chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Tongue biting, Tremor
Clinical narrative: Woke up at 1:30am with a bout of Rigors. Chills shook entire body uncontrollably for about half an hour or 45 minutes; Unexpected shaking and chills almost made mefall over a few times; Bit my tongue very hard due to shaking of jaw; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERG735) via an unspecified route of administration in the left arm on 05May2021 at 10:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no known health conditions or illness. 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 medications or supplements within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWD167) via an unspecified route of administration in the left arm on 14Apr2021 at 11:00 as a single dose for COVID-19 immunisation. On 06May2021 at 01:30, the patient woke up with a bout of rigors. Chills shook entire body uncontrollably for about half an hour or 45 minutes. His housemate brought him water and after drinking a lot of water and time, the shakes slowed down and eventually stopped. When attempted to go to the bathroom unexpected shaking and chills almost made him fall over a few times. He bit his tongue very hard due to shaking of jaw. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event  bout of rigors, chills shook entire body uncontrollably for about half an hour or 45 minutes, unexpected shaking and included drinking lot of water. Therapeutic measures were not taken as a result of the vent bit tongue very hard. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bout of rigors, chills shook entire body uncontrollably for about half an hour or 45 minutes, unexpected shaking and chills almost made him fall over a few times and bit his tongue very hard due to shaking of jaw was resolved on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea a few days following injection; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and migraines. The patient had unspecified 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 golimumab (SIMPONI), erenumab (AIMOVIG) and thyroid (as reported) (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 14Apr2021, the patient experienced diarrhea a few days following injection x 4 weeks. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with unspecified supplements antidiarrheal medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea a few days following injection was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Abnormally heavy menstrual bleeding after second shot; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 14Apr2021 at 17:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient previously received escitalopram oxalate (LEXAPRO) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration in the right arm on 17Mar2021 at 17:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 07May2021, after the second shot, the patient experienced abnormally heavy menstrual bleeding. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event abnormally heavy menstrual bleeding was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Nausea, Pyrexia
Clinical narrative: Fever; Nauseous; Terrible migraine; Fatigue; Chills; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 08May2021 at 08:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes simplex virus (HSV2), asthma. The patient was allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included Goli ACV (MANUFACTURER UNKNOWN), aciclovir (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and ibuporfen (ADVIL); all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in right arm on 11Apr2021 (at the age of 55-years-old) at 08:45 as a single dose for COVID-19 immunisation. On 08May2021 at 20:00, the patient experienced fever, nauseous, terrible migraine, fatigue and chills. 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 fever, nauseous, terrible migraine, fatigue and chills. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, nauseous, terrible migraine, fatigue and chills were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Defaecation urgency, Nipple pain, Vaccination site pain
Clinical narrative: Breast nipple soreness/tenderness; Mild local vaccine injection site tenderness; Severe abdominal cramping followed by urgent bowel evacuation 3 hours post vaccine injection (symptoms were similar to those experienced for colonoscopy bowel prep); Severe abdominal cramping followed by urgent bowel evacuation 3 hours post vaccine injection (symptoms were similar to those experienced for colonoscopy bowel prep); This is a spontaneous report from a contactable nurse, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 24Mar2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse and occasional mild 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. Concomitant medications included olmesartan medoxomil (MANUFACTURER UNKNOWN) and nature's bounty immune 24 hour; both taken for unknown indications from an unknown date and unknown if ongoing. On 24Mar2021 at 18:00, the patient experienced severe abdominal cramping followed by urgent bowel evacuation 3 hours post vaccine injection (symptoms were similar to those experienced for colonoscopy bowel preparation). On 24Apr2021, the patient also experienced breast nipple soreness/tenderness for about 3-4 days plus mild local vaccine injection site tenderness, similar to previous vaccine injections. 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 event breast nipple soreness/tenderness was resolved on an unknown date in Apr2021 while the events mild local vaccine injection site tenderness, severe abdominal cramping followed by urgent bowel evacuation 3 hours post vaccine injection (symptoms were similar to those experienced for colonoscopy bowel prep) was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Fatigue, Flatulence, Pain
Clinical narrative: Extreme gas, gas pains and bloating for 12 hours; Extreme gas, gas pains and bloating for 12 hours; Body aches and extreme tired for 48 hours; Body aches and extreme tired for 48 hours; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 07May2021 at 11:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. 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 fish oil (OMEGA 3), pre/probiotic (MANUFACTURER UNKNOWN) and unspecified multivitamin (MANUFACTURER UNKNOWN); all for 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: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 15:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation.  The patient previously received oseltamivir phosphate (TAMIFLU) and experienced drug allergy. On 07May2021 at 16:00, the patient experienced extreme gas, gas pains and bloating for 12 hours and body aches and extreme tired for 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL) and bismuth subsalicylate (PEPTO BISMOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme gas, gas pains and bloating for 12 hours was resolved on 08May2021 at 04:00 while that off body aches and extreme tired for 48 hours was resolved on 09May2021 at 16:00.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Vaccination site erythema, Vaccination site rash
Clinical narrative: Extreme pain lymph node; Golf ball size in armpit radiating pain down inside of elbow lymph node in breast; Dollar bill size red rash swollen around the injection site; Dollar bill size red rash swollen around the injection site; Swollen around injection site; Radiating pain down inside of elbow lymph node in breast dollar bill size; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 07May2021 at 14:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included focal seizures, anxiety and biliary colic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included lacosamide (VIMPAT), sertraline hydrochloride (ZOLOFT), ursodeoxycholic acid (URSODIOL), pantoprazole sodium sesquihydrate (PROTONIX), estradiol (MANUFACTURER UNKNOWN) and fluticasone propionate (SINO); all for unknown indication from unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPIRIN), erythromycin (MANUFACTURER UNKNOWN), hydroxychloroquine phosphate (PLAQUENIL) and meclofenamate sodium (MECLOMEN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Apr2021 at 14:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08May2021 at 06:45, the patient experienced extreme pain in lymph node that was golf ball size in armpit, radiating pain down inside of elbow, lymph node in breast, dollar bill size and a red rash swollen around injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme pain in lymph node that was golf ball size in armpit, radiating pain down inside of elbow, lymph node in breast, dollar bill size red rash swollen around injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Extreme pain lymph node; Golf ball size in armpit radiating pain down inside of elbow lymph node in breast; Dollar bill size red rash swollen around the injection site; Dollar bill size red rash swollen around the injection site; Swollen around injection site; Radiating pain down inside of elbow lymph node in breast dollar bill size; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 07May2021 at 14:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included focal seizures, anxiety and biliary colic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included lacosamide (VIMPAT), sertraline hydrochloride (ZOLOFT), ursodeoxycholic acid (URSODIOL), pantoprazole sodium sesquihydrate (PROTONIX), estradiol (MANUFACTURER UNKNOWN) and fluticasone propionate (SINO); all for unknown indication from unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPIRIN), erythromycin (MANUFACTURER UNKNOWN), hydroxychloroquine phosphate (PLAQUENIL) and meclofenamate sodium (MECLOMEN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Apr2021 at 14:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08May2021 at 06:45, the patient experienced extreme pain in lymph node that was golf ball size in armpit, radiating pain down inside of elbow, lymph node in breast, dollar bill size and a red rash swollen around injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme pain in lymph node that was golf ball size in armpit, radiating pain down inside of elbow, lymph node in breast, dollar bill size red rash swollen around injection site was resolving 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: Tinnitus
Clinical narrative: Tinnitus started since first dose on 9 April 2021; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Apr2021 (at the age of 36-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had no known allergies. Concomitant medications included ertugliflozin pidolate (STEGLATRO), metformin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), enalapril (MANUFACTURER UNKNOWN) and glibenclamide (GLYBURIDE); all for unknown indications from unknown dates and 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 09Apr2021, the patient experienced tinnitus which started since the first dose. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus which started since the first dose was not resolved at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Nausea
Clinical narrative: Shivering; fever; nausea; headache; tiredness; chest pain; tingling in fingers; swelling in hands and feet; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 06May2021 at 18:00 (at the age of 28-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 four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 15Apr2021 at 18:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 07:00, the patient experienced shivering, fever, nausea, headache, tiredness, chest pain, tingling in fingers, swelling in hands and feet. 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 shivering, fever, nausea, headache, tiredness, chest pain, tingling in fingers, swelling in hands and feet was recovered on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Shivering; fever; nausea; headache; tiredness; chest pain; tingling in fingers; swelling in hands and feet; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 06May2021 at 18:00 (at the age of 28-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 four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 15Apr2021 at 18:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 07:00, the patient experienced shivering, fever, nausea, headache, tiredness, chest pain, tingling in fingers, swelling in hands and feet. 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 shivering, fever, nausea, headache, tiredness, chest pain, tingling in fingers, swelling in hands and feet was recovered on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain
Clinical narrative: Constant, sore armpit pain; Pain temporarily radiates; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 14:00, the patient experienced constant, sore armpit pain which started on the second day, after her second dose. There was no noticeable swelling. Pain temporarily radiated randomly, 4 weeks later bit did not linger. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events, sore armpit pain and pain temporarily radiated was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Menstruation irregular
Clinical narrative: Irregular menstrual cycles; Irregular menstrual cycles, as long as 50 days apart; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 19Feb2021 at 08:15 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa drugs and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 25Jan2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 21Feb2021 at 00:00, the patient experienced irregular menstrual cycles, as long as 50 days apart. This began the first cycle after the vaccine and maintained since. 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 event irregular menstrual cycles, as long as 50 days apart were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Intermenstrual bleeding, Muscle spasms, Premenstrual syndrome
Clinical narrative: Increased PMS symptoms, for one full week before period started; Spotting; Cramping; Dizziness; Fatigue; 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: ER8727) via an unspecified route of administration in the right arm on 24Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient medical history reported was not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included IBUPROFEN and SONATA, both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on an unknown date in Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021, the patient experienced increased premenstrual syndrome (PMS) symptoms, for one full week before period started, including spotting, cramping, dizziness, fatigue. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of the event. The clinical outcome of the event increased premenstrual syndrome (PMS) symptoms, for one full week before period started, including spotting, cramping, dizziness, and fatigue was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Muscle aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 07May2021 at 09:30 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa drugs since an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any 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 the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 05Apr2021 at 12:15 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. On 07May2021 at 21:00, the patient experienced fever, chills and muscle aches. 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 fever, chills, muscle aches, and fatigue was resolved on an unknown date in May2021.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Head discomfort, Lymphadenopathy
Clinical narrative: Chills and fever up to 101.5 for two days; Chills and fever up to 101.5 for two days; Swollen armpit/lymph nodes in left arm for several days; Digestive upset for 1 day; Head pressure ache when bending over for a few days.; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 16Apr2021 at 15:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and 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 calcium (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN); all 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: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 15:15 as a single dose for COVID-19 immunisation. On 17Apr2021 at 02:00, the patient experienced chills and fever up to 101.5 for two days, swollen armpit/lymph nodes in left arm for several days, digestive upset for 1 day and head pressure ache when bending over for a few days. On the 17Apr2021, the patient underwent body temperature test and the result was found to be fever up to 101.5 (unspecified units). 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 digestive upset for 1 day was resolved on an 18Apr2021; and chills and fever up to 101.5 for two days was resolved on an 19Apr2021 whereas swollen armpit/lymph nodes in left arm for several days and head pressure ache when bending over for a few days were resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills and fever up to 101.5 for two days; Chills and fever up to 101.5 for two days; Swollen armpit/lymph nodes in left arm for several days; Digestive upset for 1 day; Head pressure ache when bending over for a few days.; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 16Apr2021 at 15:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and 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 calcium (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN); all 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: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 15:15 as a single dose for COVID-19 immunisation. On 17Apr2021 at 02:00, the patient experienced chills and fever up to 101.5 for two days, swollen armpit/lymph nodes in left arm for several days, digestive upset for 1 day and head pressure ache when bending over for a few days. On the 17Apr2021, the patient underwent body temperature test and the result was found to be fever up to 101.5 (unspecified units). 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 digestive upset for 1 day was resolved on an 18Apr2021; and chills and fever up to 101.5 for two days was resolved on an 19Apr2021 whereas swollen armpit/lymph nodes in left arm for several days and head pressure ache when bending over for a few days were resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; shaking chills; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, the patient experienced fever, shaking chills, headache, and fatigue. 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 fever, shaking chills, headache, and fatigue was resolved on an unknown date.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Vital signs measurement
Clinical narrative: Bad taste in her throat; This is a spontaneous report from a contactable nurse. A non-pregnant adult female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 07May2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown if the patient had known allergies. It was unknown if the patient received concomitant medications within two weeks of vaccination. It was unknown if the patient received 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: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 07May2021 at 12:00, the patient came to vaccination drive through clinic for her second Pfizer COVID-19 vaccination. Lot number, from the reporters recollection might have been EW0710, but the reporter could not recall with certainty. Within 10 minutes of receiving the vaccine, the patient reported of a bad taste in her throat. There was no tongue swelling evident and no problems breathing. The onsite paramedics were summoned and arrived within a few minutes. They took vital signs, the results of which were unknown. The patient was informed by paramedic that this adverse event was known to occur but was not very common. The patient required no further intervention. At the time the patient left the site, at least 30 minutes had elapsed and she had completely recovered from the bad taste in her throat. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event bad taste in throat was resolved on 07May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; 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: UNKNOWN) via an unspecified route of administration in the left arm on 08May2021 at 12:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. The patient had known allergies to shellfish, sulphur and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included metformin hydrochloride/ sitagliptin phosphate monohydrate (JANUMET); olmesartan (MANUFACTURER UNKNOWN); hydrochlorothiazide (MANUFACTURER UNKNOWN) and loratadine (CLARITIN); all for unknown indications, from unknown dates and unknown if ongoing. On 08May2021 at 13:00, the patient experienced itching. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event itching was recovering 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Arm injection site pain; Chills; Fever (100F); Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 06May2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included olmesartan medoxomil (MANUFACTURER UNKNOWN) taken for an unknown indication from an unknown date and unknown if ongoing. On 06May2021, the patient experienced arm injection site pain, chills, fever (100F) 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. Therapeutic measures were not taken as a result of the events. On 06May2021, the patient underwent body temperature test and the result was 100 Fahrenheit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm injection site pain, chills, fever (100F) and fatigue was resolved on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Musculoskeletal pain, Pain in extremity
Clinical narrative: Hives on the chest; Swollen and sore left armpit; Swollen and sore left armpit; Right butt cheek was sore; Chills; Headache/the next day headache/ a severe and sudden headache; Soreness in arm; Swelling and pain in the inner labia; swelling and pain in the inner labia; 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: EW0167) via an unspecified route of administration in the left arm on 05May2021 at 12:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19, and mild seasonal allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient received hpv vaccine (MANUFACTURER UNKNOWN) on 21Apr2021 within four weeks prior to the vaccination. On 05May2021 at 22:00 the patient started feeling a headache, soreness in arm and swelling and pain in the inner labia in the evening, the next day(06May2021), right butt cheek was sore and swollen, headache and chills. On 07May2021, she developed a severe and sudden headache, hives on the chest, soreness and pain in the inner labia and swollen and sore left armpit. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, soreness in arm and swelling and pain in the inner labia, right butt cheek was sore and swollen, chills, severe and sudden headache, hives on the chest and swollen and sore left armpit were not resolved 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: Swelling, Urticaria, Vulvovaginal pain, Vulvovaginal swelling
Clinical narrative: Hives on the chest; Swollen and sore left armpit; Swollen and sore left armpit; Right butt cheek was sore; Chills; Headache/the next day headache/ a severe and sudden headache; Soreness in arm; Swelling and pain in the inner labia; swelling and pain in the inner labia; 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: EW0167) via an unspecified route of administration in the left arm on 05May2021 at 12:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19, and mild seasonal allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient received hpv vaccine (MANUFACTURER UNKNOWN) on 21Apr2021 within four weeks prior to the vaccination. On 05May2021 at 22:00 the patient started feeling a headache, soreness in arm and swelling and pain in the inner labia in the evening, the next day(06May2021), right butt cheek was sore and swollen, headache and chills. On 07May2021, she developed a severe and sudden headache, hives on the chest, soreness and pain in the inner labia and swollen and sore left armpit. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, soreness in arm and swelling and pain in the inner labia, right butt cheek was sore and swollen, chills, severe and sudden headache, hives on the chest and swollen and sore left armpit were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Severe left shoulder joint pain; Severe left shoulder joint pain and arm pain in that area; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 24Apr2021 at 13:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included degenerative disc disease and herniated discs. The patient was allergic to penicillin and bee stings. 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 celecoxib (CELEBREX), atorvastatin calcium (LIPITOR), hydrocodone bitartrate, paracetamol (NORCO), morphine sulfate (MORPHINE SULF) and cyclobenzaprine hydrochloride (FLEXERIL); all taken for an unspecified indication from an unknown date and unknown if ongoing. On 25Apr2021 at 00:00, the patient experienced severe left shoulder joint pain and arm pain in that area. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any 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 severe left shoulder joint pain and arm pain in that area was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.