chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), at age 48,  via an unspecified route of administration, on Apr 1, 2021, at 08:45, single dose, for COVID-19 immunisation. No reported medical history. The patient did not receive any other medications in two weeks. The patient previously took quinine sulfate for unknown indication on unknown date and experienced drug allergy. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 1, 2021, at 10:00,  one hour after the vaccine, patient experienced itchiness and rash; which lasted for an hour or two. No therapeutic measures taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The outcome of itchiness and rash: recovered on Apr 1, 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness, dizziness immediately following injection lasting about 5-7 minutes; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the 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 09:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included cough variant asthma. Patient had no known allergies. Concomitant medications included rosuvastatin calcium (CRESTOR) 5 mg, ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D) all from an unknown date for an unspecified indication. 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 14Apr2021 at 09:00, the patient experienced light headedness, dizziness immediately following injection lasting about 5-7 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events light headedness, dizziness immediately following injection lasting about 5-7 minutes was recovered on an unspecified date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: 101 Fever; Chills all over; Severe muscle pain; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Apr2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included levothyroxine sodium (SYNTHROID) from unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021at 03:00, the patient experienced 101 fever (units unspecified), chills all over, severe muscle pain and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of 101 fever (units unspecified), chills all over, severe muscle pain and nausea were recovered on unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Developed rash on stomach, back and neck about 2.5 days after. Now at 3 days after vaccine and rash is worse. No fever or any other symptoms besides rash and itchy skin all over the body.; Developed rash on stomach, back and neck about 2.5 days after.; itchy skin all over the body; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0161) via an unspecified route of administration in the arm left on 12Apr2021 at 12:00(at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history were not reported. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the arm left on 22Mar2021 at 11:30(at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. 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 14Apr2021, about 2.5 days after, the patient developed rash on stomach, back and neck and on 3 days after vaccine rash was worse. It was reported that the patient had no fever or any other symptoms besides rash and itchy skin all over the body. The patient did not receive any treatment for the reported 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. The clinical outcome of the events rash on stomach, back and neck and itchy skin all over the body was not recovered at time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Swelling
Clinical narrative: swelling; Very painful arm,; wrist pain; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Mar2021 at 11:30(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included rare arthritis condition. Patient had no known allergies to food, medication or other products. Concomitant medications included prednisone (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and gabapentin (MANUFACTURER UNKNOWN); all for an unspecified indication from an unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 at 12:00, the patient experienced very painful arm, wrist, hand swelling, very painful. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event very painful arm, wrist, hand swelling, very painful was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness bordering on fainting when walking to check the mail; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6955) via an unspecified route of administration in the left arm on 13Apr2021 at 10:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), montelukast (MANUFACTURER UNKNOWN) and allergy injection; all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8727) via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 14Apr2021 at 13:00, the patient experienced dizziness bordering on fainting when walking to check the mail. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the event dizziness bordering on fainting when walking to check the mail was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness in neck, face and scalp; This is a spontaneous report from a contactable consumer, the patient. A 62-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 01Apr2021 at 21:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (NEURONTIN) and alprazolam (XANAX), both were taken for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 22:00, the patient experienced itchiness in neck, face and scalp. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of itchiness in neck, face and scalp was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus, Skin disorder
Clinical narrative: Itching; several open sores on scalp; Large inflamed lymphnode in arm pit same side asvaccination; This is a spontaneous report from a contactable consumer, the patient. A 49-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 09Apr2021 at 12:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic dehydration, gastroparesis, malabsorption, mastectomy and hysterectomy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient previously took Ativan and Zosyn and experienced allergy to it. Concomitant medications included sodium lactate; potassium chloride; calcium chloride (LACTATED RINGER'S), promethazine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), clonazepam (clon) (MANUFACTURER UNKNOWN), diphenhydramine; paracetamol; phenylpropanolamine hydrochloride (BENADRYL), dicycloverine (dicyclomine) (MANUFACTURER UNKNOWN), hyoscyamine (MANUFACTURER UNKNOWN) and oxycodone (MANUFACTURER UNKNOWN), all for 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: Er2613) via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced itching, several open sores on scalp and large inflamed lymph node in arm pit same side as vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of itching, several open sores on scalp and large inflamed lymph node in arm pit same side as vaccination was not recovered 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: Lymphadenopathy
Clinical narrative: 3 Swollen lymph nodes in left shoulder; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included pulmonary embolism and oligodendroglioma. The patient had a known allergy to "MPS04". Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rivaroxaban (XARELTO), memantine (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN), propranolol (PROPANOLOL) and gabapentin (GABAPEN); all from unknown dates for unspecified indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 14Apr2021, the patient experienced 3 swollen lymph nodes in left shoulder. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event 3 swollen lymph nodes in left shoulder was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Injection site pruritus, Nausea
Clinical narrative: Arm pit pain in right arm pit.; Itching at injection site.; Nausea.; Fatigue.; Headache.; Fever; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1050) via an unspecified route of administration in the right arm on 12Apr2021 at 08:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00, the patient experienced arm pit pain in right arm pit, itching at injection site, fever, nausea, fatigue and headache. No therapeutic measures were taken as a result of these events. The events did not result in doctor 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. The clinical outcome of the events of armpit pain in right armpit, itching at injection site, fever, nausea, fatigue and headache were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm pit pain in right arm pit.; Itching at injection site.; Nausea.; Fatigue.; Headache.; Fever; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1050) via an unspecified route of administration in the right arm on 12Apr2021 at 08:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00, the patient experienced arm pit pain in right arm pit, itching at injection site, fever, nausea, fatigue and headache. No therapeutic measures were taken as a result of these events. The events did not result in doctor 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. The clinical outcome of the events of armpit pain in right armpit, itching at injection site, fever, nausea, fatigue and headache were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Tremor
Clinical narrative: Extreme fatigue; extreme weakness; shaky and trembly; Loss of appetite; Weight loss; Some dizziness; light headedness; This is a spontaneous report from a contactable consumer, the patient. A 81-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 21Jan2021 at 16:00 (at the age of 81-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 12Feb2021 (at the age of 81-years-old) as a single dose for COVID-19 immunisation. Medical history included low back pain, cholesterol which was being watched and insomnia. The patient was not allergic to medications, food, or other products. Concomitant medications included montelukast sodium (SINGULAIR). 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 24Jan2021, the patient experienced extreme fatigue, extreme weakness, shaky, trembly, loss of appetite, weight loss (6 lbs in 2 weeks), some dizziness and light headedness. The patient had no fever or respiratory symptoms. The adverse symptoms lasted for 10 weeks. The event resulted in doctor or other healthcare professional office/clinic visit 4 times. Therapeutic measures were not taken as a result of the events. On an unknown date in 2021, the patient underwent chest X-RAY and multiple lab tests and the result was within normal range. The clinical outcome of the events of extreme fatigue, extreme weakness, shaky, trembly, loss of appetite, weight loss, some dizziness and light headedness were resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased, X-ray
Clinical narrative: Extreme fatigue; extreme weakness; shaky and trembly; Loss of appetite; Weight loss; Some dizziness; light headedness; This is a spontaneous report from a contactable consumer, the patient. A 81-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 21Jan2021 at 16:00 (at the age of 81-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 12Feb2021 (at the age of 81-years-old) as a single dose for COVID-19 immunisation. Medical history included low back pain, cholesterol which was being watched and insomnia. The patient was not allergic to medications, food, or other products. Concomitant medications included montelukast sodium (SINGULAIR). 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 24Jan2021, the patient experienced extreme fatigue, extreme weakness, shaky, trembly, loss of appetite, weight loss (6 lbs in 2 weeks), some dizziness and light headedness. The patient had no fever or respiratory symptoms. The adverse symptoms lasted for 10 weeks. The event resulted in doctor or other healthcare professional office/clinic visit 4 times. Therapeutic measures were not taken as a result of the events. On an unknown date in 2021, the patient underwent chest X-RAY and multiple lab tests and the result was within normal range. The clinical outcome of the events of extreme fatigue, extreme weakness, shaky, trembly, loss of appetite, weight loss, some dizziness and light headedness were resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 13Apr2021 at 02:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received PERCOCET, MORPHINE, VICODIN, LYRICA, MOVIPREP solution and experienced drug allergy. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN) and spironolactone (MANUFACTURER UNKNOWN); all for unknown indications from unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14Apr2021 at 08:00, the patient experienced nausea. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event nausea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: Soreness localised to injection site; similar to a bruise.; Soreness localised to injection site; similar to a bruise.; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male 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 14Apr2021 at 10:45 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included acute lymphocytic leukemia (Childhood acute lymphocytic leukemia: 18 years post-diagnosis, considered cured for >10 years), seasonal allergy. The patient had no known allergies for products or food. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), and vitamins nos (MULTIVITAMIN) from an unknown date for an unspecified indication. 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 an unknown date in Apr2021, the patient experienced soreness localised to injection site; similar to a bruise. It was reported that no adverse events six hours post injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness localised to injection site; similar to a bruise was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Gait inability, Hot flush
Clinical narrative: Extreme fatigue; Brain fog; Hot/cold flashes; Dizziness; Couldn't stand for at least 5 minutes due to the dizziness; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received 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 17Mar2021 at 10:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic fatigue syndrome/myalgia encephalomyelitis, eczema and asthma. The patient had no known allergies. Concomitant medications were not reported. 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 18Mar2021 at 12:00, after receiving dose 1, the patient experienced extreme fatigue, brain fog, hot/cold flashes, and dizziness. The same day at night, patient awoke and was so dizzy and collapsed onto the floor when patient tried walking to the bathroom. The patient could not stand for at least 5 minutes due to the dizziness and it only abated after taking medications. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with meclizine, XANAX 25 mg and gatorade. The clinical outcome of the events extreme fatigue, brain fog, hot/cold flashes, and dizziness and unable to stand was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Dose 1 : 30Mar2021Dose 2: 13Apr2021; Fever; chills; light headaches; lightheadedness; 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: UNKNOWN) via an unspecified route of administration in the right arm on 13Apr2021 at 17:45 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other medication within two 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 right arm on 30Mar2021 at 17:30 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 14Apr2021 at 10:00, the patient experienced fever and chills starting about 20 hours after vaccination, some light headaches and lightheadedness. 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. The clinical outcome of the event fever, chills, light headaches, lightheadedness were not recovered at the time of report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Trigeminal Neuralgia; This is a spontaneous report from a contactable consumer, the patient. A 65-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 left arm on 18Jan2021 at 13:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high cholesterol, depression and sulfonamide allergy. The patient received unspecified medications within two weeks of vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 19Jan2021, at 07:00 the patient experienced trigeminal neuralgia. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result trigeminal neuralgia which included treatment with multiple medications. The clinical outcome of the event trigeminal neuralgia was not resolved at the time of the report   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe hives on face and chest lasting longer than 4 hours; This is a spontaneous report from a contactable consumer, the patient. A 33-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 14Apr2021 at 12:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history include sulfonamide allergy(sulpha based antibiotics). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included birth control taken from unknown date. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 12:45, the patient experienced severe hives on face and chest lasting longer than 4 hours. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe hives was not resolved at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 101 fever the following day.; This is a spontaneous report from contactable healthcare professional. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6204) via an intramuscular route of administration in the right arm on 22Mar2021 at 14:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR) and valsartan (DIOVAN) for unknown indications from unknown dates and unknown if it was ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 23Mar2021 at 07:00, the following day of vaccine, the patient experienced a fever of 101 (units not reported). 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 101 fever the following day was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swollen area above the eyebrows; This is a spontaneous report from a contactable consumer, the patient. A 66-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 08Apr2021 at 14:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any allergies to medications, food or other products. Concomitant medications included ezetimibe, simvastatin (VYTORIN), esomeprazole magnesium (NEXIUM), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D3), zinc (MANUFACTURER UNKNOWN) and multi vitamins (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. 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 12Apr2021 at 09:00, the patient experienced swollen area above the eyebrows. 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 event. The clinical outcome of the event swollen area above the eyebrows was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae
Clinical narrative: petachaie on top of feet.; This is a spontaneous report from a contactable consumer. A 61-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 30Mar2021 at 12:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease, autoimmune pancreatitis, sensory neuropathy, erythromelalgia and penicillin allergy. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and tibolone (MANUFACTURER UNKNOWN) for an unknow indication from an unknown date. The patient previously took patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Mar2021 at 12:00 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 14Apr2021 at 06:00, the patient experienced petechiae on top of feet. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event petechiae on top of feet was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Nervousness, SARS-CoV-2 test
Clinical narrative: Fatigue; shaky feeling; Feeling of slightly increased heart rate; This is a spontaneous report from a contactable consumer, the patient. A 31-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 28Mar2021 at 12:00 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and known allergies to peanuts, tree nuts, shelfish and trees. Concomitant medications included fluticasone propionate (FLONASE), fexofenadine hydrochloride (ALLEGRA) and fluticasone furoate (ARNUITY); all for unspecified indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced fatigue and shaky feeling and feeling of slightly increased heart rate. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab for COVID-19 on an unknown date and tested negative. The clinical outcome of the events fatigue and shaky feeling and feeling of slightly increased heart rate was not recovered at the time of report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cold-stimulus headache, Confusional state
Clinical narrative: While working, had brain freezes and memory loss of what I had just typed. Got very confused.; While working, had brain freezes and memory loss of what I had just typed.; Got very confused.; This is a spontaneous report from a contactable consumer, the patient. A 55-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 arm left on 13Apr2021 at 08:30(at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. Concomitant medications included estrogen nos, progesterone (BIO IDENTICAL HORMONES) from an unknown date for an unknown indication. The patient previously took Codeine(MANUFACTURER UNKNOWN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced brain freezes, memory loss of what she had typed while working and got very confused. The patient did not receive any treatment for the reported 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. The clinical outcome of the events brain freezes, memory loss and got very confused was unknown 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: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic Taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male 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 14Apr2021 at 12:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications included propranolol (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, the patient experienced metallic taste in mouth. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were not taken as a result of reported event. The clinical outcome of the event metallic taste in mouth was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over body; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 16Mar2021 at 16:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, hashimoto's disease and eosinophilic esophagitis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 23Feb2021 at 16:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included insulin aspart (NOVOLOG), levothyroxine sodium (LEVOXYL), simvastatin (MANUFACTURER UNKNOWN) and enalapril (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021 at 17:00, the patient experienced hives all over body. Its reported that after the second shot patient had 1 hive at 17:00, hives all over body at 01:30. It had been 4 weeks and still breakout in hives if do not take zyrtec. Therapeutic measures were taken as a result of the adverse event and included treatment with zyrtec. The event did not result in doctor 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. The clinical outcome of the event of hives all over body was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Vaccination site mass
Clinical narrative: This is a spontaneous report from a contactable consumer. A 49-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6199), at the age of 49, via an unspecified route of administration, left leg, on Mar 9, 2021, at 12:45, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medications included as lisinopril for unknown indication, from unknown date and unknown if ongoing. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, patient experienced headache, bloody nose and large lump on injection site. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events headache, bloody nose and large lump on injection site resolved on unknown date of 2021. The patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP7533), at the age of 49, via an unspecified route of administration, right arm, on Apr 6, 2021, single dose, for COVID-19 immunisation. No follow-up attempts needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea; vomiting; fatigue; body-wide muscle aches; fever 99.1 deg. F; This is a spontaneous report from a non-contactable consumer. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 13Apr2021 at 10:00 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. Concomitant medications included vitamins nos (MANUFACTURER UNKNOWN), melatonin supplement (MANUFACTURER UNKNOWN), paracetamol (ACETAMINOPHEN) and unspecified OTC medications from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 23Mar2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 the patient experienced nausea, vomiting, fatigue, body-wide muscle aches and fever 99.1-degree fahrenheit. The events did not result in a doctor or other health care professional office/clinic visit, and the 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 nausea, vomiting, fatigue, body-wide muscle aches and fever 99.1-degree Fahrenheit was recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; vomiting; fatigue; body-wide muscle aches; fever 99.1 deg. F; This is a spontaneous report from a non-contactable consumer. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 13Apr2021 at 10:00 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. Concomitant medications included vitamins nos (MANUFACTURER UNKNOWN), melatonin supplement (MANUFACTURER UNKNOWN), paracetamol (ACETAMINOPHEN) and unspecified OTC medications from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 23Mar2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 the patient experienced nausea, vomiting, fatigue, body-wide muscle aches and fever 99.1-degree fahrenheit. The events did not result in a doctor or other health care professional office/clinic visit, and the 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 nausea, vomiting, fatigue, body-wide muscle aches and fever 99.1-degree Fahrenheit was recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.