chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Nasal discomfort, Pyrexia, SARS-CoV-2 test
Clinical narrative: high fever/fever 101.7F/fever 100.3F; chills; fatigue; headache; heavy feeling effecting whole head; agitated by movement; discomfort also at the neck just below the back of the head; pressure at the nose bridge, waxes and wanes in intesity; This is a spontaneous report from a contactable consumer(patient) other health care professional (HCP). A 22-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734), via an unspecified route of administration in left arm on 08Apr2021 at 12:00 (at the age of 22 years old) as dose 2, single for covid-19 immunisation. Medical history included hypertension. The patient had no known allergies. Concomitant medications in two weeks included amlodipine besilate (AMLODIPINE BESILATE); duloxetine. Historical vaccine included first dose of BNT162B2 (Lot number: EP7534), via an unspecified route of administration in left arm on 18Mar2021 at 08:00 PM for covid-19 immunisation. 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 has been tested for COVID-19. On 08Apr2021 at 19:00 patient experienced 4/8 evening: high fever; chills; fatigue; headache (heavy feeling effecting whole head, positional and shifting from front to rear and vice versa, agitated by movement, discomfort also at the neck just below the back of the head). This headache persists until noted 4/9 fever 101.7F; chills; fatigue; (using Ibuprofen and Acetaminophen at this point and continuing) 4/10 fever 100.3F; chills and fatigue gone; tested negative for COVID 4/11 temperature normal; started Medrol dose pack for persistent headache (headache is the only symptom at this point) 4/12 headache at 15% of the worst, now a 2-3/10 discomfort level (headache is now primarily frontal, all across the forehead from temple to temple, also pressure at the nose bridge, waxes and wanes in intesity) 4/13 Emergency Room visit for persistent headache; head CT was done-normal; received benadryl, reglan, and toradol IV which eliminated the headache 4/14 same headache as described 4/12 returns 4/15 to current: headache persists. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab, LUMIRADX SARS-COV-2 AG TEST): negative on 10Apr2021. Therapeutic measures were taken as a result of high fever/fever 101.7f/fever 100.3f, chills, fatigue, headache, heavy feeling effecting whole head, agitated by movement, discomfort also at the neck just below the back of the head, pressure at the nose bridge, waxes and wanes in intensity with medrol dose pack; IV benadryl, reglan, and Toradol. The patient visited emergency room for persistent headache. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: fatigue; bad muscle pain; sweating; headaches; nausea; diarrhea; fever; body aches; cough; chest congestion; burning in her nose and mouth; burning in her nose and mouth; This is a spontaneous report from a contactable other HCP and contactable consumer (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date (at the age of 56-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization and experienced bad fatigue. On an unspecified date, the patient experienced bad fatigue, bad muscle pain, sweating, headaches, nausea, diarrhea, fatigue, fever, body aches, cough, chest congestion and burning in her nose and mouth after the 2nd vaccine that improving some and she missed a total of about 6 days of xeljanz (1 day the 1st vaccine and 5 are days the 2nd vaccine) per her md while getting the vaccinations (she restarted again this morning). Patient said her neck, shoulder and back pain increased during the time of the recent missed doses. On an unspecified date, the patient underwent lab tests and procedures which included blood test: inflammation is under control (no specifics provided), sars-cov-2 antibody test resulted in negative and x-ray showed her lungs were clear but there were profound changes in her osteoarthritis in her spine. The patient MD was aware of tests. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lower respiratory tract congestion, Myalgia, Nasal discomfort, Nausea
Clinical narrative: fatigue; bad muscle pain; sweating; headaches; nausea; diarrhea; fever; body aches; cough; chest congestion; burning in her nose and mouth; burning in her nose and mouth; This is a spontaneous report from a contactable other HCP and contactable consumer (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date (at the age of 56-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization and experienced bad fatigue. On an unspecified date, the patient experienced bad fatigue, bad muscle pain, sweating, headaches, nausea, diarrhea, fatigue, fever, body aches, cough, chest congestion and burning in her nose and mouth after the 2nd vaccine that improving some and she missed a total of about 6 days of xeljanz (1 day the 1st vaccine and 5 are days the 2nd vaccine) per her md while getting the vaccinations (she restarted again this morning). Patient said her neck, shoulder and back pain increased during the time of the recent missed doses. On an unspecified date, the patient underwent lab tests and procedures which included blood test: inflammation is under control (no specifics provided), sars-cov-2 antibody test resulted in negative and x-ray showed her lungs were clear but there were profound changes in her osteoarthritis in her spine. The patient MD was aware of tests. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Pain, Pyrexia, SARS-CoV-2 antibody test, X-ray
Clinical narrative: fatigue; bad muscle pain; sweating; headaches; nausea; diarrhea; fever; body aches; cough; chest congestion; burning in her nose and mouth; burning in her nose and mouth; This is a spontaneous report from a contactable other HCP and contactable consumer (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date (at the age of 56-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization and experienced bad fatigue. On an unspecified date, the patient experienced bad fatigue, bad muscle pain, sweating, headaches, nausea, diarrhea, fatigue, fever, body aches, cough, chest congestion and burning in her nose and mouth after the 2nd vaccine that improving some and she missed a total of about 6 days of xeljanz (1 day the 1st vaccine and 5 are days the 2nd vaccine) per her md while getting the vaccinations (she restarted again this morning). Patient said her neck, shoulder and back pain increased during the time of the recent missed doses. On an unspecified date, the patient underwent lab tests and procedures which included blood test: inflammation is under control (no specifics provided), sars-cov-2 antibody test resulted in negative and x-ray showed her lungs were clear but there were profound changes in her osteoarthritis in her spine. The patient MD was aware of tests. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: 4 hours after receiving the second pfizer vaccine, I started to have a period; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0162 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 16Apr2021 at 12:30 hours as dose 2, single (at the age of 54-year-old) for COVID-19 immunisation. Medical history included depression, gallbladder removed and went through menopause early (have not had a menstrual period in nearly 10 years) (all from unknown date to unknown if ongoing). Patient had no known allergies. Concomitant medications within two weeks included vitamins, minerals and an antidepressant. Patient had no other vaccine in four weeks. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ER8727 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 22Mar2021 at 13:30 hours as dose 1 single (at the age of 54-year-old) for COVID-19 immunisation and experienced rash post dose 1 vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, post vaccination. On 16Apr2021, at 16:00 hours (4 hours after receiving the second dose), patient started to have a period. This lasted 48 hours. Patient plan to speak to her health care provider on Monday. This happened Friday night and went through the weekend. Patient received no treatment for the events. The outcome of the event was recovered on Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Limb discomfort, Lymph node pain, Pain
Clinical narrative: Lymph nodes underneath my right arms was hurting, and burning so bad; Lymph nodes underneath my right arms was hurting, and burning so bad; Swelling; Lot of pain; dizzy; fell asleep; Felt my arm heavy; Tiny bit of burning in my throat; pain in my right arm; This is a spontaneous report from a contactable Consumer (patient).   A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8737) via unknown route of administration in right arm on 16Apr2021 at 08:00 AM (at the age of 52 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history included was admitted to the Err prior on 28Feb2021 for anemia and allergic to Recephin. The concomitant medication included Ferrous Sulfate 325 mg 3 times a day for an unknown indication from an unknown date. Historical vaccine included first dose of PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8730) via unknown route of administration in left arm on 26Mar2021 at 08:15 AM as DOSE 1, SINGLE for COVID-19 immunisation and experienced left arm heavy after 2 hours, no pain, by 5pm increase a bit, by midnight lymph nodes hurting and fever Friday night and sweats ,fever Saturday night no sweat. Patient did not have other vaccine in four weeks. It was unknown if the patient was pregnant. After second Dose on 16Apr2021 at 08:15, the patient felt arm heavy right away after injections, by the time she drove to the Paramedic for fifteen minutes. she felt this tiny bit of burning in her throat. She informed the Paramedic and ask for some water. She made it home; felt a lot more pain in her right arm by noon, by 2 PM. She felt dizzy and fell asleep. She was in a lot of pain by 9 PM the lymph nodes underneath her right arms was hurting, and burning so bad. She was panicking. She took 2 Advil gel and fell asleep by midnight. She woke up in the morning with more pain, and more burning. She continue to take the Advil every four hours. She noticed on Sunday can visibly see the swelling, and the hardness in the area. Her friend mentioned should take pictures of the area and document and informed the right people. The patient received treatment with 2 Advil every 4 hours. Patient did not have COVID prior vaccination and not tested for COVID post vaccination. The outcome of the events were not recovered.  No follow-up attempts were possible. No further information was expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Swelling, Throat irritation
Clinical narrative: Lymph nodes underneath my right arms was hurting, and burning so bad; Lymph nodes underneath my right arms was hurting, and burning so bad; Swelling; Lot of pain; dizzy; fell asleep; Felt my arm heavy; Tiny bit of burning in my throat; pain in my right arm; This is a spontaneous report from a contactable Consumer (patient).   A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8737) via unknown route of administration in right arm on 16Apr2021 at 08:00 AM (at the age of 52 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history included was admitted to the Err prior on 28Feb2021 for anemia and allergic to Recephin. The concomitant medication included Ferrous Sulfate 325 mg 3 times a day for an unknown indication from an unknown date. Historical vaccine included first dose of PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8730) via unknown route of administration in left arm on 26Mar2021 at 08:15 AM as DOSE 1, SINGLE for COVID-19 immunisation and experienced left arm heavy after 2 hours, no pain, by 5pm increase a bit, by midnight lymph nodes hurting and fever Friday night and sweats ,fever Saturday night no sweat. Patient did not have other vaccine in four weeks. It was unknown if the patient was pregnant. After second Dose on 16Apr2021 at 08:15, the patient felt arm heavy right away after injections, by the time she drove to the Paramedic for fifteen minutes. she felt this tiny bit of burning in her throat. She informed the Paramedic and ask for some water. She made it home; felt a lot more pain in her right arm by noon, by 2 PM. She felt dizzy and fell asleep. She was in a lot of pain by 9 PM the lymph nodes underneath her right arms was hurting, and burning so bad. She was panicking. She took 2 Advil gel and fell asleep by midnight. She woke up in the morning with more pain, and more burning. She continue to take the Advil every four hours. She noticed on Sunday can visibly see the swelling, and the hardness in the area. Her friend mentioned should take pictures of the area and document and informed the right people. The patient received treatment with 2 Advil every 4 hours. Patient did not have COVID prior vaccination and not tested for COVID post vaccination. The outcome of the events were not recovered.  No follow-up attempts were possible. No further information was expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: arm pain; headache; chills; intermittent fever/,fever 100.7; fatigue; This is a spontaneous report from a non-contactable other health care professional (Patient). A 54-years-old not pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 24Mar2021 08:30 (at the age of 54-years-old) in Arm Left as dose 1, single for COVID-19 immunization. The Patient Medical history was no. Concomitant medication(s) in two weeks was levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took roxicet and experienced Drug allergy. The patient did not received other vaccine in four weeks. The Patient was diagnosed with COVID prior vaccination. The Patient did not tested COVID post vaccination. On Unspecified date, the patient experienced arm pain, fever 100.7, headache, chills-intermittent fever, fatigue between vaccinations. The Patient did not received treatment for the events. The patient underwent lab tests and procedures which included body temperature: 100.7 on. The outcome for the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: arm pain; headache; chills; intermittent fever/,fever 100.7; fatigue; This is a spontaneous report from a non-contactable other health care professional (Patient). A 54-years-old not pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 24Mar2021 08:30 (at the age of 54-years-old) in Arm Left as dose 1, single for COVID-19 immunization. The Patient Medical history was no. Concomitant medication(s) in two weeks was levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took roxicet and experienced Drug allergy. The patient did not received other vaccine in four weeks. The Patient was diagnosed with COVID prior vaccination. The Patient did not tested COVID post vaccination. On Unspecified date, the patient experienced arm pain, fever 100.7, headache, chills-intermittent fever, fatigue between vaccinations. The Patient did not received treatment for the events. The patient underwent lab tests and procedures which included body temperature: 100.7 on. The outcome for the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: arm pain; fever 103.6; headache; chills; intermittent fever; fatigue; cough; labored breathing; This is a spontaneous report from a non-contactable Nurse (patient). A 54-years-old non pregnant female patient received BNT162B2 (COVID-19 vaccine, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route, administered in Left Arm on 14Apr2021 at 09:00 (at the age of 54-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included covid-19 and Known allergies of Roxicet from an unknown date and unknown if ongoing. Concomitant medication(s) (Other medications in two weeks) included levothyroxine 25 mcg (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 as dose 1 single on 24Mar2021 at 20:30 in Left Arm for covid-19 immunisation and experienced, pain in extremity, headache, fever 100.7, chills-intermittent fever and fatigue between vaccinations. Facility type vaccine other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 post vaccination. On 14Apr2021 at 18:00 the patient experienced arm pain, fever 103.6, headache, chills, intermittent fever, fatigue, cough and labored breathing. The patient underwent lab tests and procedures which included body temperature: 100.7, intermittent fever and fatigue between vaccinations on an unspecified date and body temperature: 103.6 on 14Apr2021. No treatment received for the events. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: arm pain; fever 103.6; headache; chills; intermittent fever; fatigue; cough; labored breathing; This is a spontaneous report from a non-contactable Nurse (patient). A 54-years-old non pregnant female patient received BNT162B2 (COVID-19 vaccine, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route, administered in Left Arm on 14Apr2021 at 09:00 (at the age of 54-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included covid-19 and Known allergies of Roxicet from an unknown date and unknown if ongoing. Concomitant medication(s) (Other medications in two weeks) included levothyroxine 25 mcg (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 as dose 1 single on 24Mar2021 at 20:30 in Left Arm for covid-19 immunisation and experienced, pain in extremity, headache, fever 100.7, chills-intermittent fever and fatigue between vaccinations. Facility type vaccine other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 post vaccination. On 14Apr2021 at 18:00 the patient experienced arm pain, fever 103.6, headache, chills, intermittent fever, fatigue, cough and labored breathing. The patient underwent lab tests and procedures which included body temperature: 100.7, intermittent fever and fatigue between vaccinations on an unspecified date and body temperature: 103.6 on 14Apr2021. No treatment received for the events. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling cold, Hypertension, Pruritus, Rash
Clinical narrative: itching more and more all over her hands, eyes, ears, everything/few spots on her body; Been cold; Short of breath; Blood pressure up; itching more and more all over her hands, eyes, ears, everything/few spots on her body; This is a spontaneous report from a contactable consumer (Patient). A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 24Mar2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The Patient did not received other products. Caller received the first Pfizer COVID vaccine on 24Mar2021. Caller asks could it be related to the vaccine. On unspecified date, A week ago she started itching more and more all over her hands, eyes, ears, everything. It is only a few spots on her body. Caller asks could it be related to the vaccine. She has been cold, and shortness of breath. She got real short of breath a couple nights ago, and her blood pressure was up. She had to take her blood pressure medicine to get it down. She did not stop itching and had another spell last night. She got her breathing under control. States it is like she was itching on the inside. She has not change her laundry detergent and she is not on any new medication. Caller says maybe it is an allergy to some pollen or could it be the shot. She asks could it be affecting me after three weeks of taking it.Could this possibly be from vaccine. She do not want to take the second one if it is from the vaccine. She called her doctor and if they call back she may go see him. The outcome for the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: arm swelling and redness in the area; arm swelling and redness in the area; swelling and irritated and it was itchy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 12Apr2021 (Lot number: EW0151, Expiry date: not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: not reported) and experienced expected the area to be warm to touch, hot to touch and red with the 1st dose. The patient stated that she had a question, she got her second dose of the vaccine on Monday (12Apr2021). On Tuesday (13Apr2021), she had arm swelling and redness in the area. Yesterday (unspecified date in Apr2021) she had swelling and irritated and it was itchy. The patient stated that she expected the area to be warm to touch, hot to touch and red with the first dose and was asking if we had been getting reports of that on the second dose also. The patient stated that she knew some was normal the second day and several days out like that another day or 2 and was wondering when to call out to her healthcare provider as she did not want to freak out and call and thought she would ask the question. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Muscle fatigue, Pyrexia
Clinical narrative: Fatigue; muscle fatigue; fever; This is a spontaneous report from a contactable consumer.A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On unspecified date, the patient experienced fatigue, muscle fatigue and fever with second shot of COVID 19 vaccination. Events took place after use of product. At the time of this report, the outcome of the event was unknown.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash, Rash macular
Clinical narrative: RED AND HOT no hives just blotches slightly raised; Rash on face and neck, chest and ears; RED AND HOT no hives just blotches slightly raised; RED AND HOT no hives just blotches slightly raised; This is a spontaneous report from a contactable consumer or other non-health care professional reported for patient. A non-pregnant female patient of 36-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 18Mar2021 16:45 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. Medical history included Crohn's disease, seasonal allergy, food allergy. The patient's concomitant medications were not reported. Patient received unspecified medication in two weeks.The patient previously took gluten and experienced drug hypersensitivity. Patient did not received any other vaccine within four weeks of COVID-19. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID since vaccination. On an unspecified date in 2021, the patient experienced red and hot no hives just blotches slightly raised, rash on face and neck, chest and ears, red and hot no hives just blotches slightly raised. No treatment was received due to adverse events. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 08Apr2021 16:45 as dose 2, single for COVID-19 immunization and experienced adverse events. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Blood pressure increased, Chills, Diarrhoea
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; swelling and redness; swelling and redness; Nausea; I just feel very, just uneasy; Diarrhea; I threw up earlier today/I even it throw up; not feeling good right now; my blood pressure going up; This is a spontaneous report from a contactable consumer or other non HCP (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EP7533) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, swelling and redness, nausea, patient threw up earlier today/even it throw up, the patient just feel very, just uneasy, and diarrhea on an unknown date. The patient stated that after the first dose, had some side effect and just, the patient knowing that it was normal for the first 24 hours but like having like every single one on here except that one reaction and the patient don't have a rash. The patient had diarrhea as well which was not on here but threw up earlier today. The patient wanted to know even though it on here and does not go by certain time then the patient need to consult with physician. The patient felt like blood pressure going up, hence took unspecified blood pressure medication (further clarification unknown). The patient stated that on an unknown date, really not feeling good right now and think can't get on phone call for 8 to 10min. Therapeutic measures were taken as a result of event Blood pressure increased. The outcome of events reported as unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; swelling and redness; swelling and redness; Nausea; I just feel very, just uneasy; Diarrhea; I threw up earlier today/I even it throw up; not feeling good right now; my blood pressure going up; This is a spontaneous report from a contactable consumer or other non HCP (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EP7533) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, swelling and redness, nausea, patient threw up earlier today/even it throw up, the patient just feel very, just uneasy, and diarrhea on an unknown date. The patient stated that after the first dose, had some side effect and just, the patient knowing that it was normal for the first 24 hours but like having like every single one on here except that one reaction and the patient don't have a rash. The patient had diarrhea as well which was not on here but threw up earlier today. The patient wanted to know even though it on here and does not go by certain time then the patient need to consult with physician. The patient felt like blood pressure going up, hence took unspecified blood pressure medication (further clarification unknown). The patient stated that on an unknown date, really not feeling good right now and think can't get on phone call for 8 to 10min. Therapeutic measures were taken as a result of event Blood pressure increased. The outcome of events reported as unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Swelling, Vaccination site pain, Vomiting
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; swelling and redness; swelling and redness; Nausea; I just feel very, just uneasy; Diarrhea; I threw up earlier today/I even it throw up; not feeling good right now; my blood pressure going up; This is a spontaneous report from a contactable consumer or other non HCP (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EP7533) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, swelling and redness, nausea, patient threw up earlier today/even it throw up, the patient just feel very, just uneasy, and diarrhea on an unknown date. The patient stated that after the first dose, had some side effect and just, the patient knowing that it was normal for the first 24 hours but like having like every single one on here except that one reaction and the patient don't have a rash. The patient had diarrhea as well which was not on here but threw up earlier today. The patient wanted to know even though it on here and does not go by certain time then the patient need to consult with physician. The patient felt like blood pressure going up, hence took unspecified blood pressure medication (further clarification unknown). The patient stated that on an unknown date, really not feeling good right now and think can't get on phone call for 8 to 10min. Therapeutic measures were taken as a result of event Blood pressure increased. The outcome of events reported as unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Myalgia
Clinical narrative: muscles are hurting; joints are aching/shoulders ache/Knee cap and shoulders ache; Very uncomfortable; This is a spontaneous report from a contactable consumer or non HCP (patient) via Pfizer. A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported, expiry date was not reported), dose 2 via an unspecified route of administration on 15Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (Comirnaty, Solution for injection, Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on an unspecified date of 2021, as dose 1, single for covid-19 immunisation. On an unspecified date of 2021 the patient experienced muscles are hurting, joints are aching, knee cap and shoulders ache, very uncomfortable. and the patient wants to know if this was normal. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Insomnia, Pyrexia, Vaccination site erythema
Clinical narrative: Pain at injection site; Small redness at injection point; after 12 or 13 hours fever; Chills; they cannot sleep actually because of the chills; This is a spontaneous report from a contactable consumer (patient). This is the second case out of the two cases.  A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown, Expiry date: Unknow), via an unspecified route of administration, administered in right arm on 14Apr2021 at 10:00 (at the age of 47-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history reported as none. The patient concomitant medications were not reported. No any past drug history reported. On Apr2021, 3 to 4 hour of vaccination, the patient had pain at injection site, just a small redness in injection point, after 12 or 13 hours fever and they cannot sleep actually because of the chills. The patient underwent lab tests and procedures which included on Apr2021 body temperature: 101.3 (unit not reported). Outcome of the events was unknown for all.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; Small redness at injection point; after 12 or 13 hours fever; Chills; they cannot sleep actually because of the chills; This is a spontaneous report from a contactable consumer (patient). This is the second case out of the two cases.  A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown, Expiry date: Unknow), via an unspecified route of administration, administered in right arm on 14Apr2021 at 10:00 (at the age of 47-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history reported as none. The patient concomitant medications were not reported. No any past drug history reported. On Apr2021, 3 to 4 hour of vaccination, the patient had pain at injection site, just a small redness in injection point, after 12 or 13 hours fever and they cannot sleep actually because of the chills. The patient underwent lab tests and procedures which included on Apr2021 body temperature: 101.3 (unit not reported). Outcome of the events was unknown for all.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Myalgia
Clinical narrative: I developed fever of 102 degrees; extreme chills; intense muscle aches; diarrhea; fatigue; This is a spontaneous report from a contactable consumer (mother of the patient) or other non hcp. This consumer reported similar events for 2 patients. This report is for 2nd of 2 patients.   A 23-year-old male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in arm right on 14Apr2021 10:15 (at the age of 23 years) as dose 2, single for COVID-19 immunization. Patient medical history was reported as none. The patient had no known drug allergies. The patient did not receive other vaccine in four weeks. The patient's concomitant medications were not reported. On 14Apr2021 at 10:15, the patient experienced developed fever of 102 degrees, extreme chills, intense muscle aches, diarrhea, and fatigue that lasted 48 hours. The reporter added her 23-year-old son also suffered similar side effects and was forced to take a sick day from his job. Adverse events did not result in emergency room visit or physician office visit. Patient did not receive any treatment in response to the Adverse events. The patient underwent lab tests and procedures which included body temperature: 102 degrees on 14Apr2021 at 10:15 (she developed fever of 102 degrees). Outcome of the events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : 2021422101 same drug/reporter/event, different patient
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I developed fever of 102 degrees; extreme chills; intense muscle aches; diarrhea; fatigue; This is a spontaneous report from a contactable consumer (mother of the patient) or other non hcp. This consumer reported similar events for 2 patients. This report is for 2nd of 2 patients.   A 23-year-old male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in arm right on 14Apr2021 10:15 (at the age of 23 years) as dose 2, single for COVID-19 immunization. Patient medical history was reported as none. The patient had no known drug allergies. The patient did not receive other vaccine in four weeks. The patient's concomitant medications were not reported. On 14Apr2021 at 10:15, the patient experienced developed fever of 102 degrees, extreme chills, intense muscle aches, diarrhea, and fatigue that lasted 48 hours. The reporter added her 23-year-old son also suffered similar side effects and was forced to take a sick day from his job. Adverse events did not result in emergency room visit or physician office visit. Patient did not receive any treatment in response to the Adverse events. The patient underwent lab tests and procedures which included body temperature: 102 degrees on 14Apr2021 at 10:15 (she developed fever of 102 degrees). Outcome of the events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : 2021422101 same drug/reporter/event, different patient
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharitis, Pain, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: rash/rash on the head; continues with itching/torso with itchiness; inflammation in the mouth; inflammation in the eyelids; body ache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER2613 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 20Mar2021 (Age at vaccination was 74 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included type 2 diabetes, hypertension from an unknown date and unknown if ongoing. The patient did not covid prior to vaccination. The patient did not have known allergies. Concomitant medication(s) included losartan, bezafibrate, atorvastatin, fish oil taken for an unspecified indication, start and stop date were not reported. The patient did not take other vaccine in four weeks. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EN6198 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 27Feb2021 at 09:45 hours (Age at vaccination was 74 years) as dose 1, single for COVID-19 immunization and experienced severe inflammation in the mouth, eyelids, rash on the head, torso with itchiness and body ache. The patient followed the recommended protocol by the responsible staff of vaccinations, applied first dose he waited 15 minutes, no secondary effects were manifested or allergic reactions. After 8 days, he noticed severe inflammation in the mouth, eyelids and rash on the head and torso with itchiness, body ache, she didn't consider a reaction to the vaccine, but an allergy for having eaten almonds although there was no background (it was a mistake having considered it an allergy), she told a known doctor about the problem, who prescribed Loratadine and diet without fats, strawberries, eggs, dairy and chocolates, there was improvement and symptoms disappeared, she gave for a fact that everything was normal. On 28Mar2021 at 14:00 after the second dose, 7 or 8 days the same symptoms appeared again, not severe as with the first dose, few days the reactions disappeared, but the severe rash continues with itching, considered serious symptom related after receive Pfizer BioNTech vaccine, without completing the reaction time of minutes to 1 hour, but after. The patient underwent lab tests and procedures which included Antigen Covid-19 with nasal swab with result negative on 29Mar2021. The therapeutic measures were taken. The outcome of events Rash and Itching was not recovered and patient was recovered from rest of all events on unspecified date in 2021.  No follow up attempts are possible. No further information expected
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: rash/rash on the head; continues with itching/torso with itchiness; inflammation in the mouth; inflammation in the eyelids; body ache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER2613 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 20Mar2021 (Age at vaccination was 74 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included type 2 diabetes, hypertension from an unknown date and unknown if ongoing. The patient did not covid prior to vaccination. The patient did not have known allergies. Concomitant medication(s) included losartan, bezafibrate, atorvastatin, fish oil taken for an unspecified indication, start and stop date were not reported. The patient did not take other vaccine in four weeks. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EN6198 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 27Feb2021 at 09:45 hours (Age at vaccination was 74 years) as dose 1, single for COVID-19 immunization and experienced severe inflammation in the mouth, eyelids, rash on the head, torso with itchiness and body ache. The patient followed the recommended protocol by the responsible staff of vaccinations, applied first dose he waited 15 minutes, no secondary effects were manifested or allergic reactions. After 8 days, he noticed severe inflammation in the mouth, eyelids and rash on the head and torso with itchiness, body ache, she didn't consider a reaction to the vaccine, but an allergy for having eaten almonds although there was no background (it was a mistake having considered it an allergy), she told a known doctor about the problem, who prescribed Loratadine and diet without fats, strawberries, eggs, dairy and chocolates, there was improvement and symptoms disappeared, she gave for a fact that everything was normal. On 28Mar2021 at 14:00 after the second dose, 7 or 8 days the same symptoms appeared again, not severe as with the first dose, few days the reactions disappeared, but the severe rash continues with itching, considered serious symptom related after receive Pfizer BioNTech vaccine, without completing the reaction time of minutes to 1 hour, but after. The patient underwent lab tests and procedures which included Antigen Covid-19 with nasal swab with result negative on 29Mar2021. The therapeutic measures were taken. The outcome of events Rash and Itching was not recovered and patient was recovered from rest of all events on unspecified date in 2021.  No follow up attempts are possible. No further information expected