chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Injection site pain; severe tiredness; chills; fever 99.8 for 3 days; nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient (pregnant: No) received first dose of bnt162b2 (Batch/Lot Number: EN5318, Pfizer), via an unspecified route of administration in arm left on 06Feb2021 11:00 AM as single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium; alendronate sodium (ALENDRONATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced injection site pain, severe tiredness, chills, fever 99.8 for 3 days, nausea, feeling unwell all on 07Feb2021. The case was reported as non-serious. The outcome of events was resolving. No other vaccine in four weeks. Other medications in two weeks included: Levothoryoxine and alendronate sodium (ALENDRONATE). The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. Not known allergies.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Investigation, Musculoskeletal stiffness, Myalgia, Tendon pain
Clinical narrative: muscle tendon pain on the left side of neck/pain went to right side of neck/pain appeared both sides and still persisting; muscle tendon pain on the left side of neck/pain went to right side of neck/pain appeared both sides and still persisting; pain on the shoulder area; stiff neck; This is a spontaneous report from a contactable consumer, reporting for herself.  A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9263, via an unspecified route of administration on 09Feb2021 at 16:30 (at the age of 79 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included atrial fibrillation diagnosed about 15 years ago. Concomitant medications were not reported. . The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Feb2021, the patient experienced muscle pain and tendon pain. It was reported that she experienced a pain on the shoulder area and a "muscle tendon pain" on the left side of the neck the next day. The pain then went to her right side of her neck the day after. The day after that, she mentioned that the pain appeared on both sides of her and is still persisting until now. She mentioned she had a real stiff neck that she could barely turn her head without having great amount of pain. She could only align her ear to her shoulder on that range. She is not 100% sure it's related to the vaccine but she mentioned that this has never happened before. She is asking if this a normal side effect and how long should this last. It was "Reported she got her first COVID-19 Vaccine shot last Tuesday, 09Feb2021. She said on Wednesday, 10Feb2021, she developed a cramp on the left side of her neck (clarified as more of a muscle or tendon pain) She said the area from where her left bra strap sits to her left ear was sore. She said she got her COVID-19 Vaccine administered in her left shoulder. She said she didn't think anything about the left neck pain at first. She said she put cream on her neck and took some Tylenol as needed. She said the following day, Thursday, 11Feb2021, the left side of her neck was fine, but the right side of her neck had the same muscle pain or tendon pain.  She said both the right and left sides of her neck hurt now. She said she can barely turn her head in either direction due to the pain. Caller asked if her neck pain is some kind of reaction to the COVID-19 Vaccine." She had blood work done on Oct2020 with unknown results. As treatment, she has been taking Extra Strength Tylenol ever since she developed neck pain and arnicare cream for muscle  and tendon pain. The clinical outcome of muscle pain and tendon pain was not recovered. The outcome of stiff neck and pain on shoulder area was unknown.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Computerised tomogram, Electroencephalogram
Clinical narrative: migraine; Fever; mild chills/uncontrollable heavy shivering; cold sweats; Mild muscle pain at injection site; This is a spontaneous report from a contactable healthcare professional (the patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration in the left arm on 14Feb2021 07:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: ADHD (attention deficit hyperactivity disorder), severe migraine, unknown vestibular event in June-Jul2020 attributed to vestibular migraines based on normal CT, MRI, and EEG. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), amitriptyline, caffeine/ paracetamol (EXCEDRIN), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL4262), via an unspecified route of administration in the left arm on 26Jan2021 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Feb2021, the patient experienced mild muscle pain at injection site onset 1 hour after injection (at 08:30) lasted about 24 hours. At 01:20 on 15Feb2021, also reported as 17 hours 10 minutes post-injection, the patient woke up with mild chills, temperature (oral thermometer) was 97.6°F. Chills and cold sweats progressed rapidly, with severe chills and uncontrollable heavy shivering and sweating present within 10-15 minutes (on 15Feb2021). Temperature at 02:00 15Feb2021 was 103.0°F. Fever slowly waned without medication. By 04:30, fever at 101.2°F, chills mild, sweating persisted. At 07:00 15Feb2021, the patient started to develop early stages of migraine (preexisting condition), took EXCEDRIN 565 mg tablet x 2. At 08:00 15Feb2021, the temperature was 98.2°F. By 10:00 15Feb2021, the fever resolved, temperature 97.6 (individual baseline) and chills had resolved. Sweating has improved to be more mild, but persistent now at 16:30 15Feb2021. Treatment was received for migraine. No treatment was received for the other events. The clinical outcome of mild muscle pain at injection site was recovered on 15Feb2021 08:30, chills and fever both recovered on 15Feb2021 10:00. The clinical outcome of cold sweats and migraine was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Migraine, Pyrexia, Vaccination site pain
Clinical narrative: migraine; Fever; mild chills/uncontrollable heavy shivering; cold sweats; Mild muscle pain at injection site; This is a spontaneous report from a contactable healthcare professional (the patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration in the left arm on 14Feb2021 07:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: ADHD (attention deficit hyperactivity disorder), severe migraine, unknown vestibular event in June-Jul2020 attributed to vestibular migraines based on normal CT, MRI, and EEG. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), amitriptyline, caffeine/ paracetamol (EXCEDRIN), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL4262), via an unspecified route of administration in the left arm on 26Jan2021 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Feb2021, the patient experienced mild muscle pain at injection site onset 1 hour after injection (at 08:30) lasted about 24 hours. At 01:20 on 15Feb2021, also reported as 17 hours 10 minutes post-injection, the patient woke up with mild chills, temperature (oral thermometer) was 97.6°F. Chills and cold sweats progressed rapidly, with severe chills and uncontrollable heavy shivering and sweating present within 10-15 minutes (on 15Feb2021). Temperature at 02:00 15Feb2021 was 103.0°F. Fever slowly waned without medication. By 04:30, fever at 101.2°F, chills mild, sweating persisted. At 07:00 15Feb2021, the patient started to develop early stages of migraine (preexisting condition), took EXCEDRIN 565 mg tablet x 2. At 08:00 15Feb2021, the temperature was 98.2°F. By 10:00 15Feb2021, the fever resolved, temperature 97.6 (individual baseline) and chills had resolved. Sweating has improved to be more mild, but persistent now at 16:30 15Feb2021. Treatment was received for migraine. No treatment was received for the other events. The clinical outcome of mild muscle pain at injection site was recovered on 15Feb2021 08:30, chills and fever both recovered on 15Feb2021 10:00. The clinical outcome of cold sweats and migraine was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19/he was having cold-like symptoms/developed nasty cold; tested positive for COVID-19/he was having cold-like symptoms/developed nasty cold; This is a spontaneous report from a contactable consumer (patient). This 66-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He was scheduled to receive the second dose on 18Feb2021. He tested positive for COVID-19 on 12Feb2021. He was having cold-like symptoms/developed nasty cold. On an unspecified date, reported as "on Sunday", he received bamlanivimab infusion an antibody infusion at the hospital. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable physician via a Pfizer-Sponsored Program. This physician reported the same events for two patients. This is the first of two reports. A patient of unspecified gender in their 20s received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. A physician reported that he had a patient who received their first dose of the Pfizer COVID vaccine and then in the interim the patient became ill. The patient was diagnosed COVID positive at some point after the first dose. He stated that the patient got sick with COVID. He wanted to know what the recommendations were for this patient. Should the patient get their second dose or wait? The clinical outcome of the event positive COVID-19 test 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-2021163951 same reporter/event/drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Drug ineffective, Faeces discoloured, Nausea, SARS-CoV-2 test
Clinical narrative: Covid test result: Positive; Covid test result: Positive; Vomiting; Nausea; Diarrhea; Black Stool; This is a spontaneous report from a contactable consumer. An 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a positive COVID test result on an unknown date. It was unknown if the patient was pregnant at the time of vaccination, or had COVID prior vaccination, or if the patient had other vaccine in four weeks. The patient also had vomiting, nausea, diarrhea and black stool. The patient underwent lab tests and procedures which included Covid test: positive on an unknown date. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: Covid test result: Positive; Covid test result: Positive; Vomiting; Nausea; Diarrhea; Black Stool; This is a spontaneous report from a contactable consumer. An 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a positive COVID test result on an unknown date. It was unknown if the patient was pregnant at the time of vaccination, or had COVID prior vaccination, or if the patient had other vaccine in four weeks. The patient also had vomiting, nausea, diarrhea and black stool. The patient underwent lab tests and procedures which included Covid test: positive on an unknown date. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed Covid positive at some point after the first dose; diagnosed Covid positive at some point after the first dose; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. This Physician reported same events for 2 patients. This is 2nd of 2 reports. A patient of unspecified gender in their 40s received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was diagnosed Covid positive at some point after the first dose. The physician wanted to know what the recommendations for the patient, if patient can get the second dose or wait. Outcome of the events was unknown.  Information on the Lot/Batch Number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), and tested positive for the virus (COVID-19) on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like vaccination date and COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021161690 same reporter/event/drug, different patient
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site discomfort
Clinical narrative: some shoulder joint pain, mostly in right shoulder; minor discomfort at injection site; This is a spontaneous report from a contactable consumer. A 69-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in the left arm  on 11Feb2021 as a single dose for covid-19 immunization. The patient's medical history included high blood pressure from an unknown date and unknown if ongoing. Patient has no allergies to medications, food, or other products. Concomitant medications included atenolol; losartan; aspirin [acetylsalicylic acid] (ASPIRIN); cyanocobalamin (B12); and colecalciferol (D3) all taken for an unspecified indication, start and stop date were not reported. The patient experienced some shoulder joint pain, mostly in right shoulder (non-injection shoulder) and minor discomfort at injection site on 11Feb2021 19:00. Patient was not treated for the events. The outcome of the event was recovered on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: A little arm soreness; more tired than normal the day after receiving the 2nd dose of the vaccine.; achiness; This is a spontaneous report from a contactable consumer (patient).  A 42 -year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown, route of administration unknown in left arm on 15Feb2021 at 09:15 (at the age of 42 years) as single dose for COVID-19 immunisation.  Past vaccination included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for immunization on 25Jan2021 at 2:30pm (14:30) in left arm. The patient medical history includes hypothyroid, and the patient has a drug allergy to Bactrim.  The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine and since the vaccine the patient has not been tested for COVID-19. Concomitant medication included levothyroxine sodium (LEVOXYL).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced achiness and was more tired than normal the day after receiving the 2nd dose of the vaccine as well as a little arm soreness on 16Feb2021.  The patient did not receive any treatment for the events.  The outcome of a little arm soreness was not recovered, more tired than normal the day after receiving the second dose of the vaccine was not recovered and achiness was not recovered.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral venous disease, Urticaria
Clinical narrative: a welt the size of a ping pong ball developed below the injection site; entire arm in pain with veins swelling; entire arm in pain with veins swelling; This is a spontaneous report from a contactable nurse, the patient. A 50-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration, administered in the left arm on 12Feb2021 at 15:00 (at the age of 50 years-old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing.  The patient has no allergies to medication, food or other products. The patient's concomitant medications were not reported.  The patient previously received the first dose of BNT162B2, via an unspecified route of administration, administered in the left arm on 22Jan2021 at 16:00 (at the age of 50 years old) for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 00:00 (reported as 12:00 AM), two days after the second dose (as reported), the patient experienced entire arm in pain with veins swelling, and on 14Feb2021 (exact time unknown), day 3 after the second dose, a welt the size of a ping pong ball developed below the injection site. The patient reported the events as non-serious. Therapeutic measures were taken as a result of entire arm in pain with veins swelling and a welt the size of a ping pong ball developed below the injection site included unspecified home pain medications and creams. The outcome of the events entire arm in pain with veins swelling and a welt the size of a ping pong ball developed below the injection site was recovering. It was also reported that since the vaccination the patient has not been tested for COVID-19.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Infectious mononucleosis, Malaise, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: has not been feeling well; She has neither IgM or IGG against COVID; She has high timers against Epstein Barr - i. e diagnostic for mononucleosis; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 immunisation on an unspecified date. The patient had 2nd PFE COVID vaccine immunization about 3 weeks ago (unspecified date). She has not been feeling well and, being a physician, sent in her blood for a litany of antibody tests. She has high timers against Epstein Barr i.e. diagnostic for mononucleosis. She has neither IgM nor IGG against COVID. The issue is how to proceed to ensure immunity against COVID. If it turns out that there are some non-responders (i.e. no AB response) to the Pfizer vaccine, the logical thing to do would be to get a different vaccine. If there is immune competition and she did not respond to the vaccine because of her ongoing mono, then it makes sense to get another single dose of the Pfizer vaccine once the mono has cleared, as she will likely have memory B cells against the Pfizer antigen and may need multiple injections of the vaccine if the antigen presentation is different between the two. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: She has neither IgM nor IGG against COVID on an unspecified date. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test; This is a spontaneous report from contactable consumer (Patient). This is First of 2 reports. A male patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1st via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. Medical history and concomitant medication were not reported. On 08Feb2021, patient was tested positive for covid-19. Patient wanted to know the process of getting the vaccine after testing positive for COVID-19. if they should repeat the dose or should they wait. The outcome for the event was unknown.  Information about lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167914 same reporter, suspect, events, different patient
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Cough, Fatigue
Clinical narrative: Positive COVID-19 test; This is a spontaneous report from contactable consumer (Patient). This is First of 2 reports. A male patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1st via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. Medical history and concomitant medication were not reported. On 08Feb2021, patient was tested positive for covid-19. Patient wanted to know the process of getting the vaccine after testing positive for COVID-19. if they should repeat the dose or should they wait. The outcome for the event was unknown.  Information about lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167914 same reporter, suspect, events, different patient
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Oropharyngeal pain, Oxygen saturation, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive COVID-19 test; This is a spontaneous report from contactable consumer (Patient). This is First of 2 reports. A male patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1st via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. Medical history and concomitant medication were not reported. On 08Feb2021, patient was tested positive for covid-19. Patient wanted to know the process of getting the vaccine after testing positive for COVID-19. if they should repeat the dose or should they wait. The outcome for the event was unknown.  Information about lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167914 same reporter, suspect, events, different patient
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test; This is a spontaneous report from contactable consumer (Patient). This is First of 2 reports. A male patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1st via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. Medical history and concomitant medication were not reported. On 08Feb2021, patient was tested positive for covid-19. Patient wanted to know the process of getting the vaccine after testing positive for COVID-19. if they should repeat the dose or should they wait. The outcome for the event was unknown.  Information about lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167914 same reporter, suspect, events, different patient
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cold sweat, Dehydration, Dizziness
Clinical narrative: Chest Pain; Chills; Migraine; Cold Sweat; Light Headedness; Dehydration; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), via an unspecified route of administration in the left arm on 15Feb2021 at 08:15 (at the age of 23-years-old) as a single dose for COVID-19 vaccination.  The patient had no relevant medical history reported. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), via an unspecified route of administration in the left arm on 25Jan2021 at 08:15 (at the age of 23-years-old) for COVID-19 vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine or any other medications within two weeks of vaccine. The patient did not have COVID-19 prior to the vaccination. The patient was tested for COVID-19 on 11Feb2021 with nasal swab and the result was negative. On 15Feb2021 at 20:30 the patient experienced chills, migraine, cold sweat, chest pain, light headedness, and dehydration. The patient did not receive any treatment for the chills, migraine, cold sweat, chest pain, light headedness, and dehydration. The clinical outcome of the chills, migraine, cold sweat, chest pain, light headedness, and dehydration was not recovered.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, SARS-CoV-2 antibody test
Clinical narrative: Chest Pain; Chills; Migraine; Cold Sweat; Light Headedness; Dehydration; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), via an unspecified route of administration in the left arm on 15Feb2021 at 08:15 (at the age of 23-years-old) as a single dose for COVID-19 vaccination.  The patient had no relevant medical history reported. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), via an unspecified route of administration in the left arm on 25Jan2021 at 08:15 (at the age of 23-years-old) for COVID-19 vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine or any other medications within two weeks of vaccine. The patient did not have COVID-19 prior to the vaccination. The patient was tested for COVID-19 on 11Feb2021 with nasal swab and the result was negative. On 15Feb2021 at 20:30 the patient experienced chills, migraine, cold sweat, chest pain, light headedness, and dehydration. The patient did not receive any treatment for the chills, migraine, cold sweat, chest pain, light headedness, and dehydration. The clinical outcome of the chills, migraine, cold sweat, chest pain, light headedness, and dehydration was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on 15Feb2021 around noon (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked if nausea was one of the common side effects of the vaccine, and how long it was expected to last? The patient received her second dose of the COVID vaccine yesterday around noon (15Feb2021) and was now experiencing nausea (16Feb2021). The clinical outcome of nausea was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested for COVID-19/tested positive; tested for COVID-19/tested positive; fever; minor coughing; headaches; This is a spontaneous report from a contactable consumer (patient's husband) via the medical information team. This consumer (patient's husband) reported similar events for two patients. This is the second of two reports.  An 80-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer (patient's husband) and the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine, and they were due to receive the second dose on 14Feb2021. The consumer mentioned that when they went for their second dose, the patient had a "little fever" and they were therefore asked to go get tested for COVID-19. The consumer said that the patient tested positive and he tested negative that day, but he also tested positive the next day. The consumer specified they had "minor coughing, headaches and fever". They were in quarantine for 14 days. The consumer asked: "once the quarantine is completed, when does Pfizer recommend for us to receive the second dose? if I get the first dose of the Pfizer-BioNTech COVID-19, I should get the second dose from Pfizer, right." The consumer asked if how he could obtain an appointment for the second dose of the Pfizer-BioNTech COVID-19 vaccine. The consumer considered the case as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167315 same reporter/drug/events, different patient
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested for COVID-19/tested positive; tested for COVID-19/tested positive; fever; minor coughing; headaches; This is a spontaneous report from a contactable consumer (patient's husband) via the medical information team. This consumer (patient's husband) reported similar events for two patients. This is the second of two reports.  An 80-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer (patient's husband) and the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine, and they were due to receive the second dose on 14Feb2021. The consumer mentioned that when they went for their second dose, the patient had a "little fever" and they were therefore asked to go get tested for COVID-19. The consumer said that the patient tested positive and he tested negative that day, but he also tested positive the next day. The consumer specified they had "minor coughing, headaches and fever". They were in quarantine for 14 days. The consumer asked: "once the quarantine is completed, when does Pfizer recommend for us to receive the second dose? if I get the first dose of the Pfizer-BioNTech COVID-19, I should get the second dose from Pfizer, right." The consumer asked if how he could obtain an appointment for the second dose of the Pfizer-BioNTech COVID-19 vaccine. The consumer considered the case as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167315 same reporter/drug/events, different patient
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity
Clinical narrative: Fatigue; arm pain; general malaise; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 12Feb2021 at 16:45 (at the age of 43-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included fibromyalgia, asthma, high blood pressure and allergy to ACE inhibitors. Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 13Feb2021 at 12:00 AM, the patient experienced fatigue, arm pain and general malaise. No treatment was provided for the events fatigue, arm pain and general malaise. The outcome of the events fatigue, arm pain and general malaise was recovering. Since the vaccination, the patient has not been tested for COVID-19.  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-2021277048 same patient, different shot/event
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm soreness on same day/night; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 54-year-old, via an unspecified route of administration, administered in left arm on 15Feb2021 13:00 (Batch/Lot Number: EN9581) as single dose for COVID-19 immunisation. Medical history included treated with high blood pressure. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient experienced left arm soreness on same day/night on 15Feb2021 19:30 with outcome of recovered. No treatment was given for the event.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever (101); aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9269) via an unspecified route of administration on 15Feb2021 at 11:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included diabetes and osteoporosis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient had not been diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not have allergies to any medications, food, or other products. The patient previously received dose 1 of BNT162B2 (lot EL9261) on 25Jan2021 at 15:00 as a single dose in the left arm for COVID-19 immunization. On 15Feb2021 at 19:00 after the second dose of BNT162B2 the patient experienced fever of 101, aches, chills, and fatigue all night and into the morning. The events were reported as non-serious. The patient was not hospitalized for the events. The outcomes of fever of 101, aches, chills, and fatigue all night and into the morning were recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Energy increased, Eye swelling, Fatigue
Clinical narrative: Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on energy for an hour or so; and then all of a sudden I can't even hold my head up; Eyes were swollen; Back to my head very weak; My whole body feels like it is bruised; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9262/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 17:30 (at the age of 59 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included rheumatoid arthritis. Concomitant medication included methotrexate 2.5 mg (8 tablets, once weekly), hydroxychloroquine 200 mg, 2x/day and folic acid UNK, 1x/day(1 tablet). On 12Feb2021 (Friday night), the patient reported that she "don't still feel good". The clinical course was as follows: On 12Feb2021, an hour after the receiving the vaccination, the patient reported "it started with pain in side in my head and within minutes it was like I was jelly. I was felt like fall on to the floor. I slowed down and I was extremely tired. I even left work early. I was off Saturday and Sunday. Today I could not even get work. It is like I have a burst on energy for an hour or so.  And then all of a sudden, I can't even hold my head up. My eyes were swollen and back to my head very weak. My whole body feels like it is bruised. Treatment received for the events included ibuprofen. The consumer stated, "I took 4 on Saturday and later on like midday about 4 or 5 O'Clock. That was 200 mg each. It was total of 800mg." The outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Sluggishness
Clinical narrative: Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on energy for an hour or so; and then all of a sudden I can't even hold my head up; Eyes were swollen; Back to my head very weak; My whole body feels like it is bruised; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9262/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 17:30 (at the age of 59 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included rheumatoid arthritis. Concomitant medication included methotrexate 2.5 mg (8 tablets, once weekly), hydroxychloroquine 200 mg, 2x/day and folic acid UNK, 1x/day(1 tablet). On 12Feb2021 (Friday night), the patient reported that she "don't still feel good". The clinical course was as follows: On 12Feb2021, an hour after the receiving the vaccination, the patient reported "it started with pain in side in my head and within minutes it was like I was jelly. I was felt like fall on to the floor. I slowed down and I was extremely tired. I even left work early. I was off Saturday and Sunday. Today I could not even get work. It is like I have a burst on energy for an hour or so.  And then all of a sudden, I can't even hold my head up. My eyes were swollen and back to my head very weak. My whole body feels like it is bruised. Treatment received for the events included ibuprofen. The consumer stated, "I took 4 on Saturday and later on like midday about 4 or 5 O'Clock. That was 200 mg each. It was total of 800mg." The outcome of the events was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness
Clinical narrative: Chills; Light-headed/Dizzy; This is a spontaneous report received from a contactable consumer (patient's spouse). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267, expiry date: unknown), via an unspecified route of administration, on 13Feb2021, as single dose, for COVID-19 immunization. Medical history included hypertension, blood pressure abnormal (reported as blood pressure) and prostatic disorder (reported as prostate). Concomitant medication included amlodipine taken for blood pressure abnormal; benazepril; metoprolol; apixaban (ELIQUIS); tamsulosin; omeprazole; venlafaxine taken for prostatic disorder; and succinate sodium, all start and stop dates were not reported. The patient experienced chills and was light-headed and dizzy in Feb2021. No treatment was given for the events. The reporter wanted to know if they have to go the emergency room and asked for the treatment. The outcome of the events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: Chills; Vomiting; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2nd via an unspecified route of administration on 16Feb2021 at single dose for COVID-19 Immunization. The anatomical location was left arm. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 04:45 AM, anatomical location was left arm. The patient's medical history and medication was not reported. It was reported that the patient experienced chills and vomiting on 16Feb2021. Patient was not Pregnant at the time of vaccination. The event assessed as non-serious by the reporter. Patient did not received any treatment or any other vaccines within 4 weeks prior to the COVID vaccine. After the vaccination, patient had not been tested for COVID-19. No allergies to medications, food, or other products.  The outcome for the events was not recovered.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis, Gait disturbance, Headache, Hypertension, Hypoaesthesia oral
Clinical narrative: Debilitating headache; nausea; vomiting; ringing in the ears; L eye drooping; numbness and tingling of lips; numbness and tingling of lips; trembling of R side of body; abnormal/change in gait; change in vision; hypertension; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number and Expiration date was unknown), first dose via an unspecified route of administration on an unspecified date, second dose via intramuscularly in right arm on 16Jan2021 15:30; both at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included depression, MTHFR (methylenetetrahydrofolate reductase), latex allergy. Concomitant medications included venlafaxine, L-methylfolate; the patient received both the drugs within 2 weeks of vaccination. The patient previously took fluoxetine, citalopram and experienced known allergies for both the drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient experienced debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension on 25Jan2021 06:00. On 01Feb2021, the patient underwent lab test and procedure included nasal swab/ COVID-19 by PCR: Negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with IV Dexamethazone, Diphenhydramine, ketorolac, promethazine for all the events. The outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.; Sender's Comments: On the basis of the available information, the reported events debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension would seem most likely related to intercurrent and/or underlying medical condition and concomitant medication, which is not related to bnt162b2. This case will be reassessed when additional information becomes available. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.