVT was considered related to suspect drug BNT162B2 based on compatible temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions cannot be excluded.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Polymenorrhoea, Thrombosis
Clinical narrative: began having severe cramping and heavy bleeding with clots the next day; Started menstrual cycle a week early a day after getting second dose; began having severe cramping; heavy bleeding with clots the next day; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (BNT162B2, Pfizer COVID 19), dose 2 via an unspecified route of administration, administered in left arm on 26Apr2021 08:45 (Lot Number: unknown) as single dose for covid-19 immunization. Medical history included Anemia, ulcerative colitis, intracranial hypertension. None allergies reported. Concomitant medications included iron taken for anaemia. The patient received dose 1 on 01Apr2021 07:45 in right arm for covid-19 immunization. The patient started menstrual cycle a week early a day after getting second dose. The patient began having severe cramping and heavy bleeding with clots the next day 27Apr2021. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. The outcome was recovering.  Follow up attempts are needed. Further information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal vein occlusion
Clinical narrative: First Vaccine, BRVO in the right eye approx 1 week after injection. (sucks).; This is a spontaneous report from a contactable consumer (patient) reporting different event under the same suspect product. This is one of two reports. A 53-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 06Apr2021 15:45 (Batch/Lot Number: ER8729) at the vaccination age of 53 years old as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, Hypertension, High T3. Patient had allergies penicillin, Tetracycline, "Teramyacin". Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; liothyronine sodium (CYTOMEL) taken for an unspecified indication, start and stop date were not reported; nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported. The patient experienced BRVO in the right eye approx 1 week after injection. Therapeutic measures were taken as a result of the event and patient visited other healthcare professional office/clinic visit. Outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Menstruation irregular, Pain, Thrombosis
Clinical narrative: Blood clotting with spotting and pain; Irregular period; Pain in lower left side of abdomen; Blood clotting with spotting and pain; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Mar2021 10:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included none. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications the patient received within 2 weeks of vaccination. The patient previously received the first dose on 05Mar2021 08:00 as single dose for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The patient experienced irregular period after second dose, pain in lower left side of abdomen and blood clotting with spotting and pain on 16Apr2021 12:00. The outcome of the events was unknown.  No treatment received for the events.   Information related lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Lymphocyte count, Lymphocyte count decreased, Nephrolithiasis
Clinical narrative: kidney stone irritation; chills; aches and pains; dehydration; low white blood cell count/ White blood cells: Before: 4.9 and After: 2.4; Neutrophils, before 2.9, after 1.6; Lymphocytes: before 1.2, after 0.4; This is a spontaneous report from a contactable consumer (patient). A 46-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 46 years, administered in Right arm, on 18Apr2021 13:15 (Lot Number: 8737) as single dose for covid-19 immunisation.  Medical history included ongoing Kidney stones. The patient was not pregnant at time of vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 46 years in the Left arm on 27Mar2021 15:30 (Lot Number: 8734) as single dose for COVID-19 immunisation. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient, on 19Apr2021 01:30, had typically reported side effects (chills, aches and pains), plus dehydration which caused kidney stone irritation and resulted in ER visit. While there, noticed really low white blood cell count during labs. Here are labs two days before and two days after vaccine: White blood cells: Before: 4.9 and After: 2.4; Neutrophils: Before: 2.9 and After: 1.6; Lymphocytes: Before: 1.2 and After: 0.4. The adverse event result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". The patient received treatment for event that included Hydration, pain/nausea meds for kidney stones. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. Events outcome was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count, Neutrophil count decreased, Pain, White blood cell count, White blood cell count decreased
Clinical narrative: kidney stone irritation; chills; aches and pains; dehydration; low white blood cell count/ White blood cells: Before: 4.9 and After: 2.4; Neutrophils, before 2.9, after 1.6; Lymphocytes: before 1.2, after 0.4; This is a spontaneous report from a contactable consumer (patient). A 46-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 46 years, administered in Right arm, on 18Apr2021 13:15 (Lot Number: 8737) as single dose for covid-19 immunisation.  Medical history included ongoing Kidney stones. The patient was not pregnant at time of vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 46 years in the Left arm on 27Mar2021 15:30 (Lot Number: 8734) as single dose for COVID-19 immunisation. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient, on 19Apr2021 01:30, had typically reported side effects (chills, aches and pains), plus dehydration which caused kidney stone irritation and resulted in ER visit. While there, noticed really low white blood cell count during labs. Here are labs two days before and two days after vaccine: White blood cells: Before: 4.9 and After: 2.4; Neutrophils: Before: 2.9 and After: 1.6; Lymphocytes: Before: 1.2 and After: 0.4. The adverse event result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". The patient received treatment for event that included Hydration, pain/nausea meds for kidney stones. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. Events outcome was recovering.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Culture throat, Expired product administered, Fatigue, Headache, Illness
Clinical narrative: Sore throat; not been feeling well; Nasal congestion; Headache; Fever; Fatigue/Tiredness; she gave her son Extra Strength Tylenol 500mg tablets: NDC Number: 50580-449-09, Lot Number: LEA012, Expiration Date: Feb2021; Now sick at the Urgent Care; This is a spontaneous report from two contactable consumers one of (patient mother) via Medical information team. A 23-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0161, Expiration date was not reported), via an unspecified route of administration, on 20Apr2021 12:00 on left arm as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The transferring agent stated the caller said her son felt fatigued on 20Apr2021 the next day (21Apr2021), and had a headache, fever, and a sore throat. Reported she had called her son's doctor today (28Apr2021) because her son had not been feeling well since yesterday (27Apr2021). She said her son's doctor told her to take her son to an urgent care. She said her son had a COVID-19 Virus test and a Strep Throat Test today (28Apr2021) at urgent care. She said the urgent care also took her son's vital signs. She said she was told by an urgent care staff member that her son's symptoms could be from a number of things, but the urgent care staff member said her suspicion was that her son's symptoms were a side effect from the COVID-19 Vaccine. She clarified that her son's COVID-19 Virus Test was negative today (28Apr2021), but she was told by the urgent care staff member the negative COVID-19 Virus test could be a false negative. She stated her son's Step Throat test results had not come back yet. Clarified her son's sore throat started yesterday (27Apr2021). She said her son couldn't stand having the sore throat. She clarified her son was not feeling well yesterday, and that was why she called her son's doctor today. Reported her son's fever had subsided with Tylenol, and her son's headache had gone away, and not come back. She said her son also had nasal congestion that started yesterday (27Apr2021), but her son was not blowing his nose and also reported she gave her son Extra Strength Tylenol 500mg tablets: NDC Number: 50580-449-09, Lot Number: LEA012, Expiration Date: Feb2021. Reporter calling for her son who took the Covid vaccine and is now sick at the Urgent Care. She is wondering about side effects 7-8 days after taking the vaccine. As per the reporter seriousness criteria reported for the event now sick at the Urgent Care was medically significant. The patient underwent lab tests and procedures which included Strep throat test: unknown and COVID-19 virus test: negative on 28Apr2021. Therapeutic measures were taken as a result of fever. The outcome of the event Sickness and expired drug used was unknown, fatigue, headache, fever was recovered on Apr2021 and not recovered for another events.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nasal congestion, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sore throat; not been feeling well; Nasal congestion; Headache; Fever; Fatigue/Tiredness; she gave her son Extra Strength Tylenol 500mg tablets: NDC Number: 50580-449-09, Lot Number: LEA012, Expiration Date: Feb2021; Now sick at the Urgent Care; This is a spontaneous report from two contactable consumers one of (patient mother) via Medical information team. A 23-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0161, Expiration date was not reported), via an unspecified route of administration, on 20Apr2021 12:00 on left arm as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The transferring agent stated the caller said her son felt fatigued on 20Apr2021 the next day (21Apr2021), and had a headache, fever, and a sore throat. Reported she had called her son's doctor today (28Apr2021) because her son had not been feeling well since yesterday (27Apr2021). She said her son's doctor told her to take her son to an urgent care. She said her son had a COVID-19 Virus test and a Strep Throat Test today (28Apr2021) at urgent care. She said the urgent care also took her son's vital signs. She said she was told by an urgent care staff member that her son's symptoms could be from a number of things, but the urgent care staff member said her suspicion was that her son's symptoms were a side effect from the COVID-19 Vaccine. She clarified that her son's COVID-19 Virus Test was negative today (28Apr2021), but she was told by the urgent care staff member the negative COVID-19 Virus test could be a false negative. She stated her son's Step Throat test results had not come back yet. Clarified her son's sore throat started yesterday (27Apr2021). She said her son couldn't stand having the sore throat. She clarified her son was not feeling well yesterday, and that was why she called her son's doctor today. Reported her son's fever had subsided with Tylenol, and her son's headache had gone away, and not come back. She said her son also had nasal congestion that started yesterday (27Apr2021), but her son was not blowing his nose and also reported she gave her son Extra Strength Tylenol 500mg tablets: NDC Number: 50580-449-09, Lot Number: LEA012, Expiration Date: Feb2021. Reporter calling for her son who took the Covid vaccine and is now sick at the Urgent Care. She is wondering about side effects 7-8 days after taking the vaccine. As per the reporter seriousness criteria reported for the event now sick at the Urgent Care was medically significant. The patient underwent lab tests and procedures which included Strep throat test: unknown and COVID-19 virus test: negative on 28Apr2021. Therapeutic measures were taken as a result of fever. The outcome of the event Sickness and expired drug used was unknown, fatigue, headache, fever was recovered on Apr2021 and not recovered for another events.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Gastrointestinal inflammation, Pancreatitis, Vomiting
Clinical narrative: Pancreatitis flare-up began as the side effects intensified/ Felt like pancreatic and GI inflammation; Pancreatitis flare-up began as the side effects intensified; Felt like pancreatic and GI inflammation; Could't keep any food or liquid down; vomited green stomach bile; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 11:45 AM (Batch/Lot Number: ER8734) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 40 years old. Patient was not pregnant. Medical history included Chronic Pancreatitis (idiopathic) from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Occassional Benadryl allergy and Tylenol, both taken for an unspecified indication, start and stop date were not reported.  The patient previously took clindamycin and experienced known allergies, bnt162b2 for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (brand=Pfizer; lot number=EW0172) on Apr2021 03:45 PM at Left arm for covid-19 immunization. The patient experienced pancreatitis flare-up began as the side effects intensified (medically significant), felt like pancreatic inflammation (medically significant), GI inflammation (non-serious), could't keep any food or liquid down (non-serious), vomited green stomach bile (non-serious), all on 25Apr2021 18:00 with outcome of recovering.  Reported as pancreatitis flare-up began as the side effects intensified. Could't keep any food or liquid down and vomited green stomach bile. Felt like pancreatic and GI inflammation as my immune system responded to vax. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Arthralgia, Body temperature, Cardiac flutter, Chills
Clinical narrative: heart fluttering; arrhythmias; Fever; chills; intense pressure behind eyes; headache; muscle weakness; fatigue; brain fog; intense body pains/aches; intense body pains/aches - especially at joints (knees, wrists, ankles); heart pounding; insomnia; lack of appetite; migraine with aura; lethargy; This is a spontaneous report from a contactable pharmacist (patient). A 30-years-old male patient received bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/facility. The patient medical history was not reported. No known allergies. The patient's concomitant medications were none. No other vaccine in four weeks. No other medication in two weeks. The patient previous received the first dose on 31Mar2021 11:00 (Lot number=ER8737) as single dose at Left arm for covid-19 immunization. The patient had no reaction on previous exposure to vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Fever, chills, intense pressure behind eyes, headache, muscle weakness, fatigue, brain fog, intense body pains/aches - especially at joints (knees, wrists, ankles), arrhythmias/heart fluttering, heart pounding, insomnia, lack of appetite, migraine with aura, lethargy on 22Apr2021 13:00. The outcome of the events was recovering. No treatment received.; Sender's Comments: The contributory role of the suspect product bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization to reported events is possible based on temporal association and known profile of the product.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Headache, Insomnia
Clinical narrative: heart fluttering; arrhythmias; Fever; chills; intense pressure behind eyes; headache; muscle weakness; fatigue; brain fog; intense body pains/aches; intense body pains/aches - especially at joints (knees, wrists, ankles); heart pounding; insomnia; lack of appetite; migraine with aura; lethargy; This is a spontaneous report from a contactable pharmacist (patient). A 30-years-old male patient received bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/facility. The patient medical history was not reported. No known allergies. The patient's concomitant medications were none. No other vaccine in four weeks. No other medication in two weeks. The patient previous received the first dose on 31Mar2021 11:00 (Lot number=ER8737) as single dose at Left arm for covid-19 immunization. The patient had no reaction on previous exposure to vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Fever, chills, intense pressure behind eyes, headache, muscle weakness, fatigue, brain fog, intense body pains/aches - especially at joints (knees, wrists, ankles), arrhythmias/heart fluttering, heart pounding, insomnia, lack of appetite, migraine with aura, lethargy on 22Apr2021 13:00. The outcome of the events was recovering. No treatment received.; Sender's Comments: The contributory role of the suspect product bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization to reported events is possible based on temporal association and known profile of the product.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Migraine with aura, Muscular weakness, Ocular discomfort, Pain
Clinical narrative: heart fluttering; arrhythmias; Fever; chills; intense pressure behind eyes; headache; muscle weakness; fatigue; brain fog; intense body pains/aches; intense body pains/aches - especially at joints (knees, wrists, ankles); heart pounding; insomnia; lack of appetite; migraine with aura; lethargy; This is a spontaneous report from a contactable pharmacist (patient). A 30-years-old male patient received bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/facility. The patient medical history was not reported. No known allergies. The patient's concomitant medications were none. No other vaccine in four weeks. No other medication in two weeks. The patient previous received the first dose on 31Mar2021 11:00 (Lot number=ER8737) as single dose at Left arm for covid-19 immunization. The patient had no reaction on previous exposure to vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Fever, chills, intense pressure behind eyes, headache, muscle weakness, fatigue, brain fog, intense body pains/aches - especially at joints (knees, wrists, ankles), arrhythmias/heart fluttering, heart pounding, insomnia, lack of appetite, migraine with aura, lethargy on 22Apr2021 13:00. The outcome of the events was recovering. No treatment received.; Sender's Comments: The contributory role of the suspect product bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization to reported events is possible based on temporal association and known profile of the product.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: heart fluttering; arrhythmias; Fever; chills; intense pressure behind eyes; headache; muscle weakness; fatigue; brain fog; intense body pains/aches; intense body pains/aches - especially at joints (knees, wrists, ankles); heart pounding; insomnia; lack of appetite; migraine with aura; lethargy; This is a spontaneous report from a contactable pharmacist (patient). A 30-years-old male patient received bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/facility. The patient medical history was not reported. No known allergies. The patient's concomitant medications were none. No other vaccine in four weeks. No other medication in two weeks. The patient previous received the first dose on 31Mar2021 11:00 (Lot number=ER8737) as single dose at Left arm for covid-19 immunization. The patient had no reaction on previous exposure to vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Fever, chills, intense pressure behind eyes, headache, muscle weakness, fatigue, brain fog, intense body pains/aches - especially at joints (knees, wrists, ankles), arrhythmias/heart fluttering, heart pounding, insomnia, lack of appetite, migraine with aura, lethargy on 22Apr2021 13:00. The outcome of the events was recovering. No treatment received.; Sender's Comments: The contributory role of the suspect product bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization to reported events is possible based on temporal association and known profile of the product.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis, Muscular weakness
Clinical narrative: 2 or 3 days after first shot, I noticed my face drooping a bit on the left side of my mouth. then my left eye would not open imediately when would wake up. 2 days after my 2nd muscle weakness worsened; 2 or 3 days after first shot, I noticed my face drooping a bit on the left side of my mouth. then my left eye would not open imediately when would wake up. 2 days after my 2nd muscle weakness worsened; 2 or 3 days after first shot, I noticed my face drooping a bit on the left side of my mouth. then my left eye would not open imediately when would wake up. 2 days after my 2nd muscle weakness worsened; This is a spontaneous report from a contactable consumer (patient).  A 51-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 03Apr2021 12:15 (Batch/Lot Number: EP6955) as SINGLE DOSE, patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration, administered in Arm Left on 24Apr2021 12:30 (Batch/Lot Number: ER8735) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, stroke after surgery (No lasting effects from stroke). Relevant past drug history: known drug hypersensitivity to Sulfa drugs. Concomitant medications included lisinopril (LISINOPRIL),  atorvastatin (ATORVASTATIN), gabapentin (GABAPENTIN),  loratadine (LOTADINE). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19 On an unspecified date Apr2021,The patient experienced Bells Palsy, Facial droop, muscle weakness worsened.. The clinical course was reported as follows 2 or 3 days after first shot, patient 'I  noticed  face drooping a bit on the left side of my mouth. then my left eye would not open immediately when would wake up. 2 days after my 2nd muscle weakness worsened. The events were medically significant. The adverse events did required an Emergency Room Visit. Therapeutic measures were taken as a result of Bells Palsy, Facial droop , muscle weakness worsened. The clinical outcome of the events was recovering.    Follow up needed, further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: a blot clot discovered in lung within 2 weeks of first shot.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number En6202, on 28Feb2021 10:45 at single dose in right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no covid prior vaccination. The patient had not tested covid post vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a blot clot discovered in lung within 2 weeks of first shot on 11Mar2021. The event resulted in Physician Office Visit. Treatment included blood thinner for blood clot. The outcome of the event was unknown. The event is serious with hospitalization and disability.  Follow-up attempts are needed. Further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: Fell and blacked out briefly; Dizziness; Fell and blacked out briefly; This is a spontaneous report received from a contactable consumer (patient). A 32-years female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8735, on 15Apr2021 07:45 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The patient had no known allergies. The patient had Dizziness on Friday in the evening (16Apr2021). Fell and blacked out briefly at evening.  No treatment was received for the events. The outcome of the events was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal detachment, SARS-CoV-2 test
Clinical narrative: Detached retina; This is a spontaneous report from a non-contactable consumer (patient). A 67-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262, on 23Jan2021 at 14:00 at single dose in left arm for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The patient had no Known allergies. The patient experienced Detached retina on 01Feb2021. The event resulted Physician Office Visit. Treatment received included Surgery. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 Since the vaccination. Lab data included Nasal Swab with unknown results.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Headache, Hypertension, Syncope
Clinical narrative: having faint spells; blood pressure is a little bit higher than normal; Feeling kind of funny; had severe headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8727, second dose) solution for injection intramuscular in the left arm on 25Mar2021 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. Medical history included thyroid disease (diagnosed with probably 20-21 years ago) and blood pressure increased (takes blood pressure medicine). Concomitant medication included hydrochlorothiazide for blood pressure increased began taking this 4 or 5 years ago. Historical vaccine included BNT162B2 (first dose, lot EN6200) for COVID-19 vaccination on 04Mar2021 with no adverse effect reported. On 25Mar2021, the patient was feeling kind of funny and had a severe headache. In Apr2021, the patient had faint spells and blood pressure was a little bit higher than normal at 137/80 which began after the second dose Pfizer Covid Vaccine. The patient stated she never felt like fainting before in her life. Her blood pressure was never over 150 and can't keep blood pressure under 130 for some reason. The outcome of the events feeling kind of funny and headache was unknown. The outcome of the events faint spells and blood pressure was a little bit higher was not recovered.  Information on batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event faint spells and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Malaise, Rectal haemorrhage, Thrombosis
Clinical narrative: passing blood clots from her rectum; blood clots; deathly ill; the lymph nodes underneath the arm swell up / She swelled up on her right side; kind of in the breast/chest area, up a little higher than the breast and it was very uncomfortable; This is a spontaneous report received a contactable consumer, the patient. A 68-year-old elderly female received the first dose of intramuscular BNT162b2 (solution for injection; Lot ER8737 and expiry information not provided) as a single dose in the left arm on 08Apr2021 at 11:00 (at 68-years-old) for COVID-19 immunisation. Relevant medical history included ongoing back problems for which she takes medication. Concomitant medications included unspecified medication for back problems. The patient denied any other vaccines within four weeks prior to this vaccine. The patient reported that she generally gets the flu shot every year and has never had any adverse reactions. The patient also mentioned that she previously tramadol (for an unspecified indication) in the past but has not taken it for years. The patient reported that she received her first dose on 08Apr2021 at (Privacy). The patient explained that within six hours she was deathly ill. The patient reported that stayed very ill for quite a few days.  The patient stated when she gets up in the morning, she gets up early and she always goes to the bathroom. The patient stated that on 13Apr2021, when she went to the bathroom, she started passing blood clots from her rectum which went on until 16Apr2021. When describing the blood clots, the patient stated 'envision sunny side up eggs, between six to eight of them, and in between that was all this webbing holding the clots together'. The patient stated while she was urinating, the clots were just pouring out of her rectum. The patient clarified that there was not blood in her stool. The patient explained that she took the opportunity to get some plastic gloves and look through her stool for blood and there was not any. The patient stated that her underwear and the toilet paper was stained. The patient also stated that she was reading that whichever arm you get the vaccine, the lymph nodes underneath the arm swell up. The patient explained that her lymph nodes did not swell up underneath her left arm where she got the shot. She swelled up on her right side. She clarifies she was swollen underneath her arm, kind of in the breast area and chest area, up a little higher than the breast. It was very uncomfortable. The patient denied any visits to the emergency room or doctor's office for the events. The outcome of the event passing blood clots from her rectum was recovered on 16Apr2021. The outcome of the events deathly ill, the lymph nodes underneath the arm swell up / She swelled up on her right side, and was very uncomfortable was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She had a rapid test performed that was positive and went a received a PCR test for confirmation; She had a rapid test performed that was positive and went a received a PCR test for confirmation; This is a spontaneous report from a contactable consumer (patient self, a Physician Assistant). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, the first dose on 18Dec2020 at single dose and the second dose on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had a weekly PCR test. Her last test on Tuesday April 20th was negative. On evening (Friday 23Apr2021) patient felt exhausted and slightly congested and realized she was the only member of the household that had not received a screening test that day. She had a rapid test performed that was positive and went to receive a PCR test for confirmation. Her symptoms had progressed since then including severe fatigue, dry cough, significant congestion, and become easily winded with minimal exertion. She had been monitoring her temperatures and O2 sats. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Tested positive For Covid on 19Apr2021; Nasal Swab tested positive for Covid on 19Apr2021; body aches; Sorearm; This is a spontaneous report from a contactable consumer (patient).   A 43-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 12:15 (Lot Number: EW0150) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included hypothyroidism. The patient's concomitant medications were not reported. Relevant past drug history included Pennicilin and sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient first reported she received her first dose on 05Apr2021 and then got COVID on April 15th. She was due for her second vaccine on 26Apr2021 but due to isolation she was unable. She further reported that she had body aches and sore arm on 05Apr2021 for over a week. Nasal Swab tested positive for Covid on 19Apr2021 and was out of work for 10 days. The outcome of the events body aches and sorearm was resolving and for other events was unknown. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 on 30Apr2021.