chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain
Clinical narrative: Achy body; Achy body / joints; headache; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration in the left arm on 23Mar2021(at the age of 52-years-old), at 13:30 hours, as a single dose for COVID-19 immunisation. The medical history was not reported and the patient had no known allergies. The concomitant medications included atorvastatin calcium (LIPITOR) and amitriptyline pamoate, (amitriptyline) (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since having the vaccine. On 24Mar2021 at 06:30, the patient experienced achy body and joints was very tired and had headache. No treatment was received for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of achy body and joints, tiredness and headache were recovering at this time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Migraine, Pain
Clinical narrative: Arm felt dead with pain at injection site; Low grade fever; Chills; Body aches; Migraine pain on left side of head and neck; General malaise; Lingering headaches; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included kidney stone and liver issues. The patient did not had allergies to any medications, food, or other products. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 18:00, the patient experienced dead arm pain at injection site (for 3 days), low grade fever with chills and body aches, migraine with pain on left side of head and neck (for 3 days), general malaise. The patient experienced lingering headaches. The patient was definitely not looking forward to another shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site pain, low grade fever, chills, general body pain, migraine, general malaise and headache were resolved with sequelae (recovered with lasting effects) on an unknown date of Mar2021.  No follow up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Arm felt dead with pain at injection site; Low grade fever; Chills; Body aches; Migraine pain on left side of head and neck; General malaise; Lingering headaches; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included kidney stone and liver issues. The patient did not had allergies to any medications, food, or other products. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 18:00, the patient experienced dead arm pain at injection site (for 3 days), low grade fever with chills and body aches, migraine with pain on left side of head and neck (for 3 days), general malaise. The patient experienced lingering headaches. The patient was definitely not looking forward to another shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site pain, low grade fever, chills, general body pain, migraine, general malaise and headache were resolved with sequelae (recovered with lasting effects) on an unknown date of Mar2021.  No follow up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Myalgia, Pain of skin
Clinical narrative: Intense underarm pain, same side as shot.; Stabbing pain in skin andmuscle.; Stabbing pain in skin andmuscle.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old adult non- pregnant female patient received unknown dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot number: Er8733) via an unspecified route of administration in the right arm on 25Mar2021 at 12:00 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included overweight. Concomitant medications were not reported. The patient previously received unknown dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient had not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 13:00, the patient experienced intense underarm pain, same side of shot, had stabbing pain in skin and muscle. There was no visible swelling of area or lymph nodes. 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. No therapeutic measures were taken as the result of adverse events. The clinical outcome of armpit pain, skin pain and muscle pain was not recovered.  No follow-up attempts are needed. No further information is expected. .
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Fever; General flu like symptoms; This is a spontaneous report received from a contactable consumer, for patient. A 52-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and the patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 11:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patient medical history included multiple sclerosis (MS). The patient did not have 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 had taken concomitant medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 07:00, the patient experienced fever and general flu like symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events fever and general flu like symptoms were resolved on an unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Face Swelling; This is a spontaneous report from a contactable consumer, the patient. A 61-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 24Mar2021 at 23:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, diabetes, hypertension, depression, obesity, sleep apnoea, arthritis, glaucoma, psoriasis and rosacea. The patient was allergic to penicillin and sulphadrugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), aripiprazole (ABILIFY), venlafaxine hydrochloride (EFFEXOR), atorvastatin calcium (LIPITOR) and irbesartan (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 08:00, the patient experienced face swelling. The adverse event resulted in doctor or other healthcare professional office or clinical visit. The patient was treated with BENADRYL for face swelling. The clinical outcome of the swelling face was resolved on an unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Mass, Pain in extremity
Clinical narrative: Bump around collar bone; hurting on arm andunderneath arm; hurting on arm andunderneath arm; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8732), via an unspecified route of administration in the left arm on 25Mar2021 at 13:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) for unknown indication. 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 left arm on 03Mar2021 at 15:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Prior to 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 4 weeks prior to the COVID-19 vaccine. On 26Mar2021 at 13:45, the patient had experienced a bump around the collar bone that moved when she moved and stuck out in a certain position. The patient also experienced hurting on arm and underneath arm on 26Mar2021 at 13:45. The patient did not receive any therapeutic measures for the reported events. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events bump around collar bone, hurting on arm and underneath arm was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: peed the bed and on second day the patient had entire bladder leaks; This is a spontaneous report from a contactable consumer, the patient. A 44-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via unspecified route of administration in the left arm on 24Mar2021 at 08:45 am (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no allergies to medications, food or other products. Prior to 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 4 weeks prior to the COVID vaccine. Concomitant medication included amlodipine (MANUFACTURER UNKNOWN) used for unknown indication. On 25Mar2021 at 00:00 (on first night of the vaccination), the patient peed the bed and on second day the patient had entire bladder leaks. The patient did not receive treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event was not resolved.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event description and vaccination facility information updated.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling hot, Pyrexia
Clinical narrative: Chills; Felt hot through the night; fever; weakness; felt tired; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; UNKNOWN), via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included oral thrush. The patient had a history of allergy to oysters, Vicodin, penicillin and had seasonal allergies. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN) and DIFLUCAN for unknown indication received within two weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 27Mar2021 at 14:00, about 30 min after the vaccination, the patient felt tired. Within 1 hour at 14:30, the patient had a fever, weakness and had to lay down. This was only the first dose. On the same day at 16:00, the patient had chills which were continued and had felt hot through the night. It was reported that the patient had to take Tylenol. Adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events felt tired, fever, weakness, chills and felt hot through the night was unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 101 F; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on the right arm, on 26Mar2021 at 15:00 (at the age of 32-years) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma, A-fib heart condition. The patient had allergy towards penicillin and meat. The patient had no any concomitant medications received within two weeks of vaccine. Previously patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on the right arm, on 06Mar2021 at 18:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of vaccination or any other medications within 2 weeks of 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 27Mar2021 at 00:00, the patient experienced fever of 101 F. On 27Mar2021 at 00:00, the patient had body temperature measurement of 101 F. 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 event fever. The clinical outcome of event fever was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Paraesthesia
Clinical narrative: Hand and finger tingling; Shoulder pain; Neck pain; This is a spontaneous report from contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 09:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The patient was not allergic to medications, food, or other products The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 27Mar2021 at 00:00, the patient experienced hand and finger tingling, shoulder and neck pain. No therapeutic treatment was taken for the reported events. The clinical outcome of the events hand and finger tingling, shoulder and neck pain was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anaesthesia oral, Chills, Dry mouth, SARS-CoV-2 test, Throat irritation
Clinical narrative: Chills; Dry mouth; weird sensation on tongue (like sandpaper); Tightening sensation of soft palate; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: GP6599) via an unspecified route of administration in the right arm on 20Mar2021 at 15:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and cervical radiculopathy. Concomitant medication were not reported. The patient was allergic to tomatoes and wool. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 15:30, the patient experienced chills, dry mouth, weird sensation on tongue (like sandpaper) and tightening sensation of soft palate. On 17Mar2021, the patient was tested for COVID-19 virus test (nasal swab) which resulted in negative and on 22Mar2021, the patient was tested for COVID-19 virus test (blood test) which resulted in negative. It was unknown if treatment was received for the events. The clinical outcome of the events chills, dry mouth, weird sensation on tongue and tightening sensation of soft palate were unknown.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Lethargy, Myalgia, Pain in extremity
Clinical narrative: Soreness in arm.; Could not lift or engage arm muscle without pain.; Lethargy.; Overall fatigue; Pain in legs; Pain in back.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 25Mar2021 at 16:00 (at the age of 55-years-old) as single for COVID-19 immunisation. The patient had no known medical history and concomitant medication. The patient had no known 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 04Mar2021 at 16:00 (at the age of 55-years-old) as single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Mar2021 at 20:00, the patient experienced soreness in arm and was not able to lift or engage the muscle arm without pain. The patient also experienced overall fatigue, lethargy, pain in legs and back which was not sharp but just uncomfortable on 25Mar2021 at 20:00. The patient did not receive any treatment for the events. 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 outcomes of the events soreness in arm, not able to engage muscle arm without pain, overall fatigue, lethargy, pain in legs and back pain were resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia oral, Pain in jaw, Paraesthesia oral
Clinical narrative: Numbness and tingling in my tongue; pain in my left jaw; pain in my left knee and hip; pain in my left knee and hip; Numbness and tingling in my tongue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: ER8727), via an unspecified route of administration in the left arm on 18Mar2021 at 11:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of COVID-19 on an unspecified date and had received unspecified medications within 2 weeks of vaccination as concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021 at 12:00, 15 minutes after vaccination, the patient reported that she experienced numbness and tingling in tongue, pain in left jaw, pain in left knee and pain in hip was still ongoing and it was never been there before. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The clinical outcomes of numbness and tingling in tongue, pain in jaw, pain in knee and pain in hip were resolved with sequelae on unspecified dates.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen glands in neck; This is a spontaneous report from a contactable health care professional, the patient. A 57-year-old non-pregnant female patient received an unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 16:00 (at the age of 57 years old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccine. On 26Mar2021, patient experienced swollen glands in neck. The adverse 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 swollen glands in neck was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. An 87-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 10Feb2021 at 16:30 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of cancer survivor. The patient had no known allergies to medications, food, or other products. The patient did not take any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 22Jan2021 at 16:30 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 12:00, the patient experienced dizziness and nausea. The adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient had received any treatment for reported events. The clinical outcome of the events of dizziness and nausea was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: I work up feeling better, and more alert  than I had been in years. I felt reborn. Alive. Hard to explain. I was so happy. Hoped it wasnt a one day thing.; chills; fever; body aches; This is a spontaneous report from a contactable consumer, the patient. A 65-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 right arm on 22Mar2021 at 16:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroidectomy, high blood pressure, depression and COVID-19 in Nov2020 (during the first week the patient had fever, chills and aches. The fatigue took 3 more weeks to recover). The patient reported that she took medications (unspecified) within the two weeks prior to the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the right arm on 01Mar2021, at 16:30, (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient underwent a COVID-19 virus test and was tested positive in Nov2020. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Mar2021, at 07:00 the patient experienced expected chills, fever, and body aches. The next morning the patient woke up and felt better and more alert than the patient had been in years. The patient felt reborn and alive and found it hard to explain. The patient also felt happy and hoped it was not a one-day thing. She felt the same 3 days later and felt better than ever before in years and felt the need to make someone aware of her situation. The patient considered it to be a truly a miracle. The therapeutic measure included intake of one 500 TYLENOL for the events on 23Mar2021 at 16:00. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events were resolved with sequelae on 24Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Horrible pain in arm and entire body.; Horrible pain in arm and entire body.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Unknown), via an unspecified route of administration in the right arm on 25Mar2021 at 12:00 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. Medical history included P.O.T.S (Postural orthostatic tachycardia syndrome) and fibromyalgia. Concomitant medication included beta blocker (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 22:00, the patient had experienced horrible pain in arm and entire body and reported that she had so much pain that she could not even use a blanket or had anything touching her. It was unknown if the patient had received any treatment for the reported events. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events horrible pain in arm and entire body was resolving at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site mass
Clinical narrative: Vary swollen lymph node in neck; Hard lump at vaccination site; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA vaccine; Lot number: EP7533) via an unspecified route of administration in the left arm on 25Mar2021 at 11:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. Concomitant medications included high blood pressure medicines (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN), me (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN); all from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to 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 Mar2021, the patient experienced very swollen lymph nodes in the neck and hard lump at shot site and it was still same 3 days later. 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 events swollen lymph nodes in the neck and hard lump at shot site (vaccination site lump) were unknown.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Upper respiratory tract infection
Clinical narrative: Upper respiratory infection; This is a spontaneous report from a contactable consumer (patient reported for himself). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 12Mar2021 (at the age of 59-year-old), as single for covid-19 immunisation. Relevant medical history included: Stroke, COPD (Chronic obstructive pulmonary disease) and Cholesterol. Concomitant medications included: blood thinners and Cholesterol medicine and use a nebulizer because she had COPD. She stated that she was on blood thinners and "cholesterol because" (not clarified further). She had a couple of strokes for last 10 years, almost 10 or 12 years ago. The patient experienced upper respiratory infection on an unspecified date. On an unspecified date (on Monday) his doctor prescribed a Z-Pak and Prednisone (treatment) for an upper respiratory infection and he was scheduled for his second dose to on an unspecified date (this Friday). On an unspecified date about a month ago, the patient had blood work done in which everything came back fine. The patient stated nothing unusual for her, as she had COPD (medical history) and this time of year with the pollens and that it was not her first upper respiratory infection, and nothing was unusual. The patient wanted to know that if it would be okay to still go-ahead and get her second vaccination while on doing these antibiotics and steroids for upper respiratory infection. The outcome of the event was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Nervousness, Pain in extremity, Peripheral swelling
Clinical narrative: she is nervous after second dose of Pfizer vaccine; after the second shot PT stated her arm is red and hurting badly; after the second shot PT stated her arm is red and hurting badly; my arm is so swollen; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received crizotinib (XALKORI), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 250 mg for an unspecified indication; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was nervous after second dose of Pfizer vaccine. After the second shot, patient stated her arm was red and hurting badly. Her arm was so swollen. The action taken in response to the eventsfor crizotinib was unknown. Outcome of the events was unknown.   Information on the batch/lot number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: patient experienced genital herpes outbreak. Herpes outbreak on left butt cheek; This is a spontaneous report from a contactable consumer (patient herself). This case refers to the first vaccination of two vaccines. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER2613; expiration date was not reported), via unspecified route of administration, in the left arm, on 23Mar2021 at 14:00 (at the age of 52-year-old), as single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included progesterone, estradiol (ESTROGEN), testosterone and multivitamins. On 25Mar2021 at 04:00 patient experienced genital herpes outbreak. Herpes outbreak on left butt cheek. 3 days after 1st dose. Patient received the valtrex treatment for the genital herpes outbreak. Patient did not have known allergies. No COVID prior vaccination. Patient did not positive for COVID post vaccination. Patient did not receive other vaccine in four weeks. Outcome of the event was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Diarrhoea, Dizziness, Faeces discoloured
Clinical narrative: Within a minute or so caller reports his head felt loopy; dizziness; foggy; vision hazy; headache; weakness; body ache; chest pain; throat tightness; The following day he started passing black stools; He continues to have loose bowel movements at this time; This is a spontaneous report from a contactable consumer or other non hcp. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 14Apr2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced within a minute or so caller reports his head felt loopy, dizziness, foggy, vision hazy, headache, weakness, body ache, chest pain, throat tightness, the following day he started passing black stools and he continues to have loose bowel movements at this time. It was reported that within a minute or so caller reports his head felt loopy. Then he experienced dizziness, foggy and vision hazy. That night he was seen in the ER for extreme headache, weakness, body ache, congestion, chest pain and throat tightness. The following day he started passing black stools. He continued to have loose bowel movements at this time. Caller asking how long symptoms may last and want to know if he should take the second Pfizer Covid 19 Vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain, Throat tightness, Vision blurred
Clinical narrative: Within a minute or so caller reports his head felt loopy; dizziness; foggy; vision hazy; headache; weakness; body ache; chest pain; throat tightness; The following day he started passing black stools; He continues to have loose bowel movements at this time; This is a spontaneous report from a contactable consumer or other non hcp. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 14Apr2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced within a minute or so caller reports his head felt loopy, dizziness, foggy, vision hazy, headache, weakness, body ache, chest pain, throat tightness, the following day he started passing black stools and he continues to have loose bowel movements at this time. It was reported that within a minute or so caller reports his head felt loopy. Then he experienced dizziness, foggy and vision hazy. That night he was seen in the ER for extreme headache, weakness, body ache, congestion, chest pain and throat tightness. The following day he started passing black stools. He continued to have loose bowel movements at this time. Caller asking how long symptoms may last and want to know if he should take the second Pfizer Covid 19 Vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Condition aggravated, Dyspnoea
Clinical narrative: shortness of breath; tightness in the chest; swollen throat; heaviness on chest; when she eats something the heaviness on her chest gets worse; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9265, Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 14Apr2021 at 10:30 AM (at the age of 30 years), as a single dose for covid-19 immunisation. The patient medical history included ongoing asthma. She has had asthma since she was about 7 years old. Concomitant medications included salbutamol sulfate (VENTOLIN HFA) taken for asthma from an unspecified start date and ongoing. There was no History of all previous immunization with the Pfizer vaccine considered as suspect.There was no additional Vaccines administered on same date with the Pfizer vaccine considered as suspect. There was no prior vaccinations within 4 weeks. There was no AEs following prior vaccinations. On 14Apr2021, about an hour later, the patient had developed shortness of breath, tightness in the chest, swollen throat, heaviness on chest, when she eats something the heaviness on her chest gets worse and she still has to gasp for breath. She is calling to ask if she should get her second Covid 19 vaccine. She went to an Immediate Care and to the emergency room. She received medication for her asthma. She does have a history of asthma. She received a nebulizer with albuterol and a steroid inhaler called budesonide. She feels like she has to take in a deep breath to breath when she eats something. She also received something for her chest to calm her chest down from being cramped up and inflamed. She received Prednisone 20 mg, take 2 tablets for 2 days, then take 1 tablet for 2 days then take half a tablet for 2 days. The Prednisone was prescribed at the Immediate Care on 17Apr2021 and the emergency department prescribed it again on 21Apr2021 with the same directions. She was not admitted to the hospital, she was discharged from the emergency room. The patient underwent lab tests and procedures which included blood test: unknown results on 21Apr2021, chest x-ray: unknown results on 17Apr2021, chest x-ray: unknown results on 21Apr2021, electrocardiogram: unknown results on 21Apr2021. The outcome of event shortness of breath, tightness in the chest was unknown and Swollen throat, heaviness on chest, when she eats something the heaviness on her chest gets worse was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Pharyngeal swelling
Clinical narrative: shortness of breath; tightness in the chest; swollen throat; heaviness on chest; when she eats something the heaviness on her chest gets worse; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9265, Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 14Apr2021 at 10:30 AM (at the age of 30 years), as a single dose for covid-19 immunisation. The patient medical history included ongoing asthma. She has had asthma since she was about 7 years old. Concomitant medications included salbutamol sulfate (VENTOLIN HFA) taken for asthma from an unspecified start date and ongoing. There was no History of all previous immunization with the Pfizer vaccine considered as suspect.There was no additional Vaccines administered on same date with the Pfizer vaccine considered as suspect. There was no prior vaccinations within 4 weeks. There was no AEs following prior vaccinations. On 14Apr2021, about an hour later, the patient had developed shortness of breath, tightness in the chest, swollen throat, heaviness on chest, when she eats something the heaviness on her chest gets worse and she still has to gasp for breath. She is calling to ask if she should get her second Covid 19 vaccine. She went to an Immediate Care and to the emergency room. She received medication for her asthma. She does have a history of asthma. She received a nebulizer with albuterol and a steroid inhaler called budesonide. She feels like she has to take in a deep breath to breath when she eats something. She also received something for her chest to calm her chest down from being cramped up and inflamed. She received Prednisone 20 mg, take 2 tablets for 2 days, then take 1 tablet for 2 days then take half a tablet for 2 days. The Prednisone was prescribed at the Immediate Care on 17Apr2021 and the emergency department prescribed it again on 21Apr2021 with the same directions. She was not admitted to the hospital, she was discharged from the emergency room. The patient underwent lab tests and procedures which included blood test: unknown results on 21Apr2021, chest x-ray: unknown results on 17Apr2021, chest x-ray: unknown results on 21Apr2021, electrocardiogram: unknown results on 21Apr2021. The outcome of event shortness of breath, tightness in the chest was unknown and Swollen throat, heaviness on chest, when she eats something the heaviness on her chest gets worse was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abnormal faeces, Back pain, Flatulence
Clinical narrative: back pain; abdominal pain; abnormal feces; excessive flatulence; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on 26Mar2021 as dose 2, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was reported after receiving the second dose of vaccine, on an unspecified date the patient experienced back pain after vaccine, abdominal pain, abnormal faeces and excessive flatulence. He further reported that he used cold and hot patches, massages and has been taking Coca Cola to treat gases but none of these have worked. He had not made the consult with his physician for management treatment. Reporter called for requesting information about the adverse effects of vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Inappropriate schedule of product administration
Clinical narrative: headache; chills; warm forehead; sore left arm; second shot on 21Apr2021; he has not been able to get good sleep; tiresome.; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8729), via an unspecified route of administration in Arm Left on 21Apr2021 as single dose (at the age of 58-year-old) for precautionary measures. Medical history included left eye surgery for cataracts on 20Apr2021 and cataracts, had for over a year. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0158), on 09Apr2021 as single dose for precautionary measures and experienced Sore left arm. Reported that patient had second vaccine shot from Pfizer yesterday. Was on way to work and was tiresome. Stated that he has not been able to get good sleep. Stated that he woke up at 3am with a headache and warm forehead. On 28Apr2021, the patient had chills. Stated that he had no effects from first vaccine but a left sore arm. Stated that his left arm is sore from the second one. Later clarified as Pfizer Covid 19. Stated that he had cataracts before the vaccines. Stated that when he picks something up, strains or moves his left arm that its sore. Stated that the first time he had a sore left arm that it went away in 4-5 days. Stated that he did not take Ourezel and Besivence today. Started using Ourezel and Besivence on 18 Apr or 19 Apr. The outcome of events headache, chills, warm forehead, sore left arm was not recovered, and for other events it was unknown.  No follow-up attempts are needed. No further information is expected.