chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Heart rate increased
Clinical narrative: Sore arm; Headache; Feeling off; Sometimes lightheaded; Racing heartbeat; Tired; leg that had DVT sometimes getting sharp pain for a few seconds; 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: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 14:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, blood pressure high and DVT (deep vein thrombosis) of legs. The patient had unspecified 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 vaccination. The patient received other medications within 2 weeks of vaccination. On 26Apr2021 at 06:30, the patient experienced sore arm for 3 days so far, headache, feeling off, sometimes lightheaded, she had prior DVT and leg that had DVT sometimes getting sharp pain for a few seconds racing heartbeat, tired. The events had not resulted in doctor/other health care 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 sore arm, headache, feeling off, sometimes lightheaded, she had prior DVT and leg that had DVT sometimes getting sharp pain for a few seconds racing heartbeat, tired were not resolved 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: Pain in extremity
Clinical narrative: Sore arm; Headache; Feeling off; Sometimes lightheaded; Racing heartbeat; Tired; leg that had DVT sometimes getting sharp pain for a few seconds; 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: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 14:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, blood pressure high and DVT (deep vein thrombosis) of legs. The patient had unspecified 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 vaccination. The patient received other medications within 2 weeks of vaccination. On 26Apr2021 at 06:30, the patient experienced sore arm for 3 days so far, headache, feeling off, sometimes lightheaded, she had prior DVT and leg that had DVT sometimes getting sharp pain for a few seconds racing heartbeat, tired. The events had not resulted in doctor/other health care 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 sore arm, headache, feeling off, sometimes lightheaded, she had prior DVT and leg that had DVT sometimes getting sharp pain for a few seconds racing heartbeat, tired were not resolved 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: ''I'' have a very strong disgusting smell to all good, some drinks and more. It all smelled gross. It had been almost 3 weeks and could not enjoy food because it all  had a very strong odor.; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. The patient did not take any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 13Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021, ever since her second Pfizer vaccine, the patient experienced a very strong disgusting smell to all good, some drinks and more. It all smelled gross. It had been almost 3 weeks and the patient could not enjoy food because it all had a very strong odour ((all the same smell/maybe chemical). 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the event very strong disgusting smell to all good, smelled gross and patient could not enjoy food because it all had a very strong odour was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: After about 12 hours after vaccine, had bad body shakes for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and 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 vaccine. The patient did not receive any concomitant medication. On 07Apr2021, 12 hours after the vaccination, the patient experienced bad body shakes for 3 days. It Started to go away by 10Apr2021. The event 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 bad body shakes was resolved on 10Apr2021, after the duration of 3 days.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a non-contactable consumer. A 29-year-old female patient 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 (at the age of 29-years-old) and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient did receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date, the patient experienced fever. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment paracetamol (MANUFACTURER UNKNOWN). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event fever was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise, Rhinorrhoea
Clinical narrative: she has been feeling sick.; Cough; Runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patients daughter) reported for mother. A 52-years-old female patient received BNT162B2 (Batch/Lot Number: EW0153 Expiry Date not provided on card and NDC number were Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:45 (age at vaccination 52-year-old) as dose 1, single for covid-19 immunisation. Medical history included blood pressure increased from an unknown date and unknown if ongoing takes a medication for high blood pressure, from an unknown date and unknown if ongoing. Family Medical History Relevant was none. The patient did not have history of previous immunization with the Pfizer vaccine considered as suspect. No Prior Vaccinations within 4 weeks. Concomitant medication(s) included amoxicillin (AMOXICILLIN) taken for blood pressure measurement, start and stop date were not reported. On 26Apr2021 the patient experienced she has been feeling sick. The patient daughter was speaking on behalf of her mother. The patient received the first dose of the Covid-19 vaccine. The second dose is scheduled tomorrow. She has been feeling sick since Monday with a cough and runny nose. Cough was reported as worsened. She has been taking antibiotics for two days. Is it ok to take the second dose. The patient had been taking Amoxicillin 500mg three times daily. Her mother doesn't know why she was prescribed the medication. It was prescribed a while back, but she has only been taking it for the past two days. The patient did not visited to Emergency Room and Physician Office. The patient does not have a specific doctor. She was seen by different providers at the clinic. The outcome of the event feeling sick was unknown and cough outcome was not recovered and runny nose outcome was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Lethargy, Lymphadenopathy, Mass
Clinical narrative: The lymph node in "my" right arm pit swelled to the size of a peach and stayed swollen for 3 weeks.; "I" have sporadic (3-4 occurrences a week) chest pain in the area of "my" heart; Slightly left center mass; Bouts of lethargy; Extreme fatigue (1-2 times a week).; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 16Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to NSAIDs. 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 COVID vaccine. The patient received unspecified concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH2602) via an unspecified route of administration in the right arm on 23Feb2021 as a single dose for COVID-19 immunisation. On 18Mar2021, the patient experienced lymph node in her right arm pit swelled to the size of a peach and stayed swollen for 3 weeks. She had sporadic (3-4 occurrences a week) chest pain in the area of her heart, slightly left centre mass, bouts of lethargy and extreme fatigue (1-2 times a week). 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 lymph node in her right arm pit swelled to the size of a peach and stayed swollen for 3 weeks was resolved on an unknown date in Apr2021: whereas the events sporadic (3-4 occurrences a week) chest pain in the area of her heart, slightly left centre mass, bouts of lethargy and extreme fatigue (1-2 times a week) was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Menstruation irregular
Clinical narrative: Menstrual cycle happened a week early in the middle of birth control pack and then got a second period a week late; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Apr2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication 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 vaccination. On an unknown date in Apr2021 the patient's menstrual cycle happened a week early in the middle of birth control pack and then got a second period a week later. On an unknown date in Apr2021, 20 hours after the vaccination, the patient experienced extreme fatigue. 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 menstrual cycle happened a week early in the middle of birth control pack and then got a second period a week late and extreme fatigue were resolved on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Headache, Pain in extremity
Clinical narrative: Havent barely moved all day/''i'' just feel so unable to do anything; A pounding headache that wont go away; "My" left arm is really sore; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 02May2021 at 17:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid, anxiety, severe depression and lower back pain. The patient had no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), buspirone (MANUFACTURER UNKNOWN), clonazepam (MANUFACTURER UNKNOWN), naloxone hydrochloride, buprenorphine hydrochloride (SUBOXONE) and levynthor (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 22:00, the patient had not barely moved all day, had a pounding headache that would not go away, her left arm was really sore and she just felt so unable to do anything. 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 had not barely moved all day/she just felt so unable to do anything, a pounding headache that would not go away and her left arm was really sore was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Fatigue started 60 minutes after vaccine - lasted 48 hours; Dizziness started 30 minutes after vaccine - lasted 36 hours; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 06Apr2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and allergy to sulfa (sulfonamide allergy) and cherries (fruit allergy). 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 sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC), cyanocobalamin (B 12), probiotics (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. On 06Apr2021 at 10:30, 30 minutes after the vaccination, the patient experienced dizziness that lasted for 36 hours. On 06Apr2021 at 11:00, 60 minutes after the vaccination, the patient experienced fatigue that lasted 48 hours. 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 dizziness was recovered on 07Apr2021 at 22:30; while that of the event fatigue was recovered on 08Apr2021 at 11:00.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 26-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 26Apr2021 at 07:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. 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 COVID-19 vaccine. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 12Apr2021 at 07:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 21:30, (also reported around 21:00 to 22:00) the patient experienced chills, dizziness, muscle pain, runny nose and fever throughout the night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL) 600mg on 27Apr2021 at 06:00 and symptoms subsided. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, dizziness, muscle pain, runny nose and fever throughout the night were resolving 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: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer. A 26-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 26Apr2021 at 07:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. 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 COVID-19 vaccine. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 12Apr2021 at 07:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 21:30, (also reported around 21:00 to 22:00) the patient experienced chills, dizziness, muscle pain, runny nose and fever throughout the night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL) 600mg on 27Apr2021 at 06:00 and symptoms subsided. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, dizziness, muscle pain, runny nose and fever throughout the night were resolving 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Period has completely stopped since the first dose; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 21Jan2021 at 11:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included Known allergy to Tree nuts, seafood, dust and pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received hydrocodone bitartrate; paracetamol (VICODIN) for unknown indication on unknown date and experienced drug allergy. On 29Jan2021, the patient experienced her period had completely stopped since the first dose. The event resulted in doctor or other healthcare professional office/clinic visit. 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 period had completely stopped was not resolved at the time of report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 11Feb2021 at 11:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Things smell abnormal, food smells like feces and nothing smells the way it should; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the arm left on 19Feb2021 at 08:00 at the age of 20-years-old as a single dose for COVID-19 immunisation. Medical history included generalized anxiety disorder (GAD), seasonal allergies, and COVID-19 in early December. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included MONTELUKAST, ESCITALOPRAM, and oral birth control, all were taken for unknown indication from an unknown date and unknown if ongoing. 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: EN5318) via an unspecified route of administration in the arm left on 29Jan2021 at 10:00 at the age of 19-years-old as a single dose for COVID-19 immunisation. On 19Feb2021, after the patient received Pfizer vaccine, the patient experienced things smell abnormal, food smells like feces, nothing smells the way it should, this was ongoing at the time of reporting. The event resulted in doctor or other healthcare professional office/clinic visit. 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 things smell abnormal, food smells like feces, nothing smells the way it should was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Headache; Body aches; Fever; Nausea; injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 26Apr2021 at 17:15 as a single dose for COVID-19 immunisation. Medical history included bronchitis, exercise endured asthma and penicillin allergy on unknown dates. 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 Acetylsalicylic acid, Caffeine, Paracetamol (EXCEDRIN) and multivitamin (MANUFACTURER UNKNOWN) from unknown date for unknown indication and unknown if ongoing. On 27Apr2021 at 06:45 the patient experienced headache, body aches, fever, nausea and injection site pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included over-the-counter medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events headache, body aches, fever, nausea and injection site pain were resolved with sequelae.    No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Very painful under arm beginning 6 days after injection on right side of the body (same side as injection); Visible swelling of under arm area on right side of the body; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Apr2021 at 16:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not take any concomitant 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 COVID vaccine. On 26Apr2021 at 07:00, 6 days after the injection, the patient experienced very painful under arm on right side of the body (same side as injection) and visible swelling of under arm area on right side of the body. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown, if the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very painful under arm on right side of the body (same side as injection) and visible swelling of under arm area on right side of the body was not resolved at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Sensitive skin
Clinical narrative: Headache; Body pain; Joint pain; Chills; Sensitive skin; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 20Mar2021 at 16:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 03:00, the patient experienced headache, body and joint pain, chills and sensitive skin. 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 headache, body and joint pain, chills and sensitive skin were resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: All over body ache; Headache; Exhaustion; Site injection pain, can hardly lift left arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic strain right rhomboid, tendonitis related to elbows wrists and strain to back muscles from fall on ice on 26Feb2021. The patient was allergic to penicillin, cherries, blueberries and raspberries. 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. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), cyclobenzaprine hydrochloride (FLEXERIL), hydroxide (MANUFACTURER UNKNOWN) and hydr (MANUFACTURER UNKNOWN); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and clarithromycin (BIAXIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 15:00, the patient experienced all over body ache, headache, exhaustion and site injection pain, can hardly lift left arm. 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 events all over body ache, headache, exhaustion and site injection pain, can hardly lift left arm 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: Fatigue, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Low grade fever; Tired; Swelling and redness on injection site; Swelling and redness on injection site; This is a spontaneous report from a contactable consumer, the patient. A 66-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 right arm on 24Apr2021 at 11:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis. The patient had known allergies 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. The patient received unspecified concomitant medications taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW015-PAA 166261) via an unspecified route of administration in the right arm on 03Apr2021 at 11:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021, the patient experienced low grade fever, tired, swelling and redness on injection site. 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 low grade fever, tired, swelling and redness on injection site was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fever 101 degree F; Chills; Headache; Muscle aches; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 25Apr2021 at 12:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. 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 received unspecified concomitant medications for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: RW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 14:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On 25Apr2021 at 23:00, the patient experienced fever 101 degrees fahrenheit (F), chills, headache, muscle aches, fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 25Apr2021 at 23:00, the patient underwent body temperature test and the result was 101 degrees fahrenheit. 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 fever 101 degree F, chills, headache, muscle aches, fatigue and nausea 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: Nausea, Pyrexia
Clinical narrative: Fever 101 degree F; Chills; Headache; Muscle aches; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 25Apr2021 at 12:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. 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 received unspecified concomitant medications for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: RW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 14:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On 25Apr2021 at 23:00, the patient experienced fever 101 degrees fahrenheit (F), chills, headache, muscle aches, fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 25Apr2021 at 23:00, the patient underwent body temperature test and the result was 101 degrees fahrenheit. 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 fever 101 degree F, chills, headache, muscle aches, fatigue and nausea was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test
Clinical narrative: Severe headache; body ache; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EP6955) via an unspecified route of administration in the arm left on 26Apr2021 at 11:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not provided. 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 sucralfate (MANUFACTURER UNKNOWN) and dexlansoprazole (DEXILANT) 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: EP6955) via an unspecified route of administration in the arm left on 05Apr2021 at 11:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 the patient experienced severe headache and body ache. Therapeutic measures were not taken as a result of the events. On an unknown date in Feb2021, the patient underwent SARS-CoV2 test and the result was negative. The clinical outcome of the events severe headache and body ache were unknown at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Cough, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: horrible pain in her low back; She could not get out of the bed; Flu like symptoms; Dry hives; It is affecting her daily activities; cough; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 55-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Apr2021 (at the age of vaccination of 55-year-old) as dose 2, single for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported. After the first dose, patient experienced sore arm and then after the second dose received on 21Apr2021. She could not get out of the bed. She had horrible pain in her low back. She took Ibuprofen. She had Flu like symptoms, cough/ dry hives and it is affecting her daily activities. She thought originally it would just be initially, but this has been going on about 2 weeks. The outcome of horrible pain in her low back was not recovered and the outcome of the rest of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: horrible pain in her low back; She could not get out of the bed; Flu like symptoms; Dry hives; It is affecting her daily activities; cough; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 55-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Apr2021 (at the age of vaccination of 55-year-old) as dose 2, single for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported. After the first dose, patient experienced sore arm and then after the second dose received on 21Apr2021. She could not get out of the bed. She had horrible pain in her low back. She took Ibuprofen. She had Flu like symptoms, cough/ dry hives and it is affecting her daily activities. She thought originally it would just be initially, but this has been going on about 2 weeks. The outcome of horrible pain in her low back was not recovered and the outcome of the rest of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Had started with period/ had period 17 days ago; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. 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 sertraline hydrochloride (ZOLOFT), taken for an unknown indication from an unknown date and unknown if ongoing. On an unknown date in Apr2021, the patient woke up to find that her period had started. The patient reported that she just had her period 17 days back and her periods were very regular so it was very unusual. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period had started unusually was unknown 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Hot flush
Clinical narrative: Fever 99.9; Chills; Hot flashes; Body aches; Headache; Nausea; Weak feeling; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an intramuscular route of administration in the left arm on 26Apr2021 at 15:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. 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 sertraline hydrochloride (SERTRALINE HCL) from an unknown date and unknown if ongoing for an unknown indication. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 05Apr2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 03:00, the patient experienced fever 99.9, chills, hot flashes, body aches, headache, nausea and weak feeling. 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. On 17Apr2021, the patient underwent body temperature test and the result was 99.9 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 99.9, chills, hot flashes, body aches, headache, nausea and weak feeling were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever 99.9; Chills; Hot flashes; Body aches; Headache; Nausea; Weak feeling; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an intramuscular route of administration in the left arm on 26Apr2021 at 15:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. 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 sertraline hydrochloride (SERTRALINE HCL) from an unknown date and unknown if ongoing for an unknown indication. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 05Apr2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 03:00, the patient experienced fever 99.9, chills, hot flashes, body aches, headache, nausea and weak feeling. 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. On 17Apr2021, the patient underwent body temperature test and the result was 99.9 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 99.9, chills, hot flashes, body aches, headache, nausea and weak feeling were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.