chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Urticaria
Clinical narrative: Hives/Chronic hives; This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the right arm on 28Jan2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK4176) via an unspecified route of administration in the left arm on 06Jan2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 29Jan2021, the patient reported that she has had hives since the day after the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had been to the allergist and was awaiting a dermatologist appointment. On an unknown date, the patient underwent an allergy blood testing and the allergist diagnosed the patient with chronic hives due to the vaccination. Therapeutic measures were taken as a result of events and included treatment with prednisone (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN), and cetirizine hydrochloride (ZYRTEC). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives/chronic hives was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Chills, Confusional state, Diplopia, Feeling abnormal
Clinical narrative: Started feeling bad; Unable to function; Double vision; Memory loss; confused; Headaches; chills; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 08Apr2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Patient had unspecified medical history. Patient had no known allergies. The patient received other medications within two weeks of vaccination, names were unspecified. 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 10Apr2021, the patient experienced started feeling bad, had memory loss, was confused, unable to function. Headaches, double vision, chills. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events started feeling bad, had memory loss, was confused, unable to function. Headaches, double vision, chills was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Ill-defined disorder
Clinical narrative: Started feeling bad; Unable to function; Double vision; Memory loss; confused; Headaches; chills; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 08Apr2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Patient had unspecified medical history. Patient had no known allergies. The patient received other medications within two weeks of vaccination, names were unspecified. 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 10Apr2021, the patient experienced started feeling bad, had memory loss, was confused, unable to function. Headaches, double vision, chills. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events started feeling bad, had memory loss, was confused, unable to function. Headaches, double vision, chills was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Burning sensation, Lymphadenopathy, Rash pruritic
Clinical narrative: swollen glands under arm on left side; rash with itching; burning; pimples; This is a spontaneous report from a contactable pharmacist. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via intramuscular route of administration in the right arm on 29Mar2021 at 09:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, hyperlipidaemia, prediabetes, hypertension and hypothyroidism. The patient's allergies to medications, food, or other products were reported as not applicable. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and MVI; for unknown indications from unknown start dates and unknown if ongoing. 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 02Apr2021, the patient experienced swollen glands under arm on left side, rash with itching, burning, pimples which developed 3-4 days post first dose of vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events included treatment with valacyclovir (MANUFACTURER UNKNOWN). The clinical outcome of the events swollen glands under arm on left, rash with itching, burning and pimples were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: experienced a change in menstrual cycle; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received an unknown dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration on 27Mar2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease. The patient had allergy to contrast iodine dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in 2021,  following the vaccine, the patient experienced a change in menstrual cycle. It came 1.5 week earlier than planned in tracking device and with various different symptoms. The event 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 event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event of change in menstrual cycle was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Paraesthesia oral
Clinical narrative: tingling in tongue and gums; headache; arm pain; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 08Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to figs. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), topiramate (TOPAMAX), levonorgestrel (MIRENA), ascorbic acid (VITAMIN C) and vitamin d nos (MANUFACTURER UNKNOWN); all from unknown date for an unspecified indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation and took erythromycin (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced tingling in tongue and gums about 45 minutes after receiving the injection, which resolved after about two hours without intervention and had a headache starting few hours after the injection and arm pain. 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 reported event. Since the vaccination, patient had not been tested for COVID-19. The clinical outcome of the event tingling in tongue and gums was recovered on 08Apr2021 and of the headache was recovered on 11Apr2021 and of the arm pain was recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep, Tinnitus
Clinical narrative: Tinnitus- increase in severity; Impacted ability to sleep; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 14:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus and COVID-19. The patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient had increase in severity of tinnitus which caused patient to wake up at night and kept the patient from falling asleep, the patient had issues in the past but it never impacted the patient's ability to sleep. 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 event. The clinical outcome of the events increase in severity of tinnitus and impacted ability to sleep were not resolved at the time of the report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Influenza, Nausea, Pain
Clinical narrative: Felt like had the flu the next day; Body aches; Slightly nauseated; Severe chills; Felt like burning up; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male 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 14Apr2021 at 09:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included cystitis interstitial and nasal infection; both from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to food, medications, or other products. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN) from unknown date for unknown indication and unknown if ongoing.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 at 09:30 (at the age of 45-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 14Apr2021 at 23:00, that night, the patient had severe chills for 3 hours, then felt like he was burning up. On 15Apr2021, the next day, the patient felt like he had the flu, body aches, slightly nauseated (but no fever). 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 reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe chills was recovered on 15Apr2021 and of the events felt like he was burning, felt like he had the flu, body aches and slightly nauseated was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph gland by collar bone; Body aches; Fatigue; 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: EW0162) via an unspecified route of administration in the left arm on 13Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, hypothyroidism (reported as low thyroid syndrome). The patient had no known allergies to medications, food, or other products. The patient had received other medication (unspecified) within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 23March2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 20:00, the patient experienced swollen lymph gland by collar bone, body aches, fatigue. 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 events. The clinical outcome of the events swollen lymph gland by collar bone, body aches, fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Lymph Nodes visibly swollen; Pain; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 12Apr2021 at 20:00 (at the age of 16-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. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced lymph nodes visibly swollen and pain. 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 lymph nodes visibly swollen and pain was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenopia, Fatigue, Musculoskeletal discomfort, Myalgia
Clinical narrative: Progressive muscle soreness; Aching joints focused primarily in hips and hands; Extreme fatigue; Difficult to keep eyes open; Joint discomfort; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 07Apr2021 at 14:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included Lyme disease, the patient reported that the Lyme disease was was diagnosed with approximately 6 years ago and was identified by a tick and bullseye rash. It was treated with antibiotics within 12 hours of finding the rash. The patient reported that the recovery was slow, over two months. The patient had a known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) from an unknown date and for an unspecified indication and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 08Apr2021 at 17:00, the patient experienced progressive muscle soreness including aching joints focused primarily in hips and hands. The patient also experienced extreme fatigue where it was difficult to kept eyes open during the day "peaking on day 2 and lasting into the fifth day". The patient reported that the fatigue and joint discomfort presented exactly like the lyme disease which was diagnosed 6 years ago. The patient reported that this time the joint pain lasted almost five days. When the patient woke up in the morning after the fifth night, there was no more joint discomfort. The fatigue also subsided after the fourth night. The patient reported that the muscles were still a little sore 7 days after. 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 events progressive muscle soreness was resolved with sequelae on an unknown date in Apr2021. The clinical outcome of the event fatigue was resolved with sequelae on 12Apr2021, after a duration of 4 days and the events aching joints, difficult to kept eyes open during the day and joint discomfort were resolved with sequelae on 13Apr2021, after a duration of 5 days.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Guttate psoriasis
Clinical narrative: Developed several bumps on left forearm. Then 3 days later developed bumps on both buttocks cheeks. As a couple weeks went on developed bumps in the palm of the hand. Went to the determatogist & was diagnosed with Guttate psoriasis.; This is a spontaneous report from a contactable consumer. 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 09Feb2021 at 10:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included unspecified high blood pressure medication (CHL). The patient previously took ampicillin (MANUFACTURER UNKNOWN) on unknown date and experienced drug 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 18Feb2021, the patient developed several bumps on the left forearm. Then 3 days later developed bumps on both buttocks, cheeks. As a couple weeks went on, the patient developed bumps in the palm of the hand. The patient went to the dermatologist and was diagnosed with guttate psoriasis. Given a corticosteroid (cream) which, to her made it worse. Finally clearing up as of 10Apr2021. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with corticosteroids (cream). The clinical outcome of the event developed several bumps on the left forearm then, 3 days later developed bumps on both buttocks, cheeks, as a couple weeks went on, developed bumps in the palm of the hand, went to the dermatologist and was diagnosed with guttate psoriasis was resolving at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oral discomfort, Pain, Pyrexia
Clinical narrative: Burning lips; Body aches; Fever; Headache; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 12Apr2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), vitamin d nos (MANUFACTURER UNKNOWN) and multivitamin; all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 22Mar2021 at 16:45 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 13Apr2021, the patient experienced burning lips, body aches, fever, headache and chills. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events burning lips, body aches, fever, headache and chills were resolved on an unspecified date in Apr2021.   No follow-up attempts are possible. No further information is expected
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, Myalgia, Nasopharyngitis
Clinical narrative: Lower back spasms the first night after vaccine. Continued tension in lower back.; Muscle soreness; Bouts of mild cold; Chills; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 11Apr2021 at 10:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease. The patient was unaware of if he had any 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 COVID vaccine. On 11Apr2021, the patient experienced lower back spasms the first night after vaccine, continued tension in lower back, muscle soreness and bouts of mild cold chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events lower back spasms the first night after vaccine, continued tension in lower back, muscle soreness and bouts of mild cold chills were unknown at the time of this report.   No follow-up attempts are needed; No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Oropharyngeal pain, Vaccination site pain
Clinical narrative: Sore throat; Nausea; Headache; feeling very heavy; Pain at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 12:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient believed she had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included ethinylestradiol, norethisterone acetate (MICROGESTIN), ibuprofen (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and pseudoephedrine (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 09:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 07:30, the patient experienced sore throat, nausea, headache, feeling of very heavy and pain at the injection site. Therapeutic measures were not taken as a result of the 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 event sore throat, nausea, headache, feeling of very heavy and pain at the injection site was resolved with sequelae on 18Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nausea
Clinical narrative: Dose 1 on 08Mar2021 and dose 2 on 20Mar2021; Feeling nauseous; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: Er8732) via an unspecified route of administration in the arm left on 20Mar2021 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included iodine allergy. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and oxcarbazepine (MANUFACTURER UNKNOWN), both 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: En6199) via an unspecified route of administration in the arm left on 08Mar2021(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 the patient experienced feeling nauseous ever since she took second dose and It comes every few days. 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 feeling nauseous was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 27-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8727), at the age of 27, via an unspecified route of administration, left arm, on Mar 31, 2021, at 09:30, single dose, for COVID-19 immunisation. Medical history not reported. The patient has no known allergies to medications, food or other products. Concomitant medications included the birth control for unknown indication, from unknown date and unknown if ongoing. Prior to vaccination, it was unknown whether the patient was 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 Apr 1, 2021, at 00:00, patient experienced 103 fever overnight and then vomited the entire next day. The patient underwent lab tests and procedures, which included body temperature on Apr 1, 2021, at 00:00: 103ºF. The outcome of the event 103 fever overnight and vomited the entire next day: unknown (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: Mild fever (99.7F); Fatigue; Foggy-headed; Upset stomach; Headache; Felt very cold, could not get warm; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP-6955) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, obesity and allergic to cephalosporins. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO), fluoxetine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and fluticasone propionate (FLOVENT); all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 10:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 12:00 (26-hour post vaccine), the patient experienced felt very cold, could not get warm. On 09Apr2021 at 14:00 (28 hours post vaccine), the patient experienced upset stomach and headache. On 09Apr2021 at 16:00 (30 hours post vaccine), the patient experienced foggy-headed, mild fever (99.7F) and fatigue. On 09Apr2021, the patient underwent Body temperature and the result was mild fever (99.7F). 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 reported event. The clinical outcome of the event felt very cold, upset stomach, headache, foggy-headed, mild fever (99.7F) and fatigue was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Mild fever (99.7F); Fatigue; Foggy-headed; Upset stomach; Headache; Felt very cold, could not get warm; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP-6955) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, obesity and allergic to cephalosporins. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO), fluoxetine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and fluticasone propionate (FLOVENT); all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 10:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 12:00 (26-hour post vaccine), the patient experienced felt very cold, could not get warm. On 09Apr2021 at 14:00 (28 hours post vaccine), the patient experienced upset stomach and headache. On 09Apr2021 at 16:00 (30 hours post vaccine), the patient experienced foggy-headed, mild fever (99.7F) and fatigue. On 09Apr2021, the patient underwent Body temperature and the result was mild fever (99.7F). 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 reported event. The clinical outcome of the event felt very cold, upset stomach, headache, foggy-headed, mild fever (99.7F) and fatigue was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Hypoacusis, Lymphadenopathy
Clinical narrative: Massive headache left temporal area; Vertigo; Fullness left ear with diminished hearing; Swollen lymph node behind left ear; Metallic taste; Fever; Fatigue; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy, arteriovenous malformation (Surgical resection AVM), and penicillin allergy. Patient received other medications in two weeks, names were unspecified. The patient previously took phenytoin (DILANTIN), ceftriaxone sodium (ROCEPHIN) all from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 11:00, the patient experienced massive headache left temporal area, vertigo, fullness left ear with diminished hearing, swollen lymph node behind left ear, metallic taste, fever, fatigue, sore arm. Duration over 2 weeks and continuing.  The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with Azithromax, Advil. The clinical outcome of the events massive headache left temporal area, vertigo, fullness left ear with diminished hearing, swollen lymph node behind left ear, metallic taste, fever, fatigue, sore arm was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vertigo
Clinical narrative: Massive headache left temporal area; Vertigo; Fullness left ear with diminished hearing; Swollen lymph node behind left ear; Metallic taste; Fever; Fatigue; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy, arteriovenous malformation (Surgical resection AVM), and penicillin allergy. Patient received other medications in two weeks, names were unspecified. The patient previously took phenytoin (DILANTIN), ceftriaxone sodium (ROCEPHIN) all from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 11:00, the patient experienced massive headache left temporal area, vertigo, fullness left ear with diminished hearing, swollen lymph node behind left ear, metallic taste, fever, fatigue, sore arm. Duration over 2 weeks and continuing.  The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with Azithromax, Advil. The clinical outcome of the events massive headache left temporal area, vertigo, fullness left ear with diminished hearing, swollen lymph node behind left ear, metallic taste, fever, fatigue, sore arm was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Major vaccination site pain; Tiredness; Headache; Major muscle pain; Chills; Joint pain; Fever; Feeling unwell; Dizziness; Weakness; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 30Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus and COVID-19. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN). The patient received unspecified medication within two weeks of vaccination. 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 01Apr2021 at 09:00, the patient experienced major vaccination site pain, tiredness, headache, major muscle pain, chills, joint pain, fever, feeling unwell, dizziness and weakness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were not taken as a result of reported event. The clinical outcomes of major vaccination site pain, tiredness, headache, major muscle pain, chills, fever, feeling unwell, dizziness and weakness were recovered with sequelae on an unknown date in Apr2021. The clinical outcome of joint pain was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Major vaccination site pain; Tiredness; Headache; Major muscle pain; Chills; Joint pain; Fever; Feeling unwell; Dizziness; Weakness; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 30Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus and COVID-19. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN). The patient received unspecified medication within two weeks of vaccination. 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 01Apr2021 at 09:00, the patient experienced major vaccination site pain, tiredness, headache, major muscle pain, chills, joint pain, fever, feeling unwell, dizziness and weakness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were not taken as a result of reported event. The clinical outcomes of major vaccination site pain, tiredness, headache, major muscle pain, chills, fever, feeling unwell, dizziness and weakness were recovered with sequelae on an unknown date in Apr2021. The clinical outcome of joint pain was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - sounds like sizzling or insects; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8728 or ER8729) via an unspecified route of administration in the right arm on 09Apr2021 at 09:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient had no known allergies. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208 or CN6208) via an unspecified route of administration in the right arm on 18Mar2021 at 09:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced tinnitus - sounded like sizzling or insects. 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 event. The clinical outcome of the event tinnitus - sounded like sizzling or insects was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Myalgia
Clinical narrative: Chills; Fatigue; Muscle soreness; Weakness; 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: EW0153) via an unspecified route of administration in the left arm on 13Apr2021 at 14:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included asthma, scoliosis and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), sertraline (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL); all from unknown dates for unspecified indications and unknown if ongoing. 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 left arm on 23Mar2021 at 14:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. On 14Apr2021 at 07:00, the patient experienced the events chills, fatigue, muscle soreness and weakness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as the result of adverse events. The clinical outcome of the events chills, fatigue, muscle soreness and weakness were not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on chest and back; This is a spontaneous report from a contactable consumer, the patient. A 21-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 07Apr2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included autism, multiple severe allergies, penicillin allergy and pecans (food) allergy. Concomitant medications included levocabastine hydrochloride (ZYRTEC), cyproheptadine (MANUFACTURER UNKNOWN) and montelukast sodium (SINGULAIR) for an unknow indication since an unknown 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 07Apr2021 at 15:45, the patient experienced itchy rash on chest and back. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with benadryl and multiple doses steroid cream started from an unknown date. The clinical outcome of the event itchy rash on chest and back was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.