chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Painful eye; Swollen eye; Body ache; Sore throat; Injection site pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration on left arm on 16Mar2021 at 18:30 hours (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient medical history included possible lupus and allergies (Zithromax, Spirolactin, sulfa and wool allergy). The concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and BENADRYL, taken within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 07:30 hours, the patient experienced painful, swollen eye, headache, body ache, sore throat and injection site pain (vaccination site pain). No treatment was received for the events. The clinical outcome of the all the events was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Rust color discoloration in both hands.; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event.  A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration, administered in right arm on 28Feb2021, at 14:15 as single dose for Covid-19 immunization when the patient was 73-years-old.  Medical history included hearing problems from an unknown date. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. No allergies to medications, food, or other products were noted. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported; lisinopril (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; ezetimibe (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported.  The patient experienced rust color discoloration in both hands on 13Mar2021, at 12:00. No treatment was received for the adverse event. The clinical outcome of rust color discoloration in both hands was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus constant loud buzzing; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL9265), via an unspecified route of administration in the left arm on 12Feb2021 at 20:00 (at the age of 67-year-old) as first dose, single for COVID-19 immunization. On 12Mar2021, Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot no: EN6206; Dose number: 2nd dose), via an unspecified route of administration in the left arm. The patient was not pregnant at the time of report. The Patient's Medical history included diabetes, polymyalgia rheumatica, giant cell arteritis, thyroid. The patient did not have any allergies to medications, food or other products. Concomitant medications included methotrexate Injection (manufacturer unknown), dulaglutide (Trulicity), levothyroxine (manufacturer unknown). 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 vaccination. On 12Feb2021, patient experienced Tinnitus constant loud buzzing. The event assessed as non-serious. No treatment was received for the event. The clinical outcome of the Tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality checked of reporter, correspondence contact in slide#2, Occupation was updated from Other HCP to physician; Health care professional leave blank; "MD" was added as suffix, Patient's demographics updated (name, age/unit, Country), RMH: "giant cell arteritis" was added, RMH# 01 verbatim was updated as Thyroid, Second dose was removed from suspect product tab and was keep in narrative, Best doctor/Health care professional information added in vaccince administration tab, Vaccination facility information added, treatment information added, Concomitant therapy leave blank since the concomitant drugs were coded in product tab, event onset date/time was updated from "12FEB2021 00:00" to 12FEB2021 20:00.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Rhinorrhoea, Vaccination site pain
Clinical narrative: Runny nose; Stuffy nose; Upper arm sore around the injection site; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 16Mar2021 at 10:45 AM (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome. Concomitant medications included multivitamin, fish oil, vitamin D and vitamin B for an unknown indication. 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 had not been tested for COVID-19. On 17Mar2021 at 06:00 AM, the patient experienced upper arm sore around the injection site, and woke up with a stuffy and runny nose. No treatment received for the events. The clinical outcome of the events upper arm sore around the injection site, and woke up with a stuffy and runny nose was resolving.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Malaise
Clinical narrative: Back pain; Joint pain; Sore throat; Malaise; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A unspecified age non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on the left arm on 11Mar2021 at 10:45 as a single dose for COVID-19 Immunisation. The patient's medical history was not reported. The patient was allergic to bactrum. The patients concomitant medication included bupropion (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), multi vitamin (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN) for unknown indication from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient experienced back pain, fatigue, headache, joint pain, malaise and sore throat on 12Mar2021 at 17:00. No therapeutic measures were taken for the event of back pain, fatigue, headache, joint pain, malaise and sore throat. At the time of report, the clinical outcome of the events back pain, fatigue, headache, joint pain, malaise and sore throat were not recovered.   Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Back pain; Joint pain; Sore throat; Malaise; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A unspecified age non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on the left arm on 11Mar2021 at 10:45 as a single dose for COVID-19 Immunisation. The patient's medical history was not reported. The patient was allergic to bactrum. The patients concomitant medication included bupropion (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), multi vitamin (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN) for unknown indication from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient experienced back pain, fatigue, headache, joint pain, malaise and sore throat on 12Mar2021 at 17:00. No therapeutic measures were taken for the event of back pain, fatigue, headache, joint pain, malaise and sore throat. At the time of report, the clinical outcome of the events back pain, fatigue, headache, joint pain, malaise and sore throat were not recovered.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101.5 the next morning.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 12:30 (at the age of 50-years-old), as a second single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had no known allergies and no medical history. Concomitant medications included vitamins (MANUFACTURER UNKNOWN), move-free (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and pollen (MANUFACTURER UNKNOWN), for an unknown indication from an unspecified date and unknown if ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 (at the age of 50-years-old), as a first single dose for COVID-19 immunisation. On 17Mar2021 at 09:30 hours, the patient experienced fever of 101.5. The patient did not receive any treatment for the adverse events. The clinical outcome of fever of 101.5 was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pruritus
Clinical narrative: Small red bumps on upper body; Excessive itching.; This is a spontaneous report from a contactable consumer, a patient. A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration on the right arm on 03Feb2021 at 10:30 (age at vaccination at 74-year-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration on the right arm on 03Mar2021 at 10:30, as single dose for COVID-19 vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), omega 3 (MANUFACTURER UNKNOWN) and vitamin K2 with D3 (MANUFACTURER UNKNOWN) all for an unknown indication on an unknown date. The patient had no allergies to medication, food, or other products. Prior to 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 4 weeks prior to the vaccine. On 09Feb2021 at 09:00, the patient experienced small red bumps on upper body with excessive itching. The patient did not receive any therapeutic measure for the events blister and itching. The clinical outcome of the events blister and itching was not resolved at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Episcleritis
Clinical narrative: episcleritis/Left eye became inflamed and red; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW6208) via an unspecified route of administration in the left arm on 10Mar2021 at 12:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and elevated cholesterol levels. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient received the second dose of Shingles vaccine (MANUFACTURER UNKNOWN) in the right arm on 15Jan2021. Concomitant medications included montelukast (MANUFACTURER UNKNOWN) 10 mg, losartan (MANUFACTURER UNKNOWN) 100 mg and simvastatin (MANUFACTURER UNKNOWN) 20 mg, Hepatitis A vaccine (MANUFACTURER UNKNOWN) on 15Feb2021, all for unspecified indications. Since the vaccination, the patient was not tested for COVID-19. On 11Mar2021 at 21:00, the patient's left eye became inflamed and red. On 12Mar2021, the patient visited the ophthalmologist and was diagnosed with episcleritis. The patient was treated with prednisone acetate (MANUFACTURER UNKNOWN) 4 times per day. On an unspecified date in Mar2021, the patient's condition worsened and on 15Mar2021, the doctor had increased the frequency of prednisone acetate to 6 times a day following which the patient's condition had improved. On 17Mar2021, the left eye was slightly inflamed. The clinical outcome of the event episcleritis was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia
Clinical narrative: muscle soreness; difficult to lift arm above shoulder; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via unspecified route of administration in the left arm on 16Mar2021 at 14:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto (thyroid). It was reported that patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. Concomitant medication included NP-thyroid, daily multi-vitamins (MANUFACTURER UNKNOWN), gluco chondroitin (MANUFACTURER UNKNOWN). The patient experienced muscle soreness and difficulty to lift arm above shoulder on 16Mar2021 at 19:00. Therapeutic measures were not taken for the reported events. The clinical outcome of the muscle soreness and arm discomfort was recovering at this time of report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nasal congestion, Sinus congestion
Clinical narrative: Headache; Vomiting; Fatigue; Nasal congestion; Sinus congestion; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3247) via an unspecified route of administration on her left arm on 15Mar2021 at 12:45 PM (age at vaccination was 55-years-old) for COVID-19 immunisation. Medical history of the patient was not reported. The patient was not allergic to medications, food, or other products. Concomitant medications (received within 2 weeks of vaccination) included levothyroxine (LEVOXYL), alprazolam (XANAX) and fish oil, all used for an unknown indication started from an unreported date. Her past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration on the left arm on 22Feb2021 at 12:30 PM (age at vaccination was 55-years-old) for COVID-19 immunisation. She had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Also, prior to vaccination, she was not diagnosed with COVID-19 and since the vaccination, she had not tested for COVID-19. On 16Mar2021, at 04:00 AM, she experienced headache, vomiting, fatigue, nasal congestion, sinus congestion and muscle aches. No therapeutic measures were taken to resolve these events. The clinical outcome of the events headache, vomiting, fatigue, nasal congestion, sinus congestion and muscle aches was recovering. No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache; Vomiting; Fatigue; Nasal congestion; Sinus congestion; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3247) via an unspecified route of administration on her left arm on 15Mar2021 at 12:45 PM (age at vaccination was 55-years-old) for COVID-19 immunisation. Medical history of the patient was not reported. The patient was not allergic to medications, food, or other products. Concomitant medications (received within 2 weeks of vaccination) included levothyroxine (LEVOXYL), alprazolam (XANAX) and fish oil, all used for an unknown indication started from an unreported date. Her past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration on the left arm on 22Feb2021 at 12:30 PM (age at vaccination was 55-years-old) for COVID-19 immunisation. She had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Also, prior to vaccination, she was not diagnosed with COVID-19 and since the vaccination, she had not tested for COVID-19. On 16Mar2021, at 04:00 AM, she experienced headache, vomiting, fatigue, nasal congestion, sinus congestion and muscle aches. No therapeutic measures were taken to resolve these events. The clinical outcome of the events headache, vomiting, fatigue, nasal congestion, sinus congestion and muscle aches was recovering. No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; Chills; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6119) via an unspecified route of administration in the left arm on 04Mar2021 at 17:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications include spironolactone (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), vitamin B-12 (MANUFACTURER UNKNOWN) for an unknown indication. The patient was not tested for COVID-19 since the vaccination. On 16Mar2021 at 16:00, the patient felt chills. The patient felt fine until about mid-day and she felt she needed to take a nap. On the same day, the patient also felt exhaustion. On 17Mar2021 (reported as this morning), the patient had a slight headache. No therapeutic measures were taken for the reported events. The clinical outcome of the events chills, exhaustion and headache were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Swelling around eyes; Redness around eyes; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 15Mar2021 at 12:00 hours as a single dose for COVID-19 immunisation (age at vaccination 63-year-old). On an unknown date, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: UNKNOWN), dose 1, single, via an unspecified route of administration and anatomical location for COVID-19 immunisation. Medical history included intermittent atrial fibrillation. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 05:00, the patient experienced swelling and redness around eyes and the swelling shut when patient awoke in the same morning. The clinical outcome of swollen eyes and eye redness was recovering at the time of this report.   No follow up attempts are possible. No further information is expected; information about Lot number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chapped lips, Dry mouth
Clinical narrative: Dry mouth; chapped lips; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on the left arm on 11Mar2021 at 09:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included obese, high triglycerides, prostate cancer treatment 5 years ago. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN), VASCEPA, rosuvastatin (MANUFACTURER UNKNOWN) and fenofibrate (MANUFACTURER UNKNOWN). Since the vaccination the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 07:00, the patient experienced dry mouth and chapped lips after five days of first vaccination. No therapeutic measures were taken for the reported events. The clinical outcome of the events dry mouth and chapped lips was resolving.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Body aches; Chills; Fever; Headache; This is a spontaneous report from a contactable other health care professional, the patient. A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number: Unknown), via an unspecified route of administration on Arm left on 15Mar2021 at 11:45 (51-years-old at the age of vaccination) as a single dose for COVID-19 immunisation. Medical history included allergy to Penicillin and sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Mar2021 at 12:00 AM the patient experienced Body aches, Headache, Fever, Chills. Patient not received any treatment for the events. The clinical outcome of the reported events Body aches, Headache, Fever, Chills were not recovered at the time of report. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Rash over the entire body; Severe Chills; Body ache; Vomitting; Nausea; Frequent urination; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 69-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6199) via an unspecified route of administration in the right arm on 04Mar2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included COVID-19 (Lot number: el 9267) (MANUFACTURER UNKNOWN) unspecified route of administration in the right arm on 11Feb2021 for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 15Mar2021, the patient had experienced fatigue, headache. On 16Mar2021 the patient had experienced severe chills, fatigue, headache, body aches, vomiting, nausea, frequent urination. On 17Mar2021, the patient had experienced rash over entire body, fatigue, headache, body aches. The patient did not receive any treatment for the events. The clinical outcome of fatigue, headache, severe chills, fatigue, rash over entire body, body aches, vomiting, nausea and frequent urination were not resolved. No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Rash, Vomiting
Clinical narrative: Rash over the entire body; Severe Chills; Body ache; Vomitting; Nausea; Frequent urination; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 69-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6199) via an unspecified route of administration in the right arm on 04Mar2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included COVID-19 (Lot number: el 9267) (MANUFACTURER UNKNOWN) unspecified route of administration in the right arm on 11Feb2021 for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 15Mar2021, the patient had experienced fatigue, headache. On 16Mar2021 the patient had experienced severe chills, fatigue, headache, body aches, vomiting, nausea, frequent urination. On 17Mar2021, the patient had experienced rash over entire body, fatigue, headache, body aches. The patient did not receive any treatment for the events. The clinical outcome of fatigue, headache, severe chills, fatigue, rash over entire body, body aches, vomiting, nausea and frequent urination were not resolved. No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache
Clinical narrative: Can not seem to gain any energy back.; Headaches; Severe exhaustion for 3 days after plus heightened previously existing conditions; Loose stool; This is a spontaneous report from a contactable other health care professional. A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 09Mar2021 at 12:45 (at the age of 34-years-old) as a single dose for COVID-19 Immunisation. The patient medical history included gout, chronic depression, HF (high functioning) anxiety and BPD 2 (borderline personality disorder). The patient concomitant medications included colchicine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021 at 15:30, the patient experienced loose stools, headaches, exhaustion for 3 days plus heightened previously existing conditions. After 7 days, severe exhaustion and heightened conditions continues, coming in waves. It was also reported that the patient could not seem to gain any energy back. The patient did not receive treatment for adverse events. The clinical outcome of the loose stools, headaches, exhaustion, condition aggravated and loss of energy were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: After the shot I was fine for 4 days and then I started having a hard time breathing; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 11Mar2021,at 03:15 as single dose for covid-19 immunization, at the age of 82 years.  The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products were noted. No other vaccines were administered within 4 weeks and no other medications were given two weeks prior to the COVID vaccine. The patient was not pregnant.  The patient noted "after the shot I was fine for 4 days and then I started having a hard time breathing" on 15Mar2021, at 14:00. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Heart was beating fast; Felt dizzy in the morning and at night before bed; This is a spontaneous report received from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: el9266) via an unspecified route of administration in the left arm on 27Feb2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic and asthmatic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included metformin (MANUFACTURER UNKNOWN) and FARXIGA from unknown dates and for unknown indications, unknown if it is ongoing. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Feb2021 at 12:30, the patient reported that her heart was beating fast and she felt dizzy for 7 days in the morning and at night before bed. The patient did not receive any treatment for the events. At the time of this report in 2021 the event heart rate increased was recovered and in Mar2021 the event felt dizzy was recovered.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Body temperature, Chills, Fatigue, Nausea
Clinical narrative: fever every night, 98+, 99+, week after shot fever at 100.4,; chills; Arthritis in hip aggravated; Mild nausea; Fatigue; Arm pain at shot site; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9267), via an unspecified route of administration in the left arm on 05Mar2021 at 15:00 as single dose for COVID-19 immunisation. Medical history included osteoporosis, asthma and Graves disease (treatment received). The patient did not have any allergies to medications, food, or other products. Prior to 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. Concomitant medications included albuterol inhaler (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), lutein (MANUFACTURER UNKNOWN), multi vitamin (MANUFACTURER UNKNOWN), all for an unspecified indication. Since the vaccination, the patient had not been tested positive for COVID-19. On 06Mar2021, the patient experienced low grade fever every night (98+, 99+ units unspecified). One week after the vaccination in Mar2021, the patient experienced fever at 100.4 (units unspecified), chills. arthritis in hip aggravated, could not walk far, mild nausea, fatigue and arm pain at shot site. The patient did not receive any treatment for the adverse events. The clinical outcome of the events fever, chills, arthritis, nausea, fatigue and vaccination site pain was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: fever every night, 98+, 99+, week after shot fever at 100.4,; chills; Arthritis in hip aggravated; Mild nausea; Fatigue; Arm pain at shot site; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9267), via an unspecified route of administration in the left arm on 05Mar2021 at 15:00 as single dose for COVID-19 immunisation. Medical history included osteoporosis, asthma and Graves disease (treatment received). The patient did not have any allergies to medications, food, or other products. Prior to 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. Concomitant medications included albuterol inhaler (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), lutein (MANUFACTURER UNKNOWN), multi vitamin (MANUFACTURER UNKNOWN), all for an unspecified indication. Since the vaccination, the patient had not been tested positive for COVID-19. On 06Mar2021, the patient experienced low grade fever every night (98+, 99+ units unspecified). One week after the vaccination in Mar2021, the patient experienced fever at 100.4 (units unspecified), chills. arthritis in hip aggravated, could not walk far, mild nausea, fatigue and arm pain at shot site. The patient did not receive any treatment for the adverse events. The clinical outcome of the events fever, chills, arthritis, nausea, fatigue and vaccination site pain was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: fever every night, 98+, 99+, week after shot fever at 100.4,; chills; Arthritis in hip aggravated; Mild nausea; Fatigue; Arm pain at shot site; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9267), via an unspecified route of administration in the left arm on 05Mar2021 at 15:00 as single dose for COVID-19 immunisation. Medical history included osteoporosis, asthma and Graves disease (treatment received). The patient did not have any allergies to medications, food, or other products. Prior to 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. Concomitant medications included albuterol inhaler (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), lutein (MANUFACTURER UNKNOWN), multi vitamin (MANUFACTURER UNKNOWN), all for an unspecified indication. Since the vaccination, the patient had not been tested positive for COVID-19. On 06Mar2021, the patient experienced low grade fever every night (98+, 99+ units unspecified). One week after the vaccination in Mar2021, the patient experienced fever at 100.4 (units unspecified), chills. arthritis in hip aggravated, could not walk far, mild nausea, fatigue and arm pain at shot site. The patient did not receive any treatment for the adverse events. The clinical outcome of the events fever, chills, arthritis, nausea, fatigue and vaccination site pain was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 2 inch red oval area on the arm; A large bump developed; the area was warm/hot to the touch.; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6206) via an unspecified route of administration on the left arm on 05Mar2021 at 13:45 hours (at the age of 45-years-old), as single dose for COVID-19 immunisation. The patient had no medical history and had no allergies to medications, food or other products. The concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. No other medications were received by the patient within 2 weeks of vaccination. On 14Mar2021 at 14:30 hours, the patient experienced a 2-inch red oval area on the arm where the vaccine was given. A large bump had developed and the area was warm/hot to touch. The patient took Ibuprofen and BENEDRYL for the events. The clinical outcome of the events was resolved on 16Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: pain at the sternum base; breathing problems; Diarrhea; Chills; Slight fever; Possible swollen lymph glands; Red arm; brain fog continued; Increased irritability; Vomiting; Extreme dizziness; Swollen, red arm; This is spontaneous report from a contactable consumer, the patient. A 69-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown), via unspecified route of administration in the left arm on 03Mar2021 at 21:00 as a single dose for COVID-19 Immunisation (at the age of 69 years age at vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's medical history included gastroesophageal reflux disease (GERD) and hypothyroidism. The patient was allergic to the Penicillin and most of the antibiotics and always had a problem with flu vaccine so since retired don't get it or other vaccines. The patient's concomitant medications included pantoprazole 20mg (MANUFACTURER: UNKNOWN) and levothyroxine112mg (MANUFACTURER UNKNOWN).The patient experienced swollen, red arm, vomiting, diarrhea, extreme dizziness, chills, slight fever, possible swollen lymph glands, increased irritability and brain fog on 04Mar2021 at 03:00am and she had to be in bed for almost 40 hours. The patient also experienced repeat of extreme vomiting, diarrhea and breathing problems secondary to pain at the sternum base on 14Mar2021. No Therapeutic measures taken for the adverse event. At the time of the report the clinical outcome of the events swollen, red arm, vomiting, diarrhea extreme dizziness, chills, slight fever, possible swollen lymph glands, increased irritability and brain fog were recovering and the events breathing problems and secondary to pain at the sternum base were unknown.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Irritability, Lymphadenopathy, Peripheral swelling
Clinical narrative: pain at the sternum base; breathing problems; Diarrhea; Chills; Slight fever; Possible swollen lymph glands; Red arm; brain fog continued; Increased irritability; Vomiting; Extreme dizziness; Swollen, red arm; This is spontaneous report from a contactable consumer, the patient. A 69-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown), via unspecified route of administration in the left arm on 03Mar2021 at 21:00 as a single dose for COVID-19 Immunisation (at the age of 69 years age at vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's medical history included gastroesophageal reflux disease (GERD) and hypothyroidism. The patient was allergic to the Penicillin and most of the antibiotics and always had a problem with flu vaccine so since retired don't get it or other vaccines. The patient's concomitant medications included pantoprazole 20mg (MANUFACTURER: UNKNOWN) and levothyroxine112mg (MANUFACTURER UNKNOWN).The patient experienced swollen, red arm, vomiting, diarrhea, extreme dizziness, chills, slight fever, possible swollen lymph glands, increased irritability and brain fog on 04Mar2021 at 03:00am and she had to be in bed for almost 40 hours. The patient also experienced repeat of extreme vomiting, diarrhea and breathing problems secondary to pain at the sternum base on 14Mar2021. No Therapeutic measures taken for the adverse event. At the time of the report the clinical outcome of the events swollen, red arm, vomiting, diarrhea extreme dizziness, chills, slight fever, possible swollen lymph glands, increased irritability and brain fog were recovering and the events breathing problems and secondary to pain at the sternum base were unknown.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: pain at the sternum base; breathing problems; Diarrhea; Chills; Slight fever; Possible swollen lymph glands; Red arm; brain fog continued; Increased irritability; Vomiting; Extreme dizziness; Swollen, red arm; This is spontaneous report from a contactable consumer, the patient. A 69-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown), via unspecified route of administration in the left arm on 03Mar2021 at 21:00 as a single dose for COVID-19 Immunisation (at the age of 69 years age at vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's medical history included gastroesophageal reflux disease (GERD) and hypothyroidism. The patient was allergic to the Penicillin and most of the antibiotics and always had a problem with flu vaccine so since retired don't get it or other vaccines. The patient's concomitant medications included pantoprazole 20mg (MANUFACTURER: UNKNOWN) and levothyroxine112mg (MANUFACTURER UNKNOWN).The patient experienced swollen, red arm, vomiting, diarrhea, extreme dizziness, chills, slight fever, possible swollen lymph glands, increased irritability and brain fog on 04Mar2021 at 03:00am and she had to be in bed for almost 40 hours. The patient also experienced repeat of extreme vomiting, diarrhea and breathing problems secondary to pain at the sternum base on 14Mar2021. No Therapeutic measures taken for the adverse event. At the time of the report the clinical outcome of the events swollen, red arm, vomiting, diarrhea extreme dizziness, chills, slight fever, possible swollen lymph glands, increased irritability and brain fog were recovering and the events breathing problems and secondary to pain at the sternum base were unknown.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Feeling tired; Chills; Fever; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6199) via unspecified route of administration in the left arm on 16MAR2021 at 13:30 hours (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patients medical history includes thyroid issues from unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to medication, food, or other products. The concomitant medications included levothyroxine (UNKNOWN MANUFACTURER), TYLONOL and ibuprofen (UNKNOWN MANUFACTURER) all for unknown indications from an unknown date. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 16Mar2021, the patient experienced headache about 30 minutes to an hour after receiving the vaccination and shortly after that she felt tired. Later that night she had chills followed by fever & muscle ache. No therapeutic measures were taken for the reported events. The clinical outcome of headache, feeling tired, chills, fever and muscle ache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Painful, Two weeks since second shotand still have some pain in armpit.; Lymph node in left armpit swollen; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 27Feb2021 at 13:00 (at the age of 68-years-old) as a single dose for COVID-19 Immunisation. Medical history included degenerative disc disease and fibromyalgia. Prior to vaccination, the patient was not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN) these medications were used within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 9264) via an unspecified route of administration in the left arm on 02Feb2021 at 19:30 as a single dose for COVID-19 Immunization. On 28Feb2021 at 14:15, the patient experienced lymph node in left armpit swollen and painful. It was also reported that two weeks since second shot still the patient had some pain in armpit. No therapeutic measures were taken for the events. The clinical outcome for the event lymph node in left armpit swollen and pain in armpit was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Increased volume and new frequencies regarding existing tinitus; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199), via an unspecified route of administration in the right arm on 11Mar2021 at 18:15 (at the age of 51 years), as a single dose for COVID-19 immunisation. Medical history included tinnitus. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and LIPITOR for an unspecified indication. The patient was allergic to dilantin "Dylantin". Since the vaccination, the patient had not been tested positive for COVID-19. On 15Mar2021, the patient experienced increased volume and new frequencies regarding existing tinnitus. The patient did not receive any treatment for the event. The clinical outcome of the event tinnitus was reported as unknown.   No follow-up attempts are needed. No further information is expected.