chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain
Clinical narrative: feel tired/more tired; mind felt foggy; feel achy throughout body; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration (at the age of 52-years-old) on 01Feb2021 12:30 at a single dose in left arm for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Bactrim and clarithromycin and experienced allergies. The patient experienced feel tired/more tired, mind felt foggy, feel achy throughout body all on 01Feb2021 14:30 with outcome of recovering. The patient reported that "Approximately 1 hr (as reported) after receiving the vaccine, I started to feel tired, and my mind felt foggy. A few hours later, I began to feel achy throughout body and more tired. Next morning continued to feel achy but not as tired." No treatment received for the events. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed as non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: became very sore under my armpit and now it is very swollen and sore; became very sore under my armpit and now it is very swollen and sore; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot number: 9262) via an unspecified route of administration in the left arm on 31Jan2021 at 09:15 (at the age of 57-years-old) as a single dose for Covid-19 immunisation. Medical history included diabetes. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included metformin hydrochloride/sitagliptin phosphate monohydrate (JANUMET) and rosuvastatin. The patient previously received first dose of BNT162B2 in left arm on 10Jan2021 at 01:15 PM for Covid-19 immunisation. The patient stated two days after 2nd vaccine, 02Feb2021, she became very sore under her armpit & now it was very swollen and sore. Seriousness criteria was considered as non-serious. No treatment was received for the adverse events. The outcome of the events was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Diarrhea; severe abdominal pain; This is a spontaneous report from a non-contactable nurse. A 42-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 vaccine; lot number: EN5318; expiration date: unknown) at vaccination age of 42-year-old via an unspecified route of administration in the right arm on 31Jan2021 at a single dose for covid-19 immunization. Medical history included Pcos (polycystic ovaries). The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medication included unspecified medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 vaccine; lot number: EL3246; expiration date: unknown) at vaccination age of 42-year-old intramuscular in the left arm on 11Jan2021 09:00 AM at a single dose for covid-19 immunization. The patient received the most recent COVID-19 vaccine in a hospital. On 01Feb2021 12:00 PM, the patient had diarrhea and severe abdominal pain staring 24 hours post second vaccine which lasted for 24 hours. The patient did not receive treatment for the adverse events. The patient has not been tested for COVID-19 since vaccination. The events were non-serious. The outcome of the events was recovered on 02Feb2021 12:00.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: severe leg and hip pain; severe leg and hip pain; painful to walk; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 21Jan2021, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Feb2021, the patient developed severe leg and hip pain, making it painful to walk. The patient asked if these were from the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; Headache; Fever; Dizziness; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient (not pregnant) received the second dose bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 29Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She had her first dose of bnt162b2 on 08Jan2021 in the left arm. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 17:00, the patient had deadache, fever, dizziness and fatigue. No treatment was reported. The outcome of events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Chills, Computerised tomogram, Metabolic function test
Clinical narrative: elevated transaminase measurement; Severe abdomen pain; abdomen swelling; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 67-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el 3247), via an unspecified route of administration on the left arm on 28Jan2021 10:15 at a single dose (at the age of 67-years-old) for COVID-19 immunization. The patient was administered in a public health clinic/administration facility. Medical history included asthma, diabetes, high blood pressure and anxiety. The patient had unspecified concomitant therapy. The patient preciously took enalapril and sulfur and experienced drug allergies: "Allergies to medications, food, or other products: Sulfur, Enalapril". The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 at 21:30, the patient experienced severe abdomen pain, abdomen swelling, chills, nausea, vomiting and elevated transaminase measurement. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received unspecified treatment for the adverse events. The patient underwent lab tests and procedures in 2021 which included CT scan, comprehensive metabolic, Random amplification of polymorphic DNA (Rapd) and ultrasound all with unknown results; on 30Jan2021 elevated transaminase; and on 31Jan2021 a negative nasal swab (SARS-CoV-2 test). The events were considered non-serious by the reporter: not resulted in death, not life threatening, did not cause or prolong hospital, not disabling/incapacitating and not a congenital anomaly/birth defect. The patient has not recovered from the events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Polymerase chain reaction, SARS-CoV-2 test, Transaminases, Transaminases increased
Clinical narrative: elevated transaminase measurement; Severe abdomen pain; abdomen swelling; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 67-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el 3247), via an unspecified route of administration on the left arm on 28Jan2021 10:15 at a single dose (at the age of 67-years-old) for COVID-19 immunization. The patient was administered in a public health clinic/administration facility. Medical history included asthma, diabetes, high blood pressure and anxiety. The patient had unspecified concomitant therapy. The patient preciously took enalapril and sulfur and experienced drug allergies: "Allergies to medications, food, or other products: Sulfur, Enalapril". The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 at 21:30, the patient experienced severe abdomen pain, abdomen swelling, chills, nausea, vomiting and elevated transaminase measurement. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received unspecified treatment for the adverse events. The patient underwent lab tests and procedures in 2021 which included CT scan, comprehensive metabolic, Random amplification of polymorphic DNA (Rapd) and ultrasound all with unknown results; on 30Jan2021 elevated transaminase; and on 31Jan2021 a negative nasal swab (SARS-CoV-2 test). The events were considered non-serious by the reporter: not resulted in death, not life threatening, did not cause or prolong hospital, not disabling/incapacitating and not a congenital anomaly/birth defect. The patient has not recovered from the events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vomiting
Clinical narrative: elevated transaminase measurement; Severe abdomen pain; abdomen swelling; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 67-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el 3247), via an unspecified route of administration on the left arm on 28Jan2021 10:15 at a single dose (at the age of 67-years-old) for COVID-19 immunization. The patient was administered in a public health clinic/administration facility. Medical history included asthma, diabetes, high blood pressure and anxiety. The patient had unspecified concomitant therapy. The patient preciously took enalapril and sulfur and experienced drug allergies: "Allergies to medications, food, or other products: Sulfur, Enalapril". The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 at 21:30, the patient experienced severe abdomen pain, abdomen swelling, chills, nausea, vomiting and elevated transaminase measurement. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received unspecified treatment for the adverse events. The patient underwent lab tests and procedures in 2021 which included CT scan, comprehensive metabolic, Random amplification of polymorphic DNA (Rapd) and ultrasound all with unknown results; on 30Jan2021 elevated transaminase; and on 31Jan2021 a negative nasal swab (SARS-CoV-2 test). The events were considered non-serious by the reporter: not resulted in death, not life threatening, did not cause or prolong hospital, not disabling/incapacitating and not a congenital anomaly/birth defect. The patient has not recovered from the events.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: They both had COVID after the 15th, after the first shot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. This consumer (wife) reported similar events for herself and her husband. This is 1st of 2 reports.   A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization .  Medical history included blood pressure measurement. Concomitant medications were not reported. The wife reported that on 25Jan2021, she and her husband both had COVID after the 15th, after the first shot. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 25Jan2021. She reported that they were done with quarantine that day, 03Feb2021. Therapeutic measure was taken as a result of the event that included Zepac. And then, her husband took an additional like a steroid. She did not know what he took. But they both took Zepac and their doctor prescribed Zepac, and then her husband took a steroid too. Clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021133498 Same reporter/product,events, different patients
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood HIV RNA, Lethargy, Myalgia, Tremor
Clinical narrative: Lethargy; Muscle and Joint Pain; Muscle and Joint Pain; random Tremors; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 31Jan2021 10:45, at single dose, for COVID-19 immunization. Medical history included HIV undetectable. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient has no allergies to medications, food, or other products. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY); clonazepam; divalproex sodium (DIVALPROEX SODIUM ER); and lurasidone hydrochloride (LATUDA). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 01Feb2021, the patient experienced lethargy, muscle and joint pain, and random tremors. No treatment was given for the events. The patient underwent lab test which included Blood HIV RNA on an unspecified date with result HIV undetectable. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Vaccination site pain
Clinical narrative: body aches; chills; pain at injection site; tiredness; This is a spontaneous report from a non-contactable consumer who reported for herself. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3248, via an unspecified route of administration in the left arm on 01Feb2021 01:15 PM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination and patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3248, via an unspecified route of administration in the left arm on 12Jan2021 03:15 PM for COVID-19 immunization. On an unspecified date, the patient experienced body aches, chills, pain at injection site and tiredness. No treatment was received for the adverse events. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female (also age at vaccination) patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL3248), via an unspecified route of administration at the left arm on 19Jan2021 at SINGLE DOSE for covid-19 immunization. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) on 29Dec2020 10:00 AM at the left arm for covid-19 immunization. The patient is not pregnant at time of vaccination and was vaccinated at a hospital. Medical history included breast cancer, lichen planus, hypothyroid, allergies to Sulfa drugs and environmental. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient also received other medications within 2 weeks of vaccination (unspecified). The patient experienced shingles on 28Jan2021 08:00 AM (diagnosed on 02Feb2021). The event resulted in Doctor or other healthcare professional office/clinic visit. It was reported that treatment received for the adverse event includes: clinic visit and medication. The outcome of the event was recovering. Case was considered as non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; swelling in left armpit; This is a spontaneous report from a contactable nurse (patient).  A 47-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9Z61), via an unspecified route of administration on 01Feb2021 at 10:00 at a single dose on the left arm for COVID-19 immunization.  Medical history included diabetes, hypertension (HTN), depression and polycystic ovarian syndrome (PCOS) all from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient received the first dose of BNT162B2 (lot number: EJ1686) on 11Jan2021 at 10:00 on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache, lightheadedness, weakness, fatigue, muscle and joint pain and swelling in left armpit on 02Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Swelling
Clinical narrative: Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; swelling in left armpit; This is a spontaneous report from a contactable nurse (patient).  A 47-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9Z61), via an unspecified route of administration on 01Feb2021 at 10:00 at a single dose on the left arm for COVID-19 immunization.  Medical history included diabetes, hypertension (HTN), depression and polycystic ovarian syndrome (PCOS) all from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient received the first dose of BNT162B2 (lot number: EJ1686) on 11Jan2021 at 10:00 on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache, lightheadedness, weakness, fatigue, muscle and joint pain and swelling in left armpit on 02Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph nodes; This is a spontaneous report from a contactable other healthcare professional (HCP). A 31-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: unknown), via intramuscular route on her left arm on 22Jan2021 13:00 to 22Jan2021 13:00 at single dose for covid-19 immunization. The patient's medical history included pseudo tumor, latex allergy, retinol allergy and ovarian cyst. Concomitant medication included amitriptyline for unspecified indication. On 01Feb2021, the patient experienced enlarged lymph nodes. The outcome of the event was not recovered. The seriousness of the event was non-serious. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable other hcp reported for herself. A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular on the left arm, at the age of 24 years, on 30Jan2021 10:45 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EK9262) at the age of 24 years on 09Jan2021 in the left arm at single dose for COVID-19 immunization. The patient experienced hives on 30Jan2021 11:00. No treatment was received for the event. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: headache; body aches; fatigue; pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient, who is also 30-year-old at the time of vaccination, received second dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration on left arm on 02Feb2021 15:30 as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN). The patient received first dose of BNT162B2 on 14Jan2021 at 03:45 PM, lot number not reported; vaccine location=Left arm. On 03Feb2021 07:00, the patient experienced headache, body aches, and fatigue as well as pain at the injection site. The outcome of the events was recovering. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264), via an unspecified route of administration at the left arm on 31Jan2021 16:30 at a single dose for COVID-19 immunization. The patient's medical history included atrial fibrillation, pre-diabetic, and high blood pressure. The patient's concomitant medications included sacubitril valsartan sodium hydrate (ENTRESTO) on Oct2020 for heart failure, metoprolol on an unspecified date for atrial fibrillation, and apixaban (ELIQUIS) on an unspecified date in 2018 for blood thinner. The patient experienced shortness of breath on 31Jan2021 20:00. The vaccination facility type was not a military facility. The outcome of the event was recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient)¬. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 11Jan2021 at 12:00 (at the age of 65-years-old) at a single dose for COVID-19 immunisation. Medical history included osteoporosis, stroke history (35-years-old), significant lactose intolerance, gastrointestinal (GI) issues, and allergy to Caine family of drugs. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included evolocumab (REPATHA SURECLICK) and lorazepam (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore arm in 2021. The event was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of sore arm was recovered in 2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Neck pain, Pain
Clinical narrative: I was awoke by pain in the back of my neck and right side of my body; I was awoke by pain in the back of my neck and right side of my body/ I try to lift up my head of the pillow and trying to lift my head of the pillow was extreme pain; I am little bit tired; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) solution for injection, via an unspecified route of administration on 02Feb2021 at 1:00 PM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer COVID vaccine at a drug store yesterday (02Feb2021) at 1:00 PM and everything was fine. After eating his/her dinner, the patient was a little bit tired and went to sleep at 9:00 PM. When the patient got up around midnight, he/she was awaken by pain in the back of his/her neck and the right side his/her body. The patient tried to lift his/her head of the pillow, but it was extremely painful. So, the patient pulled a smaller pillow afterwards and had to use his/her hand to lift the head to get the other pillow underneath the patient's head, but the pain was so bad. This morning, the  pain was not quite as bad but the patient still couldn't, like if the patient tried to sit up straight to turn the head to see something, it was like somebody hit him/her in the back of the head with the bat or like an object, like the patient was in a car accident or something. The patient was going to take ibuprofen (ADVIL) but was told that he/she could take paracetamol (TYLENOL) or ADVIL if you have a side effect, the patient went on the internet and some of the websites said that it could lessen the effectiveness of the vaccine, so he/she didn't take ADVIL because the patient did not want to weaken or lessen the vaccine. The patient wanted to know if he/she should take ADVIL; if ADCIL will erase the vaccine; or if it will be bad if the patient take ADVIL for pain. The patient clarified that he/she did not take ADVIL or TYLENOL yet. The outcome of the event pain was recovering and unknown for all other events.   Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: diagnosed with shingles (on Scalp); This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration on 25Jan2021 09:00 in left arm at single dose for covid-19 immunisation. Medical history included CAD (coronary artery disease), allergies: cosmetics, some topical meds, preservatives in eye drops and some perfume. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included atorvastatin (LIPITOR) at 40mg, acetylsalicylic acid (ASPIRIN) at 81mg and fexofenadine hydrochloride (ALLEGRA). The patient historical vaccine included varicella zoster vaccine rge (CHO) (SHINGRIX) and shingles vaccine (unspecified) for shingles, and previously took codeine and experienced allergies: Codeine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Feb2021 22:00, the patient experienced shingles (on scalp). The patient has received both the Shingrix Vaccine and the earlier Shingles Vaccine. So, it doesn't make sense. The seriousness criteria were considered as non-serious. Since the vaccination, the patient has been not tested for COVID-19. Therapeutic measures were taken as a result of diagnosed with shingles (on scalp) included valaciclovir 21 tablets. The outcome of the event shingles was not recovered.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling, tenderness and stiffness at the injection site; Swelling, tenderness and stiffness at the injection site; Swelling, tenderness and stiffness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247), via an unspecified route of administration in the left arm on 04Feb2021 at 11:00 AM at the age of 52 years old at a single dose for COVID-19 Immunization at workplace clinic. The patient medical history was none. Allergies to medications, food, or other products was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive other medications within 2 weeks of vaccination. On 04Feb2021 at 15:00, the patient experienced swelling, tenderness and stiffness at the injection site, developed approximately 4-5 hours after injection. Stiffness disappeared overnight; swelling and tenderness increased overnight (now 21 hours post injection). Area was very tender, didn't affect ability to execute job function. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the event stiffness on an unspecified date in Feb2021 and recovering from other events.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Inappropriate schedule of product administration, Temperature intolerance
Clinical narrative: Severe drenching sweating; heat intolerence.; administration date: dose 2: 20Jan2021; dose 1: 19Dec2020; This is a spontaneous report from a contactable physician (patient). A 64-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el8982), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included sulpha allergy. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: ek5730) via an unspecified route of administration at the right arm on 19Dec2020 for COVID-19 immunization. On 23Jan2021, the patient experienced severe drenching sweating without fever or chills with any exertion. The patient also experienced heat intolerance. No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The outcome of the events were not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got Covid after receiving the first dose; got Covid after receiving the first dose; This is a spontaneous report from a Pfizer-sponsored program . A contactable healthcare professional reported a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# not provided), via an unspecified route of administration on 16Jan2021 at SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  The reporter stated that had a patient who received the first dose of COVID 19 vaccine shot on 16Jan2021 then the patient got COVID after receiving the first dose but recovered in 2021. The reporter was asking if the patient can still take the second dose due on 06Feb2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Today she had a fever of 102.3/ has been about 101.3 most of the day; Body aches; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient), reported for a female patient of an unspecified age received bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration on 02Feb2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 03Feb2021, she had a fever of 102.3. She took some Tylenol and it went away but came back and had been about 101.3 most of the day. She also had body aches on 03Feb2021. The outcome of fever was not recovered; for body aches was unknown.  Information on the Lot/Batch Number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling
Clinical narrative: swelling under both eyes; This is a spontaneous report based on the information received by Pfizer from other agency (reference number: GL-012221-1896).   A contactable consumer (patient) reported that a female patient of unspecified age received BNT162B2, via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization; and hyaluronic acid (RESTYLANE) via an unspecified route of administration from 23May2020 to an unspecified date at an unspecified dose and frequency for tear troughs. Medical history and concomitant medications were not reported. The patient received COVID Vaccine (Pfizer) on 18Jan2021. The patient reported swelling under both eyes on 19Jan2021 treated with prednisone per HCP. The action taken in response to the event for hyaluronic acid was unknown. The outcome of the event was not recovered.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: coughing; not feeling well; sneezing; running nose; tired; headache; nausea; muscle pain; cold like symptoms; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# not provided), via an unspecified route of administration on 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID vaccine on 06Jan2021 and second vaccine on 28Jan2021. She mentioned that she experienced reaction with both vaccines. After first vaccine she has swollen and tender lymph nodes, coughing, not feeling well, sneezing, running nose, tired, headache, nausea, muscle pain, cold like symptoms (AER 2021112057). With second dose, she had similar symptoms, but "not the swollen and tender lymph nodes, no chills or fever". She said she felt like she was going all over this again. Outcome of the events were unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Rhinorrhoea, Sneezing
Clinical narrative: coughing; not feeling well; sneezing; running nose; tired; headache; nausea; muscle pain; cold like symptoms; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# not provided), via an unspecified route of administration on 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID vaccine on 06Jan2021 and second vaccine on 28Jan2021. She mentioned that she experienced reaction with both vaccines. After first vaccine she has swollen and tender lymph nodes, coughing, not feeling well, sneezing, running nose, tired, headache, nausea, muscle pain, cold like symptoms (AER 2021112057). With second dose, she had similar symptoms, but "not the swollen and tender lymph nodes, no chills or fever". She said she felt like she was going all over this again. Outcome of the events were unknown.   Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; fever; headache; body aches; This is a spontaneous report from a contactable other healthcare professional (patient).  A 22-year-old female patient, who is also 22-year-old at the time of vaccination, received bnt162b2 (BNT162B2), lot number: EL9265, via an unspecified route of administration on Left arm on 02Feb2021 10:00 as single dose for COVID-19 immunization.  Medical history included Peanuts, tree nuts, cat allergy. The patient received first dose of BNT162B2, lot number not reported, on 12Jan2021, 11:00 AM on left arm. Concomitant medication included fluoxetine hydrochloride (PROZAC).  On 02Feb2021, the patient experienced Chills, fever, headache, body aches. The outcome of the events was recovering. No treatment was received for the events.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experienced a sore arm after 1st dose of the COVID 19 vaccination; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, 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 experienced a sore arm after 1st dose of the COVID 19 vaccination. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pink, slightly raised warm area about 2 inches below and medial to the injection site on the left upper arm.  It was not painful or itchy but continued for about 1 week gradually fading after about 3 days but the warmth was still there for several days.  No other symptoms were noted. No treatment was given.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: 10:05am Post 2nd vaccination, c/o of increased dizziness w/ expressed sweaty feeling, noted as well; then witnessed 2-4 second LOC, thereafter, O2 via FM applied,  becomes alert w/ cohesive verbal response to stimuli; 10:10 EMS activated; BP138/78 P79. 10:24am Ox3, transported to hospital via EMS for further evaluation / treatment.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Severe headache, fever high at 101, aches in joints, nausea and vomiting,fatigue. Started at about 1 am on 3/5/21.  Fever has dropped to 100 as of 4 pm. Severe headache persists. Advil every 6-7 hours, fluids regularly
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe headache, fever high at 101, aches in joints, nausea and vomiting,fatigue. Started at about 1 am on 3/5/21.  Fever has dropped to 100 as of 4 pm. Severe headache persists. Advil every 6-7 hours, fluids regularly
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Pain
Clinical narrative: On the following day of my vaccine, which was 01-13-2013 I started to have body aches and on 01-14-2021 trough 01-16-2021 I began to pee blood.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Decreased appetite, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: About 50 hours after my shot, a headache and very stiff neck and shoulders started. Severe fatigue and very weepy feeling.  Even with ibuprofen and acetaminophen continued to worsen. Next 24 hours severe and made me sleep most of the day. No appetite. The last 21 hours, symptoms lessened and tapering off. But worsen with out meds every 6 hours.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: About 50 hours after my shot, a headache and very stiff neck and shoulders started. Severe fatigue and very weepy feeling.  Even with ibuprofen and acetaminophen continued to worsen. Next 24 hours severe and made me sleep most of the day. No appetite. The last 21 hours, symptoms lessened and tapering off. But worsen with out meds every 6 hours.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Pt was released after 15 min of monitoring.  As soon as pt got in her car 9Parking lot is 3 minutes away from vaccination site) Pt developed palpitations (HR:156/min)  Pt drove to the ER (3 blocks away from parking lot)  Pt is currently in the ER, HR between 107-119.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain natriuretic peptide, Chest X-ray, Computerised tomogram, Dizziness, Full blood count
Clinical narrative: Pt was released after 15 min of monitoring.  As soon as pt got in her car 9Parking lot is 3 minutes away from vaccination site) Pt developed palpitations (HR:156/min)  Pt drove to the ER (3 blocks away from parking lot)  Pt is currently in the ER, HR between 107-119.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Scan with contrast, Troponin I
Clinical narrative: Pt was released after 15 min of monitoring.  As soon as pt got in her car 9Parking lot is 3 minutes away from vaccination site) Pt developed palpitations (HR:156/min)  Pt drove to the ER (3 blocks away from parking lot)  Pt is currently in the ER, HR between 107-119.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Cardiac stress test, Colitis ulcerative, Computerised tomogram
Clinical narrative: Pt was released after 15 min of monitoring.  As soon as pt got in her car 9Parking lot is 3 minutes away from vaccination site) Pt developed palpitations (HR:156/min)  Pt drove to the ER (3 blocks away from parking lot)  Pt is currently in the ER, HR between 107-119.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Decreased appetite, Dizziness, Dyspnoea, Echocardiogram, Fibrin D dimer
Clinical narrative: Pt was released after 15 min of monitoring.  As soon as pt got in her car 9Parking lot is 3 minutes away from vaccination site) Pt developed palpitations (HR:156/min)  Pt drove to the ER (3 blocks away from parking lot)  Pt is currently in the ER, HR between 107-119.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Hypertension, Insomnia, Laboratory test
Clinical narrative: Pt was released after 15 min of monitoring.  As soon as pt got in her car 9Parking lot is 3 minutes away from vaccination site) Pt developed palpitations (HR:156/min)  Pt drove to the ER (3 blocks away from parking lot)  Pt is currently in the ER, HR between 107-119.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia, Red blood cell sedimentation rate, Tilt table test, Ultrasound kidney
Clinical narrative: Pt was released after 15 min of monitoring.  As soon as pt got in her car 9Parking lot is 3 minutes away from vaccination site) Pt developed palpitations (HR:156/min)  Pt drove to the ER (3 blocks away from parking lot)  Pt is currently in the ER, HR between 107-119.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate increased
Clinical narrative: The next day, patient developed rapid heart rate and blood pressure.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea lasted 2weeks and 2 days. Self treatment with Brac diet, stayed hydrated. reduced stress. Lots of chicken soup broth. called physician  and assured her would follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Computerised tomogram, Dysphagia, Flushing, Full blood count
Clinical narrative: Employee received 2nd dose of Pfizer COVID-19 vaccine on January 18th at about 2pm.  By 6 pm, she noticed that she had bilateral swelling of lymph nodes in neck by the clavicle bone (more prominent on right hand side - same side as injection).  She also experienced difficulty swallowing and went to the ER at 9pm.  At the ER she received solumedrol IV, Pepcid IV and was discharged with hydroxyzine, Pepcid, solumedrol dosepak, zofran and epi-pen. At this time she was diagnosed with angioedema.  Swelling persisted and she contacted an allergist who prescribed additional antihistamines.  The allergist advised to her take Zyrtec or Claritin in addition to hydroxyzine day and night. The swelling continued to persist and two weeks later after returning to work for one day, she experienced feeling hot and flushed on right side, increased swelling and difficulty swallowing again and returned to ER on 1/25/21 and was treated with solumedrol and hydroxyzine and was discharged with solumedrol dosepak in addition to continuing antihistamines.  Upon returning to allergist, she was advised to take 4 zyrtec, 4 Claritin, Pepcid 40mg bid and hydroxyzine 10mg at bedtime.  PCP referred her to oncologist. After CT, oncologist diagnosed condition as bilateral lymphadenopathy and to return in 3 months for follow up.  PMH significant for ALL as a child (8 yrs), went into remission at 13yrs. PMH also includes DM2.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate, Impaired work ability, Lymphadenopathy, Metabolic function test
Clinical narrative: Employee received 2nd dose of Pfizer COVID-19 vaccine on January 18th at about 2pm.  By 6 pm, she noticed that she had bilateral swelling of lymph nodes in neck by the clavicle bone (more prominent on right hand side - same side as injection).  She also experienced difficulty swallowing and went to the ER at 9pm.  At the ER she received solumedrol IV, Pepcid IV and was discharged with hydroxyzine, Pepcid, solumedrol dosepak, zofran and epi-pen. At this time she was diagnosed with angioedema.  Swelling persisted and she contacted an allergist who prescribed additional antihistamines.  The allergist advised to her take Zyrtec or Claritin in addition to hydroxyzine day and night. The swelling continued to persist and two weeks later after returning to work for one day, she experienced feeling hot and flushed on right side, increased swelling and difficulty swallowing again and returned to ER on 1/25/21 and was treated with solumedrol and hydroxyzine and was discharged with solumedrol dosepak in addition to continuing antihistamines.  Upon returning to allergist, she was advised to take 4 zyrtec, 4 Claritin, Pepcid 40mg bid and hydroxyzine 10mg at bedtime.  PCP referred her to oncologist. After CT, oncologist diagnosed condition as bilateral lymphadenopathy and to return in 3 months for follow up.  PMH significant for ALL as a child (8 yrs), went into remission at 13yrs. PMH also includes DM2.