chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles 3 weeks after first dose.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 12Apr2021 at 01:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 18April2021 at 18:00, the patient developed shingles 3 weeks after first dose. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event shingles and included treatment with antibiotics (Unspecified). Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event shingles was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Large red area around injection site; Site is slightly swollen and warm to the touch; Site is slightly swollen and warm to the touch; This is a spontaneous report from a contactable consumer, the patient. A 36-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 left arm on 27Apr2021 at 10:15 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. 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. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 06Apr2021 at 10:45 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. On 28Apr2021, 15 hours after second shot, the patient experienced large red area around injection site that appeared slightly swollen and warm to the touch. The patient was still experiencing this side effect three days later. The event resulted in doctor or other healthcare professional office/clinic visit. 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 event large red area around injection site and slightly swollen and warm to the touch was not recovered at this time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Muscular weakness, Night sweats
Clinical narrative: Different feeling every day; Muscle weakness on my left side, includes the face; Night sweats; Chills; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 14Jan2021 at 09:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, degenerative disc disease (DDD), anxiety, plantar fasciitis and gastroesophageal reflux disease (GERD). The patient had allergic to statins. 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. Concomitant medications included metformin (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN) for an unknown indication. On 05Feb2021 at 09:00, the patient experienced muscle weakness on left side, included the face. Muscle that was starting on bottom of right foot. The patient had seen gentleman describing this on the news and realized he was having the same symptoms that the patient had. The patient experienced night sweats, chills and different feeling every day. Doctor informed and the patient would be going to neurologist and pain management. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event muscle weakness, night sweats, chills and different feeling was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis
Clinical narrative: Develop conjunctivitis in my left eye; This is a spontaneous report from a contactable consumer, the patient. A 49-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 arm left on 07Apr2021 at 15:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 17Apr2021, the patient developed conjunctivitis in left eye. The adverse 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 Maxitrol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event conjunctivitis in left eye was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Nausea, Ocular discomfort, Vertigo
Clinical narrative: Experienced significant worsening of symptoms from vestibular disorder, including vertigo; Ear pressure and discomfort, noise; Visual intolerance; Nausea; This is a spontaneous report from a contactable pharmacist, the patient. A female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 at 10:30 as a single dose for COVID-19 immunisation. Medical history included vestibular disorder, sinusitis and tinnitus. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 06Apr2021, the patient experienced significant worsening of symptoms from vestibular disorder, including vertigo, ear pressure and discomfort, noise and visual intolerance and nausea. The symptoms continued for past 3 weeks from this report and were only seem to be lessening at reporting time. The patient was not sure if should take the second dose. The events resulted in doctor or other healthcare professional office/clinic. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vestibular disorder, including vertigo, ear pressure noise and discomfort, visual intolerance and nausea was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Discomfort, Fatigue, Headache
Clinical narrative: Fatigue; Chills; Sweating; Sore joints; Sore muscles especially in left mid back on same side as injection,; Headache; Nausea; Inability to get comfortable; Inability to sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 11:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. 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 05Apr2021 at 11:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. 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. On 26Apr2021 at 20:00, the patient experienced fatigue, chills, sweating, sore joints, sore muscles especially in left mid back on same side as injection, headache, nausea, inability to get comfortable and inability to sleep. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events fatigue, chills, sweating, sore joints, sore muscles especially in left mid back on same side as injection, headache, nausea, inability to get comfortable and inability to sleep were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Myalgia, Nausea
Clinical narrative: Fatigue; Chills; Sweating; Sore joints; Sore muscles especially in left mid back on same side as injection,; Headache; Nausea; Inability to get comfortable; Inability to sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 11:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. 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 05Apr2021 at 11:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. 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. On 26Apr2021 at 20:00, the patient experienced fatigue, chills, sweating, sore joints, sore muscles especially in left mid back on same side as injection, headache, nausea, inability to get comfortable and inability to sleep. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events fatigue, chills, sweating, sore joints, sore muscles especially in left mid back on same side as injection, headache, nausea, inability to get comfortable and inability to sleep were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature
Clinical narrative: 101 deg temperature, measured by ear temp device; This is a spontaneous report from a contactable consumer, the patient. A 70-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 an unknown date in Apr2021 (at the age of 70-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. The medical history included allergy to penicillin.  Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medication for blood pressure within two weeks of vaccination. On an unknown date in Apr2021, the patient experienced 101 degree temperature which was measured by ear temp device. On an unknown date in Apr2021, the patient underwent body temperature test and tested with a temperature of 101 deg(unspecified unit). Therapeutic measures were not taken as a result of the reported event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event 101 deg temperature  was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue
Clinical narrative: Chills; fatigue; pain in left under-arm; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Apr2021 at 16:15 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Apr2021, the patient experienced chills, fatigue and pain in left under-arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events chills, fatigue and pain in left under-arm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills, fatigue and pain in left under-arm was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Bone pain, Fatigue, Myalgia
Clinical narrative: Bones/Muscle aches; vomiting; tired; stomach ache; weakness; Bones/Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 26Apr2021 at 08:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease, arthritis (Arthritis of spine), pain in leg, pain in spine (Chronic pain in spine and leg). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient received other medication within two weeks of COVID-19 vaccine, names were unspecified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 09:30, the patient experienced bones/muscle aches, vomiting, tired, weak, stomach ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bones/muscle aches, vomiting, tired, weak, stomach ache was not at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Bones/Muscle aches; vomiting; tired; stomach ache; weakness; Bones/Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 26Apr2021 at 08:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease, arthritis (Arthritis of spine), pain in leg, pain in spine (Chronic pain in spine and leg). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient received other medication within two weeks of COVID-19 vaccine, names were unspecified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 09:30, the patient experienced bones/muscle aches, vomiting, tired, weak, stomach ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bones/muscle aches, vomiting, tired, weak, stomach ache was not at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sores every since I got the last vaccines; This is a spontaneous report from a contactable consumer, the patient. A 59-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 on an unknown date in 2021 (at the age of 59-year-old) and 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 27Apr2021 at 14:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any other medications in two weeks. On an unknown date in 2021, the patient experienced cold sores ever since she got the vaccine. The clinical outcome of the event cold sores was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Vomiting; Fever persisting for 12 hours; Chills; Nausea; Arm pain; Muscle soreness; Tiredness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8735) via an unspecified route of administration in the right arm on 26Apr2021 at 12:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies to dogs, cats, dust mites and strawberries. 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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER7533) via an unspecified route of administration in the right arm on 05Apr2021 at 12:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 23:00, the patient experienced fever which persisted for 12 hours, chills, nausea, arm pain, muscle soreness, tiredness and headache. On 27Apr2021 at 08:00, day after getting the shot, the patient experienced vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measure for fever included treatment with TYLENOL. The patient did not receive any treatment for the chills, nausea, arm pain, muscle soreness, tiredness, headache and vomiting. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, nausea, arm pain, muscle soreness, tiredness, headache and vomiting were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Vomiting; Fever persisting for 12 hours; Chills; Nausea; Arm pain; Muscle soreness; Tiredness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8735) via an unspecified route of administration in the right arm on 26Apr2021 at 12:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies to dogs, cats, dust mites and strawberries. 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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER7533) via an unspecified route of administration in the right arm on 05Apr2021 at 12:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 23:00, the patient experienced fever which persisted for 12 hours, chills, nausea, arm pain, muscle soreness, tiredness and headache. On 27Apr2021 at 08:00, day after getting the shot, the patient experienced vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measure for fever included treatment with TYLENOL. The patient did not receive any treatment for the chills, nausea, arm pain, muscle soreness, tiredness, headache and vomiting. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, nausea, arm pain, muscle soreness, tiredness, headache and vomiting were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antinuclear antibody, Blister, Body temperature, Chills
Clinical narrative: 104 fever; chills; headache; swollen lips; blisters; felt something happen inside her chest; lips started getting red and kind of hurting; lips started getting red and kind of hurting; sick; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0151), via an unspecified route of administration, administrated in left arm, shoulder on 09Apr2021 11:45 (age at the time of vaccination 46-years-old) as a single dose for COVID-19 immunization. The patient's medical history included migraines, thyroid, and Covid last year patient did have Covid last year and was not as bad as the vaccine. Patient's family medical history included Mom had thyroid, and Dad had migraines. The patient's concomitant medications included Eletriptan, as 40 mg, (lot number PA03110, expiry date: 20Nov2022), takes when she has headaches of Migraine; Ajovy [Fremanezumab Vfrm], as 225mg injection, once a month from Feb2021, first one and from 16Mar2021, which was the second shot, for Migraine; and Methimazole as 2.5 mg (2.5mg, half of a 5mg tablet), Has been taking over 10 years for thyroid. On 09Apr2021 23:00, the patient experienced 104 fever, chills, headache, swollen lips, blisters, felt something happen inside her chest, lips started getting red and kind of hurting, and sick. On an unspecified date, the patient underwent lab tests and procedures which included antibody spike, Antibody test: 250 Uml, Positive; Nichler antibodies, Antinuclear antibody: Positive, reactive positive; and on 09Apr2021 Body temperature: 104 Fahrenheit, Positive; and on an unspecified date 2021 had Covid, SARS-CoV-2 test: Positive, Caller also reports that she had a positive antibody test, but she also had Covid before getting her first vaccine dose. Treatment was received as a result of adverse events which included Tylenol, took it every 4 hours because the fever was not going lower than 100; Benadryl; Got a little cream, does not know the name, thinks it is Abreve, it is a little cream in a very small tube. They say to use it for sore throat and lips and all that, does not have the tube with her so does not have the exact spelling of the medication; and Bags of ice and Tylenol, also has pills that she usually takes for migraines, to make the headache go away, but it didn't work. No prior vaccination within 4 weeks. The outcome of the events 104 fever was recovered on 13Apr2021; swollen lips recovered on an unspecified date; and other events chills, headache, blisters, felt something happen inside her chest, lips started getting red and kind of hurting, sick was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Lip erythema, Lip pain
Clinical narrative: 104 fever; chills; headache; swollen lips; blisters; felt something happen inside her chest; lips started getting red and kind of hurting; lips started getting red and kind of hurting; sick; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0151), via an unspecified route of administration, administrated in left arm, shoulder on 09Apr2021 11:45 (age at the time of vaccination 46-years-old) as a single dose for COVID-19 immunization. The patient's medical history included migraines, thyroid, and Covid last year patient did have Covid last year and was not as bad as the vaccine. Patient's family medical history included Mom had thyroid, and Dad had migraines. The patient's concomitant medications included Eletriptan, as 40 mg, (lot number PA03110, expiry date: 20Nov2022), takes when she has headaches of Migraine; Ajovy [Fremanezumab Vfrm], as 225mg injection, once a month from Feb2021, first one and from 16Mar2021, which was the second shot, for Migraine; and Methimazole as 2.5 mg (2.5mg, half of a 5mg tablet), Has been taking over 10 years for thyroid. On 09Apr2021 23:00, the patient experienced 104 fever, chills, headache, swollen lips, blisters, felt something happen inside her chest, lips started getting red and kind of hurting, and sick. On an unspecified date, the patient underwent lab tests and procedures which included antibody spike, Antibody test: 250 Uml, Positive; Nichler antibodies, Antinuclear antibody: Positive, reactive positive; and on 09Apr2021 Body temperature: 104 Fahrenheit, Positive; and on an unspecified date 2021 had Covid, SARS-CoV-2 test: Positive, Caller also reports that she had a positive antibody test, but she also had Covid before getting her first vaccine dose. Treatment was received as a result of adverse events which included Tylenol, took it every 4 hours because the fever was not going lower than 100; Benadryl; Got a little cream, does not know the name, thinks it is Abreve, it is a little cream in a very small tube. They say to use it for sore throat and lips and all that, does not have the tube with her so does not have the exact spelling of the medication; and Bags of ice and Tylenol, also has pills that she usually takes for migraines, to make the headache go away, but it didn't work. No prior vaccination within 4 weeks. The outcome of the events 104 fever was recovered on 13Apr2021; swollen lips recovered on an unspecified date; and other events chills, headache, blisters, felt something happen inside her chest, lips started getting red and kind of hurting, sick was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: 104 fever; chills; headache; swollen lips; blisters; felt something happen inside her chest; lips started getting red and kind of hurting; lips started getting red and kind of hurting; sick; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0151), via an unspecified route of administration, administrated in left arm, shoulder on 09Apr2021 11:45 (age at the time of vaccination 46-years-old) as a single dose for COVID-19 immunization. The patient's medical history included migraines, thyroid, and Covid last year patient did have Covid last year and was not as bad as the vaccine. Patient's family medical history included Mom had thyroid, and Dad had migraines. The patient's concomitant medications included Eletriptan, as 40 mg, (lot number PA03110, expiry date: 20Nov2022), takes when she has headaches of Migraine; Ajovy [Fremanezumab Vfrm], as 225mg injection, once a month from Feb2021, first one and from 16Mar2021, which was the second shot, for Migraine; and Methimazole as 2.5 mg (2.5mg, half of a 5mg tablet), Has been taking over 10 years for thyroid. On 09Apr2021 23:00, the patient experienced 104 fever, chills, headache, swollen lips, blisters, felt something happen inside her chest, lips started getting red and kind of hurting, and sick. On an unspecified date, the patient underwent lab tests and procedures which included antibody spike, Antibody test: 250 Uml, Positive; Nichler antibodies, Antinuclear antibody: Positive, reactive positive; and on 09Apr2021 Body temperature: 104 Fahrenheit, Positive; and on an unspecified date 2021 had Covid, SARS-CoV-2 test: Positive, Caller also reports that she had a positive antibody test, but she also had Covid before getting her first vaccine dose. Treatment was received as a result of adverse events which included Tylenol, took it every 4 hours because the fever was not going lower than 100; Benadryl; Got a little cream, does not know the name, thinks it is Abreve, it is a little cream in a very small tube. They say to use it for sore throat and lips and all that, does not have the tube with her so does not have the exact spelling of the medication; and Bags of ice and Tylenol, also has pills that she usually takes for migraines, to make the headache go away, but it didn't work. No prior vaccination within 4 weeks. The outcome of the events 104 fever was recovered on 13Apr2021; swollen lips recovered on an unspecified date; and other events chills, headache, blisters, felt something happen inside her chest, lips started getting red and kind of hurting, sick was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: 2  days if exhaustion; Headache; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced 2 days if exhaustion and headache. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event 2 days if exhaustion and headache was recovered on unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Lethargy, Pain
Clinical narrative: Overall aches and pains; Sweating; Dizziness; Lethargic; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0171) via an unspecified route of administration in the arm left on 29Apr2021 at 12:45 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The medical history were reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 12:45 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 02:00, the patient experienced overall aches and pains, sweating, dizziness and lethargic. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events overall aches and pains, sweating, dizziness and lethargic was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Apr2021 at 16:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Apr2021 (at the age of 49-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 30Apr2021 at 06:45, the patient experienced muscle aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events muscle aches and fatigue were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Nausea; Fever; Chills; Fatigue; Headache; This is a spontaneous report from a contactable consumer. An unspecified aged adult female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 12Apr2021, the patient experienced fever, chills, fatigue, headache, nausea. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of event fever, chills, fatigue, headache, nausea were recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Sensitive skin
Clinical narrative: No rash has broken our, but I have the pain, tingling and sensitivity of my skin.; No rash has broken our, but I have the pain, tingling and sensitivity of my skin.; No rash has broken our, but I have the pain, tingling and sensitivity of my skin.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-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 on 08Apr2021 as a single dose for COVID-19 immunisation. Medical history included mild achalasia and shingles 2 times. The patient had one episode on left side on an unknown date in Sept2019, second episode on right side on an unknown date in Feb2021 and had completely recovered with no post-herpetic neuralgia both times. Concomitant medications included multi-vitamins (MANUFACTURER UNKNOWN), B- complex (MANUFACTURER UNKNOWN), lysine (L-LYSINE), magnesium (MANUFACTURER UNKNOWN), olea europaea leaf extract (OLIVE LEAVES EXTRACT) for unknown indication from unknown date. The patient previously took metronidazole (FLAGYL) for unknown indication on an unknown date and experienced drug allergy. 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. On an unknown date in Apr2021, since about one week after receiving the first vaccine the patient felt like she was going to get shingles again on the left side. No rash had broken out, but patient had pain, tingling and sensitivity of the skin. The pain was milder then when she had shingles. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, tingling and sensitivity of skin was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache; Body aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER9736) via an unspecified route of administration in the left arm on 28Apr2021 at 12:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12) and colecalciferol (VITAMIN D3) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 22:30, the patient experienced headache, body aches, fatigue. Patient stated that he was in bed from 29Apr2021-30Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, fatigue was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Tremor, Vomiting
Clinical narrative: Aching; Shaking; Chills; Throwing up; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 13:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clotrimazole (LOTRIMIN) from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 30Apr2021 at 02:00, the patient experienced chills, shaking, throwing up, aching and weakness. Since the vaccination, the patient had not been tested for COVID-19. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events chills, shaking, throwing up, aching and weakness were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Movement disorder, Pain in extremity
Clinical narrative: Chills; Achy under armpit of injected arm; Swollen under armpit of injected arm; Hard to open and close hands; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 15Apr2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On 16Apr2021, at 07:00 the patient experienced chills, hard to open and close hands, achy, swollen under armpit of injected arm. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills, hard to open and close hands, achy, swollen under armpit of injected arm was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Myalgia, Vaccination site pain
Clinical narrative: lot of pain in the left side of injection arm; Chest felt incredibly heavy like someone or several people is sitting on it; Muscle pain in back and legs; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm left on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation and also second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient medical history included inflammatory bowel disease. The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included adalimumab (HUMIRA) for an unknown indication, from an unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021 the patient experienced a lot of pain in the left side of vaccinated arm, chest felt incredibly heavy, like someone or several people were sitting on it and had muscle pain as well in back and legs. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events lot of pain in the left side of vaccinated arm, chest felt incredibly heavy and muscle pain in back and legs were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.