chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: developed swelling of R ankle; pain of R ankle; 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: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history. No history of injury. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for an unknown indication on an unknown date. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 (as reported), 5 days after vaccination (31Mar2021), the patient developed swelling and pain of right (R) ankle. 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 of swelling and pain of R ankle included treatment with ibuprofen, immobilization and muscle relaxants. The clinical outcome of the event developed swelling and pain of right (R) ankle was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Severe diarrhea; Vomiting; 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: ER8733) via an unspecified route of administration in the left arm on 08Apr2021 at 15:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included obesity. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 23:00, the patient experienced severe diarrhea and vomiting continuing for over 12 hours and was continuing at the time of reporting. 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 severe diarrhea and vomiting was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: Approximately 16 hours after receiving the vaccine, had pounding headache; Chills; Nausea; Body aches; Dizzy; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 06Apr2021 at 09:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received infliximab (REMICADE) and levofloxacin (LEVAQUIN) on unknown dates for unspecified indications 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 07Apr2021 at 01:00, approximately 16 hours after receiving the vaccine, the patient experienced pounding headache, chills, nausea, body aches, dizzy and brain fog. 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 approximately 16 hours after receiving the vaccine, had pounding headache, chills, nausea, body aches, dizzy and brain fog were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Approximately 16 hours after receiving the vaccine, had pounding headache; Chills; Nausea; Body aches; Dizzy; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 06Apr2021 at 09:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received infliximab (REMICADE) and levofloxacin (LEVAQUIN) on unknown dates for unspecified indications 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 07Apr2021 at 01:00, approximately 16 hours after receiving the vaccine, the patient experienced pounding headache, chills, nausea, body aches, dizzy and brain fog. 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 approximately 16 hours after receiving the vaccine, had pounding headache, chills, nausea, body aches, dizzy and brain fog were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain
Clinical narrative: Pain at injection site; Arm tingle; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP7534) via an unspecified route of administration in the left arm on 08Apr2021, (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medication were not reported. Prior to the vaccination, the patient was 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 08Apr2021, the patient experienced pain at injection site and arm tingled for about an hour. 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 of vaccination site pain was resolving and the event of arm tingling was resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain in extremity, Vomiting
Clinical narrative: Woke the second morning with huge gastroissues symptoms included vomiting.; Woke the second morning with huge gastroissues symptoms included nausea; Woke the second morning with huge gastroissues symptoms included incredible sweating.; Woke the following morning with a sore arm; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 11:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, seizures, bipolar, ulcerative colitis, gastric ulcers, etc. Concomitant medications included  daily medications and over the counter (OTC) vitamins. The patient had several unspecified 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 07Apr2021, the patient woke up with a sore arm which was not a big deal. On 08Apr2021 at 06:00, the patient woke up with huge gastro issues and was in bed the entire day. Symptoms included vomiting, nausea and incredible sweating. No therapeutic measures were taken as a result of the adverse events. These 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 sore arm, vomiting, nausea and incredible sweating was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ear-left side.; This is a spontaneous report from a contactable healthcare professional, the patient. A 56-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 03Apr2021 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have symptoms associated with COVID-19. 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 04Apr2021 at 00:00, the patient experienced ringing in the ear-left side. 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 taken as a result of the adverse event. The clinical outcome of the event ringing in the ear-left side was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the right arm on 04Mar2021 at 13:15 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history included guillain barre syndrome (GBS) and aortic valve replacement (ON-X aortic valve replacement), on an unknown date and unknown if ongoing. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) and warfarin (MANUFACTURER UNKNOWN) all for an unspecified indication from an unknown date 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 05Mar2021, the patient experienced arm soreness. The patient did not receive any treatment for the event. The adverse 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 arm soreness was recovered on an unknown date in 2021. The patient later received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the right arm on 09Apr2021 at 09:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Influenza like illness, Migraine, Pain, Pyrexia
Clinical narrative: Severe migraine; flu like symptoms; fever; Body aches; could not get comfortable; This is a spontaneous report from a contactable consumer, the patient. A 24-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 12:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 08Apr2021 at 13:00, the patient experienced severe migraine, flu like symptoms, fever, could not get comfortable and body aches. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events migraine, flu like symptoms, fever, could not get comfortable and body aches was not recovered at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Joint pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 02Apr2021 at 11:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 12Mar2021 at 11:30 (at the age of 56-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 09Apr2021, 7 days after second shot, the patient experienced joint pain and headache. No therapeutic measures were 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 joint pain and headache were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Injection site reaction, Rash, Rash pruritic, Skin reaction
Clinical narrative: A reaction commonly called "covid arm". About a week after the second dosage of the COVID vaccine I had a rash similar to chicken pox but localized to above and below my left armpit, extending sporadically down to my left nipple. The spots were itchy but did not rupture or ooze anything. After a few days they began fading and disappeared about a week later.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Heart rate irregular, Heavy menstrual bleeding, Palpitations
Clinical narrative: My heart raced for 1 hour. Racing to 127 beats per minute and would suddenly drop to 69 beats per min. My heart was irractic for an hour. I then proceeded to have body aches in my hips for 2 days, and fatigue.  2 months after the shot my monthly period was 12 days, rather than its normal 7 days.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: patient is fully vaccinated with moderna vaccine, we do not have the lot numbers available at this time patient was exposed to someone with COVID, tested positive on 08/03/21
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration on 06Apr2021 at 18:45 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease. Concomitant medications included ustekinumab (STELARA) from unknown dates for unspecified indication, last injection was on 05Mar2021. The patients allergies to food, medications, or other products was reported as N/a. 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 08Apr2021 at 10:45, the patient experienced fever, chills and body aches starting 40 hours after vaccine and lasting 18 hours. 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 events. The clinical outcome of the events fever, chills and body aches was recovered on 09Apr2021 at 04:45.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular menstrual bleeding between cycle; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old patient of unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, anxiety, PTSD and bipolar disorder. The patient was allergic to penicillin. Concomitant medications included chlorphenamine maleate, paracetamol and pseudoephedrine hydrochloride (THERAFLU) started on an unknown date for an unknown indication. 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 16Mar2021 (at the age of 29-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 08Apr2021 the patient experienced irregular menstrual bleeding between cycle. 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 event irregular menstrual bleeding between cycle was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cold sweat, Influenza, Pain
Clinical narrative: flu or viral symptoms achey,; Achey; pain in joints, especially left shoulder arm and back; break out in cold sweat; pain in joints, especially left shoulder arm and back,; pain in joints, especially left shoulder arm and back,; 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: 1450) via an unspecified route of administration in the arm right on 26Mar2021 at 11:15(at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hypothyroidism, hypothyroidism, sulfonamide allergy and iodine allergy. Concomitant medications included nebivolol hydrochloride (manufacturer: BYSTOLIC 2.5mg), levothyroxine (MANUFACTURER UNKNOWN, 88mcg) and ibuprofen (MANUFACTURER UNKNOWN)all from unknown date and for unknown indication. The patient previously took first dose of BNT16b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 1450) via an unspecified route of administration in the arm right in Mar2021 at 11:15(at the age of 67-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. 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 28Mar2021 at 15:00 the patient experienced flu or viral symptoms achey, pain in joints, especially left shoulder arm and back, break out in cold sweat. Therapeutic measures were taken as a result of adverse events which was unspecified. The event resulted in emergency room/department or urgent care. Just had vitals checked blood work and reflux. The clinical outcome of the events flu or viral symptoms achey, pain in joints, especially left shoulder arm and back, break out in cold sweat were not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy skin; Hives showing all over body; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 12:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced itchy skin and hives showing all over body. 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 itchy skin and hives showing all over body was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizziness; weakness; 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: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 12:15 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included non-hodgkin's lymphoma, seasonal allergy, depression, anxiety and known allergy to penicillin. Concomitant medications included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN), clonazepam (MANUFACTURER UNKNOWN), loratadine (LORATIDINE), tagetes spp. (LUTEIN) and unspecified multivitamin; all for unknown indications from unknown dates . 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 18Mar2021 (at the age of 44-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 08Apr2021 at 12:30, the patient experienced dizziness and weakness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events dizziness and weakness which included observation. The clinical outcome of the events dizziness and weakness were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Rash - started at injection site, then on wrists, followed my stomach/back and arms; Rash - started at injection site, then on wrists, followed my stomach/back and arms; 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: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to any medications, food, or other products. The patient did not receive any medication within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 10:30 (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 07Apr2021, the patient experienced rash that started at injection site, then on wrists, followed by stomach/back and arms. 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 rash that started at injection site, then on wrists, followed by stomach/back and arms was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: intense itching on hand; hives on hand, spread to collarbone and other arm and also appeared on the backs of knees; This is a spontaneous report from a contactable consumer, the patient. A 58-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 arm left on 06Apr2021 at 13:00(at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse. Concomitant medications included zinc (MANUFACTURER UNKNOWN), estradiol (FEMRING), ascorbic acid (VITAMIN C), magnesium sulfate (MAGNESIUM)  and cod-liver oil (FISH OIL), all from unknown dates and for unknown 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 09Apr2021 at 02:30, the patient experienced intense itching and hives on hand. It was reported that when the patient woke up at 05:30, the hives had spread to collarbone and other arm. At 09:00, they had appeared on the backs of her knees. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for intense itching and hives which included anti histamine and steroid cream. The clinical outcome of the events intense itching and hives on hand, collarbone, other arm and back of knees were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dyspnoea, Fatigue
Clinical narrative: Feeling tired/fatigue; Shortness of breath; blood pressure remained slightly elevated.; This is a spontaneous report from a contactable pharmacist. A 77-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via intramuscular route of administration in the arm right on 17Mar2021 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (resolved hypertension), AFib (atrial fibrillation), hyperlipidemia, milk allergy, peanut allergy, food allergy (beans) and allergy to beef product. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) and carvedilol (MANUFACTURER UNKNOWN); both for an unknown indication and from 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 vaccination. On 17Mar2021, the patient experienced feeling tired /fatigue and shortness of breath. Patient was hypertensive. The patient denied dizziness and chest pain. The patient was offered oxygen supplementation but refused and stated that he felt okay. All symptoms resolved except fatigue and blood pressure remained slightly elevated. On 17Mar2021, the patient underwent blood pressure and the result was blood pressure remained slightly elevated. 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 shortness of breath was resolved on an unknown date and of the events blood pressure remained slightly elevated /fatigue and feeling tired was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache .; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8734) via an unspecified route of administration in the right arm on 04Apr2021 at 09:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included colitis ulcerative. Concomitant medications included mesalamine (MANUFACTURER UNKNOWN), desvenlafaxine succinate monohydrate (PRISTIQ) and daily vitamins (MANUFACTURER UNKNOWN) all for unknown indication and from 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 vaccination. On 04Apr2021 at 17:00, the patient experienced headache that was not affected by Tylenol or Excedrin. On day 6 and still dealing with it. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of headache and included treatment with Tylenol or Excedrin. The clinical outcome of the event headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0158) via an unspecified route of administration in the left arm on 08Apr2021 at 15:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included Factor V Leiden, ADHD and interstitial cystitis. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), cetirizine hydrochloride (ZYRTEC), fexofenadine hydrochloride (ALLEGRA), levonorgestrel (MIRENA IUD) and curcuma longa rhizome (TURMERIC PWD); all from unknown dates for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 09Apr2021 at 07:30, the patient experienced soreness at injection site. 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 soreness at injection site was 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: Anxiety, Fatigue, Night sweats, Pain in extremity
Clinical narrative: Anxiety attack; pain in upper arm; sweats overnight (no fever); fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient 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 08Apr2021 at 13:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and gastritis. The patient previously took soy, sulfa, sulfites, tetracycline and experienced allergy. Concomitant medications included lamotrigine (LAMICTAL), famotidine (PEPCID) and thyroid (ARMOUR THYROID) for unknown indications from 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 vaccination. On an unknown date in Apr2021, the patient experienced an anxiety attack, pain in upper arm, sweats overnight (no fever) and fatigue. No therapeutic measures were taken as the result of adverse 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 anxiety attack, pain in upper arm, sweats overnight (no fever) and fatigue was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Confusional state, Fatigue, Headache, Pain
Clinical narrative: Body aches; headache; fatigue; anxiety; confusion; restless legs; arm pain; This is a spontaneous report from a contactable consumer, the patient. A 25-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 left arm on 08Apr2021 at 10:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not receive any concomitant medications. The patient did not have any allergies to food, medicine and other products. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 10:15 (at the age of 25-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 09Apr2021 at 06:00, the patient experienced body aches, headache, fatigue, anxiety, confusion, restless legs 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 events. The clinical outcome of the events body aches, headache, fatigue, anxiety, confusion, restless legs and arm pain was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Restless legs syndrome
Clinical narrative: Body aches; headache; fatigue; anxiety; confusion; restless legs; arm pain; This is a spontaneous report from a contactable consumer, the patient. A 25-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 left arm on 08Apr2021 at 10:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not receive any concomitant medications. The patient did not have any allergies to food, medicine and other products. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 10:15 (at the age of 25-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 09Apr2021 at 06:00, the patient experienced body aches, headache, fatigue, anxiety, confusion, restless legs 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 events. The clinical outcome of the events body aches, headache, fatigue, anxiety, confusion, restless legs and arm pain was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dehydration, Fatigue, Headache
Clinical narrative: Vaccination site pain; Fever 99.9; Chills; Headache; Muscle aches of the whole body; Tiredness,; Feeling dehydrated; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 at 12:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to food, medications, or other products. Concomitant medications included ADULT MULTIVITAMIN, calcium (MANUFACTURER UNKNOWN) supplements, glucosamine, chondroitin sulfate (GLUCOSAMINE CHONDROITIN) all from unknown dates, for unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 17Mar2021 at 12:15 as a single dose for COVID-19 immunisation. The patient did not have symptoms associated with COVID-19. 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 08Apr2021 at 00:00, the patient experienced soreness at injection site/arm, fever 99.9, chills, headache, muscle aches of the whole body, tiredness, feeling dehydrated despite drinking lots of water. On 08Apr2021, the patient body temperature was measured and the result was 99.9 (Units not reported). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the event soreness at injection site/arm, fever 99.9, chills, headache, muscle aches of the whole body, tiredness, feeling dehydrated was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Vaccination site pain; Fever 99.9; Chills; Headache; Muscle aches of the whole body; Tiredness,; Feeling dehydrated; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 at 12:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to food, medications, or other products. Concomitant medications included ADULT MULTIVITAMIN, calcium (MANUFACTURER UNKNOWN) supplements, glucosamine, chondroitin sulfate (GLUCOSAMINE CHONDROITIN) all from unknown dates, for unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 17Mar2021 at 12:15 as a single dose for COVID-19 immunisation. The patient did not have symptoms associated with COVID-19. 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 08Apr2021 at 00:00, the patient experienced soreness at injection site/arm, fever 99.9, chills, headache, muscle aches of the whole body, tiredness, feeling dehydrated despite drinking lots of water. On 08Apr2021, the patient body temperature was measured and the result was 99.9 (Units not reported). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the event soreness at injection site/arm, fever 99.9, chills, headache, muscle aches of the whole body, tiredness, feeling dehydrated was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: 1 day post shot...swelling in the region where shot was received; This is a spontaneous report from a contactable consumer, the patient. A 46-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 right arm on 08Apr2021 at 14:15 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included depression, irritable bowel syndrome and fibro. The patient's known allergies were not reported. Concomitant medications included quetiapine fumarate (SEROQUEL) and EFFECTOR; both from an unknown date 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 09Apr2021 at 08:00, the patient experienced "1 day post shot... swelling in the region where shot was received". Therapeutic measures were taken as a result of the event and included treatment with Tylenol. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event "1 day post shot swelling in the region where shot was received" was recovering at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling at sites of mosquito bites shortly after second dose of vaccine.  Images available; This is a spontaneous report from a contactable health care professional.  A 73-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 on 03Apr2021 at 14:45 (at the age of 73-years-old) as a single dose for COVID-19immunisation. The patient did not have any relevant medical history.  The patient had no known allergies to any medications, food or other products. The patient did not receive any other medications in two weeks prior to the vaccination. 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 03Apr2021 shortly after the second dose of vaccine, the patient experienced swelling at sites of mosquito bites. The patient also stated that the images are available for the same. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event swelling at sites of mosquito bites shortly after second dose of vaccine was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity
Clinical narrative: Stomach was upset; Sore arm for about two days; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 10:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient 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 sore arm for about two days. Stomach was upset for about an hour afterwards. No other affects. No therapeutic measures were 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. The clinical outcome of the events stomach was upset and sore arm was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.