chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: My tinnitus has gotten much worse. It started getting worse about two weeks after the first vaccine and now it is pretty much constant and muchlouder.; My tinnitus has gotten much worse. It started getting worse about two weeks after the first vaccine and now it is pretty much constant and much louder.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2614) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 36-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included mild tinnitus from time to time, obsessive-compulsive disorder, anxiety, depression and panic attacks. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included sertraline (MANUFACTURER UNKNOWN); for unspecified indication from an unknown date and unknown if ongoing. On an unknown date in 2021, the patient experienced tinnitus had gotten much worse. It started getting worse about two weeks after the first vaccine and then it was pretty much constant and much louder. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events reported. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event tinnitus has gotten much worse. It started getting worse about two weeks after the first vaccine and now it is pretty much constant and much louder was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Fatigue, Feeling abnormal, Nausea, Tinnitus
Clinical narrative: Vertigo; Nausea; Ear fullness; Slight tinnitus; Fatigue; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP00151) via an unspecified route of administration in the left arm on 07Apr2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other concomitant medications. The patient previously received erythromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 07:45, the patient experienced sudden onset and lasting vertigo, nausea, ear fullness, slight tinnitus, brain fog and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with physical therapy from an unknown start date. The clinical outcome of the events lasting vertigo, nausea, ear fullness, slight tinnitus, brain fog and fatigue was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; Nausea; Ear fullness; Slight tinnitus; Fatigue; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP00151) via an unspecified route of administration in the left arm on 07Apr2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other concomitant medications. The patient previously received erythromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 07:45, the patient experienced sudden onset and lasting vertigo, nausea, ear fullness, slight tinnitus, brain fog and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with physical therapy from an unknown start date. The clinical outcome of the events lasting vertigo, nausea, ear fullness, slight tinnitus, brain fog and fatigue was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint swelling, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Severe headache; Slight fever; Left arm ached; About 25 hours after the 2nd vaccine, my ankles swelled up noticeably by Monday night.; About 25 hours after the 2nd vaccine, tops of the feet swelled up noticeably by Monday night.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW-169) via an unspecified route of administration in the left arm on 18Apr2021 at 15:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, low thyroid and ADHD (attention deficit hyperactivity disorder) and known allergy to latex and lavender. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 13:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 17:00, about 25 hours after the second vaccine, the patient's ankles and tops of the feet swelled up noticeably. The left ankle got worst. The swelling reduced overnight, but both ankles were partially swollen throughout 20Apr2021. The patient also had left arm ache. On 20Apr2021 at evening, the patient experienced a severe headache and a slight fever too. On 20Apr2021 at night, the patient's ankles got fully swollen and again, the swelling lessened overnight. On 21Apr2021 at morning, though the left ankle was puffy and on the same day at night, the left ankle got a little more swollen, but there was just barely perceptible swelling in right ankle at that time. Some minor swelling remained in the left ankle through 23Apr2021, but it was totally gone by 24Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ankles and tops of the feet swelled up was recovered with sequelae on 24Apr2021 and severe headache, slight fever and left arm ache were recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Breast pain, Decreased appetite, Heavy menstrual bleeding, Pain
Clinical narrative: Sore body; Heavy menstrual cycle; sore heavy breasts; loss of appetite during entire week; Stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine;Lot Number: 5729) via an unspecified route of administration in the left arm on 08Apr2021 at 14:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not  diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot Number: 2613) via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. On  19Apr2021 at 00:00, the patient experienced sore body, heavy menstrual cycle, sore heavy breasts, loss of appetite during entire week and  stomach pain. The events did not result in doctor or other healthcare professional office/clinic visit. No Therapeutic measures were not taken as a result of the events . Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events sore body, heavy menstrual cycle, sore heavy breasts, loss of appetite during entire week and  stomach pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Nausea; Chills; Fatigue; Body ache; Headache; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 24Apr2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 14:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 23:45, the patient experienced nausea, chills, fatigue, body ache and headache. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, chills, fatigue, body ache and headache was recovered on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Lymph node under right jaw swelled and is tender and painful; Lymph node under right jaw swelled and is tender and painful; Very dizzying; Nauseating; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 19Apr2021 at 14:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (UNITHROID), cyanocobalamin (VITAMIN B12) and colecalciferol (VITAMIN D3); taken for unknown indications from an unknown date and unknown if ongoing. On an unknown date in Apr2021, the patient experienced, the first 24 hours after the vaccination, were very dizzying and nauseating. Then she was fine. On 25Apr2021, a full week later, the lymph node under her right jaw swelled and was tender and painful. She had not seen any reports of an adverse reaction beginning a full week later, and she wanted to report it just in case. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very dizzying and nauseating was resolved on an unknown date in Apr2021. The clinical outcome of the events lymph node under right jaw swelled and was tender and painful was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle tightness, Myalgia
Clinical narrative: "I" received "my" first dose. On the 2nd day "I" started to feel fatigue; then "my" back, upper hips, calves of both legs and the left arm of the injection site all muscles was very painful.; "My" back, upper hips, calves of both legs and the left arm of the injection site all muscles was very painful anytime "I" used these areas "I" could feel the muscles tighten to the point "I" just had to lay still..; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO151) via an unspecified route of administration in the left arm on 20Apr2021 at 11:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, thyroid and depression. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. On 22Apr2021 at 06:15, on the second day after receiving the first dose, the patient started to feel fatigue, then her back, upper hips, calves of both legs and the left arm of the injection site all muscles were very painful anytime she used these areas she could feel the muscles tighten to the point that she just had to lay still. The events did not result in doctor or other health care professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of the reported events and included treatment with TYNELOL. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started to feel fatigue, back, upper hips, calves of both legs and the left arm of the injection site all muscles was very painful anytime she used these areas she could feel the muscles tighten to the point she just had to lay still were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Insomnia, Pain in extremity, Vomiting
Clinical narrative: Extreme Vomiting (5 times); extreme soreness of arm; stomach pain; fatigue; Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 14:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic pancreatitis, diabetes, insomnia and blood pressure high. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), ibuprofen (MANUFACTURER UNKNOWN) and naproxen (MANUFACTURER UNKNOWN); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 25Apr2021 at 20:00, the patient experienced extreme vomiting (5 times), extreme soreness of arm, stomach pain, fatigue and insomnia. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme vomiting (5 times), extreme soreness of arm, stomach pain, fatigue and insomnia was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Off label use, Product use issue
Clinical narrative: one of the patients wasn't feeling well; the patient took one Moderna shot and then 30 minutes later took a Pfizer shot; the patient took one Moderna shot and then 30 minutes later took a Pfizer shot; This is a spontaneous report from a contactable Other HCP. A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and, expiration date was not reported) as dose 1, 0.3 ml single and first dose of covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, lot number and expiration date was not reported) as 0.5, ml single via unspecified route of administration in the same day on 21Apr2021 (at the age of 38-year-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included gabapentin, pramipexole both taken for an unspecified indication. It was reported that the patient took one Moderna shot and then 30 minutes later took a Pfizer shot. It was reported that one of the patients wasn't feeling well on 22Apr2021(but not right afterwards it was the next day). Patient did not receive treatment for the events. Outcome of the event Malaise was recovered on unknown date in 2021 and other event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow up (23Apr2021/24Apr2021): This is a follow up#1 spontaneous report reported for a contactable reporter for a consumer. This consumer reported for a 38-years-old male patient which includes: new event, Concomitant medications, treatment information, Primary reporter's mailing address and patient DOB added, Vaccination facility information added.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Chest pain; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 23Apr2021 at 15:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The medical history included peripheral arterial disease (PAD) and antithrombin III deficiency. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included warfarin sodium (COUMADIN), atorvastatin calcium (LIPITOR), lisinopril (MANUFACTURER UNKNOWN) and 81 mg of unspecified medication; all for unknown indications from unknown dates and unknown if ongoing. On 25Apr2021 at 21:30, the patient experienced chest pain and shortness of breath. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain and shortness of breath were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Woke up on the second day after receiving the 2nd dose with a swollen and tender lymph node under my left armpit; It was sensitive to touch (slightly painful) and pressure and took about 48 hours to reduce in size; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 16Apr2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC); taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 24Mar2021 at 15:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 06:00, the patient woke up with a swollen and tender lymph node under his left armpit. It was sensitive to touch (slightly painful) and pressure and took about 48 hours to reduce in size. It was still slightly swollen but no longer sensitive to touch. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events woke up on the second day after receiving the second dose with a swollen and tender lymph node under left armpit was resolving at the time of this report. The clinical outcome of the event it was sensitive to touch (slightly painful) and pressure and took about 48 hours to reduce in size was resolved on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia
Clinical narrative: Chills; Fatigue; Couldn't sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03Apr2021 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, tremor and COVID-19, diagnosed prior to the vaccination. The patient had no known allergies. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced chills, fatigue and couldn't sleep. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fatigue and couldn't sleep was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Red spot; Warm; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 20Apr2021 at 10:15 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient received unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 30Mar2021 at 10:15 as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced red spot, warm and itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red spot, warm and itchy was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 23-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 23, via an unspecified route of administration, in the left arm, on Apr 23, 2021, at 18:30, single dose, for COVID-19 immunisation. Medical history included painful bladder syndrome, allergy to some molds and COVID-19. Prior to vaccination, patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. On unknown date in Apr 2021, patient had an extreme sore throat, shortness of breath and tight chest. She felt like she was breathing through a straw the two days after the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of  extreme sore throat, shortness of breath and tight chest: not recovered at the time of this report. No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms (Symptoms lasted for 36 hours); Chills; Slight fever (99 degrees); Headache; Pain at the injection site lasted over a week; Red rash at injection site lasted three weeks; Red rash at injection site lasted three weeks; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 26Mar2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, peptic ulcer, bipolar disorder, sleep apnea and endometriosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN) supplements for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 04Mar2021 at 12:00 as a single dose for COVID-19 immunisation. On 26Mar2021 at 20:00, the patient experienced flu like symptoms, chills, slight fever of 99 degrees (unspecified units), headache, pain at the injection site lasted over a week and red rash at injection site that lasted three weeks. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, chills, slight fever (99 degrees), headache was recovered on 28Mar2021 at 08:00, after the duration of 36 hours. The clinical outcome of the events pain at the injection site was recovered on an unknown date in Apr2021 after the duration of over a week; while that of the event red rash at injection site was recovered on an unknown date in Apr2021, after the duration of 3 weeks.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Flu like symptoms (Symptoms lasted for 36 hours); Chills; Slight fever (99 degrees); Headache; Pain at the injection site lasted over a week; Red rash at injection site lasted three weeks; Red rash at injection site lasted three weeks; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 26Mar2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, peptic ulcer, bipolar disorder, sleep apnea and endometriosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN) supplements for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 04Mar2021 at 12:00 as a single dose for COVID-19 immunisation. On 26Mar2021 at 20:00, the patient experienced flu like symptoms, chills, slight fever of 99 degrees (unspecified units), headache, pain at the injection site lasted over a week and red rash at injection site that lasted three weeks. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, chills, slight fever (99 degrees), headache was recovered on 28Mar2021 at 08:00, after the duration of 36 hours. The clinical outcome of the events pain at the injection site was recovered on an unknown date in Apr2021 after the duration of over a week; while that of the event red rash at injection site was recovered on an unknown date in Apr2021, after the duration of 3 weeks.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: Extreme asthenia; Dizziness; I had a fever over 102 degrees; Myalgias; Chills; Persistent cephalea; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0169) via an unspecified route of administration in the arm right on 22Apr2021 at 10:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, depression, chronic rhinitis and mycotic allergy (allergy to penicillum), all on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8730) via an unspecified route of administration in the arm left on 31Mar2021 at 10:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. On 22Apr2021 at 22:00, the patient experienced fever over 102 degrees, myalgias, chills, persistent cephalea, dizziness, and extreme asthenia. The cephalea remained still after four days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 22Apr2021 at 22:00, the patient underwent saliva test and the result was found to be negative and body temperature test and the result was found to be 102 degrees (unspecified units). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events extreme asthenia, dizziness, fever over 102 degrees, myalgias and chills were recovered with sequelae on an unknown date in Apr2021. The clinical outcome of the event persistent cephalea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Extreme asthenia; Dizziness; I had a fever over 102 degrees; Myalgias; Chills; Persistent cephalea; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0169) via an unspecified route of administration in the arm right on 22Apr2021 at 10:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, depression, chronic rhinitis and mycotic allergy (allergy to penicillum), all on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8730) via an unspecified route of administration in the arm left on 31Mar2021 at 10:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. On 22Apr2021 at 22:00, the patient experienced fever over 102 degrees, myalgias, chills, persistent cephalea, dizziness, and extreme asthenia. The cephalea remained still after four days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 22Apr2021 at 22:00, the patient underwent saliva test and the result was found to be negative and body temperature test and the result was found to be 102 degrees (unspecified units). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events extreme asthenia, dizziness, fever over 102 degrees, myalgias and chills were recovered with sequelae on an unknown date in Apr2021. The clinical outcome of the event persistent cephalea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Myalgia, X-ray
Clinical narrative: Muscle pain and joint paint started 3 days after first dose. Joint pain in ankles and top of foot are so bad; Muscle pain and joint paint started 3 days after first dose. Joint pain in ankles and top of foot are so bad; Muscle pain and joint paint started 3 days after first dose. Joint pain in ankles and top of foot are so bad I had to seek medical attention and can barley walk unless on medication.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW016) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced muscle pain and joint paint that started on 15Apr2021, 3 days after first dose. Joint pain in ankles and top of foot were so bad. The patient had to seek medical attention and could barely walk unless on medication. The patient was over a week out from first dose and the pain was worse each day. The patient had got X- ray done on the same day and no blood clots or issues were found on X-rays. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain and joint paint that started 3 days after first dose; joint pain in ankles and top of foot were so bad; the patient had to seek medical attention and could barely walk unless on medication was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chest pain, Fatigue, Flatulence
Clinical narrative: Abdominal/ stomach pain (mild to moderate) gas; Headache; Mild chest pain; Extreme weakness and fatigue; Upper body muscle weakness and pain, especially in left arm; Upper body muscle weakness and pain, especially in left arm; Upper body muscle weakness and pain, especially in left arm; extreme weakness and fatigue; upper abdominal/stomach pain (mild to moderate).; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD) and hernia hiatal. The patient had no known allergies. Concomitant medications included cyanocobalamin (oral B-12) (MANUFACTURER UNKNOWN), iron supplement (MANUFACTURER UNKNOWN) and multi vitamin (MANUFACTURER UNKNOWN) for unknown indication from unspecified date, unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021, on the day of vaccination, the patient experienced upper abdominal/stomach pain (mild to moderate). On 22Apr2021, 2 days after vaccination, the patient experienced headache, mild chest pain, gas, extreme weakness, fatigue, upper body muscle weakness and pain, especially in left arm. The symptoms were persistent for 3 days at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events abdominal/ stomach pain (mild to moderate), gas, headache, mild chest pain, extreme weakness, fatigue, upper body muscle weakness and pain, especially in left arm was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Abdominal/ stomach pain (mild to moderate) gas; Headache; Mild chest pain; Extreme weakness and fatigue; Upper body muscle weakness and pain, especially in left arm; Upper body muscle weakness and pain, especially in left arm; Upper body muscle weakness and pain, especially in left arm; extreme weakness and fatigue; upper abdominal/stomach pain (mild to moderate).; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD) and hernia hiatal. The patient had no known allergies. Concomitant medications included cyanocobalamin (oral B-12) (MANUFACTURER UNKNOWN), iron supplement (MANUFACTURER UNKNOWN) and multi vitamin (MANUFACTURER UNKNOWN) for unknown indication from unspecified date, unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021, on the day of vaccination, the patient experienced upper abdominal/stomach pain (mild to moderate). On 22Apr2021, 2 days after vaccination, the patient experienced headache, mild chest pain, gas, extreme weakness, fatigue, upper body muscle weakness and pain, especially in left arm. The symptoms were persistent for 3 days at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events abdominal/ stomach pain (mild to moderate), gas, headache, mild chest pain, extreme weakness, fatigue, upper body muscle weakness and pain, especially in left arm was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Severe body rash on both arms, wrist to shoulder. severe body rash on partial trunk, left leg, chest, breasts and face; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 06Apr2021 at 13:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 16Apr2021, the patient experienced severe body rash on both arms, wrist to shoulder, on partial trunk, left leg, chest, breasts and face. The events did not result in doctor or other health care professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe body rash on both arms, wrist to shoulder, on partial trunk, left leg, chest, breasts and face was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: The next morning and all day "I" had fever (101F) and body aches.; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 17Apr2021 at 12:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The medical history included hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included losartan (MANUFACTURER UNKNOWN), from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER0732) via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021, the next morning and all day the patient had fever of 101 F and body aches. On 18Apr2021, the patient underwent body temperature test and the result was 101 degrees Fahrenheit. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever and body aches were recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.