chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: I had my first dose of Covid Vaccine (Moderna) on April 20th 2021. After around 15-20 min of vaccination I had numbness and tingling  around my mouth and nose. It stayed for around 20-30 min. After it has gone I had same feeling around my eye bags for some time.   Do I need to get it checked? Should I go for second dose?
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site reaction, Pain, Rash erythematous
Clinical narrative: Chills, body aches, and headache approximately 12 hours after injection. Chills and body aches lasted a few hours. Headache lasted about a day. Red, warm rash (not itchy) near injection site approximately 3 days after injection.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Chills, body aches, and headache approximately 12 hours after injection. Chills and body aches lasted a few hours. Headache lasted about a day. Red, warm rash (not itchy) near injection site approximately 3 days after injection.
Age: 48.0
Sex: M
Vaccine: UNK
Symptoms: Eye disorder, Headache, Malaise, Myalgia
Clinical narrative: Got very sick headache muscle ache and eye problems
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed periodic ringing in left ear about 16:00 while driving. Went home rested. 4/25/2021 at 12:50 am, woke up, now constant in left ear.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysmenorrhoea, Menstrual discomfort
Clinical narrative: Increased intensity in menstrual cramps by a noticeable degree, lightheaded was/dizziness
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Sudden loss of walking ability. I can not walk. My legs below knee are hurting a lot. This has escalated in last few days
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Headache, Migraine
Clinical narrative: Within a day or 2 of receiving shot #1, I had a headache . . This headache  persisted  and within days  became a unilateral left sided migraine  whic after a 2-3 weeks became right sided. Both impacted neck to scalp (new symptom), behind the eye, nose, and even hard palate at times. All have  persisted daily since approx 2/18/21.  Tried not to take meds initially, since 18 yrs ago had ulcer rupture due to Excedrine use. Then began Excedrine and Naratriptan  (2x day) for weeks. Naratriptan has always been a successful med and would wipe out a migraine in hours. Then I was fine for weeks or months. Not the case this time. It dulled or temporarily relieved the symptoms, but they would come back that day. Still have daily headache migraine, down to 1 Excedrine a day.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Deep vein thrombosis
Clinical narrative: 3/10/2021 dvt and pe
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Mood swings, Pyrexia
Clinical narrative: Mild fever, mood swings, anxiety
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received 1st Pfizer dose 3 weeks ago, today took covid test and is positive; Received 1st Pfizer dose 3 weeks ago, today took covid test and is positive; This is a spontaneous report received via Pfizer sponsored program COVAX US Support from a contactable consumer (patient). A male patient of an unknown age received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown) via an unspecified route of administration on Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received 1st Pfizer dose 3 weeks ago, and on 06Apr2021 took COVID test and was positive. These events were considered serious (medically significant). The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood creatine phosphokinase normal, Blood lactate dehydrogenase normal, Blood thyroid stimulating hormone normal, C-reactive protein normal
Clinical narrative: severe lower extremity weakness.  on 4/13/2021 experienced myalgias and generalized weakness/malaise,  which have persisted.  on 4/21/2021 the patient was able to walk using her walker however extremely slowly.  At baseline she is able to walk around the house with a walker relatively briskly.  on 4/22/2021 the patient was unable to transfer from a sitting to standing position, and was no longer able to ambulate with her walker.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Computerised tomogram spine, Dysstasia, Full blood count normal, Gait inability
Clinical narrative: severe lower extremity weakness.  on 4/13/2021 experienced myalgias and generalized weakness/malaise,  which have persisted.  on 4/21/2021 the patient was able to walk using her walker however extremely slowly.  At baseline she is able to walk around the house with a walker relatively briskly.  on 4/22/2021 the patient was unable to transfer from a sitting to standing position, and was no longer able to ambulate with her walker.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Metabolic function test normal, Muscular weakness, Myalgia, Red blood cell sedimentation rate normal
Clinical narrative: severe lower extremity weakness.  on 4/13/2021 experienced myalgias and generalized weakness/malaise,  which have persisted.  on 4/21/2021 the patient was able to walk using her walker however extremely slowly.  At baseline she is able to walk around the house with a walker relatively briskly.  on 4/22/2021 the patient was unable to transfer from a sitting to standing position, and was no longer able to ambulate with her walker.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Treponema test negative, Urine analysis normal, Vitamin B12 normal
Clinical narrative: severe lower extremity weakness.  on 4/13/2021 experienced myalgias and generalized weakness/malaise,  which have persisted.  on 4/21/2021 the patient was able to walk using her walker however extremely slowly.  At baseline she is able to walk around the house with a walker relatively briskly.  on 4/22/2021 the patient was unable to transfer from a sitting to standing position, and was no longer able to ambulate with her walker.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Rash, Rash macular
Clinical narrative: Red blotchy rash on arms, chest, torso, and thighs. Did not itch. Saw doctor. He described as hypersensitivity rash. Prescription for prednisone. Short course of 5 days of medication.  Rash gone after day 4 and has not returned.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in hand and feet in left side of body . Tingling is intermittent.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Acute, left femoral DVT.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test normal, Electrocardiogram normal, Syncope
Clinical narrative: Fainted while seated &  experienced 3 possible atrial fibrillation events
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray normal, Chills, Dyspnoea, Eructation
Clinical narrative: Shortness of breathe with reduced pulse Ox of 93, trouble breathing, body aches, arm soreness, chills, fever, headache, excessive burping, weakness, unable to care for self
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Laboratory test normal, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Shortness of breathe with reduced pulse Ox of 93, trouble breathing, body aches, arm soreness, chills, fever, headache, excessive burping, weakness, unable to care for self
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Shortness of breathe with reduced pulse Ox of 93, trouble breathing, body aches, arm soreness, chills, fever, headache, excessive burping, weakness, unable to care for self
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Somnolence, Vaccination site pain
Clinical narrative: Injection site pain in left arm; tired/Fatigue; Lightheadedness; Sleepiness; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 68-year-old female patient received an unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left upper arm on 07Apr2021 at 12:30pm, as single dose for COVID-19 immunization. The patient medical history included slightly elevated blood pressure and slightly elevated cholesterol. The concomitant medication included hydrochlorothiazide 12.5 mg once a day for blood pressure, amlodipine 10 mg once a day for blood pressure and atorvastatin 40 mg once a day for Cholesterol. It stated that, On 07Apr2021 patient experienced, injection site pain in left arm: States that it is really uncomfortable. Has had other vaccination shots before, moved arms around a lot. She asked them to give her the shot in her upper waist and they refused. Her arms are scrawny, which is why she asked for a different spot. Tired, fatigue and sleepiness. The patient was tired yesterday and woke up this morning later than expected. Felt more fatigue yesterday but not today. States that people should have an option of another location they feel more comfortable. States that they probably don't think about that because of the way people are normally dressed. Caller notes that she wants to report for her daughter too, she had a similar experience. Caller states that she heard that the vaccines are only good for 6 months. Wants to know if, since people need to be re-vaccinated every 6 months. The patient states that in her last blood work, everything was in normal range. She took aleve as corrective treatment. After the vaccination she was asked to stay 15 minutes because of an allergic reaction she had to blood pressure medication maybe 5 years ago. States it was an anaphylactic reaction is not allergic to anything else. Vaccination facility type: hospital. There was no additional vaccines administered on same date. The AEs was not requires visit to emergency room or physician's office. No prior vaccinations within 4 weeks. The outcome of the event lightheadedness and injection site pain in left arm was not recovered and the outcome of the event sleepiness and fatigue was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use
Clinical narrative: Caller wanted to know when can they have the second dose, their doctor told them to wait for 90 days.; Caller wanted to know when can they have the second dose, their doctor told them to wait for 90 days.; on 20Mar he contacted covid; on 20Mar he contacted covid; This is a spontaneous report received from a contactable consumer (wife of patient). This consumer reported same events for two patients. This is the second of two reports. A 55-year-old male patient (husband) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route on 24Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had his first dose of the COVID vaccine on 24Feb2021 and on 20Mar2021 contracted COVID, quarantine completed and was back to work. The reporter wanted to know when can they have the second dose, their doctor told them to wait for 90 days. The clinical outcome of COVID was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381231 Same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: aches and sore arm; This is a spontaneous report from a contactable consumer. An adult female patient received second dose of bnt162b2 (Pfizer, Batch/Lot Number: Unknown), via an unspecified route of administration in left arm on 06Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previous received first dose of bnt162b2 (Batch/Lot number was not reported) via an unspecified route of administration in left arm on 17Mar2021 as single dose for covid-19 immunization. The patient experienced aches and sore arm on 06Apr2021. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of event was resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastritis
Clinical narrative: diahrea for 5 days; Gastritis; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Right arm on 01Apr2021 at 10:00 AM (at the age of 71-year-old) at single dose for COVID-19 immunisation. Medical history included Diabetes, left breast cancer, arthritis. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin calcium (CRESTOR); pramipexole dihydrochloride (MIRAPEX); levothyroxine; tramadol and celecoxib (CELEBREX). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Gastritis and diahrea for 5 days, both on 02Apr2021 at 08:00 AM. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for events. The outcome of the events was recovering. AE were not resulted in Emergency Room Visit nor Physician Office Visit.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Peripheral swelling, Seizure, Tremor
Clinical narrative: jerking movements; keeps shaking her head and her arms/trembling; a couple of seizures; swelling on her arm; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included nonverbal, Cerebral Palsy and seizure disorder. The patient's concomitant medications were not reported. The patient had swelling on her arm when they got home from getting the vaccine and they gave her some Tylenol. On 07Apr2021, the patient has been having these jerking movements, something like if she had Parkinson's, it was a trembling. The patient kept shaking her head and her arms. After the shot, the patient had a couple of seizures when they got home on 06Apr2021, which is not uncommon because she has a seizure disorder and has them pretty frequently. The jerking that the patient was doing was not like her seizures. The patient did have Cerebral Palsy, a seizure disorder, and other conditions. The event outcome for events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fall, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: tingling sensation; she fell down and could not get up; She stated that she is able to use her left hand but it is very painful.; pain in the joints, ankle, knee, hands; numbness; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tingling sensation, she stated that she is able to use her left hand but it is very painful, she fell down and could not get up, pain in the joints, ankle, knee, hands, numbness. On 10Mar2021 morning she has been having symptoms, like stoke (that is what she calls it she said) she fell down and could not get up, pain in the joints, ankle, knee, hands. Pain the hands got worse and have numbness, can't pick up things, numbness moves to the hand and fingers. Caller wanted to know can she safely take the second dose. The following morning (on 10Mar2021) she woke to a tingling sensation in her left ankle/foot that progressed to her leg and eventually into her left hand. She stated that it feels as if these regions of the left side of her body have fallen asleep and are waking up but the sensation is continuous. She stated that she is able to use her left hand but it is very painful. She wants to know if she will ever recover from these symptoms and what her recourse is. She has since canceled her appointment to receive her second dose of the vaccine. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Thinking abnormal
Clinical narrative: tingling sensation; she fell down and could not get up; She stated that she is able to use her left hand but it is very painful.; pain in the joints, ankle, knee, hands; numbness; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tingling sensation, she stated that she is able to use her left hand but it is very painful, she fell down and could not get up, pain in the joints, ankle, knee, hands, numbness. On 10Mar2021 morning she has been having symptoms, like stoke (that is what she calls it she said) she fell down and could not get up, pain in the joints, ankle, knee, hands. Pain the hands got worse and have numbness, can't pick up things, numbness moves to the hand and fingers. Caller wanted to know can she safely take the second dose. The following morning (on 10Mar2021) she woke to a tingling sensation in her left ankle/foot that progressed to her leg and eventually into her left hand. She stated that it feels as if these regions of the left side of her body have fallen asleep and are waking up but the sensation is continuous. She stated that she is able to use her left hand but it is very painful. She wants to know if she will ever recover from these symptoms and what her recourse is. She has since canceled her appointment to receive her second dose of the vaccine. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Atrial fibrillation, Chills, Headache, Heart rate
Clinical narrative: irregular heart beat/afib; Chills; fever; headache; body ache; upset stomach; irregular heart beat/afib; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 08:15 at single dose for COVID-19 immunisation. The patient's medical history included hypertension and afib. Concomitant medications included lisinopril, acetylsalicylic acid (ASPIRIN), both taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior to vaccination and was not tested for COVID post-vaccination. The vaccination facility type was Urgent Care Center (reported as Doctor's office/urgent care). On 08Apr2021 at 02:30, the patient experienced irregular heart beat/afib, chills, fever, headache, body ache, and upset stomach. No treatment was received for the events. The patient underwent lab tests and procedures which included heart beat: irregular on 08Apr2021. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular, Pain, Pyrexia
Clinical narrative: irregular heart beat/afib; Chills; fever; headache; body ache; upset stomach; irregular heart beat/afib; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 08:15 at single dose for COVID-19 immunisation. The patient's medical history included hypertension and afib. Concomitant medications included lisinopril, acetylsalicylic acid (ASPIRIN), both taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior to vaccination and was not tested for COVID post-vaccination. The vaccination facility type was Urgent Care Center (reported as Doctor's office/urgent care). On 08Apr2021 at 02:30, the patient experienced irregular heart beat/afib, chills, fever, headache, body ache, and upset stomach. No treatment was received for the events. The patient underwent lab tests and procedures which included heart beat: irregular on 08Apr2021. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Heart rate abnormal, Nausea, Pain
Clinical narrative: irregular heart beat/afib; Chills; fever; headache; body ache; upset stomach; irregular heart beat/afib; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 08:15 at single dose for COVID-19 immunisation. The patient's medical history included hypertension and afib. Concomitant medications included lisinopril, acetylsalicylic acid (ASPIRIN), both taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior to vaccination and was not tested for COVID post-vaccination. The vaccination facility type was Urgent Care Center (reported as Doctor's office/urgent care). On 08Apr2021 at 02:30, the patient experienced irregular heart beat/afib, chills, fever, headache, body ache, and upset stomach. No treatment was received for the events. The patient underwent lab tests and procedures which included heart beat: irregular on 08Apr2021. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: irregular heart beat/afib; Chills; fever; headache; body ache; upset stomach; irregular heart beat/afib; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 08:15 at single dose for COVID-19 immunisation. The patient's medical history included hypertension and afib. Concomitant medications included lisinopril, acetylsalicylic acid (ASPIRIN), both taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior to vaccination and was not tested for COVID post-vaccination. The vaccination facility type was Urgent Care Center (reported as Doctor's office/urgent care). On 08Apr2021 at 02:30, the patient experienced irregular heart beat/afib, chills, fever, headache, body ache, and upset stomach. No treatment was received for the events. The patient underwent lab tests and procedures which included heart beat: irregular on 08Apr2021. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Coccydynia, Dysstasia, Gait disturbance, Spinal pain, Vaccination site pain
Clinical narrative: Could not stand; Piercing pain in middle of spine to tailbone; Piercing pain in middle of spine to tailbone; Walking was very difficult; Left arm injection site sore; This is a spontaneous report from a contactable consumer(spouse). A 63-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number ER8729), intramuscular at Arm Left on 06APR2021 10:45 at the 63 years old at single dose for COVID-19 immunization.  The medical history was none. The concomitant medications were none. The Historical Vaccine was BNT162B2 first dose on 16MAR2021 at 63 years old for COVID-19 immunization (Lot ER2613; Injected in left arm given in the muscle).The reporter was calling on behalf of her husband who had the second vaccine yesterday. He had an odd reaction and was not good. He had to go to work after getting the vaccine and was at work for an hour. He could not stand and he is a chef. She had to go pick him up. There was a piercing pain in the middle of his spine to his tailbone. The patient experienced Walking was very difficult and Left arm injection site sore. He has been on the Tylenol which is the protocol. All of the events happened on 06APR2021 12:30. This morning on Day 2, it was not much better. She would like to know if there have been any reports of this and what Pfizer recommends for this. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram head, Drug screen, Full blood count, Investigation
Clinical narrative: right cheek tingling/ right arm tingling; This is a spontaneous report from a contactable physician.  A 20-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date at the age of 20-years-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. 15 minutes after the first dose of the Pfizer Covid19 vaccine, the patient started having tingling in her right cheek.  Labs and CT were negative. The reporter did not see any deficit, the patient was just complaining of right cheek tingling, right arm tingling. The patient had no allergies, surgeries, or medical problems, no itchiness, no shortness of breath, no hives. It was  like the CT of brain was normal, then the MRI, and that they keep getting normal. CBC, CMP, urine, and drug screen were all normal. The patient did report that she was getting better - no more right arm tingling, and the right cheek tingling was almost gone. The event outcome was recovering.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Metabolic function test, Paraesthesia, Urine analysis
Clinical narrative: right cheek tingling/ right arm tingling; This is a spontaneous report from a contactable physician.  A 20-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date at the age of 20-years-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. 15 minutes after the first dose of the Pfizer Covid19 vaccine, the patient started having tingling in her right cheek.  Labs and CT were negative. The reporter did not see any deficit, the patient was just complaining of right cheek tingling, right arm tingling. The patient had no allergies, surgeries, or medical problems, no itchiness, no shortness of breath, no hives. It was  like the CT of brain was normal, then the MRI, and that they keep getting normal. CBC, CMP, urine, and drug screen were all normal. The patient did report that she was getting better - no more right arm tingling, and the right cheek tingling was almost gone. The event outcome was recovering.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Muscular weakness, Pain
Clinical narrative: shortness of breath; body aches; weakness in arms and legs; headaches; chills; This is a spontaneous report received from a contactable consumer. A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Mar2021 (Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced shortness of breath, body aches, weakness in arms and legs, headaches, chills on 03Apr2021 with outcome of recovered on 06Apr2021.  Therapeutic measures were taken as a result of events included Acetaminophen and Ibuprofen.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Nausea, SARS-CoV-2 test, Syncope
Clinical narrative: syncopal episode; dry mouth; chills; nausea; This is a spontaneous report from a non-contactable other health professional (patient). A 20-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 12Jan2021 12:00 (Batch/Lot number was not reported), second dose on 02Feb2021 14:30 (Batch/Lot number was not reported), both via an unspecified route of administration administered in left arm, at 20-year-old female (not pregnant at the time of vaccination) at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No allergies to medications, food, or other products. The patient was not patient diagnosed with COVID-19 prior to vaccination. The patient experienced dry mouth, syncopal episode, chills, nausea on an unspecified date. The events did not result in emergency room visit or physician office visit. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on an unspecified date. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: symptoms similar to COVID/ got really sick; symptoms similar to COVID/ got really sick; This is spontaneous report from contactable consumer, the patient. A 66-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose and then received her second dose of BNT162b2, via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) (at the age of 66-years-old) as a single dose; both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she had her first shot previously and they kept her there an hour instead of 15 minutes. She got her second one yesterday on 06Apr2021 and she got really sick today on 07Apr2021 as she was in bed with symptoms similar to COVID. The outcome of event, symptoms similar to COVID/ got really sick, was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Faeces discoloured, Haemorrhoids, Illness
Clinical narrative: she has been sick as a dog; stool green; bleeding from the bowels; internal and external hemorrhoids; nausea and vomitting; nausea and vomitting; no appetite and weight loss; no appetite and weight loss; loose bowels; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old female patient received the second dose of bnt162b2 (BNT162B2) at the age of 69 years, via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER8727) as a single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 (lot: EN6205) on 05Mar2021 at the age of 69, for Covid-19 immunisation and experienced not feeling good.  The patient experienced loose bowels on 26Mar2021; bleeding from the bowels, internal and external hemorrhoids, nausea and vomiting, no appetite and weight loss on 07Apr2021; and she has been sick as a dog on an unspecified date. The patient further reported that she has been sick as a dog, clarifies this started after her second dose of the Pfizer Covid vaccine. Stated she was given some medication to help stop her loose bowels, called dipheni-atrop, 2.5mg, states to take it for three days as needed for loose stool four times a day, started the medication on 30Mar2021 but stopped taking it because it was not doing any good. The patient has lost 7lb. The patient was taking iron and was turning stool green, it bothered her to see the stool green, so she stopped taking it too. Last night the patient drank two sips of soft drink  and ate a cucumber and a cup of soup and just sat down and started vomiting. States after the second dose this started, the nausea and vomiting, no appetite, lost weight, loose stools, hemmorhoids internal and external, bleeding in the stool. States doctor wanted a stool sample but she has not been able to get one. The outcome of the event bleeding from the bowels was recovering, she has been sick as a dog was unknown and not recovered from all the other events.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Intestinal haemorrhage, Nausea, Vomiting, Weight, Weight decreased
Clinical narrative: she has been sick as a dog; stool green; bleeding from the bowels; internal and external hemorrhoids; nausea and vomitting; nausea and vomitting; no appetite and weight loss; no appetite and weight loss; loose bowels; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old female patient received the second dose of bnt162b2 (BNT162B2) at the age of 69 years, via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER8727) as a single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 (lot: EN6205) on 05Mar2021 at the age of 69, for Covid-19 immunisation and experienced not feeling good.  The patient experienced loose bowels on 26Mar2021; bleeding from the bowels, internal and external hemorrhoids, nausea and vomiting, no appetite and weight loss on 07Apr2021; and she has been sick as a dog on an unspecified date. The patient further reported that she has been sick as a dog, clarifies this started after her second dose of the Pfizer Covid vaccine. Stated she was given some medication to help stop her loose bowels, called dipheni-atrop, 2.5mg, states to take it for three days as needed for loose stool four times a day, started the medication on 30Mar2021 but stopped taking it because it was not doing any good. The patient has lost 7lb. The patient was taking iron and was turning stool green, it bothered her to see the stool green, so she stopped taking it too. Last night the patient drank two sips of soft drink  and ate a cucumber and a cup of soup and just sat down and started vomiting. States after the second dose this started, the nausea and vomiting, no appetite, lost weight, loose stools, hemmorhoids internal and external, bleeding in the stool. States doctor wanted a stool sample but she has not been able to get one. The outcome of the event bleeding from the bowels was recovering, she has been sick as a dog was unknown and not recovered from all the other events.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: the person who got the shot is dying; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had a very bad effect from the second dose of the vaccine, it was reported that the patient who got the COVID-19 shot was dying on an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling good; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205), via an unspecified route of administration, on 05Mar2021, at a single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first dose on 05Mar2021 and she was not feeling good after that one on an unspecified date in 2021, but it was not bad. The outcome of the adverse event was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Atrial flutter; Fatigue; Dizziness; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 62 years old male patient received bnt162b2 (BNT162B2, Pfizer BioNTech COVID-19 vaccine), dose 2 intramuscular, administered in Deltoid Right on 09Mar2021 (Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included Bladder issue, Elevated cholesterol, Elevated BP. Received BNT162B2 dose 1 on 16Feb2021 for COVID-19 immunization when he was 61 years old. Concomitant medications included rosuvastatin taken for Elevated cholesterol; losartan potassium taken for Elevated BP; oxybutynin taken for Bladder issue; tamsulosin taken for Bladder issue. The patient experienced fatigue on 12Mar2021, dizziness on 12Mar2021, shortness of breath on 12Mar2021, atrial flutter on an unspecified date. The patient underwent lab tests and procedures which included echocardiogram with atrial flutter on 05Apr2021, electrocardiogram with atrial flutter on 01Apr2021. After he saw the cardiologist, he was prescribed a betablocker and a blood thinner in the interim. He clarifies he was prescribed Metoprolol tartrate 25mg, twice a day. He was also prescribed Eliquis 5mg, twice a day. There were no additional vaccines administered on same date of the Pfizer. Events require a visit to physician office. prior vaccinations within 4 weeks was none. The outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Atrial flutter; Fatigue; Dizziness; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 62 years old male patient received bnt162b2 (BNT162B2, Pfizer BioNTech COVID-19 vaccine), dose 2 intramuscular, administered in Deltoid Right on 09Mar2021 (Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included Bladder issue, Elevated cholesterol, Elevated BP. Received BNT162B2 dose 1 on 16Feb2021 for COVID-19 immunization when he was 61 years old. Concomitant medications included rosuvastatin taken for Elevated cholesterol; losartan potassium taken for Elevated BP; oxybutynin taken for Bladder issue; tamsulosin taken for Bladder issue. The patient experienced fatigue on 12Mar2021, dizziness on 12Mar2021, shortness of breath on 12Mar2021, atrial flutter on an unspecified date. The patient underwent lab tests and procedures which included echocardiogram with atrial flutter on 05Apr2021, electrocardiogram with atrial flutter on 01Apr2021. After he saw the cardiologist, he was prescribed a betablocker and a blood thinner in the interim. He clarifies he was prescribed Metoprolol tartrate 25mg, twice a day. He was also prescribed Eliquis 5mg, twice a day. There were no additional vaccines administered on same date of the Pfizer. Events require a visit to physician office. prior vaccinations within 4 weeks was none. The outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, visual
Clinical narrative: begin to see faces one at a time/become grotesque looking and scary looking/hallucinations; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8727), via an unspecified route of administration on 18Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had one dose of the Covid vaccine and was supposed to have the second one on the day of the report. She was not sure whether or not to get the second dose. She felt okay after the first dose. She read all the information about side effects and said they were all general side effects and said that the information did not include the unusual side effects. The patient stated that when these happened to her she didn't relate it to the vaccine at first. The patient stated that when she would lay down at night to sleep and close her eyes she would begin to see faces one at a time. They would then become grotesque looking and scary looking. This happened a couple of times, over a couple of days, right when she would close her eyes. The patient mentioned that she had the light on in her room because she always has the light on in her room. The patient asked if is was a side effect people are having. She saw on the internet that it could be a side effect of vaccines. She mentioned it to a friend who told her that she was having hallucinations.  She looked online and it said vaccines can sometimes cause hallucinations. She said she read online about one person who said that after their second dose they had bad hallucinations like as if they were on mushrooms. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19; tested positive for covid-19; This is a spontaneous report received from a contactable consumer (Patients brother). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; lot number and Expiry Date was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history was not reported, Family history included: father has high blood pressure and diabetes. The patient's concomitant medications were not reported. Reporter initially stated, his brother (patient) only had three serious days of this, and it was from the vaccine. He had actually had covid-19. Mentioned he tested positive for covid-19, was quarantined for 2 weeks. He had three days of serious effects from the virus itself. He later confirmed it was from the virus itself, not the shot. The outcome of the events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: it is kind of warm as if the arm has a fever/yesterday it started feeling like I had a fever kind of; at the site of the injection, it was kind of itchy; it was very sore and swollen/large about the size of a peach; There is a huge bump at the side of the vaccine; it was sore/it was very sore and swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in arm on 25Mar2021 (Lot Number: EN6208) as single dose for covid-19 immunisation. Medical history included asthma. Concomitant medication included fluticasone propionate (FLOVENT) taken for asthma. In Apr2021, at the site of the injection, it was kind of itchy and she wanted to scratch it and it was very sore and swollen. So, she just had large about the size of a peach or something. There was a huge bump at the side of the vaccine and it is kind of warm as if the arm had a fever and it was sore. She mean it was sore the following day (26Mar2021). But then she didn't really notice anything until maybe yesterday or the day before (Apr2021). It started out just feeling kind of itchy but when she went to scratch it, it felt like a big notch and it was a sore and then yesterday (02Apr2021) it started feeling like she had a fever kind of. She didn't have a fever. No treatment received. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain/her back is currently hurting; This is a spontaneous report from a contactable consumer (patient) via a Pfizer- sponsored program 159558. A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 06Apr2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received her 1st dose of our COVID-19 vaccine on 06Apr2021 and scheduled to receive the 2nd dose on 27Apr2021 (exactly 21 days apart). She was asking how long it would be possible before she can take aspirin or Ibuprofen for her back pain. She mentioned that her back was currently hurting. Event outcome was unknown.  Information on the lot/batch number has been requested.