chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph node under left arm; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 10:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 the patient experienced swollen lymph node under left arm. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node under left arm was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Muscle twitching, Neck pain
Clinical narrative: Pressure on the left side of forehead; Left eye twitching; Pain in neck on the right side; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the 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 concomitant medications. The patient previously received naproxen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and experienced drug allergy. On 03Apr2021 at 13:00 (Saturday), the patient experienced pain in neck on the right side. On 04Apr2021 (Sunday), the patient had pressure on the left side of her forehead and left eye twitching. The eye twitching was still occurring on the day of report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event eye twitching was not resolved; whereas for the events pain in neck on the right side and pressure on the left side of her forehead was unknown at the time of this report. The patient received second dose of of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 23Apr2021 at 10:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes and pain in armpit in injected arm; Swollen lymph nodes and pain in armpit in injected arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 22Apr2021 at 13:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient's known allergies were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), ethinylestradiol/ etonogestrel (NUVARING) and atorvastatin calcium (LIPITOR); all for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 13:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient experienced swollen lymph nodes and pain in armpit in injected arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen lymph nodes and pain in armpit in injected arm were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen painful supraclavicular lymph nodes.; Swollen painful supraclavicular lymph nodes.; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 15:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The medical history included stomach ulcers and allergy to medical adhesives. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 21Apr2021 at 08:00, the patient experienced swollen painful supraclavicular lymph nodes. It was reported that the swelling was noticed about 7 days after vaccination and was present at the time of report (12 days after vaccination). The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen painful supraclavicular lymph nodes was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Intense pain at the injection site over two and a half weeks after the second dose. It feels the same as the day after receiving the shot; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the 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 two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation.  On 06Apr2021, the patient experienced intense pain at the injection site over two and a half weeks after the second dose and it felt the same as the day after receiving the shot. The 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 the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intense pain at the injection site was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpitations that come and go; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWQ151) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 06Apr2021, the patient experienced palpitations that come and go which lasted 4 days. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event palpitations that come and go was recovered on 10Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo lasting over 10 days; This is a spontaneous report from a non contactable consumer, the patient. A 47-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 left arm on 16Apr2021 at 17:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included Idiopathic low Complete Blood Count (CBC) (white blood cell count <2.0). The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. The patient previously 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 26Mar2021 at 18:00 (at the age of 47-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 four weeks prior to the vaccination.  On 17Apr2021 at 03:00, the patient experienced vertigo lasting over 10 days. The event 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 the event. The clinical outcome of the event vertigo  was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fall, Fatigue
Clinical narrative: Having difficulty walking without teetering and falling into things, hard to walk in straight line; Extremely nauseous; dizzy in waves; No appetite; I nearly black out and fall over if I get up quickly.  I have already fallen and cut myself twice; I nearly black out and fall over if I get up quickly.  I have already fallen and cut myself twice; Weak; fatigued; Manic mood disturbances; flu-like symptoms; This is a spontaneous report from a contactable consumer(patient). This 32-year-old female Consumer (patient) reported for herself. A 32-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EW0169) via an unspecified route of administration in arm left on 21Apr2021 13:30 as dose 2, single (age at vaccination: 32 years) for COVID-19 immunisation. Medical history included Brain aneurysms (coiled and stented), bipolar type 1, migraines, all from an unknown date and unknown if ongoing. Concomitant medications included lithium (LITHIUM); lamotrigine (LAMICTAL); diazepam (VALIUM); risperidone (RISPERIDONE); ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), all taken for an unspecified indication, start and stop date were not reported. The patient previously took buspar, predenisone and experienced known allergies Buspar, prednisone. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: ER8733) via an unspecified route of administration in arm left on 01Apr2021 01:45 pm as dose 1, single (age at vaccination: 32 years) for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination and did not test COVID post vaccination. On 22Apr2021 12:00am, it was reported that the patient experienced having difficulty walking without teetering and falling into things, hard to walk in straight line. Extremely nauseous and dizzy in waves. No appetite. I nearly black out and fall over if I get up quickly, already fallen and cut myself twice, weak and fatigued, manic mood disturbances. This is persisting after the initial flulike symptoms have gotten better. No treatment was received. The clinical outcome of the event was not resolved.  No follow up attempts are possible. No further information is expected
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Influenza like illness, Injury, Mania, Nausea
Clinical narrative: Having difficulty walking without teetering and falling into things, hard to walk in straight line; Extremely nauseous; dizzy in waves; No appetite; I nearly black out and fall over if I get up quickly.  I have already fallen and cut myself twice; I nearly black out and fall over if I get up quickly.  I have already fallen and cut myself twice; Weak; fatigued; Manic mood disturbances; flu-like symptoms; This is a spontaneous report from a contactable consumer(patient). This 32-year-old female Consumer (patient) reported for herself. A 32-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EW0169) via an unspecified route of administration in arm left on 21Apr2021 13:30 as dose 2, single (age at vaccination: 32 years) for COVID-19 immunisation. Medical history included Brain aneurysms (coiled and stented), bipolar type 1, migraines, all from an unknown date and unknown if ongoing. Concomitant medications included lithium (LITHIUM); lamotrigine (LAMICTAL); diazepam (VALIUM); risperidone (RISPERIDONE); ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), all taken for an unspecified indication, start and stop date were not reported. The patient previously took buspar, predenisone and experienced known allergies Buspar, prednisone. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: ER8733) via an unspecified route of administration in arm left on 01Apr2021 01:45 pm as dose 1, single (age at vaccination: 32 years) for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination and did not test COVID post vaccination. On 22Apr2021 12:00am, it was reported that the patient experienced having difficulty walking without teetering and falling into things, hard to walk in straight line. Extremely nauseous and dizzy in waves. No appetite. I nearly black out and fall over if I get up quickly, already fallen and cut myself twice, weak and fatigued, manic mood disturbances. This is persisting after the initial flulike symptoms have gotten better. No treatment was received. The clinical outcome of the event was not resolved.  No follow up attempts are possible. No further information is expected
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Swelling face
Clinical narrative: I experienced swelling in my face (i.e. both eyes, cheeks, lips and chin).; I experienced swelling in my face (i.e. both eyes, cheeks, lips and chin).; I experienced swelling in my face (i.e. both eyes, cheeks, lips and chin).; This is a spontaneous report from a contactable other healthcare professional (hcp) (patient). A 30-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Right on 25Apr2021 14:00 (at the age of 30-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The vaccine was administered in a Health Clinic/facility. The patient did not receive any other vaccines in four weeks prior to receiving bnt162b2. Medical history was none. No known allergies. The patient was not pregnant during vaccination and adverse events. The patient had no history of COVID prior to vaccination and was not tested for COVID post vaccination. Concomitant medications were none. On 27Apr2021 04:00, the patient experienced swelling in her face (i.e. both eyes, cheeks, lips and chin). As the patient stated, "I experienced swelling in my face (i.e. both eyes, cheeks, lips and chin)." Therapeutic measures were taken as result of the adverse events which included an IV with Antihistamine, Steroid, and Benadryl. Outcome of the events was recovering. The adverse events resulted in Emergency room/department or urgent care.; Sender's Comments: There is a reasonable possibility that the events "swelling in her face (both eyes, cheeks, lips and chin)" were related to BNT162b2 based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Had a temperature of 105.1f within 12 hours of second injection. Fever slowly subsided over the next 16 hours.; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0171), via an unspecified route of administration, on 30Apr2021 03:00 PM (at the age of 38 years old) on left arm as a dose 2, single for COVI1-9 immunization. Patient medical history and concomitant medication were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0153), via an unspecified route of administration, on 09Apr2021 05:00 PM (at the age of 38 years old) on left arm as a dose 1, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient had not received any other vaccine in four weeks and patient had not received any other medications within two weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and patient was not tested for COVID-19 since the vaccination. On 01May2021 patient had temperature of 105.1 F within 12 hours of second injection. Fever slowly subsided over the next 16 hours. Patient received the treatment of ibuprofen and acetaminophen stacking. Patient had undergone lab test and procedures which include body temperature resulted as 105.1 F on 01May2021. The outcome of the event was recovered with Sequel on unspecified date in 2021.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fungal infection, Poor quality sleep, Pyrexia, SARS-CoV-1 test
Clinical narrative: Fever; restless sleep; Found what appears to be a fungal infection on my tongue (plaque can be scrapped off); chills; This is a spontaneous report from a contactable consumer (patient himself). A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0171; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 26Apr2021 12:00 (at age of 26-years-old) as DOSE 2, SINGLE and patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0150; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 14:00 (at age of 26-years-old) as DOSE 1, SINGLE both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. 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. On 27Apr2021 03:00 the patient experienced fever, chills, restless sleep and found what appears to be a fungal infection on my tongue (plaque can be scrapped off). Patient did not receive any treatment for AEs. The patient underwent lab tests and procedures which included SARS-COV-1 test (Post vaccination; Nasal Swab) which was negative on 21Apr2021. The outcome of all events was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Pain and tenderness in both armpits (particularly on the side of the injection); This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 13Apr2021 at 12:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ubidecarenone (COQ10), prasterone (DHEA), vitamin d nos (VIT D), unspecified multivitamin and chinese herbs; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received trimethoprim (MANUFACTURER UNKNOWN) and experienced drug allergy. On 15Apr2021, the patient experienced pain and tenderness in both armpits (particularly on the side of the injection); pain was continuing and she was two weeks post vaccination. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain and tenderness in both armpits (particularly on the side of the injection) was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Illness, SARS-CoV-2 test, Sneezing
Clinical narrative: Received covid vaccine and has been sick ever since; Difficulty breathing; Cough; Sneezing; This is a spontaneous report from a contactable Other HCP (Nurse) communicated to Pfizer-sponsored program for a female patient.  A 63-year-old female patient started to receive tofacitinib citrate (XELJANZ XR, 11mg prolonged release tablet) orally from an unspecified date and ongoing at 11 mg once daily for rheumatoid arthritis; received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 01Apr2021, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); Oxycodone hydrochloride, paracetamol (OXYCODONE AND ACETAMINOPHEN); Lorazepam; Homatropine methylbromide, hydrocodone bitartrate (HYDROCODONE BIT. AND HOMATROPINE METH.); Methotrexate sodium; Ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS); Atorvastatin (LIPITOR [ATORVASTATIN]); Amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL), all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine sulphate, gabapentin and lisinopril and experienced allergy to all. The patient reported that she received the COVID vaccine on 01Apr2021 and has been sick ever since. The patient stated she was still taking tofacitinib citrate. The patient stated symptoms were difficulty breathing, cough and sneezing. It was unknown if the patient was pregnant at time of event. The patient stated she was tested for COVID and was negative. The prescribing medical doctor (MD) was not aware. Tofacitinib citrate start date unknown, first withheld ship 21Jun2016. The action taken in response to the events for tofacitinib citrate was dose not changed. The outcome of the events was not resolved.  No follow up attempts are needed. No further information is expected.  Follow-up (03May2021): This is a follow-up report combining information from duplicate reports 2021498007 and 2021497979. The current and all subsequent information will be reported under manufacturer report number 2021497979. Added the details of Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms lasting 2 days from the time of vaccination: headache and aches.; This is a spontaneous report from a contactable consumer. An adult male patient of unknown age received 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. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. It was unknown whether the patient had any concomitant medications. On an unknown date, the patient developed flu like symptoms which lasted for two days from the time of vaccination with headache and aches. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event flu like symptoms lasting 2 days from the time of vaccination: headache and aches were recovered on an unknown date.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Arm soreness; Bodyache; Fatigue; Injection site soreness,; Headache; This is a spontaneous report from a contactable consumer. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 03Mar2021 at 13:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation.  Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ibuprofen (ADVIL) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date in 2021 at 13:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 04Mar2021, the patient experienced injection site and arm soreness, headache, fatigue, body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site and arm soreness, headache, fatigue, body aches was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: fatigue moderate; muscle and joint pain; Joint pain; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration on 27Apr2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history and allergies to medications, food or other products were reported as unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an intramuscular route of administration on 06Apr2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021, the patient experienced fatigue moderate, muscle and joint pain, all lasted about 24 hours. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue moderate, muscle and joint pain was recovered on 29Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: 101.3 fever; Severe muscle aches (left arm, lower back, pelvic muscles, thighs); Headache; This is a spontaneous report from a non-contactable physician, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0170) via an unspecified route of administration in the  left arm on 27Apr2021 at 14:30, (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included contraception. It was unknown if the patient had known allergies. Concomitant medications included ethinylestradiol,gestodene (MANUFACTURER UNKNOWN) for an indication of contraception received within 2 weeks of vaccination. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the  left arm on 06Apr2021 at 13:30, (at the age of 40-year-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 four weeks prior to the vaccination. On 28Apr2021 at 06:00 the patient experienced severe muscle aches (left arm, lower back, pelvic muscles, thighs),headache and at 18:30 the patient experienced 101.3 fever. Therapeutic measures were taken as a result of events and included treatment with Acetaminophen 2x500 mg. The events 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 were muscle aches (left arm, lower back, pelvic muscles, thighs),headache and 101.3 fever were recovered on 29Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cold sweat, Decreased appetite, Pain, Pyrexia
Clinical narrative: High fever 102; Fully body aches; Cold sweats; Vomiting; No appetite for 24 hours after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8737) via an unspecified route of administration in the arm left on 26Apr2021 at 12:15(at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8737) via an unspecified route of administration in the arm left on 05Apr2021 at 10:30(at the age of 24-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 20:15, the patient experienced high fever 102, fully body aches, cold sweats, vomiting and no appetite for 24 hours after vaccine, started about 8 hours after her shot. Therapeutic measures were not taken as a result of these events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 27Apr2021, the patient underwent body temperature test and the result was 102 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event high fever 102, fully body aches, cold sweats, vomiting was recovered on an unknown date in Apr2021 and no appetite for 24 hours after vaccine was recovered on 28Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: High fever 102; Fully body aches; Cold sweats; Vomiting; No appetite for 24 hours after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8737) via an unspecified route of administration in the arm left on 26Apr2021 at 12:15(at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8737) via an unspecified route of administration in the arm left on 05Apr2021 at 10:30(at the age of 24-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 20:15, the patient experienced high fever 102, fully body aches, cold sweats, vomiting and no appetite for 24 hours after vaccine, started about 8 hours after her shot. Therapeutic measures were not taken as a result of these events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 27Apr2021, the patient underwent body temperature test and the result was 102 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event high fever 102, fully body aches, cold sweats, vomiting was recovered on an unknown date in Apr2021 and no appetite for 24 hours after vaccine was recovered on 28Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Skin on chest is itchy but NOT rashy. Usually at night during sleeping hours.; This is a spontaneous report from a contactable consumer, the patient. A 52-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 16Apr2021 at 15:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine headache. The patient previously took naproxen and experienced allergy to the medication. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included eletriptan (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication and unknown if ongoing. The patient previously received 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. On 23Apr2021 the patient experienced that her skin on chest was itchy but not rashy, usually at night during sleeping hours. Since the vaccination, the patient had not been tested for COVID-19. The 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 the events. The clinical outcome of the event skin on chest was itchy but not rashy was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Vertigo; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 09Apr2021 at 12:00(at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus. The patient was allergic to amoxicillin. The patient  received unspecified concomitant medication within two weeks prior to the COVID-19 vaccine.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine.  On 16Apr2021 at 15:30, the patient experienced vertigo and nausea. Since the vaccination, the patient had not been tested for COVID-19.  The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure were not taken as a result of the events. The clinical outcome of the events vertigo and nausea was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Light Headache; Some Myalgia; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 27Apr2021 at 11:45 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included prostate cancer and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not receive any other medication within two weeks of vaccination. Patient had no known allergies to food, medication or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation.  On 28Apr2021 at 05:00, the patient experienced light headache and some myalgia. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event light headache and some myalgia was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (age at vaccination 51-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced lump on arm at injection site, little bit of swelling, her am is still sore. Reporter stated that he first of all he wanted to thank Pfizer. He stated that he and his wife got the first shot on Tuesday. While providing details about himself he mentioned his wife has a lump at the injection site and a little bit of swelling. Her arm was still sore. To him it seems like it was going down. He did not see a problem, and he was thinking that it will take 2 weeks for it to go away. He stated that it has not even been three full days, and they got the shot on Tuesday, and she just worried about that. Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Joint swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling in face around nose and cheek area.; Right leg under knee swollen; swollen lymph node on right side of face in front of ear with alight pain,; On Monday aftershot notice swollen lymph node onright side of face in front of ear; Tired; Felt woody 1 hour after shot.; Soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 44-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 the left arm on 23Apr2021 at 14:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included paracetamol (TYLENOL EXTENDED RELIEF), glycyrrhiza glabra root (LICORICE ROOT), zingiber officinale root (GINGER) and althaea officinalis root (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took codeine (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 23Apr2021 at 15:00 the patient experienced, felt woozy 1 hour after shot, soreness in left arm. On 24Apr2021, the patient experienced tired second day through 4th day. On 26Apr2021, the patient experienced (on Monday) after shot noticed swollen lymph node on right side of face in front of ear with a light pain. On 27Apr2021, the patient experienced (on Tuesday) right leg under knee swollen, went to doctor Wednesday. On 29Apr2021, the patient experienced (Thursday) swelling in face around nose and cheek area. The events felt woozy 1 hour after shot, soreness in left arm, tired, swollen lymph node on right side of face in front of ear with a light pain, right leg under knee swollen resulted in doctor or other healthcare professional office/clinic visit. The event swelling in face around nose and cheek area did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of any of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt woozy 1 hour after shot, soreness in left arm, tired, swollen lymph node on right side of face in front of ear with a light pain, right leg under knee swollen, swelling in face around nose and cheek area was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling face
Clinical narrative: Swelling in face around nose and cheek area.; Right leg under knee swollen; swollen lymph node on right side of face in front of ear with alight pain,; On Monday aftershot notice swollen lymph node onright side of face in front of ear; Tired; Felt woody 1 hour after shot.; Soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 44-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 the left arm on 23Apr2021 at 14:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included paracetamol (TYLENOL EXTENDED RELIEF), glycyrrhiza glabra root (LICORICE ROOT), zingiber officinale root (GINGER) and althaea officinalis root (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took codeine (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 23Apr2021 at 15:00 the patient experienced, felt woozy 1 hour after shot, soreness in left arm. On 24Apr2021, the patient experienced tired second day through 4th day. On 26Apr2021, the patient experienced (on Monday) after shot noticed swollen lymph node on right side of face in front of ear with a light pain. On 27Apr2021, the patient experienced (on Tuesday) right leg under knee swollen, went to doctor Wednesday. On 29Apr2021, the patient experienced (Thursday) swelling in face around nose and cheek area. The events felt woozy 1 hour after shot, soreness in left arm, tired, swollen lymph node on right side of face in front of ear with a light pain, right leg under knee swollen resulted in doctor or other healthcare professional office/clinic visit. The event swelling in face around nose and cheek area did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of any of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt woozy 1 hour after shot, soreness in left arm, tired, swollen lymph node on right side of face in front of ear with a light pain, right leg under knee swollen, swelling in face around nose and cheek area was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.