chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Diarrhoea, Heavy menstrual bleeding, Menstrual disorder, Muscle spasms
Clinical narrative: Pfizer Vaccine received on 4/30/21.  5/4/21 at 2:40 am severe pain in lower abdomen, cramping - pain reduced but still present for over 12 hours.  Diarrhea for the next couple days. 5/11/21 approximately 3 am pain in lower abdomen, but subsided after a few hours.  Diarrhea for a few days.  5/21/21 2nd shot.  That same night some menstrual bleeding and spotted next 4 days.  I have not had a period since I went off the pill on 11/27/20.  My FSH test shows I'm in menopause.  6/6/21 - menstrual bleeding again. 6/21 & 6/22 spotting again. 7/2/21 sever cramping in the middle of the night again.  7/5/21 menstrual bleeding.  Ended on 7/9/21.  I have never in my life had cramping like this and haven't had a period this "heavy" in about 7 or 8 years.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac imaging procedure abnormal, Dyspnoea, Electrocardiogram, Electrocardiogram ambulatory abnormal, Myocarditis
Clinical narrative: Day 5 palpitations and shortness of breath, lessened over 3-4 days. Diagnostic testing only. No treatment.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Day 5 palpitations and shortness of breath, lessened over 3-4 days. Diagnostic testing only. No treatment.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Seizure, Skin laceration
Clinical narrative: Pt appeared to have seizure while sitting down & fell face forward on floor. Laceration on forehead. Ambulance was called & arrived within 10 min. Pt transported to hospital Only health hx is Penicillin Allergy
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Mobility decreased, Pain, Swelling
Clinical narrative: Bruised, sore. Can't lay on that side, swollen.  - Took Tylenol
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Right cervical lymphadonopathy about 2-3 weeks after 2nd dose of Pfizer.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: One hour after injection with the second covid vaccine, Patient developed a minor headache that was treatable with Alleve.  She developed a worse headache on Sunday and was tired, but it was also treatable with medication.  However, on Tuesday, she developed a headache that was intractable and did not improve with medication.  After talking with her primary physician, we went back to hospital for treatment.  She was hospitalized and treated again with dihydroergotamine to stop the headache.  She developed severe constipation from the medication and dizziness. She was released after 4 days when the headache pain was diminished and she has not had a major headache since.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Redness; She her arm got stiff later in the afternoon; Right side was blood red like a rash; itched/itched in her midriff; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in left arm on 09Feb2021 15:50 as dose 1, single for COVID-19 immunization. Medical history included allergies and heart problems. Concomitant medications included allergy shot every other Monday and heart medication every day by mouth. Prior Vaccinations within 4 weeks was none and No AE(s) following prior vaccinations. Patient did not received additional vaccines on same date of the Pfizer Suspect. There was no history of previous immunization with the Pfizer vaccine considered as suspect. Patient's Medical History and Family Medical History Relevant to AE(s) was none. The patient experienced itched/itched in her midriff on 09Feb2021, right side was blood red like a rash on 10Feb2021, redness and her arm got stiff later in the afternoon on an unspecified date. It was reported that, she stated that she would have a reaction when they would increase her allergy shot sometimes. No further details was provided. Patient enquired if she could have the second shot. She had an allergy shot on Monday with her allergy doctor. It was reported that she had no effects yesterday when she got it. Her arm got stiff later in the afternoon. She went to bed and itched in her midriff. This morning when she got out of the shower her right side was blood red like a rash that extended from her elbow to her waist. She said that she did not check the color of her arm and midriff last night it just itched. She was at her daughter's house and was fully clothed and was unable to provide the outcome of the redness and rash. She said that her rash felt better now. Adverse events did not required a visit to emergency room or physician office. The clinical outcome of the redness and her arm got stiff later in the afternoon was unknown and itched in her midriff and right side was blood red like a rash was recovering.  Follow-up attempts completed. No further information expected. Information on the Batch/Lot number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Musculoskeletal stiffness, Pruritus, Rash erythematous
Clinical narrative: Redness; She her arm got stiff later in the afternoon; Right side was blood red like a rash; itched/itched in her midriff; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in left arm on 09Feb2021 15:50 as dose 1, single for COVID-19 immunization. Medical history included allergies and heart problems. Concomitant medications included allergy shot every other Monday and heart medication every day by mouth. Prior Vaccinations within 4 weeks was none and No AE(s) following prior vaccinations. Patient did not received additional vaccines on same date of the Pfizer Suspect. There was no history of previous immunization with the Pfizer vaccine considered as suspect. Patient's Medical History and Family Medical History Relevant to AE(s) was none. The patient experienced itched/itched in her midriff on 09Feb2021, right side was blood red like a rash on 10Feb2021, redness and her arm got stiff later in the afternoon on an unspecified date. It was reported that, she stated that she would have a reaction when they would increase her allergy shot sometimes. No further details was provided. Patient enquired if she could have the second shot. She had an allergy shot on Monday with her allergy doctor. It was reported that she had no effects yesterday when she got it. Her arm got stiff later in the afternoon. She went to bed and itched in her midriff. This morning when she got out of the shower her right side was blood red like a rash that extended from her elbow to her waist. She said that she did not check the color of her arm and midriff last night it just itched. She was at her daughter's house and was fully clothed and was unable to provide the outcome of the redness and rash. She said that her rash felt better now. Adverse events did not required a visit to emergency room or physician office. The clinical outcome of the redness and her arm got stiff later in the afternoon was unknown and itched in her midriff and right side was blood red like a rash was recovering.  Follow-up attempts completed. No further information expected. Information on the Batch/Lot number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Lethargy; Body aches; Fever; Dry cough; Congestion in chest; loss of smell last night; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old adult male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, DM type 2. Concomitant medications included, fish oil (MANUFACTURER UNKNOWN), metformin hydrochloride (METFORMIN XR), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN); used for unknown indication, from an unspecified date. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. On 24Mar2021 at 18:00, the patient experienced lethargy, body aches, fever, dry cough, congestion in chest and loss of smell last night. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lethargy, body aches, fever, dry cough, congestion in chest and loss of smell was not recovered at the time this report.   No follow-up attempts possible. No further information expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Chest discomfort, Cough, Lethargy, Pain
Clinical narrative: Lethargy; Body aches; Fever; Dry cough; Congestion in chest; loss of smell last night; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old adult male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, DM type 2. Concomitant medications included, fish oil (MANUFACTURER UNKNOWN), metformin hydrochloride (METFORMIN XR), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN); used for unknown indication, from an unspecified date. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. On 24Mar2021 at 18:00, the patient experienced lethargy, body aches, fever, dry cough, congestion in chest and loss of smell last night. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lethargy, body aches, fever, dry cough, congestion in chest and loss of smell was not recovered at the time this report.   No follow-up attempts possible. No further information expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Lethargy; Body aches; Fever; Dry cough; Congestion in chest; loss of smell last night; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old adult male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, DM type 2. Concomitant medications included, fish oil (MANUFACTURER UNKNOWN), metformin hydrochloride (METFORMIN XR), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN); used for unknown indication, from an unspecified date. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. On 24Mar2021 at 18:00, the patient experienced lethargy, body aches, fever, dry cough, congestion in chest and loss of smell last night. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lethargy, body aches, fever, dry cough, congestion in chest and loss of smell was not recovered at the time this report.   No follow-up attempts possible. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Dizziness, Headache, Nausea, Ocular hyperaemia
Clinical narrative: mild arm discomfort; general odd feeling for two days.; Slight headache; nausea; eyes and other parts of body got pink and started itching; other parts of body got pink and started itching; vision blurred and darkened, felt like store was closing in.; When stood up to move away from people for further observation, felt dizziness; Eyes and other parts of body got pink and started itching; eyes and other parts of body got pink and started itching; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to latex, eucalyptus, ginger, cardamom, nutmeg, cilantro, coriander and cloves. The patient received unspecified concomitant medications. The patient previously erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 13:10, the patient experienced vision blurred and darkened, felt like store was closing in. When the patient stood up to move away from people for further observation, the patient felt dizziness and nausea. Her eyes and other parts of her body got pink and started itching. The patient stayed on site for 45 minutes. The vision returned to normal and dizziness passed. Nausea, pink and itchy skin (in a few places) remained. Over the next two days on 26Mar2021, the patient experienced itchiness and pinkness moved around her body. The patient also experienced slight headache, mild arm discomfort and general odd feeling for two days. The patient did not receive any treatment for the events vision blurred, dizziness on standing up, pinkeye, itchy eyes, arm discomfort, feeling bad, nausea, itchy skin, headache and skin discolouration. The clinical outcomes of the events vision blurred, dizziness on standing up, pinkeye, itchy eyes, arm discomfort, feeling bad, nausea, itchy skin, headache and skin discolouration were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: mild arm discomfort; general odd feeling for two days.; Slight headache; nausea; eyes and other parts of body got pink and started itching; other parts of body got pink and started itching; vision blurred and darkened, felt like store was closing in.; When stood up to move away from people for further observation, felt dizziness; Eyes and other parts of body got pink and started itching; eyes and other parts of body got pink and started itching; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to latex, eucalyptus, ginger, cardamom, nutmeg, cilantro, coriander and cloves. The patient received unspecified concomitant medications. The patient previously erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 13:10, the patient experienced vision blurred and darkened, felt like store was closing in. When the patient stood up to move away from people for further observation, the patient felt dizziness and nausea. Her eyes and other parts of her body got pink and started itching. The patient stayed on site for 45 minutes. The vision returned to normal and dizziness passed. Nausea, pink and itchy skin (in a few places) remained. Over the next two days on 26Mar2021, the patient experienced itchiness and pinkness moved around her body. The patient also experienced slight headache, mild arm discomfort and general odd feeling for two days. The patient did not receive any treatment for the events vision blurred, dizziness on standing up, pinkeye, itchy eyes, arm discomfort, feeling bad, nausea, itchy skin, headache and skin discolouration. The clinical outcomes of the events vision blurred, dizziness on standing up, pinkeye, itchy eyes, arm discomfort, feeling bad, nausea, itchy skin, headache and skin discolouration were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Conjunctivitis, Dizziness postural, Eye pruritus, Feeling abnormal, Headache
Clinical narrative: mild arm discomfort; general odd feeling for two days.; Slight headache; nausea; eyes and other parts of body got pink and started itching; other parts of body got pink and started itching; vision blurred and darkened, felt like store was closing in.; When stood up to move away from people for further observation, felt dizziness; Eyes and other parts of body got pink and started itching; eyes and other parts of body got pink and started itching; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to latex, eucalyptus, ginger, cardamom, nutmeg, cilantro, coriander and cloves. The patient received unspecified concomitant medications. The patient previously erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 13:10, the patient experienced vision blurred and darkened, felt like store was closing in. When the patient stood up to move away from people for further observation, the patient felt dizziness and nausea. Her eyes and other parts of her body got pink and started itching. The patient stayed on site for 45 minutes. The vision returned to normal and dizziness passed. Nausea, pink and itchy skin (in a few places) remained. Over the next two days on 26Mar2021, the patient experienced itchiness and pinkness moved around her body. The patient also experienced slight headache, mild arm discomfort and general odd feeling for two days. The patient did not receive any treatment for the events vision blurred, dizziness on standing up, pinkeye, itchy eyes, arm discomfort, feeling bad, nausea, itchy skin, headache and skin discolouration. The clinical outcomes of the events vision blurred, dizziness on standing up, pinkeye, itchy eyes, arm discomfort, feeling bad, nausea, itchy skin, headache and skin discolouration were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Nausea, Pruritus, Skin discolouration, Vision blurred
Clinical narrative: mild arm discomfort; general odd feeling for two days.; Slight headache; nausea; eyes and other parts of body got pink and started itching; other parts of body got pink and started itching; vision blurred and darkened, felt like store was closing in.; When stood up to move away from people for further observation, felt dizziness; Eyes and other parts of body got pink and started itching; eyes and other parts of body got pink and started itching; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to latex, eucalyptus, ginger, cardamom, nutmeg, cilantro, coriander and cloves. The patient received unspecified concomitant medications. The patient previously erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 13:10, the patient experienced vision blurred and darkened, felt like store was closing in. When the patient stood up to move away from people for further observation, the patient felt dizziness and nausea. Her eyes and other parts of her body got pink and started itching. The patient stayed on site for 45 minutes. The vision returned to normal and dizziness passed. Nausea, pink and itchy skin (in a few places) remained. Over the next two days on 26Mar2021, the patient experienced itchiness and pinkness moved around her body. The patient also experienced slight headache, mild arm discomfort and general odd feeling for two days. The patient did not receive any treatment for the events vision blurred, dizziness on standing up, pinkeye, itchy eyes, arm discomfort, feeling bad, nausea, itchy skin, headache and skin discolouration. The clinical outcomes of the events vision blurred, dizziness on standing up, pinkeye, itchy eyes, arm discomfort, feeling bad, nausea, itchy skin, headache and skin discolouration were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Agitation, Chest discomfort, Headache, Hyperhidrosis
Clinical narrative: Pain at injection site; Extremely tired; Headache; Very agitated; Nervousness; Sweating; Very nausea; Empty stomach feeling; Carelessness; Unable to sleep during the night; Weak; Lymph may have become swollen; Extreme discontentment - like maybe I was experiencing a detox program; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. 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, patient had not been tested for COVID-19. On 25Mar2021 at 02:00 patient experienced pain at injection site, extremely tired, headache, very agitated, nervousness, sweating, very nausea, empty stomach feeling, carelessness, unable to sleep during the night, weak, lymph may have become swollen and extreme discontentment like maybe the patient was experiencing a detox program. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site pain, fatigue, headache, agitation, nervousness, hyperhidrosis, nausea, abdominal discomfort, impaired selfcare, insomnia, lymphadenopathy and poverty of thought content was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Personality change, Restlessness
Clinical narrative: Pain at injection site; Extremely tired; Headache; Very agitated; Nervousness; Sweating; Very nausea; Empty stomach feeling; Carelessness; Unable to sleep during the night; Weak; Lymph may have become swollen; Extreme discontentment - like maybe I was experiencing a detox program; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. 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, patient had not been tested for COVID-19. On 25Mar2021 at 02:00 patient experienced pain at injection site, extremely tired, headache, very agitated, nervousness, sweating, very nausea, empty stomach feeling, carelessness, unable to sleep during the night, weak, lymph may have become swollen and extreme discontentment like maybe the patient was experiencing a detox program. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site pain, fatigue, headache, agitation, nervousness, hyperhidrosis, nausea, abdominal discomfort, impaired selfcare, insomnia, lymphadenopathy and poverty of thought content was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: Pain at injection site; Extremely tired; Headache; Very agitated; Nervousness; Sweating; Very nausea; Empty stomach feeling; Carelessness; Unable to sleep during the night; Weak; Lymph may have become swollen; Extreme discontentment - like maybe I was experiencing a detox program; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. 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, patient had not been tested for COVID-19. On 25Mar2021 at 02:00 patient experienced pain at injection site, extremely tired, headache, very agitated, nervousness, sweating, very nausea, empty stomach feeling, carelessness, unable to sleep during the night, weak, lymph may have become swollen and extreme discontentment like maybe the patient was experiencing a detox program. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site pain, fatigue, headache, agitation, nervousness, hyperhidrosis, nausea, abdominal discomfort, impaired selfcare, insomnia, lymphadenopathy and poverty of thought content was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Agitation, Asthenia, Fatigue, Headache
Clinical narrative: Pain at injection site; Extremely tired; Headache; Very agitated; Nervousness; Sweating; Very nausea; Empty stomach feeling; Carelessness; Unable to sleep during the night; Weak; Lymph may have become swollen; Extreme discontentment - like maybe I was experiencing a detox program; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. 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, patient had not been tested for COVID-19. On 25Mar2021 at 02:00 patient experienced pain at injection site, extremely tired, headache, very agitated, nervousness, sweating, very nausea, empty stomach feeling, carelessness, unable to sleep during the night, weak, lymph may have become swollen and extreme discontentment like maybe the patient was experiencing a detox program. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site pain, fatigue, headache, agitation, nervousness, hyperhidrosis, nausea, abdominal discomfort, impaired selfcare, insomnia, lymphadenopathy and poverty of thought content was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Impaired self-care, Insomnia, Lymphadenopathy, Nausea
Clinical narrative: Pain at injection site; Extremely tired; Headache; Very agitated; Nervousness; Sweating; Very nausea; Empty stomach feeling; Carelessness; Unable to sleep during the night; Weak; Lymph may have become swollen; Extreme discontentment - like maybe I was experiencing a detox program; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. 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, patient had not been tested for COVID-19. On 25Mar2021 at 02:00 patient experienced pain at injection site, extremely tired, headache, very agitated, nervousness, sweating, very nausea, empty stomach feeling, carelessness, unable to sleep during the night, weak, lymph may have become swollen and extreme discontentment like maybe the patient was experiencing a detox program. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site pain, fatigue, headache, agitation, nervousness, hyperhidrosis, nausea, abdominal discomfort, impaired selfcare, insomnia, lymphadenopathy and poverty of thought content was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness, Poverty of thought content, Vaccination site pain
Clinical narrative: Pain at injection site; Extremely tired; Headache; Very agitated; Nervousness; Sweating; Very nausea; Empty stomach feeling; Carelessness; Unable to sleep during the night; Weak; Lymph may have become swollen; Extreme discontentment - like maybe I was experiencing a detox program; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. 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, patient had not been tested for COVID-19. On 25Mar2021 at 02:00 patient experienced pain at injection site, extremely tired, headache, very agitated, nervousness, sweating, very nausea, empty stomach feeling, carelessness, unable to sleep during the night, weak, lymph may have become swollen and extreme discontentment like maybe the patient was experiencing a detox program. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site pain, fatigue, headache, agitation, nervousness, hyperhidrosis, nausea, abdominal discomfort, impaired selfcare, insomnia, lymphadenopathy and poverty of thought content was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: soreness in arm; chills; fever 101.8; extreme fatigue; body aches; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the right arm on 25Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Concomitant medications included ascorbic acid (VITAMIN C) started on an unknown date for an unspecified indication. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced soreness in arm, chills, fever (101.8), extreme fatigue and body aches. The patient had tested for body temperature on 26Mar2021 and resulted 101.8 (unspecified units). Therapeutic measure was taken as result of events and included treatment with Tylenol. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness in arm, chills, fever (101.8), extreme fatigue and body aches were resolved on 27Mar2021.   No follow up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: soreness in arm; chills; fever 101.8; extreme fatigue; body aches; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the right arm on 25Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Concomitant medications included ascorbic acid (VITAMIN C) started on an unknown date for an unspecified indication. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced soreness in arm, chills, fever (101.8), extreme fatigue and body aches. The patient had tested for body temperature on 26Mar2021 and resulted 101.8 (unspecified units). Therapeutic measure was taken as result of events and included treatment with Tylenol. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness in arm, chills, fever (101.8), extreme fatigue and body aches were resolved on 27Mar2021.   No follow up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: soreness in arm; chills; fever 101.8; extreme fatigue; body aches; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the right arm on 25Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Concomitant medications included ascorbic acid (VITAMIN C) started on an unknown date for an unspecified indication. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced soreness in arm, chills, fever (101.8), extreme fatigue and body aches. The patient had tested for body temperature on 26Mar2021 and resulted 101.8 (unspecified units). Therapeutic measure was taken as result of events and included treatment with Tylenol. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness in arm, chills, fever (101.8), extreme fatigue and body aches were resolved on 27Mar2021.   No follow up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Severe pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 17Mar2021 at 02:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included lower back pain. The patient received other medications (unspecified) within two weeks of vaccination. The patient had no known allergy, only stomach upset with past drugs aspirin and ADVIL. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 19:00, the patient experienced severe pain at injection site does not go away so far (10 days after injection). The patient received TYLENOL 650mg as treatment for the event severe pain at injection site but it does not help her much. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of severe pain at injection site was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Severe pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 17Mar2021 at 02:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included lower back pain. The patient received other medications (unspecified) within two weeks of vaccination. The patient had no known allergy, only stomach upset with past drugs aspirin and ADVIL. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 19:00, the patient experienced severe pain at injection site does not go away so far (10 days after injection). The patient received TYLENOL 650mg as treatment for the event severe pain at injection site but it does not help her much. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of severe pain at injection site was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: headache; dizzy; felt feverish; achy; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 58-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 in left arm on 26Mar2021 (58-year-old at the time of vaccination) at 10:45 as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), cymbalta (MANUFACTURER UNKNOWN) and norethindrone (MANUFACTURER UNKNOWN) from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 10:45, the patient experienced headache, dizzy, felt feverish, achy and fatigue. 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. It was reported that the patient had not received treatment for the adverse events. The clinical outcomes of the events headache, dizzy, felt feverish, achy and fatigue were recovering. No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: headache; dizzy; felt feverish; achy; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 58-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 in left arm on 26Mar2021 (58-year-old at the time of vaccination) at 10:45 as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), cymbalta (MANUFACTURER UNKNOWN) and norethindrone (MANUFACTURER UNKNOWN) from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 10:45, the patient experienced headache, dizzy, felt feverish, achy and fatigue. 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. It was reported that the patient had not received treatment for the adverse events. The clinical outcomes of the events headache, dizzy, felt feverish, achy and fatigue were recovering. No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Rash, Skin lesion, Swelling
Clinical narrative: large fluid filled blisters developed and covered her entire body; small bumps on left leg/small bumps with a dark nucleus on right arm/small bumps on left arm/ clusters on both arms; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FP8730) at the age of 59-years, via an unspecified route of administration, administered in left arm on 09Apr2021 at 09:30 at single dose for COVID-19 immunisation, in pharmacy or drug store. Medical history included hypertension; allergies to adhesives. The patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient historically received first dose of BNT162B2 (lot number: EN6207) at the age of 59-years, via an unspecified route of administration in left arm on 12Mar2021 at 09:00 PM at single dose for COVID-19 immunisation. It was reported that two clusters of small bumps formed on left leg by 10Apr2021 at 01:00. On 18Apr2021, she started seeing two clusters of small bumps with a dark nucleus on the right arm. Another large cluster of small bumps developed on the left arm in a day. The clusters engulfed her left arm by 28Apr2021. By 30Apr2021, the clusters had spread and covered more area on both arms. By 04May2021, large fluid filled blisters developed and covered her entire body (legs, arms, hands, back, stomach, chest, and buttocks). By 28May2021, the clusters had reached her neck, face, cheeks, eyes, and ears. The events were reported as serious due to hospitalization for 2 days, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received initially given mixtures of antibiotics as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was not recovered/not resolved. Since the vaccination, the patient has not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.