chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Swelling, Urticaria
Clinical narrative: Rash/hives on inner thighs, insideknee/upper calf, outside upper arms.Both arms and both legs.; hives on inner thighs, insideknee/upper calf, outside upper arms.Both arms and both legs.Red, itchy,slightly swollen; Rash/hives on inner thighs, insideknee/upper calf, outside upper arms.Both arms and both legs. Red; itchy; slightly swollen; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant 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 right arm on 07Apr2021 at 11:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and obesity. The patient did not have any 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 other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 20Mar2021 at 13:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), cannabidiol (MANUFACTURER UNKNOWN), loratadine (CLARITIN) and oral contraceptive nos (MANUFACTURER UNKNOWN); all were from unknown date and for unspecified indication. On 17Apr2021 at 06:00 the patient experienced rash/hives on inner thighs, inside knee/upper calf, outside upper arms. Both arms and both legs. Red, itchy, slightly swollen. 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 the result of adverse events and included treatment with Benadryl.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash/hives on inner thighs, inside knee/upper calf, outside upper arms. Both arms and both legs. Red, itchy, slightly swollen were resolving at the time report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythromelalgia, Foot deformity
Clinical narrative: Erythromelalgia in toes worst ever ongoing flare since the first vaccine dose; EM presents in my toes so seems related to COVID toes; Erythromelalgia in toes worst ever ongoing flare since the first vaccine dose; 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: ER8727) via an unspecified route of administration on 27Mar2021(at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included erythromelalgia and was ongoing. 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 01Apr2021, the patient experienced " have had erythromelalgia for a few years and have had the worst ever ongoing flare since the first vaccine dose". EM presents in the toes so seems to related to "COVID toes". The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or 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 " have had erythromelalgia for a few years and have had the worst ever ongoing flare since the first vaccine dose". EM presents in the toes so seems to related to "COVID toes" were not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain of skin, Pruritus, Skin burning sensation
Clinical narrative: Itching skin arms legs back; Burning skin arms legs back; Stinging skin arms legs back; This is a spontaneous report received from a contactable consumer, the parent. A 79-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 12Apr2021 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included heart (heart disorder) and kidneys (kidney disorder). The patient had unspecified allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was unknown whether the patient had received any other vaccines within 4 weeks prior to COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 20Mar2021(at the age of 79-years-old) at 13:45 as a single dose for COVID-19 immunisation. On 13Apr2021 at 12:00, the patient had itching, burning and stinging skin on arms, legs and back. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events itching, burning and stinging skin on arms, legs and back were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Gouty tophus
Clinical narrative: Acute gout on right foot, 4th toe.; The gout was accompaniedby tophi.; This is a spontaneous report from a contactable consumer, the patient. A 64-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 30Mar2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. 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 09Mar2021 at 10:00 (at the age of 64-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 01Apr2021, two days after the second vaccine, the patient developed acute gout on right foot, 4th toe. It lasted for 2 weeks. The doctor took off indomethacin, which had not helped and put the patient on prednisone, which seemed to be helping. The gout was accompanied by tophi. At the time of report, the patient felt like the gout was moving to big toe on the same foot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse events and included treatment with indomethacin, prednisone and cephalexin. The clinical outcome of the events acute gout on right foot and gout accompanied by tophi were not resolved at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Pain
Clinical narrative: Hips and legs felt like they were on fire, burning; Terrible pain and agony; Feel weak; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included avascular necrosis in both hips and both legs around the knees, caused from factor five and chronic pain. The patient had known allergies to bupropion hydrochloride (WELLBUTRIN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified drugs that were prescribed and over-the counter. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 26Mar2021 at 13:30 (at the age of 48-years-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 17Apr2021 at 18:30, the second evening after the second dose, the patient experienced hips and legs felt like they were on fire, burning, terrible pain and agony just for few hours. The patient stated that the pain slipped on after taking a nap in the early evening and the patient woke up to the terrible pain, was able to settle down and relax, and the pain was just gone. The patient still felt weak, but no more burning pain. The events did not result in doctor or other healthcare professional /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 hips and legs felt like they were on fire, burning, terrible pain and agony just for few hours and feeling weak was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Facial pain, Fatigue
Clinical narrative: A sharp stinging headache (just like having COVID-19); Severe arm pain at injection site; Fatigue; Body aches; Hot and cold spells; A consistent fever of 101.1 that lasted on and off for 2 days (more than 8 hours) that peaked at 102.7; Face and sinus pain; Face and sinus pain; loss of taste/smell short period; loss of taste/smell short period; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0169), via an unspecified route on 16Apr2021 at 14:30 (at the age of 49-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included had COVID-19 on 23Nov2020, heart failure caused by COVID-19, chronic back pain due to accident that caused a Pain Pump to be administered with Bupivacaine. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8730), via an unspecified route on 26Mar2021 at 08:30 (at the age of 49-years) as dose 1, single in the left arm 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 16Apr2021 at 11:30, the patient experienced a sharp stinging headache (just like having COVID-19), severe arm pain at injection site, fatigue, body aches, hot and cold spells, a consistent fever of 101.1 that lasted on and off for 2 days (more than 8 hours) that peaked at 102.7, Face and sinus pain, loss of taste/smell short period. The patient did not received treatment for events. The patient underwent lab tests and procedures which included covid-19 was positive on 23Nov2020, fever was 101.1 on 16Apr2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: A sharp stinging headache (just like having COVID-19); Severe arm pain at injection site; Fatigue; Body aches; Hot and cold spells; A consistent fever of 101.1 that lasted on and off for 2 days (more than 8 hours) that peaked at 102.7; Face and sinus pain; Face and sinus pain; loss of taste/smell short period; loss of taste/smell short period; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0169), via an unspecified route on 16Apr2021 at 14:30 (at the age of 49-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included had COVID-19 on 23Nov2020, heart failure caused by COVID-19, chronic back pain due to accident that caused a Pain Pump to be administered with Bupivacaine. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8730), via an unspecified route on 26Mar2021 at 08:30 (at the age of 49-years) as dose 1, single in the left arm 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 16Apr2021 at 11:30, the patient experienced a sharp stinging headache (just like having COVID-19), severe arm pain at injection site, fatigue, body aches, hot and cold spells, a consistent fever of 101.1 that lasted on and off for 2 days (more than 8 hours) that peaked at 102.7, Face and sinus pain, loss of taste/smell short period. The patient did not received treatment for events. The patient underwent lab tests and procedures which included covid-19 was positive on 23Nov2020, fever was 101.1 on 16Apr2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus pain
Clinical narrative: A sharp stinging headache (just like having COVID-19); Severe arm pain at injection site; Fatigue; Body aches; Hot and cold spells; A consistent fever of 101.1 that lasted on and off for 2 days (more than 8 hours) that peaked at 102.7; Face and sinus pain; Face and sinus pain; loss of taste/smell short period; loss of taste/smell short period; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0169), via an unspecified route on 16Apr2021 at 14:30 (at the age of 49-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included had COVID-19 on 23Nov2020, heart failure caused by COVID-19, chronic back pain due to accident that caused a Pain Pump to be administered with Bupivacaine. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8730), via an unspecified route on 26Mar2021 at 08:30 (at the age of 49-years) as dose 1, single in the left arm 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 16Apr2021 at 11:30, the patient experienced a sharp stinging headache (just like having COVID-19), severe arm pain at injection site, fatigue, body aches, hot and cold spells, a consistent fever of 101.1 that lasted on and off for 2 days (more than 8 hours) that peaked at 102.7, Face and sinus pain, loss of taste/smell short period. The patient did not received treatment for events. The patient underwent lab tests and procedures which included covid-19 was positive on 23Nov2020, fever was 101.1 on 16Apr2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Tinnitus, Vertigo
Clinical narrative: Loud constant ringing in ears; A bit of vertigo; Muscles were so painful and got worse everyday; 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: ER2613) via an unspecified route of administration in the right arm on 14Apr2021 at 11:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included interstitial cystitus, pseudo tumor cerebri, ebstein barr virus (EBV), gluten sensitivity and allergy to dairy products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included metformin hydrochloride (GLUMETZA), thyroid (ARMOUR THYROID) and alprazolam (MANUFACTURER UNKNOWN); all from an unknown date for an unspecified indication and unknown if ongoing. The patient previously received tetracycline (MANUFACTURER UNKNOWN) and sumatriptan succinate (IMITREX) from an unknown date for an unspecified indication and experienced drug allergy. On 15Apr2021 at 08:00, the patient experienced loud constant ringing in ears, a bit of vertigo, and her muscles were painful and getting worse every day. Patient stated that the ringing in ears started morning of 15Apr2021 same with the vertigo, and muscle pain was progressively getting worse. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events loud constant ringing in ears, a bit of vertigo, and muscles were painful and getting worse every day were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash has developed primarily in torso area.  I can feel it spreading to the ground and behind my ears.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 16Apr2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease (reported as hashimoto). The patient no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and escitalopram (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: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 (at the age of 57-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 17:00, rash had developed primarily in torso area. The patient could feel it spreading to the ground and behind her ears. No therapeutic measures were taken as a result of the 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 rash had developed primarily in torso area, the patient could feel it spreading to the ground and behind her ears was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Musculoskeletal stiffness, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 41-year-old (non-pregnant)  female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EW0161), at the age of 41, via an unspecified route of administration, left arm, on Apr 17, 2021, at 11:15, single dose, for COVID-19 immunisation. Medical history included genital herpes. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline for unknown indication on unknown date and unknown if ongoing. The patient has no known allergies. On Apr 18, 2021, at 08:00, patient experienced muscle pain, stiff neck, joint pain, tiredness, nausea and feeling overall unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of muscle pain, stiff neck, joint pain, tiredness, nausea and feeling overall unwell: not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 41-year-old (non-pregnant)  female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EW0161), at the age of 41, via an unspecified route of administration, left arm, on Apr 17, 2021, at 11:15, single dose, for COVID-19 immunisation. Medical history included genital herpes. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline for unknown indication on unknown date and unknown if ongoing. The patient has no known allergies. On Apr 18, 2021, at 08:00, patient experienced muscle pain, stiff neck, joint pain, tiredness, nausea and feeling overall unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of muscle pain, stiff neck, joint pain, tiredness, nausea and feeling overall unwell: not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Heart rate, Heart rate increased, Musculoskeletal stiffness
Clinical narrative: headache; legs and muscles felt like under a heavy blanket and stiff; heart rate shooting up by 30 points of 100 - 115/my heart rate was closer to the 80's and 90's; this was a terrible feeling - tachycardia and there was pain in left arm with shot; this was a terrible feeling - tachycardia and there was pain in left arm with shot; this was a terrible feeling - tachycardia and there was pain in left arm with shot; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Left arm on 16Apr2021 14:00 at the age of 56-years-old as dose 2, single for covid-19 immunisation. Medical history included thyroid issues from an unspecified date and COVID-19 on an unspecified date prior vaccination. The patient had no allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: not reported) on an unspecified date as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. Facility type vaccine was other. The patient was diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that after shot 2, on 17Apr2021, the patient experienced headache, legs and muscles felt like under a heavy blanket and stiff, and heart rate shooting up by 30 points of 100 - 115# Typically his heart rate is in the 70's so this was a terrible feeling - tachycardia and there was pain in left arm with shot, literally the next day it stopped and my heart rate was closer to the 80's and 90's, so a bit better. The patient received did not receive treatment for adverse events. Adverse events resulted in None of the above. The patient underwent lab tests and procedures which included heart rate: shooting up on 17Apr2021 (30 points of 100 - 115/my heart rate was closer to the 80's and 90's). The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tachycardia
Clinical narrative: headache; legs and muscles felt like under a heavy blanket and stiff; heart rate shooting up by 30 points of 100 - 115/my heart rate was closer to the 80's and 90's; this was a terrible feeling - tachycardia and there was pain in left arm with shot; this was a terrible feeling - tachycardia and there was pain in left arm with shot; this was a terrible feeling - tachycardia and there was pain in left arm with shot; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Left arm on 16Apr2021 14:00 at the age of 56-years-old as dose 2, single for covid-19 immunisation. Medical history included thyroid issues from an unspecified date and COVID-19 on an unspecified date prior vaccination. The patient had no allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: not reported) on an unspecified date as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. Facility type vaccine was other. The patient was diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that after shot 2, on 17Apr2021, the patient experienced headache, legs and muscles felt like under a heavy blanket and stiff, and heart rate shooting up by 30 points of 100 - 115# Typically his heart rate is in the 70's so this was a terrible feeling - tachycardia and there was pain in left arm with shot, literally the next day it stopped and my heart rate was closer to the 80's and 90's, so a bit better. The patient received did not receive treatment for adverse events. Adverse events resulted in None of the above. The patient underwent lab tests and procedures which included heart rate: shooting up on 17Apr2021 (30 points of 100 - 115/my heart rate was closer to the 80's and 90's). The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in right arm from shoulder to wrist; This is a spontaneous report from a contactable consumer, the patient. A 88-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 07Apr2021 at 00:00 (at the age of 88-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 09Apr2021, the patient experienced pain in right arm from shoulder to wrist which was present at the time of reporting (18Apr2021). The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event pain in right arm from shoulder to wrist was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Several hours after the first vaccine I became dizzy. It was not severe but it continues to this day; This is a spontaneous report from a contactable consumer, the patient. A 68-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 right arm on 10Mar2021 at 11:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included A fib (Atrial fibrillation). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021, several hours after the first vaccine, the patient became dizzy. It was not severe but it continued to the day of the report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any treatment for the event. The clinical outcome of the event dizzy was not recovered, at this time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: Tongue sores 12 - 24 hours after vaccine; This is a spontaneous report from a contactable pharmacist, the patient. A 51-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 15Feb2021 at 10:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 15Mar2021 at 10:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation  Medical history included allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Mar2021 the patient experienced tongue sores 12 - 24 hours after vaccine and occurred after each dose. The sores persisted intermittent for weeks following the vaccine. 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. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the reported events. The clinical outcome of the event tongue sores was resolved with sequelae on an unknown date in 2021 at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain
Clinical narrative: Pain under left arm, arm pit area; Pain under left arm, arm pit area, that radiates towards the breast; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for unspecified indication from an unknown date. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. 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 right arm on 01Mar2021 at 10:00 (at the age of 41-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 vaccine within four weeks prior to the COVID vaccine. On 28Mar2021 at 15:00, the patient experienced pain under left arm that radiated towards the breast. The event 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 not taken as a result of the event. The clinical outcome of the event pain under left arm that radiated towards the breast was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: I have sores in my mouth; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure and COVID-19 (Prior to vaccination the patient was diagnosed with COVID-19). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN6202) via an unspecified route of administration in the left arm on 27Feb2021 at 10:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Apr2021 at 00:00, after one week of vaccination, the patient experienced sores in mouth, they are all along the right side of the mouth. They were getting worse after three weeks, the patient had been to the doctor two times already and was about to visit again. The first time they gave anti-virus drug and the second time steroids and they are still bad and painful in my mouth. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported event which included treatment with anti-virus drug and steroids. The clinical outcome of the event sores in mouth was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Fever; Headache; Body aches; Joint pain; Fatigue and tiredness; Chills; Swollen lymph nodes in neck; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 11Apr2021 at 12:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included lipedema (connective tissue/fat disorder) and COVID-19 on an unknown date. The patient was allergic to sulfa drugs. The patient did not receive any medication within two weeks of vaccination. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy. 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 12Apr2021 at 06:30, the patient experienced fever 99.8 which then rose to 100.5, headache, body aches, joint pain, fatigue and tiredness, chills and swollen lymph nodes in neck. Therapeutic measures were taken as a result of the events and included treatment with extra-strength acetaminophen. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever was resolved on 14Apr2021; swollen lymph nodes, chills, body ache and joint pain were resolved on 17Apr2021 and headache and fatigue were resolved on 18Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever; Headache; Body aches; Joint pain; Fatigue and tiredness; Chills; Swollen lymph nodes in neck; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 11Apr2021 at 12:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included lipedema (connective tissue/fat disorder) and COVID-19 on an unknown date. The patient was allergic to sulfa drugs. The patient did not receive any medication within two weeks of vaccination. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy. 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 12Apr2021 at 06:30, the patient experienced fever 99.8 which then rose to 100.5, headache, body aches, joint pain, fatigue and tiredness, chills and swollen lymph nodes in neck. Therapeutic measures were taken as a result of the events and included treatment with extra-strength acetaminophen. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever was resolved on 14Apr2021; swollen lymph nodes, chills, body ache and joint pain were resolved on 17Apr2021 and headache and fatigue were resolved on 18Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Clumps of vaginal  blood 3 days after vaccinations; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Right on 18Mar2021 as dose 1, single; dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 16:00 (Lot number: EW0161) as dose 2, single (both doses at the age of 31-year-old) for covid-19 immunization. Medical history was reported as none. Known allergies were reported as no. The patient concomitant medications were not reported. Patient did not receive other medications in two weeks. Patient did not have covid-19 prior vaccination and covid-19 was not tested post vaccination. On 04Apr2021 at 20:00, the patient experienced clumps of vaginal blood 3 days after vaccinations. Patient stated she had mirena iud and had not menstruated in 4 years. Patient did not receive any treatment for adverse event. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Pain, Sneezing
Clinical narrative: Extreme tiredness throughout the body; Throbbing pain on the side of head and behind eyes; Lightheadedness; Cough; Occasional sneeze; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Apr2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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. On an unknown date in Apr2021, the patient experienced extreme tiredness throughout the body, throbbing pain on the side of the head and behind eyes, lightheadedness, cough and the occasional sneeze. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events extreme tiredness throughout the body, throbbing pain on the side of the head and behind eyes, lightheadedness, cough and occasional sneeze was resolving at the time of the report.  No follow-up attempts are possible; information about lot/ batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Heart rate irregular, Hot flush, Malaise
Clinical narrative: Intensifying Nausea; Pounding rapid irregular heartbeat; Pounding rapid irregular heartbeat; Hot flashes; Malaise; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 16Apr2021 at 10:15 (at the age of 48-year-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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 26Mar2021 at 10:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 09:00 (also reported as approximately 48 hours post-vaccination), the patient experienced intensifying nausea, pounding rapid irregular heartbeat, hot flashes, and malaise lasting for 6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of event malaise was recovered on 18Apr2021 at 15:00. The clinical outcome of the events intensifying nausea, pounding rapid irregular heartbeat and hot flashes were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Intensifying Nausea; Pounding rapid irregular heartbeat; Pounding rapid irregular heartbeat; Hot flashes; Malaise; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 16Apr2021 at 10:15 (at the age of 48-year-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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 26Mar2021 at 10:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 09:00 (also reported as approximately 48 hours post-vaccination), the patient experienced intensifying nausea, pounding rapid irregular heartbeat, hot flashes, and malaise lasting for 6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of event malaise was recovered on 18Apr2021 at 15:00. The clinical outcome of the events intensifying nausea, pounding rapid irregular heartbeat and hot flashes were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.