chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Blotches on arms and legs; Itchy; This is a spontaneous report from a contactable consumer, the patient. An 84-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: En6208) via an unspecified route of administration in left arm on 16Mar2021 at 11:15 (at the age of 84-year-old), as a single dose for COVID-19 immunisation. It was reported that the patient was allergic to past drug codeine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on unknown date, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within two weeks of vaccination included simvastatin (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN) for unknown indication. On 16Mar2021, at 13:15, the patient had various size blotches on his arm and legs (skin blotches) which extremely bothersome and itchy. Therapeutic measures were taken for the events skin botches and itchy included treatment with a cream (unspecified cream). The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events skin blotches and itchy was resolving at the time of this report. No follow up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable other non-health care professional. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm as a single dose on 22Mar2021 at 14:00 (at the age of 39-year-old) for COVID-19 immunisation. The patient medical history included diabetes. Concomitant medication included metformin (MANUFACTURER UNKNOWN) for diabetes. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient has not tested for COVID-19 since vaccination. On 22Mar2021 at 19:00, the patient experienced fever, chills, head-ache, dizziness, body aches, vomiting, pain and swelling at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment measures were not taken for the events. The clinical outcomes of fever, chills, head-ache, dizziness, body aches, vomiting, vaccination site pain and swelling at vaccination site were recovering at the time of report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: This is a spontaneous report from a non-contactable other non-health care professional. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm as a single dose on 22Mar2021 at 14:00 (at the age of 39-year-old) for COVID-19 immunisation. The patient medical history included diabetes. Concomitant medication included metformin (MANUFACTURER UNKNOWN) for diabetes. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient has not tested for COVID-19 since vaccination. On 22Mar2021 at 19:00, the patient experienced fever, chills, head-ache, dizziness, body aches, vomiting, pain and swelling at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment measures were not taken for the events. The clinical outcomes of fever, chills, head-ache, dizziness, body aches, vomiting, vaccination site pain and swelling at vaccination site were recovering at the time of report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Limb discomfort, Musculoskeletal stiffness
Clinical narrative: Heaviness in the injected arm; Stiff neck; Joint pain; Headache; This is a spontaneous report received from a non-contactable patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration on the left arm on 23Mar2021 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Concomitant medication within two weeks of vaccination included Over The Counter (OTC) vitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the patient experienced heaviness in the injected arm, stiff neck, joint pain and headache. The patient did not receive any treatment for the reported events. The clinical outcome of the events heaviness in the injected arm, stiff neck, joint pain and headache was reported as recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: pain and swelling in arm where hadinjection; pain and swelling in arm where hadinjection; Feeling tired; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration in the left arm on 22Mar2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have 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-19 vaccine. The patient did not receive any medications within two weeks of COVID-19 vaccine. On 22Mar2021 at 14:00, the patient had experienced pain and swelling in arm where the patient had injection and was feeling tired. The patient did not receive any treatment for the adverse events. Adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events pain and swelling in arm where had injection and feeling tired was resolved on an unspecified date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness/complains of dizziness; This is a spontaneous report from a non-contactable other healthcare professional. A 68-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration on 25Mar2021 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 25Mar2021, during 15-minute waiting period after the injection, the patient began to experience light headedness. The patient denied rash. The patient complained of dizziness. Therapeutic measures were taken as a result of light-headedness and dizziness; removed mask and provided calming measures and follow-up response to treatment was good. The clinical outcome of the event light-headedness was recovered on 25Mar2021.   No follow-up attempts are possible. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-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 in the left arm on 17Mar2021 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was allergic to penicillin. Concomitant medications were reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since having the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 25Mar2021 at 08:00, the patient experienced itching started in hands and progressively moved up arms. Hives on hands and arms, extreme itching. Hives moved to legs and feet with extreme itching. Hands are very red and hands are swollen. The patient received antihistamine treatment for reported events. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the reported events itching started in my hands and progressively moved up my arms, hives on hands and arms, hands are very red and hands are swollen was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: rapid resting heart rate (~110-130 bpm) for a couple of hours.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included congenital/neonatal emphysema. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 10:15, around 15 minutes after vaccination, the patient experienced rapid resting heart rate of approximately 110-130 bpm for a couple of hours. The patient did not experience trouble breathing and relaxed at the store until the heart rate reduced below 100 bpm for a period of approximately 30 minutes. The patient's normal resting heart rate was 60-65 bpm. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the heart rate increased. The clinical outcome of the event heart rate increased was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: This is a spontaneous report received from a contactable consumer. A 66-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route administration in the left arm on 23Mar2021, (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had not received other medications within 2 weeks prior to the COVID-19 vaccine as concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 02Mar2021 at 10:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. The patient was allergic to ciprofloxacin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 since the vaccination. On 23Mar2021, at 22:00, the patient experienced with disrupted sleep over two nights after the second dose of vaccination. No therapeutic measures were taken as a result of adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: 9 bouts of diarrhea; Abdominal cramps; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: ER8732), via an unspecified route of administration in the right arm on 24Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, insomnia, some spinal compression, some arthritis due to chronic Achilles rupture, chronic sore in nose, tongue was too big for mouth, dust mites allergy and elm pollen allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lorazepam (MANUFACTURER UNKNOWN), zolpidem (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), topiramate (MANUFACTURER UNKNOWN) and lamotrigine (LAMICTAL), all for unknown indications from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 12:40, about 40 minutes after the shot, the patient experienced abdominal cramps and on 25Mar2021 (reported as today), the patient experienced 9 bouts of diarrhea between 09:00 to 15:00. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment with OTC anti-diarrheal medications for the event's abdominal cramps, 9 bouts of diarrhea and zoom was scheduled for 18:00 on 25Mar2021. The clinical outcomes of the event's abdominal cramps and 9 bouts of diarrhea were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Fever; Chills; Muscle aches; Injection site warmth; Injection site firmness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the 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 24Mar2021, the patient experienced fever, chills, muscle aches, injection site firmness and warmth. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events.  The clinical outcome of the events fever, chills, muscle aches, injection site firmness and warmth were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Moderate body aches; Severe headache; Mild nausea; Moderate fatigue; This is a spontaneous report from a contactable company representative, the patient. A 55-Year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in left arm on 23Mar2021, at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications received within two weeks of vaccination reported as no. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E23247), via an unspecified route of administration in left arm on 01Mar2021, at 10:00 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. 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 4 weeks prior to the COVID vaccine. On 24Mar2021 at 09:00, the patient experienced moderate body aches, severe headache, mild nausea and moderate fatigue. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of headache included treatment with TYLENOL. The clinical outcome of the events moderate body aches, severe headache, mild nausea and moderate fatigue was resolved on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate increased, Nausea
Clinical narrative: Waves of chills; Rapid heart beat; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in left arm on 21Mar2021 at 16:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included coronary artery disease (CAD). The patient had no 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 been tested for COVID-19. Concomitant medications included clopidogrel (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), ASPIRIN (MANUFACTURER UNKNOWN) and C (as reported); all were taken for unknown indications from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 24Mar2021, at 09:30, the patient experienced waves of chills, rapid heartbeat, nausea and fatigue all intensely. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of the events waves of chills, rapid heartbeat, nausea and fatigue were resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph node in right armpit; mild flu like symptoms; body aches; fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 5318) via unspecified route of administration on 26Feb2021 (at the age of 53-years-old) at 13:30 in right arm for COVID-19 immunisation. Medical history of the patient included pancreatectomy (pancreatic tumor (insulinoma) removed in 2016). The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. The patient received a dose of tetanus vaccine (MANUFACTURER UNKNOWN) via unspecified route of administration on 29Jan2021 in left arm within 4 weeks of COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Feb2021 at 13:30, the patient experienced swollen lymph node in right armpit, mild flu like symptoms, body aches and fatigue for about 12 to 15 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the reported events. The clinical outcome of axillary lymphadenopathy, mild flu like symptoms, body aches and fatigue were reported as recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dry eye
Clinical narrative: Dry eyes to the point where I have difficulty wearing contact lenses; This is a spontaneous report received from a contactable consumer, the patient. A 73-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1283) via an unspecified route of administration in the left arm on 24Feb2021 (at the age of 73-year-old), as single dose for COVID-19 immunisation. The patients medical history was reported as none and known allergies were reported as no. The concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1283) via an unspecified route of administration in the left arm on 01Feb2021 at 15:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. 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 four weeks prior to the vaccination. On 01Mar2021, patient experienced dry eyes to the point where he had difficulty wearing contact lenses. Treatment received for the adverse event was reported as trying different solutions and lenses. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of dry eyes was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint stiffness
Clinical narrative: After 20 minutes of getting second dose face staryed to tingling like going numb.; Jaw stiff; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: ER2613), via an unspecified route of administration in the left arm on 25Mar2021 at 15:15 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included spina bifida. Concomitant medications included buprenorphine hydrochloride (BELBUCA), ibuprofen (ADVIL), cetirizine hydrochloride (ZYRTEC) and pseudoephedrine (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: EN6200), via an unspecified route of administration in the left arm on 04Mar2021 at 09.45 (at the age of 37-years-old), as a single dose for COVID-19 immunisation and codeine (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 15:35, 20 minutes after the second dose face started to tingle like going numb and jaw stiff. It was unknown if the patient received any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events numbness in face and jaw stiffness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Fatigue; Swollen lymph nodes; Terrible aches in lymph node areas, especially in neck.; Sore muscles in entire body, especially in neck, buttocks, arms, and legs.; Stippling and bruising on back; This is a spontaneous report received from a contactable consumer, the patient. A 33-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613,) via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 hours (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient was not reported. Concomitant medications of the patient included levonorgestrel (IUD by MIRENA). The patient did not receive any other vaccine within the 4 weeks prior to the COVID vaccine.On 10Feb2021, the patient underwent nasal swab test for COVID-19 which was negative. Prior to the vaccination, the patient had not been diagnosed with COVID-19.  The patient was not tested for COVID-19 after the vaccination. On 18Mar2021 at 11:45 hours, the patient experienced the events extreme fatigue, muscle ache, swollen lymph nodes, terrible aches in lymph node areas, especially in the neck, sore muscles in entire body, especially in neck, buttocks, arms, and legs and stippling and bruising on back. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, swollen lymph nodes, lymph node pain, muscle soreness, muscle ache and bruising were unknown.   No follow-up attempts are needed. No further information is expected.; Reporter's Comments: Stippling and bruising on back (possibly unrelated?)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fatigue; Swollen lymph nodes; Terrible aches in lymph node areas, especially in neck.; Sore muscles in entire body, especially in neck, buttocks, arms, and legs.; Stippling and bruising on back; This is a spontaneous report received from a contactable consumer, the patient. A 33-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613,) via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 hours (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient was not reported. Concomitant medications of the patient included levonorgestrel (IUD by MIRENA). The patient did not receive any other vaccine within the 4 weeks prior to the COVID vaccine.On 10Feb2021, the patient underwent nasal swab test for COVID-19 which was negative. Prior to the vaccination, the patient had not been diagnosed with COVID-19.  The patient was not tested for COVID-19 after the vaccination. On 18Mar2021 at 11:45 hours, the patient experienced the events extreme fatigue, muscle ache, swollen lymph nodes, terrible aches in lymph node areas, especially in the neck, sore muscles in entire body, especially in neck, buttocks, arms, and legs and stippling and bruising on back. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, swollen lymph nodes, lymph node pain, muscle soreness, muscle ache and bruising were unknown.   No follow-up attempts are needed. No further information is expected.; Reporter's Comments: Stippling and bruising on back (possibly unrelated?)
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Body aches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204) via an unspecified route of administration in the right arm on 23Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included PAC's and Meiners. 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 received unspecified concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 6203), via an unspecified route of administration in the right arm on 02Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 09:30, the patient experienced body aches and chills. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events body aches and chills. The clinical outcomes of the events body aches and chills were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a contactable patient. A 58-year-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 the left arm on 24Mar2021 at 1000 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Past medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 COVID vaccine. On 25Mar2021 at 1000, the patient experienced diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was taken for the event experienced. The clinical outcome of the event diarrhea was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain
Clinical narrative: Chills; Achy; Severe diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 18Mar2021 at 08:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient was allergic to codeine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 25Feb2021 at 11:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 07:00, the patient experienced chills, achy and severe diarrhea. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the chills, achy and severe diarrhea were not resolved at the time of this report.  No follow up attempts are possible; information about lot number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Computerised tomogram, Tinnitus, Toothache
Clinical narrative: ongoing intestinal difficulties; teeth hurt; ear ringing; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old elderly non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 28Feb2021 at 17:15 (at the age of 73-years-old), as a single dose for COVID-19 immunisation. Medical history included celiac disease, Hashimotos thyroid from an unknown date. The patient was allergic to gluten and penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) for unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021, the patient experienced intestinal difficulties and was only able to have liquid diet for many weeks (continuing). The patient also experienced teeth hurt and ear ringing. The adverse events resulted in the doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included CT scan, blood test on an unknown date. The patient received special diet and medications as a treatment for the adverse events. The clinical outcome of the events abdominal discomfort was not resolved and the outcome of the events tooth ache, tinnitus was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: have been having a site right hip. It's hard to put any weight on right leg and hard to walk.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 57-years-old), as single dose for COVID-19 immunisation. The medical history includes epilepsy, hypothyroidism, diabetes 2, hypertension, systolic murmur, anxiety/depression/OCD (obsessive-compulsive disorder), vestibular migraines and weakness. Concomitant medication included vitamins (MANUFACTURER UNKNOWN), prescription drugs, OTC medicine. The patient previously received lisinopril (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 21Mar2021 at 19:00, approximately 32 hours after the shot, after a several hours sitting, the patient had a site right hip and was hard to put any weight on right leg and hard to walk. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive treatment for walking difficulty. The clinical outcome of the event walking difficulty was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: weird headache; chills; This is a spontaneous report from consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the right arm on 22Mar2021 at 16:00 (at the age of 61-year-old) as single dose for COVID-19 immunisation. The medical history included simple partial seizures (mild form of epilepsy). Concomitant medication included lexapro (MANUFACTURER UNKNOWN) started on an unknown date for simple partial seizures. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the right arm on 01Mar2021 at 15:00 (at the age of 61-year-old), as single dose for COVID-19 immunisation. The patient previously experienced drug allergy with codeine. 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 four weeks prior to the vaccination. It was reported that after getting the 2nd shot on Monday (22Mar2021), the patient felt a weird headache which was started on Tuesday on 23Mar2021 afternoon. The patient came home from work to rest. The patient experienced chills for a few hours and the headache worsened. The chills ceased but the headache lingered. Wednesday on 24Mar2021 and today (Thursday 25Mar2021) the patient still had the headache and today (at the time of reporting) was the worse day so far. It was a weird headache, the patient felt it on the top right side of head and the pain goes down the back right side. The patient rarely gets headaches and was very concerned that this has gone on for several days and was persisting at this moment. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken. The clinical outcome of chills was recovered and the outcome of headache was not resolved at the time of report.  No follow-up attempts are possible; No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: Under the armpit swollen ganglion; Swollen upper arm; This is a spontaneous report received from a contactable other healthcare professional, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 as a single dose for COVID-19 immunisation. The Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route in the left arm, on 25Feb2021 at 18:00 as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was allergic to penicillin. Patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks. On 19Mar2021 at 14:00 hours, the patient experienced under armpit swollen ganglion and also had swelling in the upper arm. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was administered for the events. The clinical outcome for the events arm pit swollen ganglion and upper arm swelling were not recovered.   No follow-up attempts possible. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Rigors x2 hours approximately 12 hrs after the vaccine; Low grade temp to 101 for 24 hrs post injection; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 24Mar2021 at 11:30 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes. Concomitant medications included insulin (MANUFACTURER UNKNOWN), ethinylestradiol; norgestimate (ORTHO TRI-CYCLEN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date. The patient previously took AUGMENTIN for an unspecified indication and experienced allergy. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 23:45, the patient experienced rigors for 2 hours approximately 12 hours after the vaccine and low-grade temp to 101 (units unspecified) for 24 hours post injection. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of the events rigors for 2 hours approximately 12 hours after the vaccine and low-grade temp to 101 for 24 hours post injection were resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nosebleed; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old adult male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 14:30 (at the age of 40-years-olds), as a single dose for COVID-19 immunisation. Medical history was not reported. Other medications received within two weeks of vaccination reported as not applicable (NA). 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 COVID vaccine. On 25Mar2021 at 18:00, the patient experienced nosebleed. The patient did not receive any treatment for the event nosebleed. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event nosebleed was resolving at the time of this report.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever of 100.6 degree; tiredness; Injection site soreness; headache; This is a spontaneous report received from a contactable consumer, the patient. A 39-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in left arm on 24Mar2021 at 14:00 (at the age of 39 years), as a single dose for COVID-19 immunisation. Medical history included asthma, ADHD (attention deficit hyperactivity disorder) and spinal arthritis. The patient was allergic to penicillin, amoxicillin, ceclor, erythromycin, onions and garlic. The patient received amfetamine aspartate, amfetamine sulfate, dexamfetamine sulfate, dexamfetamine saccharate (ADDERALL) and salbutamol (ALBUTEROL), both for unknown indication since unknown dates within two weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the 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 24Mar2021 at 21:30, the patient experienced fever of 100.6 degree celsius, tiredness, injection site soreness (vaccination site pain) and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of events fever, tiredness, vaccination site pain and headache were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via unspecified route of administration on left arm on 25Mar2021 at 10:30 (at the age of 53 years old) as a single dose, for COVID-19 immunisation. Medical history included thyroid disorder, asthma and depression. The patient was allergic to penicillin and metronidazole(FLAGYL) from an unspecified date. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), clarithromycin (MANUFACTURER UNKNOWN), levothyroxine sodium (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN) from an unspecified date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 COVID vaccine. On 25Mar2021, at 12:00, the patient experienced soreness at injection site (vaccination site pain). The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No treatment  was taken in response to the event. The clinical outcome of the event vaccination site pain was not recovered at the time of the report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-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 left arm on 24Mar2021 at 10:15 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and overweight. The patient had no known allergies to medications, food or other products. The patient received other unspecified medications within two weeks of vaccination. The patient did not receive any other vaccine in four weeks prior to COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 24Mar2021 at 12:15, the patient had diarrhea. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of event diarrhea was recovered on unknown date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.